effective commissioning initiative - pages...the south west london effective commissioning...

Date Approved: TBD Review Date: Jan 2017 Version 1.8.X

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ATTACHMENT – TO MERTON CCG GOVERNING BODY PAPER

2014/15 South West London Effective Commissioning Initiative

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Version Control:

Version Description of Change(s) Reason for Change Author Date

1.0 NHSE Policies removed from 2013-14 Policy

Updated as per NHSE commissioning arrangements

SL CSU February 2014

1.1 Document formatted Policies numbered and

text formatted to create a

user-friendly, readable

document.


1.2 • Amended to 2014-15 date • Version control added • Revised draft policies added; MLD, Varicose Veins, Circumcision and Open MRI • AS edit of clarifying ambiguous policies • ECI form deleted to be replaced with current IFR form (in progress) • Contact details updated • Governance section revised • Contents page updated and appendices aligned

Updating to a 2014/15

document to take into

account contact changes,

clarifying unclear policy

wording and including 4

revised policies as agreed

by CCG ECI Working

Group


1.3 Changes reflecting discussion at ECI Group Meeting held on 05.03.14: • Revised policies: MLD, Varicose Veins, Circumcision, Open MRI, Dupuytren’s Contracture, Autologous Chondrocyte, Carpal Tunnel • Clarification of unclear policies • Removal of outdated prior approval table in Appendix A • Croydon CCG prior approval process updated • Insertion of table of policies now commissioned by NHS England • Insertion of Wandsworth CCG IVF criteria • Revised IFR Application Form inserted (v2.1)

Changes agreed at ECI Group Meeting held on 05.03.14 and resulting virtual discussion.

SL CSU March 2014

1.4 Changes reflecting virtual discussions by ECI Group on changes to v1.3

Changes reflecting virtual discussions by ECI Group on changes to v1.3

SL CSU March 2014

1.5 Changes reflecting discussion by ECI Group Meeting held on 28.05.14: • Revised policies agreed: MLD, Varicose Veins, Circumcision, Open MRI and Pinnaplasty. • Policy reviews and updates removed for 14/15 ECI:

Changes agreed by ECI Group Meeting held on 28.05.14

SL CSU May 2014


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Dupuytren’s Contracture, Autologous Chondrocyte, Carpal Tunnel

1.6 • Revised IFR Application Form inserted (v2.2) • Sutton IVF Policy updated • Merton IVF Policy updated • Kingston IVF Policy updated • Richmond IVF Policy updated • St George’s Hospital deviation from Dupuytren’s and Carpal Tunnel policy clause inserted

Appendices updated SL CSU Jul 2014

1.6.1 • Croydon IVF Policy updated • Merton IVF Policy updated

Appendices updated SL CSU Aug 2014

1.7 • Fertility Preservation Policy updated • Croydon CCG deviation from Varicose Veins Policy included

Policy wording clarified following response to clinical consultation

SL CSU Aug 2014

1.7.1 • Merton IVF Policy updated Appendices updated SL CSU Sep 2014

1.7.2 • Sutton IVF Policy updated Appendices updated SL CSU Sep 2014

1.8.0 Series of revisions – Details to be confirmed

Jan 2017


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Contents

Introduction ....................................................................................................................... 8

Aesthetic Surgery ........................................................................................................... 10

General Principles ........................................................................................................... 10

1. Breast Procedures this is where you could state if this is INNF/CBA or CBA+PA policy 12

1.1 Reduction mammoplasty .................................................................................... 12

1.2 Gynaecomastia .................................................................................................... 13

1.3 Augmentation/ Mammoplasty ............................................................................. 13

1.4 Revision of breast augmentation ....................................................................... 14

1.5 Mastopexy ........................................................................................................... 14

1.6 Surgical correction of nipple inversion .............................................................. 14

2. Facial Procedures .................................................................................................... 15

2.1 Rhytidectomy ...................................................................................................... 15

2.2 Rhinoplasty .......................................................................................................... 15

2.3 Pinnaplasty/Otoplasty ......................................................................................... 16

2.4 Repair of external ear lobes ................................................................................ 17

2.5 Hair replacement techniques to correct hair loss.............................................. 18

3. Body Contouring Procedures .................................................................................. 18

3.1 Apronectomy or Abdominoplasty ...................................................................... 18

3.2 Body contouring .................................................................................................. 19

3.3 Liposuction .......................................................................................................... 19

4. Skin and Subcutaneous Lesions............................................................................. 19

4.1 Facial skin procedures ........................................................................................ 19


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4.2 Tattoo removal ..................................................................................................... 20

4.3 Treatment of skin hyperpigmentation ................................................................ 20

4.4 Treatment of vascular lesions ............................................................................. 20

5. Miscellaneous ........................................................................................................... 20

5.1 Injection of facial botulinum toxin for cosmetic indications ............................. 20

5.2 Hair depilation...................................................................................................... 20

5.3 Cosmetic genital surgery .................................................................................... 21

5.4 Keloidectomy ....................................................................................................... 21

6. Asymptomatic gallstones ........................................................................................ 21

7. Circumcision ............................................................................................................. 23

8. Diagnostic ................................................................................................................. 25

8.1 Open magnetic resonance imaging (MRI) .......................................................... 25

8.2 Wireless capsule endoscopy and double balloon enteroscopy in obscure gastrointestinal bleeding ..................................................................................... 29

8.3 Wireless capsule endoscopy and double balloon enteroscopy in Crohn’s disease ................................................................................................................. 31

9. ENT ............................................................................................................................ 32

9.1 (Adeno)Tonsillectomy ......................................................................................... 32

9.2 Grommets in older children (12 and above) and adults (ventilation tubes) (Insertion of) ........................................................................................................ 34

9.3 Grommets in children under 12 (ventilation tubes) (Insertion of) ..................... 36

10. Eyes ....................................................................................................................... 38

10.1 Blepharoplasty (surgery on the upper & lower lid) ....................................... 38

10.2 Brow lift............................................................................................................ 38

10.3 Cataract surgery .............................................................................................. 38

11. Minor Skin Lesions (Treatment of) ........................................................................ 40

12. Obstructive sleep apnoea in adults ....................................................................... 43

13. Obstetrics, Gynaecology & Reproduction ............................................................ 47

13.1 Dilatation & curettage (D&C) .......................................................................... 47


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13.2 Female genital prolapse/stress incontinence (assessment of) .................... 48

13.3 Fertility preservation techniques ................................................................... 51

13.4 Hysterectomy for heavy menstrual bleeding ................................................ 53

13.5 IVF .................................................................................................................... 55

13.6 Uterine fibroids (minimally invasive surgery for) .......................................... 57

14. Orthopaedic & Pain Management .......................................................................... 59

14.1 Acupuncture for Non- Specific Low Back Pain (LBP) ................................... 59

14.2 Autologous chondrocyte implantation .......................................................... 61

14.3 Carpal tunnel syndrome (surgical treatment of) ............................................ 62

14.4 Discectomy for lumbar disc prolapse (elective) ............................................ 65

14.5 Dupuytren’s contracture (fasciotomy/fasciectomy) ...................................... 67

14.6 Epidural injections for lumbar back pain ....................................................... 69

14.7 Ganglia (Excision of ganglia) ......................................................................... 70

14.8 Hip replacement surgery (primary) ................................................................ 71

14.9 Knee arthroscopy ............................................................................................ 75

14.10 Knee replacement surgery (primary) ............................................................ 78

14.11 Knee washout (in patients with knee osteoarthritis) ................................... 81

14.12 Therapeutic facet joint injections/medial branch blocks ............................ 81

14.13 Thermal radiofrequency denervation of lumbar & cervical facet joints ..... 84

14.14 Trigger Finger ................................................................................................ 86

14.15 Hallux Valgus (Bunions) [NEW POLICY] ....................................................... 87

Rationale .......................................................................................................................... 87

15. Vascular .................................................................................................................. 89

15.1 Manual lymphatic drainage (MLD) ................................................................. 89

15.2 Varicose veins ................................................................................................. 91

Appendix A: Local funding application processes SWL ECI Application/Funding process ............................................................................................................................ 95

Croydon CCG Funding request pathway: ................................................................ 95

Kingston CCG Funding request process: ................................................................ 96


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Merton CCG Individual Funding Request (IFR) Pathway ........................................ 97

Richmond CCG Funding Request Process .............................................................. 98

Sutton CCG Process Individual Funding Request (IFR) Pathway .......................... 99

Wandsworth CCG Funding Request Process ........................................................ 100

Appendix B: Individual Funding Request Application Form ..................................... 101

Appendix C: Principles and processes for decision making for the SWL Effective Commissioning Initiative (ECI) ..................................................................................... 108

Appendix D: Policy on alternative/homeopathic/ complementary therapies ............ 113

Appendix E – Eligibility for NHS funded wigs.............................................................. 114

Appendix F: Epworth Sleepiness Scale 1 .................................................................... 115

Appendix G: Local CCG variations to IVF criteria ...................................................... 116

CROYDON CCG - IVF criteria 2014/2015 ................................................................ 116

KINGSTON CCG – Assisted Conception Guidelines 2014/2015 ........................... 118

MERTON CCG – Assisted Conception Policy 2014/2015 ...................................... 127

RICHMOND CCG – IVF criteria 2014/2015 .............................................................. 136 Appendix A: Management of Subfertility ................................................... 138 Annex B: RICHMOND CCG – Subfertility Investigations-2014/2015 ......... 139 Annex C: RICHMOND CCG – Assisted Conception-IVF/ICSI/IUI-2014/2015

................................................................................................................ 140 Appendix D: Fertility preservation techniques (SWLECI Criteria 2013/14)

................................................................................................................ 142

SUTTON CCG – IVF criteria 2014 ............................................................................ 143

WANDSWORTH CCG - IVF criteria 2013/2015 ........................................................ 150

Appendix H: Classification of Pain Levels and Functional Limitations Table for Primary Hip Replacement and Oxford Hip Score ........................................................ 152

Appendix I: Knee Symptomatology, Radiology and Localisation and Oxford Knee

Score7

............................................................................................................................ 154

Appendix J – Lymphoedema Staging and Referral Criteria .......................................... 156

Appendix K – NHS England Policies.............................................................................. 157

Appendix L – Governance 2014/2015 ........................................................................... 158


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Introduction This document describes the South West London Effective Commissioning Initiative (SWL ECI). It provides a set of patient criteria to inform the commissioning of clinical interventions in South West London. They have been developed by the South West London Public Health Network. For some procedures, such as dental implants and aesthetics, all cases need to be reviewed through an individual application as per local agreement (this may be Individual Funding Request (IFR) including Exceptional Circumstances application or other prior approval process e.g. referral review via a Clinical Assessment Service (CAS)). See Appendix A for local processes. Aesthetic surgery for cosmetic purposes will not normally be funded by CCGs. For other procedures, such as hip replacement, specific criteria must be met before it can be carried out. In such cases it will be up to individual CCGs to decide how adherence to these criteria is monitored (e.g. prior approval, audits, notification only). The criteria for the following procedures have been added since the Document 2012/2013: Acupuncture for non-specific low back pain, deep brain stimulation (DBS) for Parkinson’s disease, (ENT) grommets in adults, fertility preservation techniques and sacral nerve stimulation (SNS) for faecal incontinence. Amendments to/clarification of criteria, have been made to procedures already in the 2012/2013 Document as follows: aesthetic surgery, bariatric surgery, ENT (adeno)tonsillectomy, bone anchored hearing aids (BAHA’s), cochlear implants and grommets in children, minor skin lesions, discectomy for lumbar disc prolapse, Dupuytren’s contracture, epidural injections for lumbar back pain, ganglia, therapeutic facet joint injections/media branch blocks, thermal radiofrequency denervation of lumbar and cervical facet joints and trigger finger. It should be noted that procedures that have been the subject of NICE Technology Appraisals will be amended without going through the usual consultation period. A list of those procedures amended will be published as they occur. This document includes the criteria (with rationale/supporting evidence) that are required to be met in order to receive approval for funding. In order for funding to be agreed for an ECI procedure outside of the criteria (or for procedures where no specific criteria are given), the applicant must make a case for exceptional circumstances by demonstrating that there is some unusual clinical factor about the patient that suggests that they are:

Significantly different to the general population of patients with the condition in question.

Likely to gain significantly more benefit from the intervention than might be normally expected for the average patient with the condition.

The fact that the treatment is likely to be efficacious for a patient is not, in itself, a basis for exceptionality. Also the patient’s social circumstances including family or work-related factors are not taken into consideration by the Individual Funding Request panel, which will consider the evidence and decide upon funding. The IFR form is available as an appendix to this Document (Appendix B).


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The SWL ECI Group Principles and Processes for Decision Making are attached as Appendix C. Applications for funding should be made on behalf of the patient by primary or secondary care clinicians. The South West London Effective Commissioning Initiative (SWL ECI) was established in 2006 and consists of representatives from all six SWLondon Cluster Borough Teams. Membership of the group is made up of representatives from Public Health, the SWLondon Acute Commissioning Unit and a Patient/Lay Representative. The SWL ECI provides a set of patient criteria to inform the commissioning of clinical interventions in South West London. The SWL ECI is driven by the need to ensure that NHS funded treatments are effective and evidence-based and that access to treatment throughout the SWL area is equal for patients with similar need. It also attempts to define more clearly and openly the limits of NHS funding for procedures with social but not physical benefits cosmetic procedures. Although not the main driving force, it is also linked to the need to ensure that the NHS provides value for money and achieves financial balance. The current procedures included in the ECI document can broadly be classified into four groups:

Procedures with limited evidence of effectiveness.

Procedures where initial conservative therapy is possible.

Effective procedures where a threshold for intervention may be appropriate.

Procedures where NHS provision may be inappropriate.

Criteria for funding of procedures included in the SWL ECI document are developed on the basis of current evidence of best practice and in consultation with local clinical teams. A rolling programme is in place to ensure that criteria for procedures are up to date, are based on best available evidence, and that new procedures are added to the document. Homeopathic/Complementary therapies

These therapies are not funded by the NHS (Appendix D).

Procedures with limited evidence of benefit

This includes grommet insertion and tonsillectomy. For these procedures, the available evidence suggests limited benefit and significant risks.

Procedures where initial conservative therapy is effective This includes procedures such as hysterectomy for heavy menstrual bleeding where surgical treatment may be considered but conservative therapy is effective and can avoid the risks associated with surgery. Procedures where a threshold for intervention may be appropriate This includes cataract surgery. For these procedures, it is possible to select patient groups who are unlikely to benefit from treatment. Procedures where NHS provision may be inappropriate This includes all cosmetic surgery and removal of some minor skin lesions. They are procedures for which the primary purpose is to improve appearance and the evidence for other benefits, including


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psychological, is limited.

Aesthetic Surgery Definition In this guidance aesthetic or cosmetic surgery is defined as surgery undertaken to improve one’s appearance or reshape normal body parts to improve appearance. This differs from reconstructive surgery which is undertaken to reshape abnormal structures of the body, from accidents, injuries, infections, cancers or other diseases, as well as congenital deformities. Aesthetic surgery for cosmetic purposes will not normally be funded by the CCG. All proposals need to be approved as per local agreement (this may be Individual Funding Request (IFR) (See appendix B) including Exceptional Circumstances application or other prior approval process e.g. referral review via a Clinical Assessment Service (CAS)). Note: Minor skin lesions are covered in a separate section of this document. National Aesthetic Surgery Guidelines were published in Action on Plastic Surgery ‘Information for Commissioners of Plastic Surgery Services. Referrals and Guidelines in Plastic Surgery’. The SWL Public Health ECI network reviewed these guidelines, existing NHS policies and evidence of effectiveness for individual procedures to produce a set of guidelines/criteria. Where the group found no robust evidence, the guidelines/criteria in the table below represent a consensus view of who might be considered appropriate for surgery and the actions which need to be taken before sending a proposal to the IFR/exceptions/prior approvals panel. The table below describes the criteria/guidelines for aesthetic procedures and should be considered against requests for procedures as indicated in this policy document.

General Principles

1. Patients should be at least 18 years of age for most procedures (where this is the case the procedure is annotated with “**”). It should be demonstrated that the conservative treatments/options had been exhausted.

2. CCGs will not generally fund cosmetic procedures solely to improve appearance in the

absence of the following:

Disease, eg recurrent infection;

Congenital deformity (this does not include normal variation);

Limitation of function;

Impaired ability to perform activities of daily living.

3. Psychological distress alone will normally not be accepted as a reason to fund surgery.

4. In exceptional circumstances psychological distress alone may be considered as a reason for

cosmetic surgery if it may alleviate severe and enduring psychological dysfunction. In these cases a NHS psychiatrist or psychologist must provide demonstrable evidence of treatment(s) used to alleviate/improve the patient’s psychological wellbeing, including impact and duration of treatment(s). Patients should be currently engaged or have undergone appropriate psychological or psychiatric treatment. Patients should NOT be referred into mental health services specifically to support an application for aesthetic surgery.


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5. Clinicians are requested to refer to NICE CG31 Obsessive-compulsive disorder (OCD): Core interventions in the treatment of obsessive-compulsive disorder and body dysmorphic

disorder1

prior to referring on psychological grounds alone.

6. For patients with anxiety or depression, clinicians should consider a referral to the local

Improving Access to Psychological Therapies service before requesting cosmetic surgery.

References: 1. National Institute for Health & Clinical Excellence (NICE) CG31 Obsessive-Compulsive Disorder (OCD) and Body Dysmorphic Syndrome (BDS), Nov 2005


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1. Breast Procedures

These criteria do not apply to cosmetic surgery following breast cancer treatment as this is covered by cancer network commissioning policies and pathways.

1.1 Reduction mammoplasty ** (Female breast reduction) Funding may be considered in the following circumstances:

The patient should be 18 or over at the time of application.

AND

Gross asymmetry of at least 2 cup sizes* difference between the breasts.

OR

BMI equal to or below 27;

AND

The patient has a bra cup size of F or more or requires at least 500g of tissue to be removed from each breast**;

AND

If the patient has at least TWO of the following for at least one year (and documented

evidence of GP visits for these problems) 1:

Pain in the neck

Pain in the upper back

Pain in shoulders

Pain / discomfort / ulceration from bra straps cutting into shoulders;

AND

Pain symptoms persist as documented by the physician despite a 6-month trial of therapeutic measures including all of the following:

Supportive devices (e.g., appropriate bra/support bra fitted by a trained bra fitter, wide bra straps).

Analgesic / non-steroidal anti-inflammatory drugs (NSAIDs) interventions.

Physical therapy / exercises / posturing

manoeuvres.

Chronic intertrigo, eczema or dermatitis alone will not be considered as grounds for this procedure unless all of the above are met and the patient has failed to respond to 6 months of conservative treatment.


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*AA, A, B, C, D, DD, E, F, FF, G, GG, H, HH, J, JJ, K, L

** 500g estimates to a 4 cup size reduction in patients with chest sizes 30 to 34 or 2 cup size reduction in patients with wider chests 34-40+.

1. Aetna. Clinical Policy Bulletin: Breast Reduction Surgery and Gynaecomastia Surgery.

http://www.aetna.com/cpb/medical/data/1_99/0017.html

1.2 Gynaecomastia ** (Male breast reduction for gynaecomastia) (liposuction may form part of the treatment plan for this condition)

It is important that male breast cancer is not mistaken for gynaecomastia and, if there is any doubt, an urgent consultation with an appropriate specialist should be obtained. The patient should meet the following criteria:

The patient should be 18 or over at the time of application;

AND

BMI of equal to or below 27;

AND

Have gynaecomastia of Grade III * i.e. Gross breast enlargement with skin redundancy and ptosis so as to simulate a pendulous female breast;

AND

Have been screened for endocrinological or drug related causes.

Notes: *Simon’s classification for gynaecomastia I Minor but visible breast enlargement without skin redundancy. Ila Moderate breast enlargement without skin redundancy IIb Moderate breast enlargement with minor skin redundancy III Gross breast enlargement with skin redundancy and ptosis so as to simulate a pendulous female breast. *Simon BE, Hoffman S, Kahn S. Classification and surgical correction of gynecomastia. Plast Reconstr Surg. Jan 1973;51(1):48- 52.

1.3 Augmentation/ Mammoplasty ** (Breast enlargement)

Criteria


AND

Has significant asymmetry. (Significant asymmetry will be defined as a difference of at least 2 full cup sizes*) to the extent that they cannot get a bra to fit; OR

http://www.aetna.com/cpb/medical/data/1_99/0017.html


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There is complete absence of breast tissue unilaterally or bilaterally.

*AA, A, B, C, D, DD, E, F, FF, G, GG, H, HH, J, JJ, K, L

1.4 Revision of breast augmentation **

Criteria


AND

Removal of implants will be considered, but not replacement, if at least one of the following criteria are met:

Rupture of silicone-filled implant.

Implants complicated by recurrent infections.

Extrusion of implant through skin.

Implants with Baker Class IV contracture associated with severe pain.

Implants with severe contracture that

Interferes with mammography.

Replacement of implants will be considered, for clinical reasons, if the original implants were funded by the NHS for non-cosmetic reasons.

1.5 Mastopexy ** (Breast lift)

The patient should be 18 or over at the time of application. Mastopexy (Breast lift) will not be funded for purely cosmetic/aesthetic purposes such as post-lactational ptosis. NB for asymmetry see breast augmentation, for back pain as a result of breast size, see breast reduction.

1.6 Surgical correction of nipple inversion **


See General Principles above.

Nipple inversion may occur as a result of an underlying breast malignancy and it is essential


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that this be excluded.

2. Facial Procedures

2.1 Rhytidectomy ** (Face lifts)


See General Principles Above

2.2 Rhinoplasty (Surgery to reshape the nose)

Nasal airway obstruction causing significant symptoms (e.g., chronic rhinosinusitis,

difficulty breathing).

OR

Obstructive symptoms persist despite conservative management for three months or greater, which includes, where appropriate, nasal steroids or immunotherapy.

OR

Correction of complex congenital conditions unless covered by specialised commissioning arrangements.

Prior ENT consultation should take place for patients with isolated airway problems (in the absence of visible nasal deformity). This policy does not apply to immediate post trauma nasal manipulation which normally occurs two to three weeks after the trauma and does not require IFR approval from the Commissioner.

Rhinoplasty surgery is not routinely commissioned by the CCG

Septo-rhinoplasty is not routinely commissioned by the CCG

Septoplasty is only funded where there is evidence of a clinical blockage Nasal surgery to correct the following is not routinely funded by the CCG:

to stop snoring


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cosmetic appearance of the nose

for patients who are unhappy with the outcome of previous surgeries including immediate post-trauma

corrections (whether provided by the NHS or private providers)

Consideration may be given for the following:

post- traumatic nasal injury causing continuous and chronic bi-lateral nasal airway obstruction associated with septal/bony deviation of the nose which as part of reconstructive head and neck surgery (including traumatic deformity)

AND

there is significant functional impairment demonstrated

applications put forward must demonstrate some unusual or unique clinical factor about the patient that

suggests they are exceptional as defined below:

o Significantly different to the general population of patients with the condition in question o Likely to gain significantly more benefit from the intervention than might be expected from the

average patient with the condition o applications should be supported by photographs. The CCG will accept patients own photographs

o the CCG will NOT reimburse the costs of medical photography

2.3 Pinnaplasty/Otoplasty (Correction of prominent ears)

Patients should be aged less than 18 years of age at the time of application.

See General Principles above. The following criteria should be referred to by the IFR Panel when considering funding on an exceptional basis:

1. The patient should be between 5 and 18 years of age (surgery under 5 should only be considered for children who require a hearing aid and where this will be better supported following a correction of ear prominence)

2. The angle between the side of the head and the external ear should be more than 35 degrees. (Normal angle is between 20 to 35 degrees).

3. The level of psychological distress felt by the patient - The child rather than the parents are concerned about prominent ears.

There a need to demonstrate impact of the condition Cartilage moulding devices are advised in infants up to 6 months of age. Surgery in the NHS should be available for children with significant deformity or asymmetry, where the prominence measures >30mm (using the measuring guide below)

ANDWhere there is evidence of psychological distress (presenting as documented episodes of bullying and or


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school refusal) in children and adolescents with prominent ears in whom corrective surgery should help to resolve these issues. Details should be provided in the referral letter.

o Surgery below the age of 5 should only be offered if correction of prominence will help

in retaining hearing aids securely, in children for whom they are required. o It is recommended that surgery is only offered to children above 5 years of age and

below 18 years of age, i.e. the upper age limit for referral is 17 years and 364 days. Children under the age of 5 are less likely to tolerate the procedure well or be

compliant with dressings care. Psychological distress is unlikely to have developed prior to the age of 5 and surgery can therefore be delayed until later.

NHS surgery for prominent ears should not be offered to adults over the age of 18 years. Supporting Information for consideration of exceptionality Where surgery is requested outside of the policy criteria above, the following supporting information is required:

o The size of the prominence, using the measuring guide below.

o Details of any psychological distress, this should include documented evidence of, for

example, bullying or school refusal to support the application.

o Details of any functional problems.

o Non-identifiable photographs, preferably medical illustrations if available to support the decision making process. Photographs will be considered but will not form the sole basis of the decision. It is not mandatory for photographs to be provided by a patient. If photographs are submitted then the measuring device should not be touching the ear

and thereby aiding the prominence.

o Details of any clinical exceptional circumstances. It is important that it is the child who

desires surgical correction; referral should not be made for children who appear indifferent or opposed to the idea of surgery. Parents requesting surgery for their child in order to prevent psychological distress when their child starts school or at some time in the future should be advised that referral should wait until their child specifically

requests treatment. Prominence of the ears is associated with bullying and significant

psychological distress. In individuals in whom preoperative distress is high, psychological

therapy, whether or not subsequent surgery is offered, should be provided. Measuring

guideOne of the most consistent methods for measuring the degree of prominence is the helical-mastoid (H-M) distance. Typically, the HM distance is 18-20 mm. As the H-M

distance increases, the ear is perceived to be increasingly prominent. Measure from

the posterior aspect of the Helix. Prominence = H-M distance > 20mm, but Pinnaplasty will only be considered in patients who have a >30mm prominence, unless there are

other considerations e.g. in helping to retain hearing aids. DO NOT REFER for prophylactic or cosmetic reasons for any case (Adult or Paediatric) as these applications will automatically be refused.

References:

1. http://www.nhs.uk/Conditions/Ear-reshaping/Pages/Introduction.aspx 2. http://www.rcseng.ac.uk/healthcare-bodies/docs/published-guides/pinnaplasty 3. http://www.patient.co.uk/doctor/Prominent-Ears.htm 4. http://baaps.org.uk/procedures/setting-back-prominent-ears 5. http://www.jprasurg.com/article/S1748-6815(07)00478-0/abstract

2.4 Repair of external ear lobes (Lobules)

http://www.nhs.uk/Conditions/Ear-reshaping/Pages/Introduction.aspx

http://www.rcseng.ac.uk/healthcare-bodies/docs/published-guides/pinnaplasty

http://www.patient.co.uk/doctor/Prominent-Ears.htm

http://baaps.org.uk/procedures/setting-back-prominent-ears

http://www.jprasurg.com/article/S1748-6815(07)00478-0/abstract


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Consideration will be given to completely split ear lobes as a result of direct trauma. Note: If a previously repaired earlobe is pierced and the split recurs, no further treatment will be offered. If approved, Panels will agree funding for one episode of repair only

2.5 Hair replacement techniques to correct hair loss (e.g. due alopecia or male pattern baldness)

This procedure is not routinely funded by the NHS. If clinical exceptional circumstances exist, applications for funding can be made in the form of an individual application (such as an Individual Funding Request. (IFR). In certain circumstances wigs may be considered clinically appropriate. Some patients, depending on their social circumstances may be eligible for a NHS funded wig (see Appendix E). Wigs will not be provided for normal hair loss due to age including male or female pattern baldness.

3. Body Contouring Procedures

3.1 Apronectomy or Abdominoplasty ** (Tummy tuck)


AND

At the time of the application the patient should have a BMI of between 18 and equal or

less than 27 kg/m2

and must have maintained a BMI in this range for at least 24 months.

OR Further consideration may be given to people who have had very significant weight loss

post bariatric surgery who should have lost at least 50% of their original excess weight*

and maintained this weight for at least 6 months, and be at least 18 months post-surgery.

AND

Have severe functional problems which should include at least one of the following:

Severe difficulties with daily living i.e. ambulatory restrictions.

Documented record of recurrent intertrigo beneath the skin folds that recurs or

fails to respond despite appropriate medical therapy for at least 6 months

* Percentage of excess weight lost = initial weight – current weight x 100

initial weight – (25 x height2)


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(NB where weight is in kilos and height is in metres)

3.2 Body contouring ** (Other skin excision for contour e.g. buttock lift, thigh lift, arm lift (brachioplasty)

(For apronectomy/abdominoplasty in respect of body contouring see criteria for

apronectomy/adominoplasty above)


AND

At the time of the application the patient must have a BMI of equal to or below 27 kg/m2

and must have maintained a BMI in this range for at least 18 months;

AND

Have severe functional problems which may include:

Documented record of recurrent intertrigo beneath the skin folds that recurs or fails to respond despite appropriate conservative treatment for at least 6 months.

Severe difficulties with daily living i.e. ambulatory restrictions.

3.3 Liposuction

Liposuction will not be routinely funded to correct the distribution of fat. If clinical

exceptional circumstances exist, applications for funding can be made in the form of an

individual application (such as an Individual Funding Request (IFR).

4. Skin and Subcutaneous Lesions

4.1 Facial skin procedures

Skin resurfacing and other surgical interventions for scarring, including laser, dermabrasion and chemical peels)

Skin resurfacing procedures for cosmetic purposes or purely to improve appearance will not be routinelyis not normally funded. Individual requests will be considered on an exceptional basis where there is evidence that the procedure will improve clinically significant signs and symptoms.


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4.2 Tattoo removal


4.3 Treatment of skin hyperpigmentation (including laser therapy, chemical peels etc.)


4.4 Treatment of vascular lesions

See General Principles above. Individual requests will be considered on an exceptional basis which may include evidence that facial lesions cause significant disfigurement or obstructive symptoms. Small, benign, acquired, vascular lesions such as thread veins and spider naevi would not normally be treated.

5. Miscellaneous

5.1 Injection of facial botulinum toxin for cosmetic indications

Botulinum toxin is not routinely funded for the treatment of facial ageing or excessive wrinkles. If clinical exceptional circumstances exist, applications for funding can be made in the form of an individual application (such as an Individual Funding Request (IFR). Botulinum toxin is available for the treatment of pathological conditions by appropriate specialists in cases such as Frey’s syndrome-gustatory sweating after parotid surgery; Botox A injection is recommended as a first line treatment for Frey’s syndrome and can be used in conjunction with or instead of oral anticholinergic medication.

5.2 Hair depilation (Hair removal by electrolysis and/ or laser)

Treatment of severe hirsutism on the facial, neck and/or chest area will be considered if standard treatments have failed and exceptionality is demonstrated. The methods of hair removal used should be diathermy electrolysis performed by a registered electrologist or, if appropriate, laser in the following circumstances and after all standard treatments have been tried:


21

Abnormally located hair-bearing skin following reconstructive surgery.

Treatment for pilonidal sinuses to reduce recurrence.

Funding will be agreed for a course of treatment after which a review of effectiveness will be required prior to any further funding being agreed.

5.3 Cosmetic genital surgery

See General Principles above

5.4 Keloidectomy

If the keloid:

Results in significant functional impairment.

OR

Causes significant pain requiring chronic analgesic medication.

OR

Bleeding.

OR

Suspicion of malignancy.

OR

Obstruction of orifice or vision.

OR

Failure to respond to intralesional steroid injection.

Panels will take into consideration the number of previous surgeries. If approved, Panels will agree funding for one repair only and for steroid and/or radiotherapy as clinically indicated.

6. Asymptomatic gallstones CCGs will not routinely fund cholecystectomy for asymptomatic gallstones. Applications for funding should be made in the form of an individual application via an Individual Funding Request (IFR). The CCG will only support the funding of cholecystectomy via an individual funding request in mild or asymptomatic gallstones where one or more of the following criteria are met:

1. High risk of gall bladder cancer, e.g. gall bladder polyps ≥1cm, porcelain gall bladder,


22

strong family history (parent, child or sibling with gallbladder cancer) 2. Transplant recipient (pre or post transplant) 3. Diagnosis of chronic haemolytic syndrome by a secondary care specialist 4. Increased risk of complications from gallstones: presence of stones in the common bile duct, stones larger than 2cm or smaller than 3mm with a patent cystic duct or presence of multiple stones.

The CCG will not support the funding of cholecystectomy in asymptomatic patients outside of the above criteria. It is noted that GPs can refer to secondary care for an expert opinion in cases where diagnostic uncertainty exists. Patients experiencing one episode of pain only and who can be safely managed in primary care/a community setting do not require referral for surgery. In keeping with the Royal College of Surgeons guidelines on gallstones

5, these patients can be managed with oral analgesia and advised to follow a

low fat diet. If they develop further episodes or they have symptoms in addition to the pain, or their pain cannot be safely managed in primary care ora community setting then they can follow the referral pathway for patients with symptomatic gallstones. Asymptomatic gallstones are gallstones detected incidentally in patients who do not have any

abdominal symptoms or have symptoms that are not thought to be due to gallstones 1.

Rationale

The natural history of asymptomatic gallstones is that serious symptoms and complications

only develop in 1-2% of patients annually 2 3 4

.

The cumulative risk of requiring treatment in the first 5 years after the detection of

asymptomatic gallstones is 7.6% 3 4 5

.

The World Gastroenterology Organisation (WGO) Practice Guidelines do not recommend

cholecystectomy in patients with asymptomatic gallstones 6.

Evidence A Cochrane review concluded that only patients with symptomatic gallstones should be treated due

to the complication rates for elective cholecystectomy 5.

References:

1. Friedman G. Natural history of asymptomatic and symptomatic gallstones. Am J Sur. 1993 Apr; 165 (4):399-404

2. Halldestam I, Enell E, Kullman E et al. Development of symptoms and complications in

3. individuals with asymptomatic gallstones. Br J Surg. 2004; 91 (6):734-8

4. Keus F, Gooszen H, Van Laarhoven C. Open small-incision or laparoscopic cholecystectomy for patients with symptomatic cholelithiasis. An overview of Cochrane Hepato-Biliary Group reviews. Cochrane Database of Systematic Reviews 2010. Issue 1 Art No : CD008318

5. Sakorafas G, Milingos D, Peros G. Asymptomatic cholelithiasis: Is cholecystectomy really needed? A critical reappraisal 15 years after the introduction of laparoscopic cholecystectomy. Dig Dis Sci 2007; 52 (5): 1313-25

6. Gurusamy K, Samraj K. Cholecystectomy for patients with silent gallstones. Cochrane Database of Systematic Reviews 2007. Issue 1 Art No CD006230

7. WGO Practice Guideline: Asymptomatic gallstone disease. World Gastroenterology Organisation 2006-08.


23

7. Circumcision Circumcision is an effective operative procedure with a range of medical indications. This statement refers to circumcision (the surgical removal of the penile foreskin) in males only. Female circumcision or Female Genital Mutilation is prohibited by law (The Prohibition of Female Circumcision Act 1995). Non therapeutic circumcision for personal, social, cultural and religious reasons is not normally funded by the CCG. The CCG does not commission circumcision surgery for the prevention of sexually transmitted diseases or where a patient is suffering from pain on arousal or interference with sexual function. Indications for surgery are: (as per RCS guidance, 2013):

Pathological phimosis- The most common cause is lichen sclerosus, (balanitis xerotica obliterans BXO is an old fashioned descriptive term)

Recurrent episodes of balanoposthitis

There a number of relative indications for surgery which can be considered via the Individual Funding Request process in exceptional clinical circumstances such as (as per RCS, 2013):

Prevention of urinary tract infection in patients with an abnormal urinary tract

Recurrent paraphimosis

Traumatic (e.g. zipper injury)

Tight foreskin causing pain on arousal/ interfering with sexual function

Congenital abnormalities Rationale

The foreskin is still in the process of developing at birth and is often non- retractable up to the age of three years. The process of separation is spontaneous and does not require any manipulation or intervention. By 3-11 years of age 90% of boys will have a par t ia l l y o f f u l l y retractable foreskin. By the age of 14+ only 1% of boys will have an unretractile foreskin.

Pathological phimosis (scarring of the foreskin making it non-retractable) is unusual under 5 years of age.

Paraphimosis can usually be reduced under anaesthetic and the chance of recurrence reduced by avoiding forcibly retracting the foreskin. Paraphimosis is not a routine indication for circumcision.

Evidence

As with other types of surgery circumcision carries potential anaesthetic risks, and the short term risk of bleeding and infection. Longer term potential complications include pain on erection, penile disfigurement, and psychological problems. There is some evidence that the procedure can also reduce local sensitivity

Balanoposthitis can be successfully treated using antibiotics. Most people do not have further infections. Circumcision is usually recommended only in adults in rare cases where someone has repeated infections.

References:


24

1. Statement on Male Circumcision. Statement from the British Association of Paediatric Surgeons, The Royal College of Nursing, The Royal College of Paediatrics and Child Health, The Royal College of Surgeons of England and the Royal College of Anaesthetists. 6th March 2001.

2. Szabo R et al. Education and Debate. How does male circumcision protect against HIV infection? Br Med J. 2000; 320:1592-1594

3. The law and ethics of male circumcision – guidance for doctors. BMA June 2006

4. Williams N, Kaplia L. Complications of circumcision. Br J Surg1993;80:1231-6.

5. Peterson SE. Assaulted and mutilated. A personal account of circumcision trauma. In: Denniston GC, Hodges FM, Milos MF, eds. Understanding circumcision.New York: Kluwer

Academic, 2001;271

6. Sorrells ML, Snyder JL, Reiss MD, Eden C, Milos MF, Wilcox N, et al. Fine touch pressure thresholds in the adult penis. BJU Int2007;99:864-9

7. NCL guidance [check reference] 8. NHS North West London Circumcision 5/11/10 9. NHS Surrey List of low priority procedures and procedures with thresholds. July 2010. 10. ONEL Acute Commissioning Unit April 2010 11. South East London http://testsite1.bromley.nhs.uk/et/POLCM002.pdf 12. BMJ Best Practice, viewed January 11 2013, http://bestpractice.bmj.com/best-

practice/welcome.html. Balanoposthitis, 06 Sep 2012, viewed 11 January 2013, http://bestpractice.bmj.com/best-practice/monograph/401/treatment/step-by-step.html

13. RCS (2013) Commissioning guide: Foreskin conditions https://www.rcseng.ac.uk/standards-and-research/nscc/commissioning-guides/topics/

http://testsite1.bromley.nhs.uk/et/POLCM002.pdf

http://bestpractice.bmj.com/best-practice/welcome.html

http://bestpractice.bmj.com/best-practice/welcome.html

http://bestpractice.bmj.com/best-practice/monograph/401/treatment/step-by-step.html

https://www.rcseng.ac.uk/standards-and-research/nscc/commissioning-guides/topics/


25

8. Diagnostic

8.1 Open magnetic resonance imaging (MRI) Prior approval should be sought from the CCG. Criteria CCGs will fund:

Low field MRI for interventional and intraoperative procedures only.

Fund Open MRI of greater than >0.5T as an alternative to conventional MRI in the following circumstances:

Patients who suffer from claustrophobia where taking an oral prescription sedative1 to

support conventional MRI has been tried and was not effective.

OR

Patients who cannot fit safely or comfortably in a conventional MRI, due to obesity or to some other confirmed clinical condition.

1. In patients with claustrophobia GPs should prescribe an oral sedative for use during a

conventional MRI before referring for an Open MRI 2. Standard MRI has a 60 cm bore and can tolerate a maximum weight of 250 kg. Latest

Standard MRI machines have an 80cm bore and are able to scan obese patients. Please check before referring for an Open MRI.

CCGs will not routinely fund: Introduction MRI is a widely used diagnostic imaging technology and is particularly useful in detecting soft tissue damage and disease. The patient undergoing imaging is placed in a gradient magnetic field delivering radiofrequency pulses to the patient and processing the resulting electromagnetic signals emitted from

the region being examined.1

(CADTH) T h e standard (closed/high-field) method of MRI requires the patient to be in a supine or recumbent position. The orientation of standard MRIs requires the patient to be horizontal and stationary. (Washington State) Magnetic resonance (MR) imaging (MRI) is particularly useful in detecting soft tissue damage or disease. For most scanners, the patient examination table is positioned in a long, narrow tube. Some patients may experience claustrophobic reactions which might be effectively controlled by sedation or anaesthesia. Obese individuals may not fit into the tube. Open MRIs in which patients lie, sit or stand between two plates overcome these difficulties. They are also used for intraoperative imaging or image-guided interventions where easy access to the patient is required. The technology

Standing, Weight-Bearing, Positional, or Upright MRI except on an exceptional basis via the IFR route.


26

The quality of MRI images is partly dependent on the field strength of the magnet which is measured in Tesla (above 1 Tesla (T) is considered high). Closed MRIs have magnet field strengths of >1.5 tesla whereas open MRIs have medium strengths magnets of 0.5-1.0T The lower field strength of open MRIs results in poorer quality images in comparison to closed MRIs, with lower signal-to-noise ratios and more motion artefacts. The length of time required to obtain an image is also longer. Generally low field strength is below 0.5T, mid-field strength is 0.5 T, up to 0.9 T or 1 T; and high-field strength is at/and or above 1 T. High-field devices are usually closed-bore magnets due to the fact that the stronger magnetic fields (1–3 T) require more robust shielding and gradient structure to maintain field homogeneity. The open magnet’s field strength usually varies from 0.2–1.0 T.

Evidence

MRI studies reported in the literature are generally based on intermediate- or high-field MRI. There is insufficient evidence in the published peer-reviewed literature to support the use of low-field strength MRI for any diagnostic indication including but not limited to the following: breast (Paakko, et al., 2005); cardiac (Klein, et al., 2007; Rupprecht, et al., 2002); cerebral/stroke (Terada, et al., 2006; Mehdizade, et al., 2003); pulmonary (Abolmaali, et al., 12004; Wagner, et al., 2001); renal (Stecco, et al., 2007; Kajander, et al., 2000); multiple sclerosis (Ertl-Wagner, et al., 2001) and retrocochlear disorders (Dubrulle, et al., 2002).

An evidence review performed by the Canadian Agency for Drugs and Technologies in Health (CADTH)1 found several non-randomised trials which compared high and low field MRIs.

In a prospective study comparing a 0.2 T open scanner and a 1.5 T highfield system were used to examine 401 patients.2 There was no significant difference in the diagnostic accuracy of the two types of scanners in examinations for patients with diseases of the kidney (n=78), shoulder (n=122), or spine (n=105), using surgical or clinical follow-up as the reference finding. In cerebral examinations (n=96), the high-field system had a statistically significant advantage in accuracy (p=0.01). The authors suggest that limitations due to field strength are relevant only in a small number of cases that warrant high-field examination.

In a study on MRI arthrography of the shoulder, a 0.2 T open MRI and a 1.5 T high-field system were used to examine 38 patients. Correlation of surgical and MRI findings was available for 27 patients (71%). The high-field MRI produced better image quality and fewer motion artefacts than the open low- field MRI, but diagnostic accuracy in the cases with surgical correlation was the same for both systems. The authors conclude that low-field MRI compares favourably to high-field MRI in detecting major abnormalities of the shoulder, but has disadvantages because of the duration of the examination, and the increased risk of reduced image quality due to motion artifacts.

Michel et al. compared patients’ acceptance of MRI pelvimetry that was done using open 0.5 T and closed 1.5 T systems. Of 30 women referred for pelvimetry, 60% preferred the open system, 7% the closed system, and 33% had no preference. The image quality was adequate in both systems.3 In a British study, 47 of 50 patients (94%) who had failed to complete a scan in a conventional machine underwent successful MRI in a 0.5 T open system.

Enders et al (2011), a randomised controlled trial19

was carried out to investigate whether an open panoramic MR scanner is superior to a short-bore MR scanner in reducing the occurrence of claustrophobic events. A total of 174 were enrolled, 87 in the short-bore MR group and 87 in the open MRI group. With 33 claustrophobic events in the short-bore group (39% [95% confidence interval [CI] 28% to 50%) versus 23 in the open scanner group (26% [95% CI 18% to 37%]; P = 0.08) the difference was not significant. Enders and colleagues noted that the most problematic phases of the scan were patient positioning and entry into the exam suite. The researchers also noted that the claustrophobic event rates remained consistent—at more than 25 percent—regardless of patient characteristics and the anatomical region being scanned. The conclusions were that even recent MR cannot prevent claustrophobia suggesting that further developments to create a more patient-centered MR


27

scanner environment were needed. The claustrophobia screening tool, CLQ may be a useful tool to detect patients at risk before claustrophobia occurs.

Interventional and Intraoperative The use of MRI in guiding interventional and intraoperative procedures has become widely accepted as standard of care in equipped facilities

2. There are limited comparative studies

between this and conventional approaches but there are several small, observational studies which indicate that MRI can be used safely and effectively

2.

Low–field MRI There is insufficient evidence in the published peer-reviewed literature to support the use of low-field strength MRI for any indication other than intervention guidance. There is a lack of data: clarifying the impact of treatment decisions—based upon low- field interpretation—on patient outcomes; addressing accuracy and impact of interpretation of low-field MR images outside the hospital setting (i.e., non-radiologist interpretation); addressing any value of dynamic or positional low-field MRI compared to conventional MRI, or impact to patient outcomes; and clarifying what role low-field imaging should hold in the diagnostic algorithm of joint conditions. Due to insufficient evidence, it remains unknown if substituting low-field strength MRI in place of conventional MRI causes a negative impact to diagnostic accuracy, treatment planning and overall patient outcomes. The limited evidence fails to prove that the use of low-field strength MRI in place of conventional MRI improves diagnostic accuracy, treatment

planning and overall patient outcomes2.

Open and Semi-Open MRI Open (i.e., extremity, upright, positional) MRI allows for imaging without the patient being placed within an enclosed space. Open and semi-open MRI systems have a variety of configurations wherein the patient is not completely surrounded by the magnet. Instead of a tunnel as with standard MRI, common configurations are open along the sides and/or consist of a shorter tunnel such that only the portion of the body being imaged is surrounded by the magnet. Some designs have flared ends or two large discs separated by a pillar. Both are open on the sides, allowing for imaging in different patient positions and for axial loading

1. Open-design has become the standard of care when conventional

design is contraindicated. Specifically, this includes patients with pulmonary and/or cerebrovascular disease as well as patients who would require sedation for a conventional MRI such as severely claustrophobic or paediatric patients.

Standing, Weight-Bearing, Positional, or Upright MRI Upright, standing or positional MRI (uMRI) is a type of vertically open MRI that has been developed in recent years. Such systems are open at the front and top, with the magnetic poles placed on either side of the patient and allow for vertical (upright, weight bearing), horizontal (recumbent) positioning, and dynamic kinetic flexion and extension maneuvers. Current uMRI scanners generally use medium field magnets of 0.5T (e.g., GE Signa™ SP/i) or 0.6T (e.g., FONAR Upright™MRI). Washington State published a Health Technology Assessment on Standing, Weight- Bearing,

Positional, or Upright MRI (2006). Some conclusions included 1:

There is limited scientific data available on the accuracy and diagnostic utility of standing, upright, weight-bearing or positional MRI.

There is no evidence from well-designed clinical trials demonstrating the accuracy or effectiveness of weight-bearing MRI for specific conditions or patient populations.

Due to the lack of evidence addressing diagnostic accuracy or diagnostic utility, standing, weight-bearing, positional MRI is considered investigational and experimental.


28

References:

1. CADTH. Open Magnetic Resonance Scanner. Issue 92. November 2006 2. CIGNA. Magnetic Resonance Imaging- low field. CIGNA coverage policy 0444 3. Paakko E, Reinikainen H, Lindholm EL, Rissanen T. Low-field versus high-field MRI in

diagnosing breast disorders. Eur Radiol. 2005 Jul;15(7):1361-8. Epub 2005 Feb 12. 4. Klein HM, Meyners W, Neeb B, Labenz J, Truümmler KH. Cardiac magnetic resonance

imaging using an open 0.35 T system. J Comput Assist Tomogr. 2007 May-Jun;31(3):430-4. 5. Rupprecht T, Nitz W, Wagner M, Kreissler P, Rascher W, et al. Determination of the pressure

gradient in children with coarctation of the aorta by low-field magnetic resonance imaging. Pediatr Cardiol. 2002 Mar-Apr;23(2):127-31. Epub 2002 Feb 19.

6. Terada H, Gomi T, Harada H, Chiba T, Nakamura T, Iwabuchi S, et al. Development of diffusion-weighted image using a 0.3T open MRI. J Neuroradiol. 2006 Feb;33(1):57-61.

7. Mehdizade A, Somon T, Wetzel S, Kelekis A, Martin JB, Scheidegger JR, et al. Diffusion weighted MR imaging on a low-field open magnet. Comparison with findings at 1.5T in 18 patients with cerebral ischemia. J Neuroradiol. 2003 Jan;30(1):25-30.

8. Abolmaali ND, Schmitt J, Krauss S, Bretz F, Deimling M, Jacobi V, et al. MRI of lung parenchyma at 0.2 T: evaluation of imaging techniques, comparative study with chest radiography and interobserver analysis. Eur Radiol. 2004 Apr;14(4):703-8. Epub 2004 Feb 10.

9. Wagner M, Bowing B, Kuth R, Deimling M, Rascher W, Rupprecht T. Low field thoracic MRI--a fast and radiation free routine imaging modality in children. Magn Reson Imaging. 2001 Sep;19(7):975-83

10. Stecco A, Oronzo P, Armienti F, Borraccino C, Fossaceca R, Canalis L, et al. Contrast-bolus MR angiography of the transplanted kidney with a low-field (0.5-T) scanner: diagnostic accuracy, sensitivity and specificity of images and reconstructions in the evaluation of vascular complications. Radiol Med (Torino). 2007 Oct;112(7):1026-35. Epub 2007 Oct 21.

11. Kajander S, Kallio T, Alanen A, Komu M, Forsstrom J. Imaging end-stage kidney disease in adults. Low-field MRI with magnetization transfer vs. ultrasonography. Acta Radiol. 2000 Jul;41(4):357-60.

12. Ertl-Wagner BB, Reith W, Sartor K. Low field-low cost: can low-field magnetic resonance systems replace high-field magnetic resonance systems in the diagnostic assessment of multiple sclerosis patients? Eur Radiol. 2001;11(8):1490-4.

13. Dubrulle F, Delomez J, Kiaei A, Berger P, Vincent C, Vaneecloo FM, et al. Mass screening for retrocochlear disorders: low-field-strength (0.2-T) versus high-field-strength (1.5-T) MRI. AJNR Am J Neuroradiol. 2002 Jun-Jul;23(6):918-23.

14. Merl T, et al. Eur J Radiol 1999;30(1):43-53. 15. Loew R, et al. Eur Radiol 2000;10(6):989-96. 16. Michel SC, et al. Eur Radiol 2002;12(12):2898-905. 17. Spouse E, et al. Br J Radiol

2000;73(866):146-51. 17. Spouse E, et al. BR J Radiol 2000;73(866):146-51 18. Washington State Department of Labor and Industries, Office of the Medical Director.

Standing,weight-bearing, positional or upright MRI. Health Technology Assessment. Olympia Washington State Department of Labor and Industries; May 31 2006

19. Enders J et al. Reduction in claustrophobia with short-term bore versus open Magnetic Resonance Imaging – A Randomised Controlled Trial. PLoS One. 2011;6(8):e23494


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8.2 Wireless capsule endoscopy and double balloon enteroscopy in obscure gastrointestinal bleeding

Criteria CCGs will fund wireless capsule endoscopy or double balloon enteroscopy for obscure gastrointestinal bleeding when:

Patients with gastrointestinal bleeding have undergone a gastroscopy and/or endoscopy and results are negative then

Capsule endoscopy for investigation

A) If wireless capsule endoscopy identifies source of bleeding in small bowel

then

Where indicated, double balloon enteroscopy for treatment

B) If results of wireless capsule endoscopy are normal but there is persistent

bleeding then

Consider second look wireless capsule endoscopy

OR

Double balloon enteroscopy for investigation and treatment where appropriate

Rationale

The evidence available shows that WCE and DBE are safe and effective diagnostic procedures for the detection of OGIB. Both have a higher diagnostic yield than conventional methods.

CE and DBE have common indications but different features. CE can cover the whole GI tract, requires no sedation and is better tolerated by patients. Its major limitations are the inability to obtain a biopsy, precisely localise a lesion, or perform therapeutic endoscopy. DBE has the advantage of being controllable and enabling therapeutic treatment to take place simultaneously. The procedure is invasive and not as well tolerated as CE, requiring additional staff, typically two physicians or an additional specialist nurse.

Cost-effectiveness modelling suggests that that CE-guided DBE may be associated with better long-term outcomes because of the potential for fewer complications and decreased utilisation of endoscopic resources.

Evidence

NICE produced interventional procedure guidance on WCE in 2004 1.


30

Guidelines produced by British Society of Gastroenterologists in 2008, state DBE should be used complementary to WCE, particularly in the context of therapeutic intervention beyond the reach of push enteroscopy.

References:

1. NICE. 2004. IPG 101. Wireless capsule endoscopy for investigation of the small bowel – guidance.


31

8.3 Wireless capsule endoscopy and double balloon enteroscopy in Crohn’s disease

Criteria

CCGs will fund wireless capsule endoscopy or double balloon enteroscopy for Crohn’s disease when:

Following inconclusive ileocolonoscopy and/or small bowel radiology clinical suspicion of Crohn’s disease remains then:

A) If pain is not a significant feature or where pain is a significant feature and there is no evidence of strictures on small bowel radiography.

Wireless capsule endoscopy for diagnosis

B) If pain is significant feature and there is evidence of strictures on small bowel

radiography or wireless capsule endoscopy results are inconclusive.

Double balloon enteroscopy to obtain histology

Rationale

The evidence available shows that WCE is a safe and effective diagnostic procedure for the detection of Crohn’s disease. WCE has a higher diagnostic yield than push enteroscopy and other conventional methods. The results suggest that it is superior to conventional radiological procedures in the detection of lesions in patients with Crohn's disease. However, the high number of patients with strictures limits its use as a first line diagnostic test in patients previously diagnosed.

Capsule retention remains a risk in patients with Crohn’s disease with significant strictures. The risk is greater in patients with established Crohn’s disease compared to patients suspected to have Crohn’s disease.

Evidence

NICE produced interventional procedures guidance on WCE in 2004 1.

Guidelines produced by British Society of Gastroenterologists in 2008, state DBE should be used complementary to WCE, particularly in the context of therapeutic intervention beyond the reach of push enteroscopy.

References:

1. NICE. 2004. IPG 101. Wireless capsule endoscopy for investigation of the small bowel – guidance.


32

9. ENT

9.1 (Adeno)Tonsillectomy These criteria refer to tonsillectomies with or without adenoidectomies. Adenoidectomies, for clinical reasons, are routinely funded. Criteria If there is suspicion of malignancy funding need not be requested in advance of surgery.

Recurrent sore throat where the majority of episodes required antibiotic treatment and have been adequately treated and who meet all of the criteria within one of the following groups:

Group 1

Sore throat is due to diagnosed tonsillitis

AND

7 or more episodes in the last year, OR 5 or more episodes in each of the last two successive years, OR 3 or more episodes in each of the last 3 years;

1

AND

i) There has been significant severe impact on quality of life indicated by

documented evidence of absence from school/work;

AND/OR

ii) Failure to thrive.

OR

Group 2 Documented evidence of 2 or more episodes of tonsillitis or quinsy (peri-tonsillar abscess) requiring admission to hospital.

OR

Group 3 Severe halitosis (evaluated using a recognised grading scheme) due to tonsil crypt debris following conservative management in primary care.

OR

Group 4

1 Threshold based on SIGN Guidance (which has set a threshold of 7 or more episodes of tonsillitis*

in the last year (http://www.sign.ac.u k/pdf/sign117.pdf).


33

Tonsillitis exacerbating existing disease such as febrile convulsions, guttate psoriasis, glomerulonephritis or rheumatic fever.

The CCG will only consider funding for (adeno) tonsillectomy as a treatment for sleep apnoea syndrome in children who meet the criteria in one of the following Groups.

Group 1 The patient must meet two out of the three following criteria:

A significant impact on quality of life demonstrated by supporting evidence

such as sleep studies, growth charts, letters from GPs and letters from

employer and school.

A strong clinical history suggestive of sleep apnoea Detailed documentation

of the criteria that are fulfilled is mandatory in the referral letter to secondary

care. Clinically inappropriate referrals will be sent back to the GPs.

OR

Group 2 If the patient has habitual snoring with laboured breathing and falls into one of the following complex high risk category for sleep apnoea:

Down’s syndrome

Cerebral palsy

Craniofacial disorders

Chronic lung disease

Sickle cell disease

Neuromuscular disorders

Genetic/metabolic/storage disease

Central hyperventilation syndromes

Applications for funding are more likely to be approved where there is documented supporting evidence such as attendance at general practice or other health care settings, sleep studies, growth charts, letters from GPs and letters from employers, school or playgroup in respect of time off work, school or playgroup which may be considered as evidence of an episode of tonsillitis. For tonsillectomy in adults for sleep apnoea please see surgical treatment of ‘sleep apnoea in adults’ guidance. Patients have a right to be fully informed about this procedure, as part of this process, clinicians should engage the patients (or their carers) in shared decision making about alternative management and the risks and benefits of surgery using a Patient Decision Aid – Recurrent Sore Throat available at http://sdm.rightcare.nhs.uk/pda/ Rationale


34

The natural history of tonsillitis is for the episodes to get less frequent with time.

Watchful waiting is more appropriate than tonsillectomy in children with mild sore throats.

Exposure to second hand smoke in children leads to an increased risk of respiratory tract

infections including tonsillitis and otitis media5.

The frequency of sore throat episodes and upper respiratory infections reduces with time whether or not tonsillectomy has been performed. Tonsillectomy offers relatively small clinical benefits compared with non-surgical treatment.

Tonsillectomy probably gives an additional, but small, reduction of sore throat episodes, days of sore throat associated school absence, and upper respiratory infections compared to watchful waiting.

The benefit in the year after the operation is roughly 2.8 less days off school.

This benefit needs to be weighted against the risk of mortality (estimated to be between 1/8,000 - 1/35,000) and other surgical complications.

Evidence

A Cochrane systemic review1

concluded that, “There is no evidence from randomised controlled trials to guide the clinician in formulating the indications for surgery in adults or children”. References:

1. Lim J, McKean MC. Adenotonsillectomy for obstructive sleep apnoea in children. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD003136. DOI:10.1002/14651858.CD003136.pub2.

2. Diagnosis and Management of Childhood Obstructive Sleep Apnea Syndrome. Pediatrics Vol 109 No 4 April 2002.

3. Management of sore throat and indications for tonsillectomy, SIGN 117, Scottish Intercollegiate Guidelines Network, April 2010

4. World Health Organisation, Tobacco Free Initiative, 2002.

5. Lock C., et al. North of England and Scotland Study of Tonsillectomy and Adeno-tonsillectomy in Children(NESSTAC): a pragmatic randomised controlled trial with a parallel non-randomised preference study. Health Technol Assess. 2010 Mar;14(13):1-164, iii-iv.

9.2 Grommets in older children (12 and above) and adults (ventilation tubes) (Insertion of)

These criteria apply to children aged 12 and above. These criteria do not apply for grommet insertion as part of a procedure for the diagnosis or management of head and neck cancer and/or its complications. The CCG will fund treatment with grommets for older children with:

A middle ear effusion causing measured conductive hearing loss of 26–401

dB or worse averaged at 0.5, 1, 2 and 4 kHz, and resistant to medical treatments.

OR


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Persistent Eustachian tube dysfunction resulting in pain (e.g. due to air pressure changes when flying)

OR

As one possible treatment for Meniere’s disease.

OR

Severe retraction of the tympanic membrane if the clinician feels this may be reversible and reversing it may help avoid erosion of the ossicular chain or the development of cholesteatoma.

The CCG will only fund grommet insertion in adults (aged 18 and over) when thefollowing criteria are

met:

Insertion of grommets as part of a more extensive surgical procedure

OR

Severe retraction of the tympanic membrane and in the expert view of the consultant that this may be reversible and reversing it may help avoid erosion of the ossicular chain or the development of cholesteatoma

OR

Eustachian tube dysfunction that prevents the commencement or completion of hyperbaric oxygen treatment.or acute or chronic otitis media with risk of complications of facial palsy or intracranial infection eg meningitis

OR

As a treatment for Ménière’s disease or in the case of conditions e.g. nasopharyngeal carcinoma, ethmoidal cancer, maxillectomy, olfactory neuroblastoma, sinunasal cancer, and complications relating to its treatment (including radiotherapy), if judged

that the risks outweigh the benefit by the responsible clinician.

Rationale Although the outcome of otitis media with effusion (OME) in children is generally good, it is less clear in adults. Watchful waiting is often not appropriate. Many patients with adult-onset OME have underlying pathology that could lead to recurrence of OME following ventilation tube extrusion. In addition, the underlying pathology needs investigation to exclude atopy or malignancy. These criteria have been adapted from the NHS Surrey and NHS Brighton and Hove criteria for grommets in adults.

References:

1. WHO Report of the Informal Working Group On Prevention Of Deafness And

Hearing Impairment Programme Planning. Geneva, 1991

2. NHS Institute for Innovation and Improvement. NHS Better Care, Better Value

Indicators: Surgical thresholds indicators. 10 October 2007 At

http://www.productivity.nhs.uk/Definitions.aspx


36

http://www.productivity.nhs.uk/Definitions.aspx Accessed 26.3.08

3. Yung MW, Arasaratnam R. Adult-onset otitis media with effusion: results following ventilation tube insertion. J Laryngol Otol. 2001 Nov;115(11):874-8

4. Montandon P, Guillemin P, Häusler R. Prevention of vertigo in Ménière's syndrome by means of transtympanic ventilation tubes. ORL J Otorhinolaryngol Relat Spec. 1988;50(6):377-81.

9.3 Grommets in children under 12 (ventilation tubes) (Insertion of)

Criteria These criteria apply to children aged under 12 years only. The CCG will fund treatment with grommets for children with persistent otitis media with effusion

(OME) 1

where:

Persistent bilateral OME has been documented over a period of 3 months with a hearing level in the better ear of 25–30 dBHL or worse averaged at 0.5, 1, 2 and 4 kHz (or equivalent dBA where dBHL not available).

OR

Persistent bilateral OME with a hearing loss less than 25–30 dBHL where the impact of the hearing

loss on a child’s developmental, social or educational status is judged to be significant. In children with additional disabilities such as Down’s Syndrome or cleft palate, involvement of a

multidisciplinary team with expertise in assessing and treating OME in these children is essential1

. Patients have a right to be fully informed about this procedure, as part of this process, clinicians should engage the patients (or their carers) in shared decision making about alternative management and the risks and benefits of surgery using a Patient Decision Aid: Patient Decision Aid – Glue ear available at http://sdm.rightcare.nhs.uk/pda/glue-ear/ Rationale

The reduced risk of serious complications of anaesthesia and surgery must be balanced against the increased hearing loss and episodes of infection requiring antibiotic treatment and time off school or playgroup. The evidence of effectiveness is limited.

Restricting access to grommets is not a new phenomenon. A 1995 survey revealed that 23 of the 129 health authorities in England, Scotland and Wales had excluded grommets. The key points are summarised below:

Surgery may resolve glue ear and improve hearing in the short term compared with non-

surgical treatment, but there is less certainty about long-term outcomes and large variation in effect between children.

There continues to be debate about how best to select children for surgery. This issue is

complicated by the high rate of resolution of glue ear, particularly in younger children3.

http://www.productivity.nhs.uk/Definitions.aspx


37

The timing of surgery may not be critical2. An initial period of watchful waiting is

recommended for most children4. If watchful waiting is being considered, the child should

undergo audiometry to exclude amore serious degree of hearing loss.

The benefits of surgery have to be balanced against possible harms. One third of children who have grommets have complications. Tympanosclerosis frequently occurs after grommet insertion, infection may occur, and there is a slightly increased incidence of chronic perforation

Evidence

Cochrane review 2

showed that the benefits of grommets in children are small compared with myringotomy or non-surgical treatment. The effect of grommets on hearing diminished during the first year. It recommends an initial period of watchful waiting for most children with OME.

A 1999 trial 4 compared 9 months 'watchful waiting' with immediate surgery and found outcomes to be similar to 18 months. However, by this time, 85% of children in the watchful waiting group had been treated with grommets.

References: 1. National Institute for Health & Clinical Excellence (NICE) CG60 Surgical Management of otitis

media with effusion in children, Feb 2008

2. Cochrane review: Grommets for hearing loss associated with otitis media with effusion.

January 2005

3. Cochrane review: Grommets (ventilation tubes) for recurrent acute otitis media in children.

October 2008, assessed as up-to-date January 2011

4. SIGN. Diagnosis and management of childhood otitis media in primary care. February 2003.

5. Maw, R., Wilks, J., Harvey, I. et al (1999) Early surgery compared with watchful waiting for glue ear and effect on language development in preschool children: a randomised trial [published

erratum appears in Lancet 1999 Oct 16;354(9187):1392]. Lancet 353(9157), 960-963

6. Adjuvant adenoidectomy in persistent bilateral otitis media with effusion: hearing and revision surgery outcomes through 2 years in the TARGET randomised trial

7. MRC Multicentre Otitis Media Study Group Article first published online: 19 APR 2012

DOI: 10.1111/j.1749-4486.2012.02469.x


38

10. Eyes

10.1 Blepharoplasty (surgery on the upper & lower lid) This procedure is not routinely funded by the NHS but may be funded through the local prior approval process. Applications can be made in the form of an individual application as per local agreement (this may be Individual Funding Request (IFR) including Exceptional Circumstances application or other prior approval process e.g. referral review via a Clinical Assessment Service (CAS)) in the following situations.

To relieve entropion or ectropion.

OR

To remove lesions of the eyelid skin or lid margin in the following situations:

1. Impairment of vision by lid as evidenced by photographs.

OR

2. Impairment of the visual field by lid as evidenced by visual field test.

OR

Other demonstrated complications, e.g. disruptions of the tear film, evidence of chronic compensation of ptosis through elevation of the brow.

10.2 Brow lift This procedure is not routinely funded by the NHS but may be funded through the local prior approval process. Applications can be made in the form of an individual application as per local agreement (this may be Individual Funding Request (IFR) including Exceptional Circumstances application or other prior approval process e.g. referral review via a Clinical Assessment Service (CAS)) in the following situations.

Impairment of vision by lid as evidenced by photographs.

OR

To correct impairment of the visual field by lid as evidenced by visual field test.

10.3 Cataract surgery Criteria

All requests for the surgical removal of cataract(s) will only be supported by the CCG when all of the following apply:


39

The patient should have sufficient cataract in the eye you are proposing to refer cataract surgery on, to account for the visual symptoms as evidenced in the Cataract Referral Form:

Blurred or dim vision with a corrected binocular distance acuity of 6/12* (0.20 logMAR) or worse,

Or

Blurred or dim vision with a monocular distance acuity of 6/18 (0.40 logMAR) or worse

and

The cataract should affect the patient’s lifestyle scoring ≥3 as evidenced in the Cataract Assessment Form

http://www.rotherhamccg.nhs.uk/Downloads/Medicines%20Management/Therapeutic%20guidelines/RCCG%20Cataract%20Surgery%20Checklist%20CT9.pdf - example from Rotherham CCG - which can be adapted to local needs.

And

The patient has waited 7 days to make a decision and wishes to undergo cataract surgery and understands the risks and benefits of this surgery. *6/10 equates to 6/9 on Snellen chart

Exceptional Circumstances Should a patient not meet the criteria detailed within this protocol, the CCG Policy for Independent Funding Requests recognises that there will be occasions when patients who are not considered for funding may have good clinical reasons for being treated as exceptions. In such cases the requesting clinician must provide further information to support the case for being considered as an exception . Rationale

Visually impairing cataract is common in persons of 65 years and over.

The effectiveness of cataract surgery (first and second eye) is established.

Up to one third of cataract operations are for second eye surgery.

Delay in second eye surgery is associated with poorer quality of life and functioning.

Evidence

Cost utility studies based on a prospective cohort study determined a cost utility value of

£1000/QALY 1

for first eye and around £1300/QALY for second eye surgery1.

A recent cost benefit analysis used the English Longitudinal Survey of Ageing (ELSA) to explore the self-reported effect of cataract operations on eyesight. The survey did not distinguish first and second eyes. ‘The average expected welfare gain from surgery is valued

at £1,110 in the year after surgery costing £6722.

References:

1. Busbee BG, Brown MM, Brown GC, Sharma S. Incremental cost-effectiveness of initial cataract surgery. Ophthalmology 109 (3): 606-612 MAR 2002

2. Weale et al. Cost Benefit Analysis of Cataract Surgery – English Longitudinal Survey of Ageing. National Institute of Economic and Social Research Discussion Paper 349 – November 2009.

http://www.rotherhamccg.nhs.uk/Downloads/Medicines%20Management/Therapeutic%20guidelines/RCCG%20Cataract%20Surgery%20Checklist%20CT9.pdf

http://www.rotherhamccg.nhs.uk/Downloads/Medicines%20Management/Therapeutic%20guidelines/RCCG%20Cataract%20Surgery%20Checklist%20CT9.pdf


40

11. Minor Skin Lesions (Treatment of)

Minor skin lesions include benign pigmented moles, comedones, corn/callus, lipoma, milia, molluscum contagiosum, sebaceous cysts (epidermoid or pilar cysts), seborrhoeic keratoses (basal cell papillomata), skin tags including anal tags, spider naevi (telangiectasia), warts, xanthelasma and neurofibromata. This policy applies to treatment of minor skin lesions in primary and secondary care.

Suspicion of malignancy If there is any suspicion of malignancy, patients should be referred immediately to an appropriate service as described in the NICE improving outcomes guidance

1

Criteria for Surgical excision:

Obstruction of an orifice or vision.

OR

Functional limitation on movement or activity.

OR

Moderate to large facial lesions causing disfigurement.

OR

Recurrent bleeding / infection / inflammation, or marked itching, or severe pain which fails to respond to pharmacological treatment.

OR

The lesion is located in an anatomic area subject to recurrent trauma.

Asymptomatic skin lesions Destructive interventions to treat benign asymptomatic skin lesions are not normally funded. This includes the treatment of:

Warts

Seborrhoeic keratoses (benign skin growths, basal cell papillomas, warts)

Spider Naevi

Benign pigmented naevi (moles)

Dermatofibromas (skin growths)

Skin tags

‘Sebaceous’ cysts (pilar and epidermoid cysts)

Xanthelasmas (cholesterol deposits underneath the skin)

Where removal is supported, the CCG expects removal to generally be undertaken in Primary Care through the Minor Surgery Direct Enhanced Service. Treatment in secondary care will only be approved where the removal is beyond GP surgical care. Subject to approval through the IFR route funding approval may be granted by the CCG in the case of:


41

o Severe disfiguring non-malignant lesions of the face

o Severe port wine stains that extend onto the face and neck (For both the

above, requests to be supported by photographic evidence or confirmation of the extent to which the face is covered, taking into account the patient’s normal

hairstyle)

Lipomata Soft tissue subcutaneous lesions, particularly over 5cms, that are not clearly longstanding

and asymptomatic may of course be a soft tissue sarcoma. NICE guidance suggests that a rapid access ultrasound scan is usually the most appropriate diagnostic test to check the nature of any suspicious lesions which then, if abnormal, should be referred on to a Specialist Sarcoma Centre

(usually Birmingham for Gloucestershire residents) as a Two Week Wait. Referral for secondary care

treatment is appropriate if the following is met and funding approval for removal of lipomata must be sought via the Prior Approval process:

Removal cannot be undertaken in Primary Care under the Minor Surgery Direct Enhanced Service because it is beyond GP surgical care or the Practice is not signed up to the Enhanced Service (GP to confirm this at the time of application)

Obvious/proven lipomata that are large (>5cms) or in a particularly difficult site OR

The patient is experiencing significant problems (details of the impact on daily activities to be included in the application) Symptomatic skin lesions

Removal of benign symptomatic skin lesions is commissioned by the CCG subject where the lesion is associated with at least one of the following criteria. Funding approval for removal of symptomatic skin lesions must be sought via the Prior Approval funding process:

Repeated infection, inflammation or discharge OR

Bleeding in the course of normal everyday activity OR

Obstruction of an orifice to the extent that function is impaired OR

Pressure symptoms e.g. on an organ, nerve or tissue OR

Its size or position is causing severe functional impairment of activities of daily living

For mucus/myxoid cysts to the hand please see the commissioning policy for ganglia Biopsies Biopsies are not covered by this policy and may be undertaken as required at the discretion of the managing clinician. Other procedures not normally funded

Keloid and hypertrophic scars, cosmetic scar revision is not normally funded, exceptions will only be considered where scarring impacts severely on physical function. Symptomatic keloid scars (itching or pain) can be treated in primary care with topical or intralesional steroids.

Labiaplasty (unless where labia are directly contributing to recurrent urinary tract disease or infection or where repair of the labia is required after trauma)

Vaginoplasty, hymenopathy

Penile enlargement

Tattoo removal (by any method)

Skin ‘resurfacing’ e.g., dermabrasion, laser and chemical peels

Treatments for hirsutism / hair depilation Rationale

There is limited evidence that surgery on these lesions for aesthetic reasons offers benefit to patients.


42

Where there is no suspicion of malignancy or complications, benign skin lesions may be self-limiting, respond to conservative measures and have nolong-term health consequences for patients.

There is a wide clinical consensus on the list of lesions included, and similar policies have been adopted by a number of CCGs.

Evidence

This approach is consistent with the national aesthetic surgery guidelines2.


43

References: 1. National Institute for Health & Clinical Excellence (NICE). Improving outcomes for people with

skin tumours including melanoma (update): the management of low-risk basal cell carcinomas in the community (2010 partial guidance update). NICE; May 2010. Available at: http://guidance.nice.org.uk/CSGSTIM

2. NHS Modernisation Agency. Action on Plastic Surgery. Information for Commissioners of Plastic Surgery Services. Referrals and Guidelines in Plastic Surgery. (Reviewed October 2009). Available at: http://www.glosCCG.nhs.uk/pdf/publications/innf/commissionersplasticsurgery.pdf

12. Obstructive sleep apnoea in adults (surgical treatment of)

Surgical treatments specifically for Sleep Apnoea should be considered as a last resort as one off treatments where all other conservative treatments have failed. The choice of procedure should be decided based on a multi-disciplinary planning approach between all specialists treating the patient. Patient should be well informed about the consequences and the complications and should be involved in decision making. Continuous positive airways pressure (CPAP) is recommended as the first choice therapy in patients with moderate to severe OSAHS who are sufficiently symptomatic to require intervention. Minor side effects are common and intensive support may be needed to increase uptake and compliance. Intra-oral devices including mandibular advancement devices are recommended for patients with mild OSAHS and normal daytime sleepiness, or for patients unable to tolerate CPAP. Note: Surgery for obstructive sleep apnoea will only be funded through a prior approval route. Applications for funding can be made in the form of an individual application as per local agreement. This may be Individual Funding Request (IFR) including Exceptional Circumstances application or other prior approval process e.g. referral review via a Clinical Assessment Service (CAS). Criteria

Patient has moderate to severe symptoms (measured for example by the Epworth Sleepiness Score: 15-18= moderate, >18 = severe); OR Patient is sleepy in dangerous situations such as driving (regardless of Epworth Sleepiness Score) Appendix F;

AND

Patient has significant sleep disordered breathing (as measured during a sleep study, usually by the Apnoea/Hypopnoea Index: 15-30/hr = moderate, >30/hr = severe);

AND

Patient has already tried continuous positive airways pressure (CPAP) unsuccessfully for 6 months prior to being considered for surgery OR patient had major side effects to CPAP such as significant nosebleeds;

AND

Patient has already tried an intra-oral device, with monitoring to allow device

http://guidance.nice.org.uk/CSGSTIM

http://www.glospct.nhs.uk/pdf/publications/innf/commissionersplasticsurgery.pdf


44

adjustment and assessment of symptom control, unsuccessfully for 3 months OR patient has been unable to tolerate intra-oral device due to recurrent dislodgement of the device during sleep or temporomandibular pain;

AND

A specialist believes the individual patient will benefita;

AND

The patient is fully informed as to the limited effectiveness of procedures, the lack of long term outcomes and likely adverse effects including pain following surgery.

Note: Please refer to Appendix F for Epworth Sleepiness Score. This guidance does not make detailed recommendations on the use of individual surgical procedures, although studies have shown varying levels of effectiveness in terms of outcomes and adverse effects between the different surgical procedures. However exceptional circumstances/prior approval panels should take account of the fact that palatal surgery, such as UPPP and LAUP is not recommended by SIGN (2003) and it may compromise the patient’s subsequent ability to use nasal CPAP, although the

extent of this risk is not known 1. Current evidence on soft-palate implants for obstructive sleep

apnoea (OSA) raises no major safety concerns, but there is inadequate evidence that the procedure is efficacious in the treatment of this potentially serious condition for which other treatments exist.

Therefore, soft-palate implants should not be used in the treatment of this condition 2.

Rationale

The prevalence of obstructive sleep apnoea/hypopnoea syndrome (OSAHS) in men is estimated between 0.3% and 4%, and in women between 0.5% and 1%.

Untreated OSAHS can affect daily function and quality of life. Resultant excessive daytime sleepiness and impaired concentration is estimated to cause a 1-12 fold increased risk of accidents. Sleepiness at the wheel is estimated to cause 20% of road accidents, with high mortality rates due to the lack of avoidance reactions when the patient falls asleep.

Continuous positive airways pressure (CPAP) is recommended as the first choice therapy in patients with moderate to severe OSAHS who are sufficiently symptomatic to require intervention. Minor side effects are common and intensive support may be needed to increase uptake and compliance.

Intra-oral devices including mandibular advancement devices are recommended for patients with mild OSAHS and normal daytime sleepiness, or for patients unable to tolerate CPAP.

Weight loss may benefit some patients according to uncontrolled studies 3,4

although a Cochrane review was unable to identify any research of good enough quality to quantify the

effectiveness of weight loss on sleep apnoea 5. Failure to lose weight should not delay the

institution of other therapies of proven effectiveness such as CPAP.

Exercise is primarily to aid weight loss and may benefit some patients, although a Cochrane review (see below) was unable to identify any research of good enough quality to quantify the

effectiveness of exercise on sleep apnoea 3.

Pharmacological therapies should not be used as first line treatments for OSAHS.

‘Sleep hygiene’ includes using a comfortable bed in a warm, dark, quiet room, mentally winding down and avoidance of evening alcohol, caffeine and hypnotics. A Cochrane review (see below) was unable to identify any research of good enough quality to quantify the effectiveness of sleep hygiene on sleep apnoea.


45

The place of surgery for OSAHS is controversial.

Choice of procedure The main surgical procedures might include:

Tracheostomy.

Radiofrequency tissue ablation.

Tonsillectomy and adenoidectomy, most usually in children.

Maxillo-mandibular osteotomy and advancement.

Removal of local specific obstructing pathologies.

This is not a definitive list. Evidence

A Cochrane Review on Surgery for Obstructive Sleep Apnoea 6

and the SIGN Guidelines on the Management of Obstructive Sleep Apnoea/Hypopnoea Syndrome in Adults (2003, last confirmed as up to date 2009) have been used as the basis for this guidance. The Cochrane review states that the place of surgery for OSAHS is controversial and that most studies recommending a particular surgery are based on evidence from case series. The review found eight randomised controlled trials of mixed quality. The trials found an inconsistent impact on subjective and objective markers of OSAHS in patients. The individual trials do not support the widespread use of surgery as a means of improving sleep quality over other therapeutic options available. Surgery potentially offers a ‘one-off treatment’ to alleviate signs and symptoms of OSAHS, but long terms benefits are not known. It is unknown if the long terms risk of cardiovascular disease and other events are reduced by surgery, due to lack of follow up. References:

1. SIGN (2003) Scottish Intercollegiate Guidelines Network. Management of Obstructive Sleep Apnoea/hypopnoea syndrome in adults (Guideline Number 73) 2009 Review Report

2. National Institute for Health & Clinical Excellence (NICE) IPG241 Soft-palate implants for obstructive sleep apnoea, Nov 2007

3. Lojander et al (1998) A nurse-managed weight reduction programme for obstructive sleep

apnoea syndrome. Journal of internal medicine 1998: 244,251-5

4. Noseda et al (1996) Sleep apnea after 1 year domiciliary nasal continuous positive airway pressure and attempted weight reduction. Chest 1996: 109: 138-43

5. Shneerson J, Wright J. Lifestyle modifications for obstructive sleep apnoea. Cochrane

Database of Systematic Reviews 2001 issue 1. Art No. CD002875 DOI

6. Sundaram S, Bridgeman SA, Lim J, Lasserson TJ. Surgery for obstructive sleep apnoea.

Cochrane Database of Systematic Reviews 2005, Issue 4. Art No: CD001004. DOI 10.1002/14651858.CD001004.pub2

a

According to available literature the subgroups in which surgical intervention may be effective are


46

currently not known


47

13. Obstetrics, Gynaecology & Reproduction

13.1 Dilatation & curettage (D&C) Funding will NOT be routinely provided for the following indications: investigation and/or treatment of menorrhagia; investigation of dysfunctional uterine bleeding or post-menopausal bleeding; treatment of irregular periods; treatment of endometrial hyperplasia; removing unwanted tissue, endometrial polyps or benign tumours of the womb; removing an IUD that has become embedded in the wall of the womb Referral for D&C for evacuation of retained products of conception or removal of a molar pregnancy should only be considered if vacuum aspiration/suction curettage is contraindicated. Criteria D&C for the investigation of abnormal uterine bleeding should only be considered if:

Transvaginal ultrasound with Pipelle endometrial aspirate has failed due to cervical stenosis or pain and facilities for a hysteroscopy with targeted biopsy are unavailable

OR

Hysteroscopy with targeted biopsy has failed/is not possible due to cervical stenosis, pain or inability to dilate the cervix

OR

Transvaginal ultrasound has demonstrated focal pathology and facilities for a hysteroscopy with targeted biopsy are unavailable

Rationale

D&C is no longer recommended as a diagnostic tool in heavy menstrual bleeding (HMB). To detect histological abnormalities in HMB endometrial sampling or hysteroscopy with directed biopsy have superseded D&C for obtaining endometrial tissue. Evacuation of retained products of conception after incomplete miscarriage or delivery has been recommended in order to reduce potential complications such as haemorrhage or infection. Surgical evacuation has been considered the most effective method by D&C or vacuum aspiration/suction curettage. Evidence suggests that vacuum aspiration/suction curettage was safe, quick and easy to perform, and less painful than D&C and is therefore recommended as the first treatment option, with D&C only recommended where this is contra-indicated. Evidence

Limited evidence is available on the therapeutic use of D&C for HMB. The NICE recommendation that D&C should not be used as a treatment for HMB was based on clinical expert opinion

1.

A Cochrane review found that vacuum aspiration/suction curettage was safe, quick and easy to perform, and less painful than D&C. In most developed countries vacuum aspiration/suction curettage has replaced D&C for surgical evacuation of the uterus in incomplete miscarriage

2 3 4 5.

Vacuum aspiration/suction curettage (rather than D&C/sharp metal curettage) is the preferred method of evacuation irrespective of uterine size in patients with hydatidiform mole who want to preserve fertility

6.


48

References:

1. National Institute for Health & Clinical Excellence. Heavy menstrual bleeding. Clinical guideline 44. 2007

2. Nanda K, Peloggia A, Grimes D et al. Expectant care versus surgical treatment for miscarriage.Cochrane Database Systematic Rev. 2006 (2): CD003518

3. Forna F, Gulmezoglu AM. Surgical procedures to evaluate incomplete abortion. Cochrane Database Systematic Rev 2001 (1):CD001993

4. Trinder J, Brocklehurst P, Porter R et al. Management of miscarriage: expectant, medical or surgical? Results of randomised clinical trial (miscarriage treatment (MIST) trial). Br Med J. 2006 May 27; 332 (7552): 1235-40

5. Chen BA, Creinen M. Contemporary management of early pregnancy failure. Clin Obstet Gynecol. 2007 Mar; 50 (1):67088

6. Seckle M, Sebire N, Berkowitz R. Gestational trophoblastic disease. Lancet 2010 Jul 28.

13.2 Female genital prolapse/stress incontinence (assessment of) Initially patients should be assessed and managed conservatively. Continent women with prolapse should be offered a trial of a ring pessary with a discussion of the potential benefits and risks. Evidence of this discussion should be documented in the primary and secondary care notes. Surgical treatment is not funded for asymptomatic prolapse

1.

Surgical treatment of severe symptoms of prolapse/incontinence will be funded following assessment

1

2.

Criteria Referral for specialist assessment is indicated for:

Assessment and fitting of pessary only if this cannot be undertaken in primary care.

OR

Prolapse combined with urinary or faecal incontinence.

OR

Moderate to severe symptoms of prolapse.

OR

Failure of pessary.

Rationale

Symptoms of prolapse can be classified as mechanical, sexual, lower urinary tract or bowel. Mechanical symptoms include tissue protruding from the vagina, having to manually reduce the bulge to urinate or defecate, spotting from ulceration of the protrusion and vaginal pain/discomfort. Sexual symptoms include dyspareunia, decreased sexual satisfaction and incontinence/prolapse during intercourse. Lower urinary tract symptoms include stress


49

incontinence and urge incontinence. Bowel symptoms include faecal and flatus incontinence 3 4

5 6.

Four main POP grading systems are currently in use – quantitative POP (POPQ), vaginal profile, grading system and severity

7.

Pelvic organ prolapse (POP) is common and many women with POP are asymptomatic. POP is not always chronic and progressive. Although prolapse can be associated with varied symptoms few are specific to prolapse. The extent of prolapse does not correlate well with symptoms

8.

Evidence suggests that

pessaries are effective and should be considered before surgery in women with symptomatic POP at any level of severity.

Evidence

A Cochrane review in 2004 found that there were no RCTs of pessary use in women

with POP and no consensus on type or use of devices. Expert opinion is that pessaries are effective and should be considered before surgery in women with symptomatic POP at any level of severity. Pessaries can be used for short term relief before surgery or as a long term non surgical option. They can also be used to predict

surgical outcomes or unmask occult urodynamic stress incontinence pre-operatively 9

10 11.

The POPPY multicentre trial pilot study suggested that pelvic floor muscle training delivered by a physiotherapist to symptomatic women could reduce the severity of prolapse. A Cochrane review on the role of pelvic floor muscle exercises in the management of POP concluded that the evidence from the 3 RCTs included were insufficient to judge their use in the conservative management of POP and that further

trials were needed 12 13 14.

A Cochrane review on the use of vaginal oestrogen creams found limited evidence of

their effectiveness in reducing or preventing the symptoms of prolapse 13 15.

References:

1. CG40 Urinary Incontinence. National Institute of Health & Clinical Excellence. October 2006

2. Maher C, Feiner B, Baessler K et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2010 (4): CD004014

3. Doshani A, Teo RE, Mayne CJ et al. Uterine prolapse. Br Med J. 2007 Oct 20;335 (7624):819- 20

4. Jelovshek J, Maher C, Barber MD. Pelvic organ prolapse. Lancet 2007 Mar 24; 369 (9566):1027-38

5. Thakar R, Stanton S. Management of genital prolapse. BMJ 2002; 324:1258-1262.2.18

6. Jackson S, Smith P. Diagnosing and managing genitourinary prolapse. BMJ 1997;314:875-80.

7. Mouritsen L. Classification and evaluation of prolapse. Best practice research Clinical Obstetrics & Gynaecology. Vol. 19, No. 6, pp 895-911

8. Hendrix S, Clark A, Nygaard I et al. Pelvic organ prolapse in the Women’s Health Initiative: gravity and gravidity. Am J Obst Gynecol. 2002 Jun; 186 (6):1160-6


50

9. Atnip SD. Pessary use and management for pelvic organ prolapse. Obstet Gynecol Clin North Am. 2009 Sep; 36 (3): 541-63

10. Machana t. Ring pessary for all pelvic organ prolapse. Arch Gynecol Obstet. 2010 Sep 17

11. Adams E, Thomson A, Maher C et al. Mechanical devices for pelvic organ prolapse in women. Cochrane Database Syst Rev. 2004 (2): CD004010

12. Hagen S, Stark D, Glazener C et al. A randomised controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan; 20 (1): 45-51

13. Hagen S, Stark D, Maher C et al. Conservative management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2006 (4):CD003882

14. Kuncharapu I, Majeroni B, Johnson D. Pelvic organ prolapse. Am Fam Physician. 2010 May 1;81 (9):1111-7

15. Ismail S, Bain C, Hagen S. Oestrogens for treatment or prevention of pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2010 (9): CD007063


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13.3 Fertility preservation techniques This policy is not applicable to Kingston CCG – Refer to Kingston CCG’s Assisted Conception Guidelines for cryopreservation & cryostorage policy. The following preservation techniques: semen cryostorage, oocyte cryostorage, embryo cryostorage, will be routinely funded by SWL CCGs in the following circumstances:

Where a man or a woman requires medical or surgical treatment that is likely to have a permanent harmful effect on subsequent sperm or egg production. Such treatment includes radiotherapy or chemotherapy for malignant disease.

OR

Where a man or a woman requires on going medical treatment that, whilst on treatment, causes harmful effects on sperm or egg production, impotence or has possible teratogenic effects, and in whom stopping treatment for a prolonged period of time to enable conception is not an option.

It is important to note that the eggs are extracted for cryostorage using drugs and procedures of egg collection normally used for assisted conception; therefore the funding includes assisted conception drugs and procedures as well as the storage costs. This will not progress to IVF/ ICSI or any other assisted conception procedures to form an embryo in these cases, unless this is sought separately later through the assisted conception pathway. Note:

Women should be offered oocyte or embryo cryostorage (without simultaneous assisted conception treatment) as appropriate if they are well enough to undergo ovarian stimulation and egg collection, provided this will not worsen their condition and that sufficient time is available.

Women preparing for medical treatment that is likely to make them infertile should be informed that oocyte cryostorage has very limited success, and that cryopreservation of ovarian tissue is still in an early stage of development.

Storage

If agreed, will be funded for five (5) years. The HFEA would grant a license to cryostore oocytes for ten years. The further extension up to ten years can still be offered to the patient but as a self funded process.

Will not be available where a man or woman chooses to undergo medical or surgical treatment whose primary purpose is that it will render her infertile, such as sterilisation.

Will not be available where a man or woman requests cryostorage for personal lifestyle reasons, such as wishing to delay trying to conceive.

Post-storage Treatment Funding of assisted conception treatments would be made available on the same basis as other patients who have not undergone such storage. Self -funding following cessation of NHS funding Once the period of NHS funding ceases, patients can elect to self-fund for a further period, not to exceed appropriate HFEA regulations on length of storage. Embryo Cryostorage after NHS funded assisted conception


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Suitable embryo’s that are not transferred in IVF/ICSI cycle - Storage will be funded for a minimum period of one (1) year. Rationale Adverse effects associated with a number of medical treatments can impact on fertility, either by direct injury or via systemically administered agents. In some cases the individual’s fertility will return after the treatment is completed but in other cases fertility never returns, or is severely impaired. Technological advances mean that cryopreservation of semen, oocytes, embryos and ovarian/testicular tissue offers opportunities to preserve fertility prior to the start of treatment. NICE Guideline for Fertility, updated 2016, recommends access to cryopreservation and storage associated with treatment induced infertility is considered separately to assisted reproduction services and the general fertility pathway. This policy gives guidance on the funding of cryopreservation and storage of gametes embryos and clarifies that approval of cryopreservation does not guarantee future funding of assisted conception or fertility treatment. Local fertility policies and criteria for eligibility in place in the commissioning area in which the patient is living at the time of application will apply. NICE Guidelines recommend cryopreservation of eggs, sperm and embryos. Currently, the freezing of ovarian and testicular tissue is not normally funded by the NHS as research and evidence are still emerging. NICE gives guidance relating to cryopreservation for people before starting chemotherapy or radiotherapy that is likely to affect their fertility, it does not offer recommendations for cryopreservation relating to other medical or surgical treatments. NICE recommends storage of cryopreserved material for an initial period of 10 years with continued storage of cryopreserved sperm beyond 10 years to men who remain at risk of significant infertility. This policy recommends storage for a period of 5 years and allows for self- funding if further storage is required. This recommendation is made within the context of CCG budget allocation for assisted reproduction services and the associated opportunity costs. Evidence:

NICE Clinical Guideline for Fertility, updated 2016.1

NICE Quality Standards for Fertility Problems.2

Evidence shows cryopreservation to be an effective and safe treatment. References:

1. https://www.nice.org.uk/guidance/cg156 2. https://www.nice.org.uk/guidance/qs73

https://www.nice.org.uk/guidance/qs73


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13.4 Hysterectomy for heavy menstrual bleeding Criteria: CCGs will fund hysterectomy for heavy menstrual bleeding only when:

A levonorgestrel intrauterine system or LNG-IUS (e.g. Mirena) has been trialled for at least 6 months (unless contraindicated

1 or declined by patient) and has not

successfully relieved symptoms (1

st line pharmaceutical treatment).

AND A trial of at least 3 months each of two other pharmaceutical treatment options has not effectively relieved symptoms (or is contraindicated, or not tolerated). These

treatment options include:

Non-steroidal anti-inflammatory drugs (NSAIDs) (2nd line pharmaceutical treatment) e.g. mefenamic acid

Tranexamic acid

Combined oral contraceptive pill

Oral and injected progestogens AND Surgical treatments such as endometrial ablation, thermal balloon ablation, microwave endometrial ablation or uterine artery embolisation (UAE)

2 have either

been ineffective or are not appropriate or are contraindicated

Endometrial ablation has been tried (unless the patient has fibroids >3cm, an abnormal uterus or other contraindications) Note: endometrial ablation is suitable for women who do not want to conceive in the future and should only be offered after full discussion of risks and benefits and other treatment options

Hysterectomy should not be used as a first-line treatment solely for HMB. Hysterectomy should only be considered when:

other pharmaceutical, surgical and radiological treatment options have failed, are contraindicated or are declined by the woman

there is severe impact on quality of life

fibroids (if present) are >3cm in diameter

there is structural/histological abnormality of the uterus

the woman no longer wishes to retain her uterus and fertility

1Contraindications to LNG-IUS use include suspected or confirmed untreated sexually transmitted

infections (STIs), pregnancy, pelvic inflammatory disease (PID), distorted or small uterine cavity, active trophoblastic disease, genital malignancy and Immunosuppression3 2UAE may be appropriate for some women with HMB associated with uterine fibroids.

Rationale


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The levonorgestrel intrauterine system is effective in the treatment of heavy menstrual bleeding and is considerably cheaper than performing a hysterectomy, even if required for many years, and fertility of the woman may be maintained.

A number of effective conservative treatments are available as second line treatments after failure of Mirena or where it is contra-indicated.

Evidence

NICE released guidelines on heavy menstrual bleeding in January 20072

and these form the basis of these proposals.

A Cochrane systemic review concluded that levonorgestrel intrauterine system improved the quality of life of women with menorrhagia as effectively as hysterectomy.

In a NICE study of long-acting reversible contraception3, the average annual cost of Mirena

was estimated at £70. This compares to the average cost to the CCG of performing a hysterectomy of £2,362.

References: 1. Contraindications to the levonorgestrel intrauterine system are severe anaemia,

unresponsive to transfusion or other treatment, distorted or small uterine cavity, genital malignancy, active trophoblastic disease, pelvic inflammatory disease, established or marked immunosuppression.

2. National Institute for Health & Clinical Excellence (NICE) CG44 Heavy menstrual bleeding, Jan 2007

3. National Institute for Health & Clinical Excellence (NICE) CG30 National cost-impact report: Implementing the NICE clinical guideline on long-acting reversible contraception, Dec 2005


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13.5 IVF See Appendix G for individual CCG variations

Criteria Rationale

Duration of subfertility

Couples will be eligible for referral for treatment if they have experienced thirty six months of unexplained infertility or have an identified cause of infertility

84% of women will conceive within one year of regular unprotected sexual intercourse, this increases to 92% after 2 years and 93% after 3 years

Age of woman at start of treatment cycle

The age range will be a local CCG (Borough) decision.

The likelihood of a live birth following assisted conception declines with age. Chances of live birth per IVF cycle are: >20% for women aged 23-35 15% for women aged 36-38 10% for women aged 39 years 6% for women aged 40 years and over

Body mass index of woman

19 – 30 kg/m2,

weight to be maintained for the last 6 months prior to application.

Higher body mass index reduces the probability of success associated with assisted conception techniques

Smoking status of couple

Both partners should have been non-smokers for at least six months prior to commencement of treatment.

Smoking can adversely affect the success rates of assisted reproductive techniques.

Previous cycles The number of NHS funded cycles including the number of frozen embryo transfers and duration of storage of frozen embryos will be a local CCG decision.

The probability of a live birth following the IVF is consistent for the first three cycles but effectiveness of subsequent cycles is uncertain.

Childlessness Neither partner must have any living children from this or previous relationships (including adopted children)

As funding for assisted conception is limited, priority will be given to couples with the greatest need.

Sterilisation Treatments will not be available if either partner has undergone previous sterilisation.

Sterilisation is offered as an irreversible method of contraception and individuals on the NHS are made aware of this at the time of the procedure.

HFEA Code of Practice

Couples must comply to a Welfare of the Child assessment

Human Fertilisation and Embryology (HFE) Act 1990 (as amended) states: Section 13 (5): A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting), and of any other child who may be affected by the birth. Section 2 (1) … “treatment services” means medical, surgical or obstetric services provided ... for the purpose of assisting women to carry children.

Women in same sex couples/ and women not in a partnership

Sub fertility treatment will be funded for women in same sex couples or women not in a partnership if those seeking treatment are demonstrably

This section was copied from the South Central criteria to ensure equality of access to the service.


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sub fertile. In the case of women in same sex couples in which only one partner is sub fertile, clinicians should discuss the possibility of the other partner receiving treatment before proceeding to interventions involving the sub fertile partner. NHS funding will not be available for access to insemination facilities for fertile women who are part of a same sex partnership or those not in a partnership. In circumstances in which women in a same sex partnership or individuals are eligible for sub fertility treatment, the other criteria for eligibility for sub fertility treatments will also apply. Women in same sex couples and women not in a partnership should have access to professional experts in reproductive medicine to obtain advice on the options available to enable them to proceed along this route if they so wish.

FSH The level of FSH would be a local CCG (Borough) decision.

CCGs may wish to add additional criteria to this list based on local circumstances References:

1. National Institute for Health & Clinical Excellence (NICE) CG11Fertility: assessment and treatment for people with fertility problems, Feb 2004

2. National Institute for Health & Clinical Excellence (NICE) CG156 Fertility: assessment

and treatment for people with fertility problems, Feb 2013


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13.6 Uterine fibroids (minimally invasive surgery for) Criteria The CCGs will only fund the following procedures

1, 2, & 3

for uterine fibroids via the prior approval route. Applications for funding can be made in the form of an individual application as per local agreement (this may be Individual Funding Request (IFR) including Exceptional Circumstances application or other prior approval process e.g. referral review via a Clinical Assessment Service (CAS)).

MRI-guided percutaneous laser ablation

Laparoscopic laser myomectomy

MRI-guided focused ultrasound ablation

CCGs will fund uterine artery embolisation when the following criteria are met:

The fibroid is greater than 3 cm in diameter;

AND

The fibroid is causing other symptoms that have a severe impact on the woman’s quality of life such as heavy or painful menstrual bleeding, problems with fertility or pressure symptoms;

AND

The woman wants to avoid surgery and / or retain uterus.

Rationale

Uterine fibroids or leiomyomata are benign tumours that occur in the uterus. They are the most common type of female tumour and their aetiology is not fully understood. They are found anchored to the uterine wall and can vary in size from the size of the grape to large masses

that can be palpated through the uterine wall4.

Current evidence5, 6

on UAE suggests that it is safe enough for routine use and there are symptomatic benefits in the majority of patients in the short term. However more evidence is required on the degree and duration of the benefits and of its effects on fertility.

Evidence review commissioned by NICE showed that3

Laparoscopic Laser Myomectomy may be suitable for small fibroids, most of which are asymptomatic, and therefore the Specialist Advisors to NICE questioned the clinical value of the procedure.

The NICE clinical guideline on heavy menstrual bleeding7

(HMB) states that when surgery for fibroid-related HMB is felt necessary, UAE, myomectomy and hysterectomy must all be considered discussed and documented. UAE should be considered in women with HMB associated with fibroids who want to retain their uterus and /or avoid surgery.

Evidence

NICE commissioned a review of the evidence of UAE5

and found that the procedure was efficacious in reducing mean fibroid volume from between 40- 70% but the reduction in volume did not correlate with changes in symptoms. Improvement in symptoms was reported in between 62-95% of women.


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NICE issued ‘Interventional procedure guidance2 i

n September 2007 which advised that MRgFUS should only be used with special arrangements for consent and for audit and research.

Evidence on the safety and efficacy of MRI-guided percutaneous laser ablation of uterine

fibroids1 is insuf f ic ient

to support its use without special arrangements for consent, audit and research.

Current evidence on the safety and efficacy of laparoscopic laser myomectomy3

does not appear adequate to support the use of this procedure without special arrangements for consent, audit or research.

References:

1. NICE MRI-guided percutaneous laser ablation of fibroids – IPG 30 (2003)

2. NICE MRI-guided transcutaneous focused ultrasound ablation for uterine fibroids---IPG 231 (2007

3. NICE Laparoscopic Laser Myomectomy – IPG 23 (2003)

4. Agency of Healthcare research and clinical quality: Management of uterine fibroids: an update of the evidence. AHRQ Publication No 07-e011 July 2007

5. NICE Uterine artery embolisation for fibroids – IPG 94 (2004)

6. Coleman, Ayiku et al. Systematic review of the efficacy and safety of uterine artery embolisation in the treatment of fibroids. ScHARR University of Sheffield. July 2004.

7. NICE Heavy Menstrual Bleeding Clinical Guideline 44 July 2007

8. Unigwe. S. The clinical and cost effectiveness of MRgFUS for the treatment of uterine fibroids- Horizon Scanning Briefing-Wandsworth NHS July 2008


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14. Orthopaedic & Pain Management

14.1 Acupuncture for Non- Specific Low Back Pain (LBP) CCGs will only fund acupuncture if all of the following criteria are met under the following circumstances.

A maximum of 10 sessions should be offered over a period of 121

weeks as a one-off treatment. Any additional treatments sessions will require prior approval for funding. Acupuncture is more effective if it is offered as an adjunct to other conventional treatments. The treatment may be offered in primary care. Criteria

LBP exists for more than 6 months;

AND

LBP is severe as assessed by one of the grading systems 2

e.g. RMDQ;

AND

All other conventional treatments such as exercise, pharmacological management, physiotherapy etc. have been tried without any improvement in symptoms for a minimum of 6 months;

AND

Acupuncture is used in conjunction with other conventional treatments3

as part of a pain management programme.

Rationale

Acupuncture is more effective for pain relief than no treatment or sham treatment, in measurements taken up to three months. The results also show that for chronic low-back pain, acupuncture is more effective for improving function than no treatment, in the short-term. Acupuncture is not more effective than other conventional and “alternative” treatments. When acupuncture is added to other conventional therapies, it relieves pain and improves function better

than the conventional therapies alone 3.

There is evidence that acupuncture provides a short-term clinically relevant effect when compared

with a waiting list control or when acupuncture is added to another intervention 4.

Traditional acupuncture care delivered in a primary care setting was safe and acceptable to

patients with non-specific low back pain 5.

A study showed a statistically significant difference in pain scores between the acupuncture and no acupuncture groups (P <0.001 at 8 weeks). However, no significant difference in pain between the acupuncture and minimal acupuncture groups was found at 8, 26 and 52 weeks (the

acupuncture group did have slightly better outcomes than the minimal acupuncture group) 6.

Estimates of the prevalence of low back pain vary considerably between studies - up to 33% for

point prevalence, 65% for 1- year prevalence, and 84% for lifetime prevalence 7.


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A study reported that 1 in 4 people can get localised erythema due to acupuncture as a side-effect 8.

The QALY gain for the acupuncture group over 24 months was 1.453 (0.248) compared to a mean of 1.426 (0.191) for the usual care group. The mean incremental health gain from Low Back Pain acupuncture at 24 months was 0.027 QALYs, leading to a base case estimate of £4241 per QALY

gained 9.

References:

1. NICE. Low back pain: early management of persistent non-specific low back pain. Clinical Guideline No 88. : National Institute for Health and Clinical Excellence. 2009

2. Karen J Sherman Daniel C Cherkin, Laura Ichikawa, Andrew L Avins,William E Barlow, Partap S Khalsa and Richard A Deyo. Characteristics of patients with chronic back pain who benefit from acupuncture. BMC Musculoskeletal Disorders 2009, 10:114

3. Furlan AD, van Tulder MW, Cherkin D, Tsukayama H, Lao L, Koes BW, Berman BM Acupuncture and dry-needling for low back pain (Review). The Cochrane Library 2011, Issue 2

4. Sidney M. Rubinstein • Marienke van Middelkoop • Ton Kuijpers •Raymond Ostelo • Arianne P. Verhagen • Michiel R. de Boer •Bart W. Koes • Maurits W. van TulderA systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain . European Spine Journal, August 2010, vol./is. 19/8(1213-1228), 0940-6719 (August 2010)

5. KJ Thomas, H MacPherson, J Ratcliffe, L Thorpe, J Brazier, M Campbell, M Fitter, M Roman, S Walters and JP Nicholl Longer term clinical and economic benefits of offering acupuncture care to patients with chronic low back pain Health Technology Assessment 2005; Vol. 9: No. 32

6. Brinkhaus B, Witt CM, Jena S, Linde K et al. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med. 2006; 166 (4):450-457.

7. Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000; 13 (3):205-217.

8. HG Endres et al. An internal standard for verifying the accuracy of serious adverse event reporting: the example of an acupuncture study of 190,924 patients. European Journal of Medical Research 2004 9: 545-551. http://www.medicine.ox.ac.uk/bandolier/band151/b151- 6.html

9. Ratcliffe J, Thomas KJ, MacPherson H, Brazier J. A randomised controlled trial of acupuncture care for persistent low back pain: cost effectiveness analysis. BMJ. 2006; 333 (7569):626

http://www.medicine.ox.ac.uk/bandolier/band151/b151-6.html

http://www.medicine.ox.ac.uk/bandolier/band151/b151-6.html


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14.2 Autologous chondrocyte implantation NICE has produced technical guidance on the use of autologous chondrocyte implantation (ACI) Criteria:

ACI is NOT recommended for the treatment of articular cartilage defects except in the context of ongoing or new clinical studies that are designed to generate robust and relevant outcome data.

SWL CCGs will not routinely fund health care interventions that NICE has recommended should only be undertaken in the context of research. Clinicians wishing to undertake such procedures should ensure they fulfil the normal requirements for undertaking research. Rationale

If trials are undertaken patients should be fully informed of the uncertainties about the long-term effectiveness and potential adverse effects of this procedure.

Any outcome data from trials should include measurement of health related quality of life and long-term follow up.

Evidence NICE assessed a number of trials but found inconsistent evidence of the clinical effectiveness of ACI. The studies were heterogeneous in terms of the patients recruited, the ACI technique used and the measures used to assess outcome. In addition, comparative trial follow-up was limited to 1–2 years. The longer term case series showed similar benefits under most modes of treatment. There were no trials comparing ACI (or any of the other interventions in the studies reviewed) with conservative management. References:

1. NICE TA 89. National Institute for Health & Clinical Excellence (NICE). The use of autologous chondrocyte implantation for the treatment of cartilage defects in knee joints. May 2008


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14.3 Carpal tunnel syndrome (surgical treatment of) This policy is not applicable to St George’s Hospital - Refer to the ‘St. George’s Hospital Carpal Tunnel Management Guidelines & Referral Protocol’. All referrals should be through an agreed pathway to optimise access to conservative treatment. Criteria The CCG will fund carpal tunnel surgery where:

Symptoms persist for more than six months after conservative therapy with oral/local corticosteroid injections and/or splinting. If there is no improvement in mild-moderate symptoms after 6 months conservative management which includes nocturnal splinting used for at least 8 weeks (documentation of dates and type(s) of conservative measures is required)

2

*This criterion includes all individuals whose symptoms are severe where six months conservative management would be detrimental to the management of the condition. Evidence should be provided to demonstrate severity of symptoms. Patients have a right to be fully informed about this procedure. As part of this process, clinicians should use the Shared Decision Making Tool to explain the treatment to patients, together with its risks and benefits:

Patient Decision Aid – Carpal Tunnel Syndrome

This policy update represents a change in the duration of expected conservative management of CTS from 3 to 6 months prior to referral for surgical opinion and adds detail to the methods of conservative management. This is a departure from the RCS recommendation of 3 months of conservative management. However, the policy allows for early surgical intervention based on clinical assessment as necessary. Evidence and rationale

Evidence suggests that surgical treatment is more effective than splinting and hand function in midterm and long term (6-18 months), but evidence is conflicting when

comparing conservativetreatment to surgery in the short term3,4. An RCT in 2009, showed

outcomes were better in terms of hand function and symptoms at 3 months and one year

compared to a control group1.

No RCTs published at present explore the optimal timing strategy for

surgery4. There is no validated evidence to identify which patients should undergo surgery as

initial treatment1.

OR

2 European consensus guideline: Carpal Tunnel Syndrome - Hand Surgeons, Hand Therapists, and Physical

Medicine and Rehabilitation Physicians Agree on a Multidisciplinary Treatment Guideline - Results from the European HANDGUIDE Study (2014), advises the following:

the duration of wearing the splint should be 4-12 weeks (at night or both at night and day in case of aggravating activities)

the number of steroid injections up to 3; at intervals of 2-3 months.


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There is neurological deficit or median nerve denervation for example sensory blunting, muscle wasting or weakness of thenar abduction.

OR

Severe symptoms significantly interfering with daily activities.

Rationale

Carpal Tunnel Syndrome (CTS) presents with symptoms ranging in severity and should be recognised before permanent deficits develop. Risk of nerve damage is low for most patients and the relationship between symptoms and nerve conduction study results is not strong.

Conservative treatment offers short-term benefit (0-3 months) and symptom severity can be seen to improve after 2-7 weeks of initial treatment.

Conservative treatment offers the opportunity to avoid surgery and have the advantage of being relatively inexpensive and without serious adverse side effects.

Steroids (oral and local injection) and nocturnal splinting in the neutral position are considered the most effective conservative therapies.

In the mid and longer term (3-18 months), surgery is more effective than conservative treatment.

Open carpal tunnel release/decompression is the most common surgical treatment performed. The choice of endoscopic or open technique is usually guided by surgeon’s experience and patient’s preference.

Evidence

This approach is supported by evidence from several recent systematic reviews, randomized control trials, guidelines (including American Academy of Orthopaedic Surgeons 2009) and

recommendations1-8

.

Studies have shown that provocative physical tests such as Phalen’s sign and Tinel’s sign

range in sensitivity (8-100%) and specificity (55-87%) and are less reliable in advanced CTS7.

There is moderate evidence that splints are effective in decreasing symptom severity and two

reviews suggests neutral position is more effective than wrist cock-up splint.1,3,5,6

Two systematic reviews suggest strong evidence of effectiveness of oral steroids compared to

placebo, but there is no evidence of difference in effectiveness of dosage3,5

.

In the short term (0-3months), there is strong evidence of the effectiveness of steroid injections in providing symptom relief and moderate evidence local steroid injections are more

effective than either oral steroids or systemic corticosteroids injections1,3,5

. There is no evidence in effectiveness of short acting compared to long-acting corticosteriod injection in the

short term3.

Other non-surgical treatments, such as non-steroidal anti-inflammatories, diuretics, botulinum toxin, therapeutic exercises, vitamin B6 and physical treatments (e.g. ultrasound, low power

laser) have limited or no evidence that they are effective in the short term3,5,6

.

In the literature, conservative treatment is given preference in mild to moderate cases and surgical treatment is mainly applied in severe cases including nerve denervation. Surgical

treatment is also indicated in cases in which initial conservative management fails4.

Evidence suggests that surgical treatment is more effective than splinting and hand function in midterm and long term (3-18 months), but evidence is conflicting when comparing

conservative treatment to surgery in the short term3,4

. An RCT in 2009, showed outcomes were better in terms of hand function and symptoms at 3 months and one year compared to a

control group1.

No RCTs published at present explore the optimal timing strategy for surgery4. There is no


64

validated evidence to identify which patients should undergo surgery as initial treatment1

.

One study found that 75% of patients surveyed (n=4000) having surgery under usual NHS

conditions found the operation an unqualified success about two years after surgery7

.

There is no unequivocal evidence that suggest one surgical treatment is more effective than

the other1,4

. References:

1. Ono S, Clapham PJ and Chun KC. Optimal management of carpal tunnel syndrome. Int J Gen Med 2010:3 255-261.

2. Shores JT and Lee WPA. A Evidence-Based Approach to Carpal Tunnel Syndrome. Plast Reconstr Surg 2010;126:6 2196-204.

3. Huisstede BM, Hoogvliet P, Randsdorp MS, Glerum S, Middlekoop M, Koes BW. Carpal Tunnel Syndrome. Part I: Effectiveness of Nonsurgical Treatments- A Systematic Review. Arch Phys Med Rehabil 2010;91 981-1004.

4. Huisstede BM, Hoogvliet P, Randsdorp MS, Glerum S, Middlekoop M, Koes BW. Carpal Tunnel Syndrome. Part II: Effectiveness of Surgical Treatments- A Systematic Review. Arch Phys Med Rehabil 2010;91 1004-1024.

5. Piazzini DB, Aprile I, Ferrara PE, et al. A systematic review of conservative treatment of carpal tunnel syndrome. Clin Rehabil. 2007; 21 (4): 299-314

6. Muller, M., Tsui, D., Schnurr, R., Biddulph-Deisroth, L., Hard, J., & MacDermid, J.C.. Effectiveness of hand therapy interventions in primary management of carpal tunnel syndrome: a systematic review. Journal of Hand Therapy, 2004; 17(2), 210-228

7. Bland JDP. Carpal Tunnel Syndrome. Clinical Review. 2007 BMJ; 335:343-6 8. BSSH Evidence for Surgical Treatment Carpal Tunnel Syndrome (CTS)

http://www.bssh.ac.uk/education/guidelines/carpal_tunnel_syndrome.pdf




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14.4 Discectomy for lumbar disc prolapse (elective) Criteria

The patient must be 18 years or older;

AND

The patient has had magnetic resonance imaging, showing disc herniation (protrusion, extrusion, or sequestered fragment) at a level and side corresponding to the clinical symptoms; AND The patient has radicular pain (below the knee for lower lumbar herniation, into the anterior thigh for upper lumbar herniation) consistent with the level of spinal involvement.

OR

There is evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raise–positive between 30° and 70° or positive femoral tension sign); AND Symptoms persist despite some non-operative treatment for at least 6 weeks (e.g. analgesia, physical therapy, bed rest etc.) provided that analgesia is adequate and there is no imminent risk of neurological deficit.

Rationale

Herniated lumbar discs account for less than 5% of lower back pain but are responsible for most cases of sciatica (nerve root pain). Ninety per cent of cases of sciatica resolve with

conservative management1.

The primary aim of surgery is to provide relief of symptoms in those patients who have failed to respond to conservative treatment.

A Cochrane review concluded that surgical discectomy for carefully selected patients with sciatica due to lumbar disc prolapse, provides faster relief from an acute attack than conservative management although any positive and negative effects on the lifetime natural history of the disease are unclear.

In the absence of clear indications for surgery, postponing surgery to further assess progress may delay recovery but does not produce long-term harm.

There is little evidence on the optimal timing of surgery.

Microdiscectomy is broadly as effective as open/macro discectomy.

Microdiscectomy is a longer procedure than open discectomy but there are no differences in

peri-operative bleeding, length of hospitalisation or formation of scar tissue1.

Discectomy is cost effective with a willingness to pay 40,000 Euros per QALY.

Evidence

A 2008 Cochrane review concluded that surgical discectomy for carefully selected patients with sciatica due to lumbar disc prolapse provides faster relief from the acute attack than


66

conservative management. They also concluded that open and microdiscectomy are more

effective than chemonucleolysis 1.

There are several low quality RCTs that have compared discectomy with conservative management (including epidural injection, physiotherapy and education). They conclude that discectomy provides better clinical outcomes than conservative management and it is more

effective than conservative management at one year 2. Systematic reviews

3, 4 undertaken in

2008 and 2009 also agreed with these findings. No significant differences were found between

surgery and usual conservative care in any of the clinical outcomes after 1 and 2 years 2

.

The evidence for minimally invasive techniques for discectomy remains unclear. One systematic review on the effectiveness of nucleoplasty procedure concluded that nucleoplasty is potentially effective in patients with symptomatic disc herniation who are refractory to conservative treatment, but higher quality evidence is necessary to confirm efficacy and risks 5.

References:

1. Gibson JNA, Waddell G. Surgical Interventions for lumbar disc prolapse (Update). The Cochrane Collaboration. 2007

2. Jacobs W, van Tulder M, Arts M et al. Surgery versus conservative management of sciatica due to a lumbar herniated disc: a systematic review. Eur Spine J (2011) 20:513-522

3. Chou R, Baisden J, Carragee EJ, Resnick DK, Shaffer WO, Loeser JD. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine (Phila Pa 1976). 2009 May 1;34(10):1094-109.

4. Jordan J, Konstantinou K, O’Dowd J. Herniated Lumbar Disc Clinical Evidence 2009;03:1118

5. Gerges F, Lipsitz S, Nedeljkovic S. A systematic review on the effectiveness of the nucleoplasty procedure for Discogenic Pain. Pain Physician 2010; 13:117-132.

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Chou%20R%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Chou%20R%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Carragee%20EJ%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Carragee%20EJ%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Shaffer%20WO%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Shaffer%20WO%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract


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14.5 Dupuytren’s contracture (fasciotomy/fasciectomy) (surgical treatment of) This policy is not applicable to St George’s Hospital - Refer to the ‘St. George’s Hospital Dupuytren's Contracture Guidelines & Referral Checklist’. Surgery for mild Dupuytren’s contracture is not normally funded. Moderate and severe diseases- Surgery is the only effective method of treatment for Dupuytren's contracture. However, patients must be advised that approximately 40% of people will have a recurrence following surgery: Dupuytren’s contracture can return to the same place on the hand or may reappear somewhere else. Recurrence is more likely in younger patients; if the original contracture was severe; or if there is a strong family history of the condition. BSSH classifies Dupuytren’s disease as:

Mild: no functional problems, no contracture or metacarpophalangeal joint contracture of less than 30°.

Moderate: functional problems, metacarpophalangeal joint contracture of 30° to 60°, proximal interphalangeal joint contracture of less than 30°, or first web contracture.

Severe: severe contracture of both metacarpophalangeal joint (greater than 60°) and proximal interphalangeal joint (greater than 30°).

Collagenase clostridium histolyticum is not normally funded for treating Dupuytren’s contracture due to limited evidence. Radiation therapy for early Dupuytren's disease is not normally funded due to limited evidence. Criteria for surgical treatment

Metacarpophalangeal joint contracture or proximal interphalangeal joint contracture of

30 degrees or more at least in one joint (inability to put hand flat on table) 1

OR

Patient has at least 10 degrees loss of extension in 2 or more joints 2.

OR

Metacarpophalangeal joint contracture or proximal interphalangeal joint contracture is

less than 30 degrees 1

at least in one joint AND All additional risk factors for aggressive progression are present, specifically - bilateral

disease, family history of condition, ectopic lesions, age under 50 and male gender 7

AND

There is significant threat to hand function 1,7

Evidence

Symptoms of Dupuytren’s contracture are often mild and painless and do not require treatment. Disease progression is unpredictable; where the contractures themselves are not

functionally limiting management should compose of reassurance and observation 1.

Surgery should not be considered a cure and patients should be advised of the risks of


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recurrence when deciding whether to consider surgical intervention 1.

As the condition progresses it can become difficult to fully extend the finger(s) affected,

eventually becoming permanently fixed in a flexed (bent) position 3

affecting activities of daily living.

Treatment seeks to restore hand function and prevent progression, however the underlying

disease will remain 1. Recurrence following surgical intervention is common, ranging from 30-

40% following open partial fasciectomy to 60% following needle aponeurotomy/fasciectomy 4.

Evidence is lacking on the effectiveness of non-surgical treatments for Dupuytren’s

contracture such as vitamin E cream ultrasonic therapy and radiation therapy, 5, 6

. Radiation therapy should only be used with special arrangements for clinical governance, consent and

audit or research 6.

There is a lack of evidence on the long-term efficacy of collagenase injections7.

Clinical consensus suggests surgical intervention is recommended when metacarpophalangeal joint contracture or proximal interphalangeal joint contracture reaches

30 degrees 1

.

Dupuytren’s contracture has a greater tendency for aggressive progression and recurrence after surgical treatment in the presence of 5 factors - bilateral disease, family history of

condition, ectopic lesions, age under 50 and male gender 8.

References:

1. British Society for surgery of the hand (2010) Evidence for surgical treatment – Dupuytren’s disease

2. Lee S and Baytion M. Dupuytren contracture. E-Medicine. December 2006 3. NHS Choices http://www.nhs.uk/Conditions/Dupuytrens-contracture/Pages/Introduction.aspx

(accessed 10/01/2012) 4. Chen et al. Cost-effectiveness of open partial fasciectomy, needle aponeurotomy and

collegenase injection for Dupuytren contracture. Journal of hand Surgery, 2011 vol 36 pp 1826 - 1833

5. National Institute for Health and Clinical Excellence (NICE). Needle fasciotomy for Dupuytren's contracture. Interventional procedure guidance 43. London: NICE; 2004

6. National Institute for Health and Clinical Excellence (NICE). Radiation therapy for early Dupuytren's disease. Interventional procedure guidance 368. London: NICE; 2011

7. Map of Medicine Dupuytren's contracture – management http://healthguides.mapofmedicine.com/choices/map/dupuytren_s_contracture2.html#anchorFu rtherInfo (accessed 18/01/2012)

8. Hindocha et al. Dupuytren’s Diathesis Revisited: Evaluation of Prognositic Indicators for risk of Disease Recurrence. The Journal of Hand Surgery 2004 Vol 31A pp 1626-1633

http://www.nhs.uk/Conditions/Dupuytrens-contracture/Pages/Introduction.aspx

http://healthguides.mapofmedicine.com/choices/map/dupuytren_s_contracture2.html#anchorFurtherInfo




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14.6 Epidural injections for lumbar back pain CCGs will fund lumbar interlaminar, transforaminal and caudal epidural injections for patients with radicular pain due to herniated disc (sciatica) when the following criteria have been met. Criteria

The patient must be 18 years or above;

AND

The patient has radicular pain (below the knee for lower lumbar herniation, into the anterior thigh for upper lumbar herniation) consistent with the level of spinal involvement. OR There is evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raise–positive between 30° and 70° or positive femoral tension sign).

AND

Symptoms persist despite some non-operative treatment for at least 3 weeks (e.g. analgesia, physical therapy, bed rest etc.).

AND

The patient is part of a comprehensive pain management programme and all conservative management options (physiotherapy treatments and guided exercise programmes, pharmacotherapy including analgesia and muscle relaxants) have been tried and failed,

AND

Patient experienced moderate to severe pain (assessed by a pain specialist using a Visual Analogue Pain Scale) and the impact of pain (using the Brief Pain Inventory, as per national pain audit OR Roland Morris Disability Questionnaire (RMDQ) as appropriate, lasting for more than 12 months.

Repeat injections The patient must meet all the following three criteria to be considered for repeat injections with a

minimum period of 6 months between injections:

1. Positive response is defined as documented evidence of >50% pain relief for more than 4 months, AND 2. Documented evidence of improved function using a validated tool (VAS scale) and/or functional outcome measure that can be attributed to the effects of the injection,

AND 3. The patient has been reviewed by a pain specialist prior to each injection. Patients may receive up to three injections a minimum of 6 months apart provided there has been >50% reduction in symptoms for 4 months and improved function using a validated tool (VAS scale)I and documented impact on quality of life as measured by British Pain Inventory or a locally agreed questionnaire (RMDQ).


70

Injections MUST be carried out under radiological guidance. Epidural injections beyond the first three injections are provided as part of a comprehensive pain management programme. Patients may receive up to six injections 2-3 months apart provided there has been >50% reduction in symptoms for six weeks. Evidence

Epidural injection for the management of spinal pain is one of the commonest interventions performed in many countries although there is still some uncertainty regarding their

effectiveness and safety1. Spinal pain is a common cause of chronic pain with lifetime

prevalence 54-80%. Annual prevalence of chronic low back pain ranges from 15-45%.

A number of systematic reviews2, 3

concluded that for sciatica or prolapsed lumbar disc with radiculopathy, there is fair evidence that epidural steroid injection is moderately effective for short-term (but not long term) symptom relief. They found insufficient evidence to determine the optimal route of administration.

Another systematic review, by Manchikanti et al4

, looked at the epidural administration by the caudal, interlaminal and transforaminal routes separately. They found strong evidence of the effectiveness of the caudal route in the short and long term, and moderate evidence for the effectiveness of the transforaminal and interlaminal approaches in the short and long term.

Complications The most common type of complications are related to needle placement and drug administration including dural puncture, spinal cord trauma, subdural injections and abscess formation. References:

1. Henschke N, Kuijpers T, Rubinstein S et al. Injection therapy and denervation procedures for chronic low back pain: a systematic review. Eur Spine J (2010) 19:1425-1449

2. Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine (Phila Pa 1976). 2009 May 1;34(10):1078-93.

3. Parr AT, Diwan S, Abdi S. Lumbar interlaminar epidural injections in managing chronic low back pain and lower extremity pain: a systematic review. Pain Physician 2009:12:1:163-188.

4. Manchikanti L, Boswell MV, Datta S, Fellows B, Abdi S, Singh V, Benyamin RM, Falco FJ, Helm S, Hayek SM, Smith HS; ASIPP Comprehensive review of therapeutic interventions in managing chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):E123-98.

14.7 Ganglia (Excision of ganglia) Criteria for surgical removal

The ganglia are painful seed ganglia1.

OR

http://www.ncbi.nlm.nih.gov/pubmed/19363456?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=3





71

The ganglia are mucoid cysts arising at the distal interphalangeal joint and disturbing

nail growth or discharging2.

OR

The ganglion is causing significant functional impairment and/or pain1.

Clinicians could consider aspiration as an alternative to excision due to its lower complication rates. The higher recurrence rates for treatment with aspiration should be considered in this assessment

(20% for aspiration vs. 10% for surgical)3.

If aspiration has not been attempted, referrals may be redirected to a GP with Special Interest (GPwSI) in minor surgery for aspiration where available. Ganglia on the feet should be referred to a GPwSI in

Podiatry where available 2.

Rationale

Most ganglia are symptom free, but some give pain, weakness, mobility disorders or pressure

neuropathy 2

.

The recurrence rate after excision of wrist ganglia is between 10-45%1, 2

.

Evidence The Trent regional audit (which reviewed the progress of 729 ganglions up to 10 years from attendance) indicated that 33% of dorsal ganglions and 45% of volar-wrist ganglia would resolve

spontaneously in six years2

. References:

1. British Society of Hand Surgeons Recommendations for ganglia. 2008. http://www.bssh.ac.uk/education/guidelines/ganglion.pdf

2. FD Burke et al. Primary care referral protocol for wrist ganglia. Postgrad Med J 2003;79:329-331.

3. Health Technology Assessment Database 2012 Issue 1. Rapid Review, Clinical treatments for wrist ganglia. Report No. 63. Stepney: Australian Safety and Efficacy Register of New

Interventional Procedures, Surgical (ASERNIP‐ S), 2008:41. R Soobrah. Is surgery more effective than aspiration with or without steroid injection in the management of ganglion cysts? Best Evidence Topics. 2010 http://www.bestbets.org/home/bets-introduction.php (accessed 17/04/2012)

14.8 Hip replacement surgery (primary) Criteria The CCG will agree to fund elective surgery when any one of the following sets of criteria have been completely met:

http://www.bssh.ac.uk/education/guidelines/ganglion.pdf

http://www.bssh.ac.uk/education/guidelines/ganglion.pdf

http://www.bestbets.org/home/bets-introduction.php


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Group 1 Adults where the patient’s Oxford Hip score (Appendix H) is ≤ 26 on the 0 to 48

system; or ≥ 34 on the 60 to 12 system1

OR

Group 2

Patient complains of severe joint pain (as defined in Appendix H)2;

AND Has severe functional limitation despite the use of an extended course of non-

surgical treatments3

such as adequate doses of appropriate analgesia (see Appendix H), weight control treatments and physical therapies; AND

Has radiographic evidence of joint damage 3

(e.g. loss of joint space, marginal

osteophytes)3

, 4.

OR

Group 3

Patient complains of severe joint pain (as defined in Appendix H)3;

AND Patient has minor to moderate functional limitation, despite the use of an extended

course of non-surgical treatments 3

such as adequate doses of appropriate analgesia (see Appendix H), weight control treatments and physical therapies. AND

Has radiographic evidence of joint damage3

(e.g. loss of joint space, marginal

osteophytes)3.4

.

OR

Group 4

Patient complains of mild to moderate joint pain (as defined in Appendix H)5;

AND Has severe functional limitation, despite the use of an extended course of non-surgical treatments such as adequate doses of appropriate analgesia (see Appendix I), weight control treatments and physical therapies. AND Has radiographic evidence of joint damage (e.g. loss of joint space, marginal osteophytes)


73

Note: Please refer to Appendix H for classifications of the pain levels and functional limitations. Prior to referral Patients should meet all of the following criteria:

1. There is evidence that conservative measures (see section 3.2) have been trialled for at least six months and failed to alleviate pain and/or disability.

2. A holistic assessment of the patient has been undertaken 3. Patients with a BMI of over 30 must be advised to lose weight to reduce the risk

of complications and improve outcomes. 4. Patients with a BMI of over 30 should be offered referral (where available) or

signposted to local weight management programmes to support weight loss. 5. Patients who smoke should stop smoking for at least eight weeks prior to surgery

to reduce the risk of surgery and post-surgery complications. Patients should be offered referral to a stop smoking programme.

6. The patient is suffering from persistent pain which has not been controlled by conservative measures and which has been documented over a period of six

7. The patient has functional limitation which has not been improved by conservative measures and which has been documented over a period of six months.

8. There is evidence of joint damage. 9. The patient is assessed with a score of 15 or over using the locally modified

version of the New Zealand score 10. The patient has been advised to use the NHS Patient Decision Aids to support

making an informed choice and is willing to consider surgery. All patients who smoke should be referred to appropriate smoking cessation services. All patients who are overweight (BMI 25-29.9) or obese (BMI > 30) should be encouraged and supported to reduce their BMI, including referral to specialist weight management services where indicated. Patients who are morbidly obese (BMI > 40) should not normally be listed for knee joint replacement surgery (and should proceed for funding via the IFR process) unless all reasonable attempts have been made to reduce weight and there are exceptional circumstances such as:

Patients whose pain is so severe and/or mobility so compromised that they are in immediate danger of losing their independence and that joint replacement would relieve this threat, or

Patients in whom the destruction of their joint is of such severity that delaying surgical correction would increase the technical difficulty of the procedure.

Initial management of osteoarthritis Evidence from the Musculoskeletal National Service Framework (NSF), NICE, the GP Training

Network and the National Institute of Health (NIH) Consensus Panel8

suggests that management of common musculoskeletal problems, including hip pain, should ideally be undertaken in primary care. Patients should be referred for a specialist opinion on total joint replacement when prolonged use of all conservative means has failed to alleviate the patient’s pain and disability. This initial non-surgical management of hip pain due to osteoarthritis (OA) may include (as appropriate for the individual patient) weight reduction, activity modification, patient specific exercise programmes, adequate doses of NSAIDS and analgesics, joint injection, walking aids, home adaptations, curtailment of inappropriate activities and other forms of physical therapies. Note on Hip Resurfacing

NICE guidance for metal on metal (MoM) hip-resurfacing 9,10

states that “MoM hip resurfacing arthroplasty is recommended as one option for people with advanced hip disease who would otherwise receive and are likely to outlive a conventional primary total hip replacement”. In considering hip resurfacing arthroplasty, it is recommended that surgeons take into account activity levels of


74

potential recipients and bear in mind that the current evidence for the clinical and cost-effectiveness of MoM hip resurfacing arthroplasty is principally in individuals less than 65 years of age. This guidance indicates that resurfacing is recommended for younger patients in order to avoid future revision surgery. However, there is uncertainty over the long-term reliability of hip resurfacing. MoM hip resurfacing should only be only be performed by a surgeon with specific training in this technique. As part of the consent process patients should be made aware of the medium to long term safety and reliability of MoM devices and the likely outcome of revision surgery compared to conventional total hip replacement. References:

1. Murray, D. W., Fitzpatrick, R., Rogers, K., Pandit, H., Beard, D. J., Carr, A. J., and Dawson, J. The use of the Oxford Hip and Knee Scores. J Bone Joint Surg [Br] August 2007

2. Dreinhofer KE, Dieppe P, Sturmer T et al. Indications for total hip replacement: comparison of assessments of orthopaedic surgeons and referring physicians. Ann Rheum Dis 2006: 65: 1346-1350

3. National Institutes of Health. National Institutes of Health Consensus Development Conference: Statement- Total hip replacement. September 12-14, 1994

4. Johnson SA, Kalairajh Y, Moonot P et al. Fast track assessment clinic: selection of patients for a one-stop assessment clinic. Ann R Coll Surg 2008; 90: 208-212

5. Dreinhofer KE, Dieppe P, Sturmer T et al. Indications for total hip replacement: comparison of assessments of orthopaedic surgeons and referring physicians. Ann Rheum Dis 2006: 65: 1346-1350

6. British Orthopaedic Association. Primary Hip Replacement: a guide to good practice. August 2006

7. Busato A, Roder C, Herren S et al. Influence of high BMI on functional outcome after total hip arthroplasty. Obesity Surgery, May 2008: 18/5 (595-600); 0949-2658

8. The Musculoskeletal Services Framework – A joint responsibility: doing it differently. Department of Health,2006.

9. Alberta Bone and Joint Institute. Evidence Review: Appropriateness Criteria for THA and TKA. Version 1: May 17,2006.

10. National Institute for Health & Clinical Excellence (NICE) TA44 Hip disease - metal on metal hip resurfacing, June 2002


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14.9 Knee arthroscopy This policy only covers the use of knee arthroscopy as a surgical intervention or diagnostic tool for chronic knee pain. It does not cover arthroscopy recommended by an orthopaedic specialist in those under 18 years of age or in adults following acute injury with suspected internal joint derangement, septic arthritis or suspected malignancy. Assessment of knee pathology should include a competent clinical examination (or MRI scans if there is diagnostic uncertainty or red flag signs/symptoms/conditions). If examination and/or MRI have demonstrated clear evidence of an internal joint derangement and conservative treatment has failed, or it is clear that conservative treatment will not be effective, knee arthroscopy should be considered. Arthroscopy will NOT be routinely funded as primary diagnostic tool. Primary/Community Care In patients with chronic knee pain, where evidence is provided that a comprehensive course of conservative treatment (lifestyle advice, optimum pharmacological treatments rest, self or physiotherapy guided mobilisation and strengthening exercises, intra-articular corticosteroids) has been tried for 12 months and failed, patients can be referred for specialist consultation. Conservative management can include advice, physio and support from the intermediate musculoskeletal services and pain management with non-steroidal anti-inflammatory drug (NSAID) painkillers. A trial of conservative management should be the first-line treatment for all patients with degenerative meniscal tears. (Khan M, 2014) Note: Evidence of symptoms and compliance with conservative management must be documented in the patient’s clinical records and demonstrated in any referral to secondary care. However, where patients have mechanical locking or symptoms that worsen with conservative treatment, these patients should be referred after shorter periods of conservative treatment. Referral for MRI scans should only be made by secondary care consultants or specialists working in CCG commissioned MSK services. Criteria CCGs will only fund arthroscopy of the knee for the following diagnostic indications:

Patients with medial knee pain with suspected Plica syndrome

OR

Suspected chondromalacia patellae

OR

When information is required on the degree and distribution of joint damage to inform the type of knee replacement that should be performed

Current evidence suggests that arthroscopic knee washout alone should not be used as a treatment for

osteoarthritis because it cannot demonstrate clinically useful benefit in the short or long term. (NICE)

ORPatients without mechanical symptoms aged over 65.

However, knee arthroscopy will not be funded for:

procedures that are not recommended by NICE, eg lavage for OA; procedures restricted by NICE, eg knee meniscus replacement with biodegradable scaffold,

mosaicplasty, autologous chondrocyte implantation and trochleoplasty for patellar instability;

debridement, except in cases where there is mechanical locking


76

Where a competent clinical examination or MRI scan has demonstrated clear evidence of a significant internal joint derangement which is likely to be the cause of the symptoms and suitable for treatment by knee arthroscopy, surgery will be funded. CCGs will only fund arthroscopy of the knee for the following therapeutic indications:

Removal of loose body causing mechanical symptoms

OR

Meniscal surgery (repair or resection)

OR

Ligament repair or reconstruction (including lateral release)

OR

Synovectomy

OR

Treatment of articular defects e.g. microfracture

OR

Debridement of arthritis in younger patients (i.e. under 60 years of age) delaying need for total knee replacement.

Rationale

Knee arthroscopy should not be considered a primary diagnostic tool. MRI should be used where there is diagnostic uncertainty. In the majority of cases clinical assessment (history and examination) by an experienced clinician will provide a diagnosis and demonstrate if internal joint derangement is present.

Red flag symptoms: recent trauma, constant progressive non-mechanical pain (particularly at night), previous history of cancer, long term oral steroid use, history of drug abuse or HIV, fever, being systemically unwell, recent unexplained weight loss, persisting severe restriction of joint movement, widespread neurological changes and structural deformity

Red flag conditions: infection, carcinoma, nerve root impingement, bone fracture, avascular necrosis

Evidence NICE guidance states that arthroscopic lavage and debridement alone should not be used as a treatment for osteoarthritis unless the patient has knee osteoarthritis with a clear history of mechanical locking NOT swelling, giving way or X-ray evidence of loose bodies because it cannot demonstrate clinically useful benefit in the short or long term. References:

1. CG59 Osteoarthritis. National clinical guideline for care and management in adults.

National Institute of Health & Clinical Excellence 27th Feb 2008


77

2. IPG230 Arthroscopic knee washout, with or without debridement, for the treatment of osteoarthritis. National Institute of Health & Clinical Excellence August 2007

3. Laupattarakasem W, Laopaiboon M, Laupattarakasem P et al. Arthroscopic debridement for knee osteoarthritis. Cochrane Database of Systematic Reviews 2008, Issue 1. Art No: CD005118


78

14.10 Knee replacement surgery (primary) Criteria Candidates for elective Total Knee Replacement (TKR) should have: Moderate* to severe* persistent pain not adequately relieved by an extended course of non-surgical*

management (including weight management where appropriate – see below) AND clinically significant functional limitation resulting in a diminished quality of life AND radiographic evidence of joint damage. The CCG will agree to fund elective surgery when any one of the following sets of criteria has been completely met:

Group 1 When the patient’s Oxford Knee score (Appendix I) is ≤ 20 on the 0 to 48 system; or

≥ 40 on the 60 to 12 system 1 2

OR

Group 2 Where the patients complains of intense or severe symptomatology (see Appendix I) not adequately relieved by an extended course of non-surgical

management1

such as adequate doses of appropriate analgesia (see Appendix I), weight control treatments and physical therapies AND Has radiological features of severe disease; AND Has demonstrated disease within all three compartments of the knee (tri- compartmental) or localised to one compartment.

OR

Group 3 Where the patients complains of intense or severe symptomatology (see Appendix I) not adequately relieved by an extended course of non surgical management such as adequate doses of appropriate analgesia (see Appendix I), weight control treatments and physical therapies AND Has radiological features of moderate disease; AND Is troubled by limited mobility or instability of the knee joint.

OR

Group 4 The patient complains of severe symptomatology (see Appendix I) not adequately relieved by an extended course of non surgical management such as adequate doses of appropriate analgesia (see Appendix I), weight control treatments and physical therapies;


79

AND Has radiological features of slight disease; AND Is troubled by limited mobility or stability of the knee joint.

Note: Please refer to the Appendix I for the classifications of symptoms, radiology and localisation Prior to referral

Any other pre-existing medical conditions have been investigated and optimised3

Smoking cessation and weight management should be considered as an integral part of appropriate clinical management prior to consideration of any elective surgery. In addition to this general consideration, weight management is a specific part of the non-surgical management of osteoarthritis affecting the hip and knee joints. Evidence about the relationship between obesity and the outcomes of knee replacement surgery appears to be mixed. This is discussed in appendix 2. However, although evidence suggests that TKR can give beneficial outcomes in both obese and non-obese patients, the functional improvement appears to be greater, and the incidence of complications lower, in patients with lower „body mass index‟ (BMI).

All patients who smoke should be referred to appropriate smoking cessation services.All patients

who are overweight (BMI 25-29.9) or obese (BMI > 30) should be encouraged and supported to reduce their BMI, including referral to specialist weight management services where indicated. Patients who are morbidly obese (BMI > 40) should not normally be listed for knee joint replacement surgery (and should proceed for funding via the IFR process) unless all reasonable attempts have been made to reduce weight and there are exceptional circumstances such as:

Patients whose pain is so severe and/or mobility so compromised that they are in immediate danger of losing their independence and that joint replacement would relieve this threat, or

Patients in whom the destruction of their joint is of such severity that delaying surgical correction would increase the technical difficulty of the procedure.

Exceptions include patients whose pain is so severe and/or mobility so compromised that they are in immediate danger of losing their independence and where joint replacement would relieve this threat. An exception would also be patients in whom destruction of the joint is of such severity that delaying surgical correction would increase the technical difficulty of the procedure. Initial management of osteoarthritis Evidence from the Musculoskeletal National Service Framework (NSF), NICE, the GP Training

Network and the National Institute of Health (NIH) Consensus Panel 5 6 7

suggests that management of common musculoskeletal problems, including knee pain, should ideally be undertaken in primary care. Patients should be referred for a specialist opinion on total joint replacement when prolonged use of all conservative means has failed to alleviate the patient’s pain and disability. This initial non-surgical management of knee pain due to osteoarthritis (OA) may include (as appropriate for the individual patient) weight reduction, activity modification, patient specific exercise programmes, adequate doses of NSAIDS and analgesics, joint injection, walking aids, home adaptations, curtailment of inappropriate activities and other forms of physical therapies. References:

1. Total knee replacement – Ontario Health Technology Assessment Series 2005; vol5, no.9


80

2. Murray, D. W., Fitzpatrick, R., Rogers, K., Pandit, H., Beard, D. J., Carr, A. J., and Dawson, J. The use of the Oxford Hip and Knee Scores. J Bone Joint Surg [Br] August 2007

3. Yasunaga H, Tsuchiya K, Matsuyama Y et al. Analysis of factors affecting operating time, postoperative complications, and length of stay for total knee arthroplasty: nationwide web based survey. Journal of Orthopaedic Science, January 2009 , 14/1 (10/6), 0949-2658

4. Hunter DJ, Felson DT. Osteoarthritis. BMJ 2006; 332:639-642

5. Quintana JM, Escobar A, Arostegui I, Bilbao A, Azkarate J, Goenaga I and Arenaza J. Health related quality of life and appropriateness of knee or hip joint replacement.

6. The Musculoskeletal Services Framework – A joint responsibility: doing it differently. Department of Health,2006.

7. Dawson J., Fitzpatrick R., Murray D., Carr A. Questionnaire on the perceptions of patients about total knee replacement surgery. J. Bone Joint Surg 1998; 80-B:63-69)

81 Date Approved: TBD Review Date: Jan 2017 Version 1.8.X

14.11 Knee washout (in patients with knee osteoarthritis) Criteria CCGs will only fund arthroscopic lavage and debridement in patients with knee osteoarthritis for the following indication:

Patients with a clear history of true mechanical locking

NICE guidance states that arthroscopic lavage and debridement alone should not be used as a treatment for osteoarthritis unless the patient has knee osteoarthritis with a clear history of mechanical locking NOT gelling, giving way or X-ray evidence of loose bodies because it cannot demonstrate clinically useful benefit in the short or long term. References:

1. CG59 Osteoarthritis. National clinical guideline for care and management in adults.

National Institute of Health & Clinical Excellence 27th Feb 2008

2. IPG230 Arthroscopic knee washout, with or without debridement, for the treatment of osteoarthritis. National Institute of Health & Clinical Excellence August 2007

3. Laupattarakasem W, Laopaiboon M, Laupattarakasem P et al. Arthroscopic debridement for knee osteoarthritis. Cochrane Database of Systematic Reviews 2008, Issue 1. Art No: CD005118

14.12 Therapeutic facet joint injections/medial branch blocks These criteria do not relate to cancer related pain. CCGs will fund medial branch blocks for the management of cervical, thoracic and lumbar back pain as specified below. CCGs will fund medial branch blocks when all the following criteria are met:

The pain has lasted for more than one year;

AND

The pain has resulted in moderate to significant impact on daily functioning;

AND

All conservative management options (bed rest, exercise, pharmacotherapy including analgesia and muscle relaxants) have been tried and failed.

CCG will only commission a spinal facet joint injection (medial branch block) for lumbar pain where:

There is a reasonable clinical suspicion that the pain experienced is generated by the spinal facet joints.

Patients have actively participated in the decisions in respect of their treatment;

Patients show commitment to taking responsibility for managing their condition by demonstrating relevant lifestyle changes which include weight loss, increased fitness through exercise and physiotherapy; diet control, avoidance of illicit drugs and alcohol, improvement in sleep patterns, managing mood and mental health; and improved engagement in activities of daily living and purposeful occupation where appropriate;


Back or neck pain is rated at a level of 7/10 on the standard pain scale;

Back or neck pain causes significant impact on daily functioning which has been assessed

using the HAD tool; AND

Patients have given their informed consent.

“ Clinical practice Prior to the administration of the medial branch blocks facet joint pain should be confirmed by controlled diagnostic local anaesthetic block. In the diagnostic phase the patient may receive up to 3 injections 1-2 weeks apart, in the therapeutic phase, up to six injections 2-3 months apart provided there has been >50% reduction in symptoms for six weeks. Medial branch blocks beyond the first three injections should be provided as part of a comprehensive pain management programme. Evidence Medial Branch Blocks Injection of a local anaesthetic, steroid or other agents around the primary nerve innervating the facet joint (the medial branch of the posterior primary ramus) is termed a medial branch block. It can be used as a diagnostic procedure intended to establish whether pain originates from the facet joint, and it may also be used as a therapeutic procedure.

Manchikanti et al. 2

identified four randomized trials that assessed medial branch block using an active control design, demonstrating strong evidence of both short and long term pain relief in the

cervical, thoracic and lumbar spine. However Chou et al. 1

found no randomized control trials that compared efficacy of therapeutic medial branch block versus sham or placebo injection, and concluded that there is insufficient evidence to reach reliable conclusions regarding the effectiveness of therapeutic median nerve block. Intra-articular facet joint injections Intra-articular facet joint injections will not normally be funded as there is good evidence from

randomised control trials that facet joint injections are not effective1, 2

. The UK RCGP guidelines found that facet joint injection do not produce pain relief or global improvement, with neither the type of agent injected nor the site of injection making a significant

difference to outcomes 3. This is supported by American Pain Society Guidelines

1 and other

evidence reviews2.

NICE guidance4, relating only to treatment of back pain of less than 1 year’s duration states: “Do not

offer injections of therapeutic substances into the back for non- specific back pain.” Diagnostic facet joint blocks Diagnostic facet joint blocks have a specificity of 8% and sensitivity varying from 27- 63% for cervical spine, 42-58% thoracic spine and 17-50% in the lumbar spine. The positive predictive value has been estimated at 31% and the diagnostic effect may be confounded by leakage into the peri-articular tissues. The European COST guidelines recommend against facet joint blocks for the diagnosis of facet joint


pain3.

Complications The most common complications are related to needle placement and drug administration e.g. dural puncture, spinal cord trauma, infection, intra-arterial and intravenous injection, spinal anaesthesia, chemical meningitis etc. References:



3. Chou R, Huffman L. Guideline for the Evaluation and Management of Low Back Pain Evidence Review. American Pain Society, Publisher Glenview, IL. http://www.ampainsoc.org/library/pdf/LBPEvidRev.pdf

4. National Institute for Health & Clinical Excellence (NICE) CG88 Low back pain: Early management of persistent non-specific low back pain, May 2009





http://www.ampainsoc.org/library/pdf/LBPEvidRev.pdf


14.13 Thermal radiofrequency denervation of lumbar & cervical facet joints

These criteria do not relate to cancer related pain. Criteria CCGs will fund thermal radiofrequency controlled denervation of the medial branch of the dorsal rami of the lumbar and cervical facet joints (medial branch neurotomy) in the following circumstances:

The patient must be aged over 18 or above.

AND

Non-radicular lumbar (all levels) or cervical (C3-4 and below) facet joint pain.

AND

Failure of one year of non-invasive therapy, such as medication and physiotherapy and bed rest.

AND

Radiological imaging to rule out any correctable structural lesion e.g. MRI.

AND

At least 2 anaesthetic diagnostic blocks, one of which must be of the medial branch of the dorsal ramus innervating the target facet joint with at least 80% reduction in pain

following each block during the activities that normally generate pain1

. The pain relief must be consistent with the expected duration of the anaesthetic block.

AND

All procedures must be performed under fluoroscopy (x-ray guidance).

Thermal radiofrequency denervation is provided as part of a comprehensive pain management programme. CCGs will not fund cryoneurolysis or laser denervation. CCGs will fund up to three facet denervations on one occasion. CCGs will not fund re-treatment at the same location unless at least six months have elapsed since prior treatment. Evidence of the effectiveness of the treatment of facet joint pain associated with a neurological deficit, radiculopathy or overt disc herniation, metastatic diseases, patients awaiting back surgery or patients with multiple, focal or chronic pain syndromes is limited . Background Facet or zygopophysial joints are innervated by the medial branches of the dorsal rami. Facet joint pain is responsible for spinal pain in 15-45% of patients with low back pain, 36-67% of people with neck pain and 34-48% of people with thoracic pain. The procedure


Radiofrequency denervation is the destruction of nerves using heat generated by a radiofrequency current. It involves the placement of a catheter or electrode near or in the target nerve. Once the position of the catheter is confirmed by fluoroscopy, a radiofrequency current is applied in order to heat and coagulate adjacent tissues, including the target nerve. Complications The most common complications are related to the placement of the catheter or electrode near to or in the target nerve. Evidence

Chou et al.1

found insufficient evidence from nine randomized trials to reach reliable conclusions regarding the use of radiofrequency denervation for chronic back pain, due to conflicting results from the RCTs.

Manchikanti et al. 2

identified nine randomised control trials, but only considered two of sufficient quality. On this basis they concluded that there is evidence of short term effectiveness at the lumbar level, and short and long- term effectiveness at the cervical level.

NICE guidance 3, relating only to treatment of back pain of less than 1 year’s duration

recommends not referring people for radiofrequency facet joint denervation.

The European COST guidelines found insufficient evidence to recommend radiofrequency

denervation of dorsal root ganglion for chronic low back pain4

.

References:



3. National Institute for Health & Clinical Excellence (NICE) CG88 Low back pain: Early management of persistent non-specific low back pain, May 2009

4. Chou R, Huffman L. Guideline for the Evaluation and Management of Low Back Pain Evidence Review. American Pain Society, Publisher Glenview, IL. http://www.ampainsoc.org/library/pdf/LBPEvidRev.pdf





http://www.ampainsoc.org/library/pdf/LBPEvidRev.pdf


14.14 Trigger Finger Criteria for surgical treatment

Initial conservative treatment (e.g. activity modification, non-steroidal anti- inflammatory drugs for pain control, joint immobilisation (splinting)) has been unsuccessful; AND The patient has failed to respond or experiences recurrence of triggering following one

corticosteroid injection 1.

OR

The patient has a fixed contracture 2.

Rationale

Spontaneous recovery has been reported in up to 29% of cases2.

Initial treatment should be conservative involving activity modification, non- steroidal anti-inflammatory drugs for pain control, joint immobilisation (splinting) and corticosteroid

injection2.

Splinting has been shown to have a 55 - 73% success rate3.

An RCT comparing corticosteroid injection with surgical interventions indicated success rates

following a single corticosteroid injection are 57%4

. Success rates as high as 97% have been

reported for patients with mild trigger finger5.

Corticosteroid injection is associated with low morbidity and is a less painful method of treating

trigger finger than surgery2.

Some patient groups are less likely to benefit from corticosteroid injections; these include diabetic patients, those with multiple digit involvement and those with symptom duration ≥6

months 2. However corticosteroid injection should still form the first line of treatment for these

patients as it still offers the opportunity for the avoidance of surgery1.

References:

1. Local clinical consensus developed via email, April 2012

2. British Society for Surgery of the hand (2010). Evidence for surgical treatment – trigger finger (thumb)

3. Colboum J et al. Effectiveness of splinting for the treatment of trigger finger. Journal of Hand Therapy Oct-Dec 2008 pp 336-342

4. Sato E at al. Treatment of trigger finger: randomized clinical trial comparing the methods of corticosteroid injection, percutaneous release and open surgery. Rheumatology (2012) 51(1): 93-99

5. Salim N et al, Outcome of corticosteroid injection versus physiotherapy in the treatment of mild trigger fingers. Journal offhand Surgery (European Volume) 2012 vol 37 no 1 27-34


14.15 Hallux Valgus (Bunions) [NEW POLICY] Surgery for patients with asymptomatic bunions is not normally funded, regardless of the cosmetic appearance. The removal of bunions that are causing symptoms will only be funded where: All appropriate conservative measures have been tried for a minimum of 3 months and have failed. Conservative measures include: avoiding high heels shoes, wearing roomier footwear with soft leather uppers, the use of oral analgesia for pain management, the use of bunion pads or ice packs, the use of customised footwear; orthoses for appropriate patients, treatments for ulceration, use of bunion splints for pain (these can be obtained online or on advice from a Podiatrist/GP/MSK physio/ orthotist / Orthopaedic clinic) AND The patient suffers from:

Severe deformity

(with or without lesser toe deformity) that causes significant functional impairment that prevents the patient from properly fulfilling work, domestic or carer activities, or

educational responsibilities,

despite optimised footwear renders the patient at risk of ulceration. OR

Severe pain that causes significant functional impairment that prevents the patient from properly fulfilling work, domestic or carer activities, or educational responsibilities. Pain may

include transferred pain to second metatarsal or the ball of the foot.

Prior to referral, patients should be counselled to understand the outcomes of surgery and made aware of the potential complications which include, pain, stiffness to the big toe, infection, swelling, non-union, recurrence and Deep Vein Thrombosis(DVT) / Pulmonary Embolism (PE). There is no guarantee that the foot will be perfectly straight or pain-free after surgery. Patients should be informed that they are unable to drive for 6 weeks after surgery and full recovery can take an average of four to six months. Patients may still have to alter their footwear post surgery; transfer hyperkeratotic lesions may develop after surgery which may require attention.

Rationale

Hallux valgus is thought to be common with a prevalence of 28.4% in adults older than 40 years. Bunions are usually progressive. Management includes conservative measures such as wearing low-heeled, wide shoes; oral analgesics; the use of ice packs; bunion pads; orthoses placed inside the shoe; bunion splints. Referral for bunion surgery is indicated only for pain and is not routinely performed for cosmetic purposes. There are a number of surgical options for bunion. The procedure selected will depend on patient symptoms / signs and patient choice having considered the risk and benefits of each. Osteotomy is the most commonly used type of bunion surgery. Surgery can be done under local or general anaesthetic and is usually done as a day case procedure.


Evidence: Royal College of Surgeons (RCS) Commissioning guide: Painful deformed great toe in adults, 2013, lays out how a painful deformed great toe should be managed in primary, intermediate and secondary care and includes assessment and management recommendations for each. Clinical Knowledge Summaries (CKS) Bunions, 2012, provides information on cause, prevalence and complications of bunions. It also provides guidance on management and referral. There is no evidence specific to criteria and thresholds for bunion surgery. There is very little evidence comparing conservative treatments with surgery.

A Cochrane systematic review concluded that there is some evidence that for people aged less than 60 years with a painful bunion, mild to moderate hallux valgus and no limitation of the first MTP joint range of motion, custom-made foot orthoses are less effective than surgery for reducing foot pain after six or 12 months of wear but are more effective than no intervention for reducing foot pain after six months but not after 12 months of wear. A prospective experimental trial concluded that custom made foot orthotics had no effect in the evolution of mild and moderate hallux valgus in the women over a 12 month period.


15. Vascular

15.1 Manual lymphatic drainage (MLD)

CCGs will not routinely fund MLD as part of the Decongestive Lymphoedema Treatment (DLT) 1

or on its own. It can only be considered through the prior approval route. Applications for funding can be made in the form of an individual application (such as an Individual Funding Request (IFR)). The panels may consider referral criteria, staging (at appendix J) and guidelines contained in the Best Practice for the management of Lymphoedema (Lymphoedema Framework 2006) to determine exceptionality. In all circumstances, MLD should not be funded on its own but in combination with DLT. Rationale

The components of DLT are:

Manual lymphatic drainage (MLD) - a specialised massage technique designed to stimulate

the flow of fluid and reduce swelling,

Multilayer lymphoedema bandaging (MLLB) - MLLB uses elastic compression bandages and compression garments to support muscles to encourage the movement of fluid out of the affected limb.

Remedial exercises - designed to strengthen the muscle in the limb in order to improve lymph circulation, and skin care - required to prevent infection

There is good evidence that other components of DLT work well except for MLD.1,2,3,4

A crossover study of MLD followed by self administered massage versus no treatment concluded that improvements in both groups were attributable to the use of compression sleeves and that

MLD provided no extra benefit1.

The Cochrane review concluded that more research is needed in order to evaluate the

effectiveness of massage in the treatment of lymphoedema 1.

Multilayer bandaging as an initial phase of treatment for lymphedema patients followed by hosiery

achieves greater and more sustained limb volume reduction than hosiery alone2.

International consensus guidelines acknowledge the limited amount of research data to conclusively support the use of MLD. The guidelines state that “although there is a wealth of clinical opinion advocating the benefits of MLD, there are little research data to conclusively support its use. The most appropriate techniques, optimal frequency and indications for MLD, as

well as the benefits of treatment, all remain to be clarified3.

There is moderate evidence that compression bandages decreased lymphoedema but pneumatic pumps had no effect on lymphoedema. No conclusions could be drawn regarding other

interventions, such as manual lymphatic drainage due to poor quality of studies4.

High level evidence indicates that the addition of MLD to compression and exercise therapy for the treatment of secondary lymphoedema is unlikely to produce a significant reduction in the

volume. Although individual studies reported advantages associated with MLD11

. Therefore, the referral criteria and guidelines included in the Best Practice for the management of Lymphoedema 2006 guidelines should be considered.


Evidence

There are two systematic reviews (one of very poor quality), several low quality RCTs, some case series and prospective trials available that have reviewed MLD along with other conservative

treatments1, 2,3,4,5,6,7,8,9,10

. They concluded that there was a need of large scale clinical trial in this area. The Cochrane review carried out in 2008 agreed with these findings.

Cochrane review (carried out in 2008) concluded that more research is needed in order to evaluate the effectiveness of massage in the treatment of lymphoedema. The review aimed to assess the effect of physical treatment programmes on the volume, shape, condition and long term control of oedema in lymphoedematous limbs. Three RCTs were included involving 150 patients were included. Only one considered MLD. This crossover study of MLD followed by self administered massage versus no treatment concluded that improvements in both groups were

attributable to the use of compression sleeves and that MLD provided no extra benefit1.

References

1. Rockson SG, Miller LT, Senier et al. Lymphoedema workshop III Cancer 1998; 83: 28882-5

2. Preston N, Seers K, Mortimer P. Physical therapies for reducing and controlling lymphoedema of the limbs. Cochrane Database Syst Rev2004;4 CD003141. Last assessed as up-to-date on 19th February 2008

3. Badger C, Peacock J, Mortimer P. A Randomised, controlled, Parallel-group clinical trial comparing multilayer bandaging followed by hosiery versus hosiery alone in the treatment of patients with lymphoedema of the limb February 2000

4. Lymphoedema framework. Best practice for the management of lymphoedema. International consensus. London: MEP Ltd 2006.

5. Karki A, Anttila H, Tasmuth T, Rautakorpi U M. Lymphoedema therapy in breast cancer patients a systematic review on effectiveness and survey of current practices and cost in Finland> Acta Oncologica, 2009, Vol. /is. 48/6 (850-859

6. Moseley A.L, Carati C.J, Piller N.B. A systematic review of common conservative therapies for arm lymphoedema secondary to breast cancer. Annals of Oncology 18:639-646, 2007

7. Karki A, Anttila H, Tasmuth T, Rautakorpi U M. Lymphoedema therapy in breast cancer patients a systematic review on effectiveness and survey of current practices and cost in Finland> Acta Oncologica, 2009, Vol. /is. 48/6 (850-859)

8. Torres Lacomba M et al. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ, 2010, vol./is.340 (b5396), 0959-535X; 1468-5833

9. Karadibak D, Yavuzsen T, Saydam S. Prospective trial of intensive decongestive physiotherapy for upper extremity lymphoedema. Journal of Surgical Oncology2008; 97: 572-577

10. Kafejian-Haddad AP, Perez J, Castiglioni ML et al. Lymphoscintigraphic evaluation of manual lymphatic drainage for lower extremity lymphoedema. Lymphology 2006 Mar;39 (1):41-8

11. Clemens KE, Jaspers B, Klaschik E, Nieland P. Evaluation of the clinical effectiveness of physiotherapeutic management of lymphoedema in palliative care patients. Jpn J Clin Oncol. 2010;40(11):1068-72


15.2 Varicose veins This policy is not applicable to Croydon CCG – Croydon CCG will continue to apply the ECI 2013/14 Policy for Varicose Veins. This guidance applies to each leg individually. Patients with varicose veins that are exacerbated by pregnancy are excluded from this guideline, and should be managed conservatively except in

exceptional circumstances1,2

.

Criteria1,2

Only symptomatic patients should be referred to a vascular service. Aesthetic surgery for cosmetic purposed will not normally be funded by CCGs.CCGs will normally fund interventions for varicose veins if they are confirmed with duplex ultrasound and truncal reflex is present: Severe Varicose Veins Referral to a vascular service should take place for patients with severe varicose veins – these are varicose veins that are associated with one of the following:

They are bleeding from a varicosity that has eroded the skin.

They have bled from a varicosity and are at risk of bleeding again. Note: If either of the above are present the patient should be referred as a matter of urgency.

They have an ulcer which is progressive and/or painful.

They have a stable, pain-free, ulcer and/or progressive skin changes indicative of varicose eczema that may benefit from surgery.

The above should be accompanied by a Venous Clinical Severity Score which would be expected to be 9 or more. Moderate Varicose Veins Patients with moderate varicose veins (symptoms, include: Itching, aching, mild swelling, and the minor skin changes of eczema haemosiderosis) may be considered for surgery if there is objective evidence of rapid worsening of the condition. Individual Funding approval must be obtained prior to referral. Serial Venous Clinical Severity Scores should be included with the funding request, detailing the worsening of symptoms.

Patients should only be referred for vascular review if they are affected by one or more of the following complicationsPrimary or recurrent varicose veins in association with lower limb symptoms (typically pain, aching, discomfort, swelling, heaviness or itching) severely affecting the patient’s quality of life as evidenced by a full account of their symptoms.

OR

Superficial vein thrombosis (characterised by the appearance of hard, painful veins) and suspected venous incompetence.

OR

Lower-limb skin changes, such as pigmentation or eczema, thought to be caused by chronic venous insufficiency.

OR

A venous leg ulcer (a break in the skin below the knee that has not healed within 2 weeks).


OR

A healed venous leg ulcer.

Patients not suitable for NHS vascular surgical treatment:

A. Patients with no symptoms or skin changes associated with venous disease

B. Patients whose concerns are cosmetic including telangectasia and reticular veins C. Patients with mild symptoms including itch, ache, mild swelling, minor changes of skin eczema and haemosiderosis D. Pregnant women presenting with varicose vein should be given information on the effect of pregnancy on varicose veins. Interventional treatment for varicose veins during pregnancy should not be carried out other than in exceptional circumstances. Compression hosiery should be considered for symptom relief of leg swelling associated with varicose veins during pregnancy

Background The number of procedures undertaken for varicose veins in the NHS means there is a considerable financial cost and impact on workload attributable to the condition. There had previously been no established framework within the NHS for the diagnosis and management of varicose veins, which led to considerable regional variation in the management of varicose veins in the UK. The aim of the National Institute for Health and Care Excellence (NICE) Guideline published in 2013 was to give healthcare professionals guidance on the diagnosis and management of varicose veins in the leg, in order to improve patient care and minimize such disparities in care across the UK

1. These SWL ECI

guidelines have therefore been modified substantially to reflect the new NICE recommendations. Management The techniques that are normally approved are the endovenous techniques, endovenous laser ablation (EVLA) and radiofrequency ablation (RFA). They provide minimally invasive alternatives to surgical ligation and stripping of the great saphenous vein. Foam sclerotherapy will not normally be funded unless endothermal ablation is unsuitable. Open surgery (ligation and stripping) is reserved for cases where minimally invasive options are inappropriate. Compression hosiery should only be offered if interventional treatment is not suitable or declined by the patient. Rationale

Varicose veins are common in the adult population, and the majority of patients do not experience complications or symptoms

3.

Conservative methods such as compression hosiery (support stockings or tights) reduce patient ratings of ankle swelling, cramps and the feeling of tired/ heavy legs, but these reductions are small

1. There is insufficient evidence to determine whether or not compression

stockings are effective as the sole and initial treatment of symptomatic varicose veins in people without healed or active venous ulceration

4.

A cost-utility analysis of management options was undertaken for the purposes of NICE guideline development. Endothermal ablation was found to dominate surgery and conservative care, with more QALYs gained at less cost

1.

There is little to choose between the minimally invasive techniques in terms of efficacy or cost, and each offers a viable, clinically effective alternative to stripping

5.

Although endothermal treatment is more expensive than foam sclerotherapy, it is also more effective. The NICE model found endothermal treatment to be the most cost-effective treatment strategy

1.


Evidence Referral Thresholds

1,2

NICE identified eleven studies that provided evidence for risk factors for disease progression or that predict increased benefits or harms from interventional treatment. These studies ranged in quality from moderate to very low quality. Factors which predict prognosis and those most likely to benefit from treatment were unclear.

In the absence of any clear indicators of referral, NICE based their recommendations on the limited evidence and expert consensus. Given that interventional treatments were found to be highly cost effective, and superior to conservative strategies, they felt that evaluation of all symptomatic patients by a vascular service is warranted to ensure clinician and patient decisions are fully informed. This should include specialist clinical and duplex Doppler ultrasound assessment. Compression stockings

NICE found there was currently no evidence for improvement of health related quality of life for compression stocking treatment versus no treatment or lifestyle advice. The evidence base, however, showed their use resulted in small improvements in patient ratings of ankle swelling, cramps and the feeling of tired/heavy legs. There was a clinical benefit in terms of reduced complaints in the group with compression. Results for other outcomes such as pain relief and overall body image satisfaction were less conclusive

1. A Cochrane review published in December 2013 studied the evidence from

eleven studies involving 356 participants with varicose veins without healed or active venous ulceration. They found insufficient high quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in this group

4.

NICE found no convincing evidence for using or not using compression therapy post operatively so did not recommend their long term use

1. A meta-analysis of 4 RCTs published since found no benefits

to long-term compression therapy after varicose vein surgery of the great saphenous vein6.

Interventional management During the development of the NICE guideline the evidence comparing clinical benefits and harms of traditional stripping surgery, endovascular surgery and foam sclerotherapy was reviewed. Each option was compared to the others in turn. Overall, the quality of evidence was considered to be of low to very low quality. Generally the reviewers found insufficient evidence to suggest a large clinical benefit of one treatment modality over another, however did conclude that endothermal ablation was the only treatment judged to have any clinical advantage over the others

1.

A search of The Cochrane Library, PubMed and Trip Database on the 24

th of January 2014 for

relevant research published since the NICE literature review found four new RCTs comparing two or more of these treatment modalities. In two studies foam sclerotherapy was found to be associated with a higher recurrence of venous reflux than endovenous ablation

7 and conventional surgery

8, and

in another endovenous ablation was more effective in reducing venous reflux and was associated with less periprocedural morbidity compared to conventional surgery

10. However, none of the four found

significant symptomatic benefit of one intervention over another at follow-up periods ranging from 15 months to 5 years

7,8,9,10. The literature search also found one meta-analysis published in 2013

comparing conventional surgery with endovenous ablation in a total of a total of 2245 lower limbs. Duplex-detected and clinical recurrence rates were similar between the two interventions after one and two years

11. Evidence published since the NICE review generally supports the finding that there

is no large clinical benefit for one interventional management approach over another. Choice of treatment

1,2

NICE recommendations for choice of interventional management and Royal College of Surgeons commissioning guidelines were largely based on an economic model developed buy NICE to combine


best available evidence on the efficacy of the various interventional treatments and conservative care for varicose veins. Endothermal ablation was found to dominate surgery and conservative care, with more QALYs gained at less cost. It was cost-effective in 71% of model simulations. Although endothermal treatment is more expensive than foam sclerotherapy, it is also more effective. The model found endothermal treatment to be the cost-effective treatment strategy, with foam sclerotherapy ranked second, and surgery third. The model was robust to all sensitivity analyses surrounding key assumptions and data used to inform the model. No more recent economic evidence was found in the development of these SWL ECI guidelines. References:

1. National Institute for Health and Care Excellence. Varicose veins in the legs: The diagnosis and management of varicose veins. CG168. National Institute for Health and Care Excellence. 2013.

2. Royal College of Surgeons. Commissioning guide: Varicose veins. Royal College of Surgeons. 2013.

3. Rabe E. Epidemiology of varicose veins. Phlebolymphology. 2010; 17(1):21

4. Shingler S, Robertson L, Boghossian S, Stewart M. Compression stockings for the initial treatment of varicose veins in patients without venous ulceration. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD008819. DOI: 10.1002/14651858.CD008819.pub3

5. Carroll C, Hummel S, Leaviss J, Ren S, Stevens J, Everson-Hock E, et al.Clinical effectiveness and cost-effectiveness of minimally invasive techniques to manage varicose veins: a systematic review and economic evaluation. Health Technol Assess 2013;17(48)

6. Huang TW, Chen SL, Bai CH, Wu CH, Tam KW. The optimal duration of compression therapy following varicose vein surgery: a meta-analysis of randomized controlled trials. Eur J Vasc Endovasc Surg. 2013 Apr;45(4):397-402. doi: 10.1016/j.ejvs.2013.01.030. Epub 2013 Feb 19.

7. Lattimer CR, Kalodiki E, Azzam M, Makris GC, Somiayajulu S, Geroulakos G. Interim results on abolishing reflux alongside a randomized clinical trial on laser ablation with phlebectomies versus foram sclerotherapy. Int Angiol. 2013 Aug;32(4):394-403.

8. Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.

9. Rasmussen L, Lawaetz M, Bjoern L, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years. J Vasc Surg. 2013 Aug;58(2):421-6. doi: 10.1016/j.jvs.2012.12.048. Epub 2013 Jun 12.

10. Samuel N, Carradice D, Wallace T, Mekako A, Hatfield J, Chetter I. Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. Ann Surg. 2013 Mar;257(3):419-26. doi: 10.1097/SLA.0b013e318275f4e4.

11. Pan Y, Zhao Z, Mei J, Shao M, Zhang J. Comparison of endovenous laser ablation and high ligation and stripping for varicose vein treatment: a meta-analysis. Phlebology. 2013 Feb 6.


Appendix A: Local funding application processes SWL ECI Application/Funding process

Croydon CCG Funding request pathway:

.

* NB: ECI Applications completed by an Acute Trust/Provider, where there is no formal triage function, as opposed to a GP, should be submitted to the IFR Team. IFR Team contact details:

South West London IFR Team South London CSU 120 The Broadway Wimbledon London SW19 1RH Email: [email protected] Phone: 020 3668 1222

NB: This pathway is subject to change.

GP * determines that patient fulfils Effective Commissioning Initiative

criteria

GP completes Prior Approvals form and sends to CReSS

CReSS confirms funding approved and GP advised.

CReSS process referral

If GP receives rejection through Prior Approval process but GP believes patient is exceptional

then an IFR application is completed

In rare circumstances specialist confirms exceptionality or appropriate for effective

commissioning criteria and completes IFR form

IFR Panel considers application and GP/specialist advised of decision

mailto:[email protected]


Kingston CCG Funding request process:

Address for IFR applications:


Applications are sent to KCAS (GP referrals through Choose & Book) and are then triaged.

Three routes – approved, rejected or returned to GP for further information.

Following receipt of further information (if requested), three routes – approved, rejected, sent to IFR/EC

Panel.

Administrator advises clinician of decision.



Merton CCG Individual Funding Request (IFR) Pathway

Address for IFR applications:


GP determines that patient fulfils effective commissioning criteria or exceptionality exists

The GP is uncertain that patient fulfils effective commissioning criteria or exceptionality exists

GP refers patient to specialist to clarify the above

GP completes IFR form

Consultant in rare circumstances is

uncertain that patient fulfils effective

commissioning criteria or exceptionality exists

Specialist confirms exceptionality or appropriate for effective commissioning criteria

IFR Panel confirms funding request and informs GP

GP undertakes referral to

The specialist undertakes completion of the IFR form

IFR Panel confirms funding request and informs the

specialist



Richmond CCG Funding Request Process Address for IFR applications:


GP referrals are sent to RCAS (GP referrals through Choose & Book) and are then triaged. Not including

exclusions such as Cancer 2WW.

Three routes – approved, returned to GP for further information or rejected as inappropriate referral or RCAS GP Assessor would like public health input,

e.g. second opinion, evidence search etc.

Following PH input or further information received, three routes – approved, rejected, Referrer asked to

complete IFR as does not meet SWLECI/Local guidance etc and should therefore be exceptional.

Decision conveyed via C&B Practice managing their work list etc.



Sutton CCG Process Individual Funding Request (IFR) Pathway

Applications should be sent to:










IFR Panel confirms funding

request and informs GP




specialist



Wandsworth CCG Funding Request Process

Applications should be sent to: South West London IFR Team South London CSU 120 The Broadway Wimbledon London SW19 1RH Email: [email protected] Phone: 020 3668 1222









IFR Panel confirms funding request and informs GP




specialist



Appendix B: Individual Funding Request Application Form

INDIVIDUAL FUNDING REQUEST (IFR) APPLICATION FORM

Please tick or select the corresponding CCG that the patient is registered to:

Croydon CCG Kingston CCG Merton CCG

Sutton CCG

Richmond CCG

Wandsworth CCG

Bexley CCG Greenwich CCG Lambeth CCG

Lewisham CCG Southwark CCG

All forms must be typed and all fields must be completed (or n/a stated where field is not applicable). Incomplete

mandatory fields and hand-written forms will result in the form being returned and may cause delays to consideration for funding.

Anonymity – Please ensure that in order to protect patient’s identity, apart from Section A, the patient is not

referred to by name or initials within the application form.

* Mandatory field for all requests ** Mandatory field for drug requests

*** Mandatory fields for non-drug requests

SECTION A: CONTACT INFORMATION

3. Applicant Details The applicant should have clinical responsibility for this intervention for this patient for this specific clinical indication. Please ensure the declaration is signed and dated (Section H)

Name: *

Designation: *

Tel: *

nhs.net address - No other email accepted *

4. Patient Details Initials: *

NHS Number: *

Hospital ID number:

DoB: *

Patient Address: *

Registered Consultant:

Registered GP name: *


GP practice code: *

Date of referral: *

SECTION B: INTERVENTION REQUESTED (NB: Intervention refers to requested treatment, investigation, etc)

5. Patient Diagnosis or condition (for which intervention is requested) *

6. Do you consider this condition to be rare? If so please state UK prevalence and quote the source/reference *

Yes No

UK prevalence: Ref:

7. Other relevant diagnosis or co-morbidities

8. Details of intervention (for which funding is requested).

If the intervention forms part of a drug regimen, please document the full regimen (e.g. Drug X as part of regimen Y (consisting of drug V, drug W, drug X and drug Z).

Name of intervention: *

Type of Intervention: *

Drug Procedure Device Other

Planned duration of intervention: (please do not use abbreviations)

Dose and frequency of drug: **

Route of administration of drug: **

9. Anticipated start date Clinical Urgency The decision to treat in the event of immediate or life-threatening circumstances must be made in accordance with NHS Approved Provider (Trust) governance mechanisms.

Your request will be acknowledged within 5 working days of receipt. A funding decision usually takes the CSU up to 4 weeks from the date of receipt of a full & accurately completed application with copies of supporting clinical papers and completion of section I.

Is the case more urgent than this? * Yes No

If ‘Yes’ please state why

10. Is requested intervention part of a clinical trial?

Yes No

If Yes, then STOP HERE. This funding route is not appropriate. Please speak to your Trust Chief Pharmacist for drug trials. There is no need to complete the rest of this proforma.

11. NHS Approved Provider Name

12. Address


13. Does the intervention requested fall under a TAP or ECI procedure? If yes and this application is being submitted by a GP, please check whether your CCG provides a referral management/ clinical assessment service which processes TAP and ECI requests before submitting this to the IFR Team

Yes No

14. If yes, has this request already been declined by a referral management/clinical assessment centre?

Yes No

SECTION C: COMPARISON WITH STANDARD COMMISSIONED INTERVENTION 15. (a) What would be the

standard intervention / management at this stage?

(b) What would be the expected outcome from the standard intervention?

(c) What are the patient specific reasons that make the standard intervention inappropriate for this patient?

SECTION D: CURRENT STATUS OF PATIENT 16. For all conditions

Please summarise the current status of the patient in terms of quality of life, symptoms etc including any recognised condition-specific QoL / status scores.

What is the patient’s current clinical severity? Please use standard scoring systems e.g. WHO, DAS28, 6MW, cardiac index or those applicable to the patient’s clinical diagnosis. Please include interpretation of the score

SECTION E: PREVIOUS TREATMENT/INTERVENTIONS 17. Summary of previous

intervention(s) this patient has received for the condition. * Reasons for stopping may include:

Course completed No or poor response Disease progression

Adverse effects/poorly tolerated (please detail nature of adverse effect/intolerance)

Start Date:

Stop Date:

Name of Intervention

(for drugs include name, dose and

frequency of use)

Reason for stopping* / Response achieved or

indicate if still continuing

18. Has a previous application been submitted on behalf of this patient?

Yes No

SECTION F: EVIDENCE FOR EFFECTIVENESS OF INTERVENTION REQUESTED


19. Is the requested intervention licensed for the requested indication in the UK? **

Yes No

20. Governance

Has the Approved NHS Provider approved the requested intervention for use through its recognised clinical governance arrangements?

Drugs- Has the trust Drugs and Therapeutics Committee (DTC) or equivalent approved the requested intervention for use? **

Yes No

If No, then STOP HERE. The application requires DTC approval Evidence MUST be supplied e.g. DTC minutes, a letter from the DTC Chairman, if Chairman’s action has been taken

Medical devices & interventions-has the device/ intervention been approved in accordance with Approved NHS Provider clinical governance arrangements***

Yes No

If No, then STOP HERE. The application requires approval Evidence MUST be supplied e.g. meeting minutes where approval was given

21. Evidence It is the applicant’s responsibility to provide robust*, relevant and valid evidence to support the use of the intervention in this patient.

All relevant evidence should be provided. Give details of national or local guidelines/ recommendations (e.g. NICE, Scottish Medicines Consortium, London (Cancer) New Drugs Group etc) and/or full published papers (rather than abstracts) supporting the use of the requested intervention for this condition, unless the application relates to the use of an intervention in a rare disease. Please include any available data on the use of this treatment by your unit including audits Copies of key references MUST be provided

*Hierarchy of Evidence (Taken from NPC ‘Supporting rational local decision-making about medicines (and treatments) Feb 2009) 1. Well-conducted meta-analysis of several, similar, large, well-designed RCTs 2. Large well-designed RCT 3. Meta-analysis of smaller RCTs 4. Case-control and cohort studies 5. Case reports and case series 6. Consensus from expert panels 7. Individual opinion

22. Outcomes * (a) What would you consider to be a successful outcome for this intervention in this patient? – include details of the parameters you intend to measure

(b) How will you monitor this and how frequently will you monitor this?

(c) What is the minimum timeframe/course of treatment at which a clinical response can be assessed?

(d) What stopping criteria will be used to decide when the intervention is no longer effective?

(e) Detail the current status of the patient according to these


measures.

23. What are the anticipated adverse effects and potential risks of the intervention for this patient? *

24. How do the benefits outweigh the risks?

SECTION G: STATEMENT OF EXCEPTIONALITY OR RARITY

25. On which basis are you making this request? * Exceptional clinical circumstances

Rarity of condition or presentation

26. If exceptionality, please describe why the patient’s clinical circumstances are exceptional *

Give specific information to indicate how this patient is significantly different from the cohort of other patients with the same clinical condition

27. If rarity, please describe why this patient’s condition or clinical presentation is so unusual that there is no relevant commissioning arrangement in place

28. How many patients with the same condition or presentation as this patient do you expect to see in the next 12 months? *

SECTION H: COSTS and REVIEW

If the application is for a drug, the completed form must be sent to the Trust Chief Pharmacist, for completion of Part A. If the application is for a medical device or other intervention, the completed form must be sent to the Trust Service Manager (or equivalent) for completion of Part B. Part C needs to be completed for both drug and non-drug applications by the service manager.

PART A – DRUG INTERVENTIONS (to be completed by approved NHS provider Chief Pharmacist)**

27. Total Acquisition cost (inc VAT) for duration of treatment being applied for (or annual cost if treatment for longer than year),

28.State the value of any offset costs

29.Please benchmark these costs against London Procurement Prices

30. Application reviewed by Chief Pharmacist or nominated authorised deputy

Name:

Signature or email confirmation:

PART B - NON-DRUG INTERVENTIONS (to be completed by approved NHS provider service manager)***

31. Total Acquisition cost (inc VAT) for duration of treatment being applied for (or annual cost if treatment for longer than one year),


32. State the value of any offset costs

33. Please benchmark these costs against London Procurement Prices

PART C- ALL INTERVENTIONS ( to be completed by approved NHS provider service manager )

34. Application reviewed by Service Manager or nominated authorised deputy

Name:

Signature or email confirmation:

SECTION I: APPLICANT’S DECLARATION 35. Declaration * I declare that this application is complete and accurate and that all necessary supporting information and evidence has been provided on this form (& attachments).

Yes No

36. Patient Consent *

I confirm that this IFR has been discussed in full with the patient, including an appraisal of the benefits/risks of the intervention and they have consented to the proposed treatment. I confirm the patient has consented to CCG & CSU staff involved in the preparation, consideration and funding of their case to access confidential clinical information about them (including their NHS no.) to enable full consideration of this request and payment of invoices. In the case of a minor or vulnerable adult I confirm I have complied with the relevant legislation guidance including the Children Act 2004 and Mental Capacity Act 2005.

Yes No

Patient Signature (Optional):

37. Correspondence and Contact * The IFR team will copy the patient into correspondence concerning progress and outcome of their application. If you do not want the patient to be contacted or to receive correspondence please indicate this.

Please copy the patient into correspondence. * Yes No

Responsible Clinician Name: *

Signature or email confirmation: *

Date: * DD/MM/YY

Forward application to the IFR team (via Trust Service Agreements Department or equivalent, if applicable).

For SW London CCGs: Croydon, Kingston, Merton, Sutton, Richmond and Wandsworth Forms should be

submitted to [email protected] Tel. enquiries: 020 3668 1222

For SE London CCGs: Lewisham, Bexley, Greenwich, Southwark and Lambeth Forms should be submitted to: [email protected] Tel. enquiries: 020 3049 4154




Patient Equality Monitoring Data * This section is for data monitoring purposes only and will be removed from the application prior to consideration by the IFR Panel. Information unavailable Prefer not to disclose

1 Ethnic Origin

White British Irish Any other White background

Mixed

White and Black Caribbean

White and Black African

White and Asian

Any other Mixed background

Asian or Asian British

Indian Pakistani Bangladeshi Any other Asian background

Black or Black British

Caribbean African Any other Black background

Other Ethnic Groups

Chinese Any other ethnic group

2 Gender

Male Female Transgender Not disclosed

3 Sexuality

Heterosexual Bisexual Gay Lesbian

Not disclosed

4 Age Group

16-25 26-35 36-45 46-55

56-65 66+

5 Do you consider yourself to have a disability?

Registered disabled Unregistered disabled Not disabled

Nature of disability

Hearing impairment

Speech impairment

Mobility Impairment

Age related impairment

Visual impairment Learning disability Mental health Other

6 Religion

No religion Christian Buddhist Other

Hindu Jewish Muslim


Appendix C: Principles and processes for decision making for the SWL Effective Commissioning Initiative (ECI)

Introduction The South West London Effective Commissioning Initiative (SWL ECI) provides a set of patient criteria to inform the commissioning of clinical interventions in South West London. The ECI is driven by the need to ensure that NHS funded treatments are effective and evidence-based. The initiative aims to provide equal access to treatment for patients with similar levels of need throughout South West London. It also attempts to define more clearly and openly the limits of NHS funding for procedures with social but not physical benefits e.g. cosmetic procedures. Although not the main driving force, it is also linked to the need to ensure that the NHS provides value for money and achieves financial balance. The current proposals can broadly be classified into four groups:

Procedures with limited evidence of effectiveness.

Procedures where initial conservative therapy is possible.

Effective procedures where a threshold for intervention may be appropriate.

Procedures where NHS provision may be inappropriate

This principles and processes document sets out the values that the SWL ECI group applies in developing the SWL ECI document. The ECI group will use the principles as laid out in this document across the full range of its work and decision making. The need for principles and processes document The NHS constitution states that the one of the key principles of the NHS is that it should make ‘the most effective, fair and sustainable use of finite resources’. The CCGs in South West London are duty bound to promote the health of the local community but they also receive a fixed budget from central government with which to fund health care for their populations. Therefore CCGs have an obligation to ensure that resources are used wisely, in general to provide the greatest health benefit. Factors such as an ageing population, developments in technology and new drugs mean that the demand for health care outstrips funding. Therefore decisions will be required regarding relative priorities for allocating funding. These decisions must take account of national directives, guidance from the National Institute of Health & Care Excellence and the Department of Health as well as local factors relating to the availability of resources and facilities. The way in which these difficult, complex and sensitive decisions are made is extremely important and as public bodies the CCGs are accountable for these decisions. A key requirement is for the SWL ECI group, on behalf of all 6 CCGs, to demonstrate that their decision-making is reasonable, consistent, takes account of all relevant factors, is underpinned by locally established principles and is defensible and open to external scrutiny.


There is no purely objective or value-free method by which health policy decisions can be reached. Making decisions will involve the exercise of judgement and discretion and there will be differences of opinion on the outcomes. This principles and processes document is designed to provide guidance to those decision-makers to help them make fair and consistent decisions which respects the needs of individuals and the community and ensure that all relevant factors have been considered in the light of key principles, with reference to local conditions and with a conscious intent to avoid discrimination. This document outlines these principles and should be read in conjunction with the SWL ECI document and the SWL ECI group terms of reference.

The SWL ECI group will assess implementation of the principles and processes through an annual review process. Principles for decision making In line with the legal and ethical duties to CCG populations the following four key groups of values will be applied to all decisions:

Rationality

Affordability

Inclusivity

Clarity, consistency and transparency

1. Rationality

Aspects of this principle include:

Being logical in reasoning towards a decision

Ensuring that the decision is based on evidence of clinical effectiveness

Making a realistic appraisal of the likely benefit to patients.

Weighing up all the relevant factors, including risks and costs.

Taking into account the wider political, legal and policy context.

Ensuring individuals involved in decision-making are appropriately trained.

Decisions will be made on the basis of a reasonable evaluation of the available evidence of efficacy, safety and clinical effectiveness. Those involved in decision making will seek to gather the best evidence of clinical effectiveness available and consider the views of local providers and commissioners. Where available, existing national standards and guidelines will be considered. Local factors, including existing provision, may also be considered. The approach to assessing the validity and credibility of evidence should be broad but maintain high standards of critical appraisal. The SWL ECI group will follow a well developed scientific approach to hierarchy of evidence. Both qualitative and quantitative evidence will be taken into consideration, where appropriate. Outcome measures will be considered in terms of their importance to patients.

Rational decisions will weigh up likely outcomes, the wider contexts in which treatments can be provided, the implications for service delivery, clinical pathways, and benefits, costs and risks.


The position, qualifications and skills of decision makers will be appropriate to ensure due deliberation of all the relevant factors.


2. Affordability

Given the finite resources available to CCGs their budgets must be managed responsibly so the cost of an intervention must be considered alongside the evidence of effectiveness. This is important as investing in one area of healthcare inevitably diverts resources from other areas. Decisions will be based on careful consideration of the trade-offs between costs and benefits, both in the short and longer term, but also recognise that complex trade-offs cannot necessarily be reduced to simple cost- benefit calculations. Ensuring efficacy and effectiveness of spend are key considerations and a clear understanding of costs and opportunity cost is required. There is a need to balance cost impact against other factors such as health impact for the population. Impacts need to be considered both in the short and longer term.

3. Inclusivity

The term inclusivity may be interpreted as including:

Reinforcing the concept of equal opportunity of access to health care.

Ensuring patient and public engagement in decision-making.

Balancing the rights of individuals with the rights of the wider community. The aim of this principle is to achieve equitable and consistent resource allocation

between individuals and groups in society.

The SWL ECI group considers each individual within its population to be of equal value. Commissioning and provision of health care services is based on clinical need, within the resources made available. CCGs will uphold their public equality duty to eliminate unlawful discrimination, advance equality and opportunity and foster good relations. They will not discriminate on age, disability, pregnancy and maternity, gender reassignment, race, religion (including the lack thereof), sex and sexual orientation. Decision-making will not discriminate on characteristics which are irrelevant to health conditions and the efficacy of treatment. Consideration of factors such as age and ethnicity will only be considered where this is clinically relevant. Decision-making will be non-partisan and individuals will need to be able to take an objective view of the topic, and maintain an open mind about the evidence. As far as possible consensus decision-making will be used.

4. Clarity, consistency and transparency

The SWL ECI document itself, the way that it is produced and the process of making decisions about its contents will be clearly specified, consistent, easy to understand and transparent. Patients and the public should have easy access to the processes of decision-making and these processes should be consistently applied. Both the decisions themselves, and the way they are determined, will be clearly specified, including roles and responsibilities of individuals involved, accountabilities and governance arrangements. Decision-makers will provide the rationale for their decisions, any particular

factor that has influenced a decision will be clearly stated.


This document has used content from the ethical frameworks used by NHS SWL IFR decision making framework, NHS Kingston, Surrey & Sussex Health Priorities Support Unit, Berkshire Priorities Committee and Oxford Priorities Forum. It has also referenced the NHS constitution: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/document s/digitalasset/dh_132958.pdf.

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/%40dh/%40en/documents/digitalasset/dh_132958.pdf

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/%40dh/%40en/documents/digitalasset/dh_132958.pdf


Appendix D: Policy on alternative/homeopathic/ complementary therapies

The literature on the effectiveness of alternative (complementary) therapies is notable by the lack of good quality studies. That much more rigorous evidence is demanded for complementary therapies compared to other areas of medical practice is an argument often advanced but this is not true. All new developments/ innovations are to be backed up by evidence of effectiveness. South West London CCGs have accepted the effectiveness agenda and attempting to introduce unevaluated therapies would be a departure from this, more so since alternative therapies are not without side effects and complications, and this is especially so for spinal manipulation.

There is absolute lack of well-conducted systematic reviews that permits any basic analyses of these therapies. The only procedure that seems to have any effect is acupressure on pre- and postoperative nausea and vomiting, as explained below.

For the rest of the procedures:

Homeopathy: There is very little, if any, evidence of effectiveness of homeopathy and, even when it is claimed to exist (such as for asthma), it is inconclusive and based on poorly designed studies. Although some CCGs have a clear policy denying the commissioning of homeopathy, the present system for dealing with homeopathic referrals allows again the patient’s GP to justify the referral. This justification is hardly ever based on scientific grounds but on social need, failure of traditional methods or pressure on the part of the patient. It is, therefore, recommended that funding homeopathy for any procedure should cease completely in any form or through any possible referral route, be it from Primary Care or be it through consultant to consultant referral. This policy should also be extended to palliative patients, as there is no evidence whatsoever that homeopathy benefits in any way to these patients.

Acupuncture: Acupuncture appears to be effective for chemotherapy-related and postoperative and nausea and vomiting in adults and that related mainly to acupressure. It is also effective for low back pain for a cohort of patients who fulfil the criteria for Low Back Pain included in this document. It should not be funded for any other indications (like obesity or smoking cessation, etc), other than the mentioned above.

Osteopathy and Spinal Manipulation: The present state of evidence is such that the effectiveness of spinal manipulation has been shown only for acute low back pain. Spinal manipulation is of different types (osteopathy, chiropractor, physiotherapy) and it is not clear which of these are effective. There is no data on cost-effectiveness. In view of this, SWL CCGs should not commission osteopathy services.

Clinical Ecology: Multiple Chemical Sensibilities and all the treatments attached to this, including rotation diet, avoidance, antifungal treatment for candidiasis, and provocation-neutralisation procedure, lack of sound scientific evidence to support their use. EPD and other forms of allergy immunotherapy it should be considered investigational.

Other Alternative Therapies: No sound evidence of the effectiveness of aromatherapy, Chinese medicines, chiropractice therapy, herbal remedies, hydrotherapy, hypnotherapy, massage or reflexology has been found.


Appendix E – Eligibility for NHS funded wigs

Any patient recommended by a dermatologist for wigs may have to be paid for in part by the

patient. Patients can get free wigs and fabric supports if they:*

are under 16

are aged 16, 17 or 18 in full-time education are a hospital in-patient are a war pensioner and the wig or fabric support is for them accepted disablement and they have a valid war pension exemption certificate are getting or their partner gets:

– Income Support – Income-based Jobseeker’s Allowance (Incapacity Benefit or Disability Living

Allowance do not count as they are not income related.) – Pension Credit Guarantee Credit

are entitled to, or named on, a valid NHS tax credit exemption certificate are named on a valid HC2 certificate.

Partial help: if they are named on a valid HC3 certificate they might get some help. http://www.dh.gov.uk/prod_consum_dh/groups/ dh_digitalassets/@dh/@en/documents/digitalasset/dh_4138953.pdf

http://www.dh.gov.uk/prod_consum_dh/groups/%20dh_digitalassets/%40dh/%40en/documents/digitalasset/dh_4138953.pdf

http://www.dh.gov.uk/prod_consum_dh/groups/%20dh_digitalassets/%40dh/%40en/documents/digitalasset/dh_4138953.pdf


Appendix F: Epworth Sleepiness Scale 1

How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? This refers to your usual way of life in recent times. Even if you have not done some of these things recently try to work out how they would have affected you. Use the following scale to choose the most appropriate number for each situation 0 = no chance of dozing 1 = slight chance of dozing 2 = moderate chance of dozing 3 = high chance of dozing

SITUATION CHANCE OF DOZING

Sitting and reading.

Watching TV.

Sitting inactive in a public place (e.g a theatre or a meeting).

As a passenger in a car for an hour without a break.

Lying down to rest in the afternoon when circumstances permit.

Sitting and talking to someone.

Sitting quietly after a lunch without alcohol.

In a car, while stopped for a few minutes in traffic.

USER GUIDE As a guide, a total score of 11 or more may mean a sleeping disorder such as obstructive sleep apnoea. A very high score such as 17 or more may indicate narcolepsy Normal Epworth Sleepiness Scale (ESS) Scores (4) Data from Australia show that “normal” adults (N = 72) who do not have evidence of a chronic sleep disorder (including snoring) have a mean Epworth Sleepiness Scale (ESS) score of 4.6 (confidence intervals 3.9 - 5.3) with a standard deviation of 2.8 and a range from zero to 10. The normal range defined by the 2.5 and 97.5 percentiles is also zero to 10 (2). This is different from the results first published in 1991, in which the normal range was reported as 2-10 (3). It is not yet clear whether the Epworth Sleepiness Scale (ESS) scores of normal subjects in other cultures are the same. Epworth Sleepiness Scale (ESS) scores do not differ significantly between normal men and women (1), nor do they change much with age.

References 1. Johns MW. A new method for measuring daytime sleepiness: the

Epworth Sleepiness Scale. Sleep 1991; 50-55. 2. Hardinge FM, Pitson DJ, Stradling JR. Use of the Epworth Sleepiness Scale to

demonstrate response to treatment with nasal continuous positive airways pressure in patients with obstructive sleep apnea. Respiratory Medicine 1995; 89:617-620.

3. Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep 1991; 50-55

4. http://epworthsleepinessscale.com/about-epworth-sleepiness/

http://epworthsleepinessscale.com/about-epworth-sleepiness/


Appendix G: Local CCG variations to IVF criteria

CROYDON CCG - IVF criteria 2014/2015

Criteria Rationale


Couples will be eligible for referral for treatment if they have experienced thirty six months of unexplained infertility or have an identified cause of infertility



The patient should be 39 or younger at the time of application. (nb treatment, if approved, should be started within six months of the application)

The likelihood of a live birth following assisted conception declines with age. Chances of live birth per IVF cycle are:

>20% for women aged 23-35

15% for women aged 36-38

10% for women aged 39 years

6% for women aged 40 years and over


19 – 30 kg/m2,






Previous cycles Couples will be eligible for one NHS funded cycle and a maximum of two un-stimulated frozen cycles. The storage cost for frozen embryos for up to three years or a live birth (whichever is sooner) would be paid for by the PCT’s. Where couples have self- funded previous cycles, these must not exceed TWO.

The probability of a live birth following the IVF is consistent for the first three cycles but effectiveness of subsequent cycles is uncertain







Human Fertilisation and Embryology (HFE) Act 1990 (as amended) states: Section 13 (5): A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting), and of any other child


who may be affected by the birth. Section 2 (1) … “treatment services” means medical, surgical or obstetric services provided ... for the purpose of assisting women to carry children.


Sub fertility treatment will be funded for women in same sex couples or women not in a partnership if those seeking treatment are demonstrably sub fertile. In the case of women in same sex couples in which only one partner is sub fertile, clinicians should discuss the possibility of the other partner receiving treatment before proceeding to interventions involving the sub fertile partner. NHS funding will not be available for access to insemination facilities for fertile women who are part of a same sex partnership or those not in a partnership. In circumstances in which women in a same sex partnership or individuals are eligible for sub fertility treatment, the other criteria for eligibility for sub fertility treatments will also apply. Women in same sex couples and women not in a partnership should have access to professional experts in reproductive medicine to obtain advice on the options available to enable them to proceed along this route if they so wish.


References

1. National Institute for Health & Clinical Excellence (NICE) CG11Fertility: assessment and

treatment for people with fertility problems, Feb 2004 2. National Institute for Health & Clinical Excellence (NICE) CG156 Fertility: assessment

and treatment for people with fertility problems, Feb 2013


KINGSTON CCG – Assisted Conception Guidelines 2014/2015

Assisted Conception Commissioning Guidelines Kingston Clinical Commissioning Group

Principles When commissioning healthcare for its population, Kingston CCG, in line with the RCGP Ethical Commissioning Guidance 2011, aims to ‘use limited resources to do as much good as possible whilst being fair.’ With respect to assisted conception, Kingston CCG aims to:

Treat subfertility secondary to disease processes

Follow NICE guidance as far as it is compatible with the CCG’s resources to treat its population

Treat any couple with no existing children (from either party, including adopted children), or woman with no existing children.

Limit treatment to one live birth per couple.

Equality Statement “This document demonstrates Kingston CCG’s commitment to create a positive culture of respect for all individuals, including staff, patients, their families and carers as well as community partners. The intention is, as required by the Equality Act 2010, to identify, remove or minimise discriminatory practice in the nine named protected characteristics of age, disability, sex, gender reassignment, pregnancy and maternity, race, sexual orientation, religion or belief, and marriage and civil partnership. It is also intended to use the Human Rights Act 1998 and to promote positive practice and value the diversity of all individuals and communities”.

Engagement Kingston CCG’s previous In Vitro Fertilization (IVF) guidelines were developed by the South West London Effective Commissioning Group with lay representation from the South West London. The working group responsible for updating local IVF guidelines included representation from Kingston CCG (lead GP), Royal Borough of Kingston (Public Health consultant and senior registrar) and Kingston Hospital NHS Foundation Trust (two Consultant Gynaecologist Leads from the Assisted Conception Unit and a service manager). Kingston Hospital NHS Foundation Trust representatives provided a clinical perspective and they also provided the working group with the views of their service users. The final draft of the updated KCCG guidelines was shared with Kingston Healthwatch. It was also discussed at Kingston Governing Body Seminars and presented to the Kingston Integrated Governance Committee before approval was granted by the Kingston Governing Body.

http://www.rcgp.org.uk/revalidation-and-cpd/~/media/Files/News/RCGP-Ethical-Commissioning-Guidance.ashx


Kingston CCG Assisted Conception Pathway

Note to Kingston GPs about the timing of referrals to secondary care Assessment and management of fertility problems involves several stages (see diagram) so it is imperative that referrals for further investigation are timely. . The Fertility Clinic consultant will decide if assisted conception is indicated and if so forward the names of the couple to the Assisted Conception Unit (ACU) at Kingston Hospital NHS Foundation Trust. The ACU will ensure that the CCG criteria are met and if so will offer treatment. Once treatment is offered the couple will be treated within an appropriate 18 week timetable.

Refer for further clinical assessment and investigation, with her partner,

- a woman of reproductive age who has not conceived after 1 year of unprotected vaginal sexual intercourse (or six cycles of artificial insemination) in the absence of any known cause of infertility

Offer an earlier referral when:

- the woman is aged 36 years or over (please note that if IVF is considered a possible treatment option, referral should be by the 42nd birthday to allow sufficient time for investigation and expectant management)

- there is a known cause of infertility or a history of predisposing factors of infertility. Even if patients do not meet the criteria set out in the guidelines for assisted conception treatments, patients who demonstrate subfertility can still be referred to the Fertility Clinic for further investigations (subject to agreement by the GP and patient and approval by KCAS).

6. ASSISTED CONCEPTION

UNIT

Assisted reproduction

4. FERTILITY CLINIC

Investigation of fertility

problems and management

strategies

5. Couple undergo

expectant management or management of identified

fertility problems

2. PRIMARY CARE

Defining infertility and criteria for assessment and

referral

1. Couple demonstrate subfertility

3. Primary to secondary

care referral


Policy statement 1: IVF

Kingston CCG will fund 1 fresh IVF cycle (cycle starts once ovarian stimulation has been commenced) and 2 frozen embryo transfer (FET) cycles with embryos generated from the fresh cycle3, with or without ICSI, for the following groups of women:

OR

who also meet the additional criteria outlined below:

Criteria Rationale Duration of subfertility

Couples will be eligible for referral for treatment if they have not conceived after 2 years of regular unprotected intercourse or up to 12 cycles of intrauterine insemination. OR where investigations show there is no chance of pregnancy with expectant management and where IVF is the only effective treatment (for example women with apparently occluded fallopian tubes or severe endometriosis, or obstructive azoospermia).

84% of women will conceive within one year of regular unprotected sexual intercourse, this increases to 92% after 2 years and 93% after 3 years (te Velde et al., 2000)1,2.

3 The storage cost for frozen embryos for up to three years or a live birth (whichever is sooner) would

be paid for KCCG. Requests for funding for storage beyond three years should be made via an Individual Funding Request. iii this is defined as age at egg collection.

iv this is in line with NICE recommendations stating that, due to the lower chance of successful IVF in

this age-group, IVF is only cost-effective when offered to women who have not had any previous cycles.

Group 2: Age at treatmentiii: 40 up to 43rd birthday AND No previous self-funded cyclesiv

Group 1: Age at treatmentiii: up to 40th birthday AND Have had a maximum of two previous self-funded cycles



19 – 30 kg/m2 weight to be maintained for the last 6 months prior to application.

Female BMI outside this range reduces the probability of success associated with assisted conception techniques3.



Smoking can adversely affect the success rates of assisted reproductive techniques3.





Same sex couples and women not in a partnership

IVF treatment will be funded for same sex couples or women not in a partnership if those seeking treatment are demonstrably subfertile and have undergone a period of expectant management. They would first need to demonstrate subfertility through 6 self-funded attempts at artificial insemination using donor sperm in a clinical setting, and undergo a period of expectant management involving up to a further 6 cycles of self or NHS-funded donor intra-uterine insemination (see policy statement 4).

Note: Men in same-sex relationships wanting a baby can either adopt or use some form of surrogacy. The CCG will not fund surrogacy arrangements. However, when a pregnancy does not occur through surrogacy after 6 cycles of self-funded intra-uterine insemination in a clinical setting there is an increased risk of some underlying problem. In those circumstances, the man whose sperm is being used and the surrogate partner would be eligible to be referred for further clinical assessment and possible treatment4.

Same-sex couples should have access to IVF on equivalent grounds to heterosexual couples. In this respect, failure to conceive after six cycles of self-funded artificial insemination has been deemed an equivalent indicator of sub-fertility, given clinical and practical considerations3. Further NHS-funded cycles of intra-uterine insemination (up to six) constitutes the period of expectant management required prior to being eligible for IVF, during which pregnancy may be achieved (based on NICE recommendation3 and advice of local clinicians).


In the case of same sex couples where only one partner is sub fertile, clinicians should discuss the possibility of the other partner receiving treatment before proceeding to interventions involving the sub fertile partner.

The other criteria for eligibility for IVF will also apply.

All same sex couples and women not in a partnership should have access to professional experts in reproductive medicine to obtain advice on the options available to them.

FSH Women aged 40 up to 43rd birthday only: There is no evidence of low ovarian reserve when assessed in accordance with the treatment provider’s protocol.

In this age group, falling ovarian reserve is the commonest cause of infertility. The use of ovarian reserve testing allows IVF to be targeted to women with a demonstrable chance of success3.

Rationale The likelihood of a live birth following assisted conception declines with age. Chances of live birth per IVF cycle5 are:

32.2% for women aged 18-34





The overall chance of a live birth following IVF treatment also falls as the number of unsuccessful cycles increases. Model-based evidence for cost-effectiveness of treatment for women aged 40 years and over is based on the assumption they have not previously attempted IVF3.


Policy statement 2: Cryopreservation & cryostorage for pre-cancer

treatment

Criteria Kingston CCG will fund cryopreservation in the following circumstances:

Storage

Will be funded up until one of the following (whichever is soonest) o 10 years after the collection o [For oocytes or embryos] the woman’s 43rd birthday o a live birth.

Requests for storage beyond 10 years should be assessed on a case by case basis via an individual funding request (IFR).

Post storage treatments

Will be made available on the same basis as other patients who have not undergone such storage (see criteria for IVF). There is thus the potential for individuals to meet the criteria for cryopreservation and not to meet the criteria for infertility treatments at a later date, which should be explained to them.

Egg preservation for delayed conception in other (non-medical) circumstances

This will not be funded on the NHS

Rationale

Cryopreservation of sperm, oocytes and embryos is an effective method of achieving future clinical pregnancies or live births to people undergoing treatment for cancer which has the potential to affect fertility3.

Sperm cryopreservation to men and adolescent boys who are preparing for medical treatment for cancer that is likely to make them infertile. OR Oocyte or embryo cryopreservation as appropriate to women of reproductive age (including adolescent girls) who are preparing for medical treatment for cancer that is likely to make them infertile if:

they are well enough to undergo ovarian stimulation and egg collection and

this will not worsen their condition and

enough time is available before the start of their cancer treatment


Policy statement 3: Intrauterine Insemination 3.1 Using partner sperm Criteria Kingston CCG will fund up to 6 cycles of unstimulated intrauterine insemination (IUI) in the following groups as an alternative to vaginal intercourse:

Couples who are unable to, or would find it very difficult to, have vaginal intercourse because of a clinically diagnosed physical disability or psychosexual problem

Couples with conditions that require specific consideration in relation to methods of conception (for example after sperm washing where the man is HIV positive)

Intra-uterine insemination should not be offered routinely to people with unexplained fertility, mild endometriosis or mild male factor infertility.

Rationale The NICE guideline3 states that for these groups, where vaginal sex is

inappropriate or not possible, that IUI without stimulation with sperm from a male partner or donor would be the first-line approach.

3.2 Using donor sperm (donor insemination) Criteria Kingston CCG will fund up to 6 cycles of unstimulated donor insemination (including donor sperm), without ovarian stimulation, for

1. obstructive azoospermia 2. non-obstructive azoospermia 3. severe deficits in semen quality in couples who do not wish to undergo ICSI 4. couples in a same-sex relationship who can demonstrate subfertility through

failure to conceive following 6 self-funded cycles of intra-uterine insemination within a clinical setting.

Donor insemination should be considered in conditions such as: 5. where there is a high risk of transmitting a genetic disorder to the offspring 6. where there is a high risk of transmitting infectious disease to the offspring or

woman from the man 7. severe rhesus isoimmunisation.


Rationale Donor insemination is an effective treatment option for male factor infertility, although in some men with azoospermia, semen can be surgically extracted and be used in intracytoplasmic sperm injection (ICSI) procedures3. Donor insemination is also indicated where the male partner is likely to pass on an inheritable genetic condition, an infection such as HIV or if severe rhesus incompatibility has been a problem because of the male partner’s homozygous status3. Up to six cycles of donor insemination for subfertile same-sex couples constitutes the period of expectant management required prior to being eligible for IVF, during which pregnancy may be achieved3.

Donor insemination is specified since this provides a number of benefits: (i) donor screening and cryopreservation of sperm to protect against transmission of sexually transmitted infections, (ii) optimisation of timing of insemination to maximise chance of conception, and (iii) early identification of sub-fertility.

Policy statement 4: Surgical Sperm Retrieval

Criteria Surgical sperm retrieval as part of ICSI will be commissioned in appropriately selected patients provided the azoospermia is not the result of a sterilisation procedure or the proven absence of sperm and the couple meets all other criteria for ICSI. Cryopreservation of remaining sperm will be funded for up to 1 year or a live birth, whichever is sooner.

Rationale Spermatozoa can be retrieved from both the epididymis and the testis using a variety of techniques with the intention of achieving pregnancies for couples where the male partner has obstructive or non-obstructive azoospermia. Sperm recovery is also used in ejaculatory failure and where only non- motile spermatozoa are present in the ejaculate. Surgically collected sperm in azoospermia are immature (because they have not traversed the epididymus) and have low fertilising ability with standard IVF. It is therefore necessary to use ICSI.


Policy statement 5: Ovulation Induction Criteria Kingston CCG will fund up to 3 cycles of ovulation induction using pulsatile administration of gonadotrophin-releasing hormone or gonadotrophins with luteinising hormone activity, for women with WHO Group I ovulation disorders (hypothalamic pituitary failure), to be used with timed intercourse. Couples may proceed to IVF if they meet the criteria outlined in that policy should ovulation induction fail.

Rationale Evidence from case series studies have demonstrated that pulsatile GnRH induces ovulation, achieving cumulative pregnancy rates of up to 82% in women with hypogonadotrophic hypogonadism and 95% in women with weight-related amenorrhoea after 12 cycles. The corresponding figures for live birth rates were 65% and 85%, respectively [Evidence level 3] 3.

References:

(1) te Velde ER, Eijkemans R, Habbema HDF. Variation in couple fecundity and time to pregnancy, an essential concept in human reproduction. Lancet 2000;355:1928–9, as quoted in NICE Clinical guideline 156 (2013). Fertility; Assessment and treatment for people with fertility problems.

(2) Bongaarts J. A method for the estimation of fecundability. Demography 1975;12:645–60, as quoted in NICE Clinical guideline 156 (2013). Fertility; Assessment and treatment for people with fertility problems.

(3) NICE Clinical guideline 156 (2013). Fertility; Assessment and treatment for people with fertility problems.

(4) NICE Full guideline: Fertility; Assessment and treatment for people with fertility problems. National Collaborating Centre for Women’s and Children’s Health. February 2013.

(5) HFEA, Fertility treatment in 2011: Trends and Figures (www.hfea.gov.uk/104.html))

http://www.hfea.gov.uk/104.html)


MERTON CCG – Assisted Conception Policy 2014/2015

1. Introduction 1.1 This policy describes circumstances in which Merton CCG will fund treatment for assisted conception as defined in appendix 1. 1.2 The objective of treatment for subfertility is to achieve a successful pregnancy quickly and safely with the least intervention required and the delivery of a healthy child. 1.3 The criteria set out in this policy apply irrespective of where the residents of Merton CCG have their treatment. A Merton CCG patient is defined as someone registered with a GP practice which is part of Merton CCG 1.4 This policy has drawn on guidance issued by the Department of Health, Infertility Network UK and the revised NICE guidance (CG 156) published in February 2013. http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_101068.pdf http://www.infertilitynetworkuk.com/uploadedFiles/Standardising%20Access%20Criteria%20to%20NHS%20Fertility%20Treatment%2009%2006%2009.doc http://guidance.nice.org.uk/CG156 (summary guidance) http://www.nice.org.uk/nicemedia/live/14078/62770/62770.pdf (full guidance)

2. Defining infertility 2.1 Infertility is a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse.

3. Types of infertility treatment

3.1 There are three main types of infertility treatment –

medical management (such as drugs for ovulation induction),

surgical treatment (i.e. to correct a physical cause for infertility such as blocked fallopian tubes)

assisted conception

3.2 Assisted conception is a collective name for treatments designed to lead to conception by means other than sexual intercourse where gametes are manipulated. Assisted conception techniques include intrauterine insemination (IUI), in vitro fertilisation (IVF), donor insemination (DI), intracytoplasmic sperm injection (ICSI) and cryopreservation (of sperm, oocytes and embryos).

4. Pathway and provider arrangements for assisted conception (IUI, IVF, ICSI)

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_101068.pdf

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_101068.pdf

http://www.infertilitynetworkuk.com/uploadedFiles/Standardising%20Access%20Criteria%20to%20NHS%20Fertility%20Treatment%2009%2006%2009.doc

http://www.infertilitynetworkuk.com/uploadedFiles/Standardising%20Access%20Criteria%20to%20NHS%20Fertility%20Treatment%2009%2006%2009.doc

http://guidance.nice.org.uk/CG156

http://www.nice.org.uk/nicemedia/live/14078/62770/62770.pdf


4.1 Merton CCG will have a waiting list for assisted conception at three providers:

Epsom and St Helier University Hospitals Trust

Guys and St Thomas NHS Foundation Trust

Kingston Hospital NHS Foundation Trust

5. Commissioning policy

5.1 In Vitro Fertilisation (IVF) / Intracytoplasmic sperm injection (ICSI):

5.1.1 Definition: In Vitro Fertilisation (IVF) is a technique by which eggs are collected from a woman and fertilised with a man’s sperm outside the body. Usually one or two resulting embryos are then transferred to the womb. If one of them attaches successfully, it results in a pregnancy. Intracytoplasmic sperm injection (ICSI) is a variation of IVF in which a single sperm is injected into an egg. 5.1.2 Policy statement: Merton CCG will fund one (1) fresh cycle of IVF or ICSI for patients who meet all of the criteria in Appendix 1. Where the couple produces more than one good quality embryo and have an elective single embryo transfer, the PCT will fund 12 months of cryopreservation of the remaining embryos. If the initial embryo transfer does not result in a live birth, the CCG will then fund a single unstimulated frozen embryo transfer. It is expected that the majority of patients receiving Merton CCG funded IVF/ICSI will undergo single embryo transfer. This will reduce the number of multiple pregnancies within Merton CCG and falls within HFEA guidance. The IVF providers will be expected to have in place a “Minimisation of Multiple Birth Strategy” which gives precise details of those couples who will be required to have single embryo transfer. More information is available at www.oneatatime.org.uk 5.2 Intrauterine insemination (IUI)

5.2.1 Definition: Intra-uterine insemination (IUI) is a technique to place sperm into a woman’s womb through the cervix 5.2.2 Policy statement Merton CCG will fund three (3) cycles of intrauterine insemination for couples undergoing insemination for the following conditions:

Obstructive azoospermia (i.e. where the man has no sperm in his semen)

Where there is a high risk of transmitting a genetic disorder to the offspring

Where there is high risk of transmitting an infectious disease from the man to the woman or to the offspring

Severe rhesus isoimmunisation


5.3 Pre-implantation genetic diagnosis 5.3.1 Definition: Pre-implantation genetic diagnosis can be used when one partner is known to have a faulty gene. It involves having in-vitro fertilization (IVF) treatment, then genetically testing the embryo in a laboratory to see if it has the faulty gene. The embryo will only be placed inside the woman if it does not have the faulty gene. 5.3.2 Policy statement Merton CCG will consider funding up to one fresh cycle of IVF or ICSI for couples who have had this recommended by the Pre-implantation Genetic Diagnosis (PGD) Clinical Advisory Group. 5.3.3 Rationale The Pre-implantation Genetic Diagnosis (PGD) Clinical Advisory Group has been set up by the Genetics Consortium to consider individual requests for funding and make recommendations to commissioners of member CCGs on the clinical appropriateness to fund individual PGD cases. Couples wishing to access PGD will therefore not be treated in the same way as couples requesting assisted conception. As such they will not be limited by the requirements of this policy (e.g. joining the centrally managed list, other aspects of the clinical criteria). However, each case will need to receive specific prior approval for funding from the CCG which will then act on the recommendations of the PGD Clinical Advisory Group. Funding for PGD does not fall within the financial allocation for assisted conception. 5.4 Egg Donation 5.4.1 Definition: Egg donation is the process by which a fertile woman donates her eggs for use in the treatment of other women 5.4.2 Policy statement Merton CCG will fund one cycle of IVF/ICSI using egg donation for women with:

Premature ovarian failure

Gonadal dysgenesis including Turner’s syndrome

Bilateral oophorectomy

Ovarian failure following chemotherapy of radiotherapy Women must meet all of the criteria in Appendix 1. Eggs must be donated through an altruistic donor, egg sharing schemes or sourcing eggs from overseas will not be funded 5.4.3 Rationale: Some women cannot produce eggs, usually because their ovaries are not functioning, have been removed or they have a chromosomal abnormality. 5.5 Donor insemination 5.5.1 Definition: This form of treatment involves using sperm donated anonymously by another man.


5.5.2 Policy statement Merton CCG will fund donor insemination using IUI for the following conditions if appropriate:

Non-obstructive azoospermia

Where there is a high risk of transmitting a genetic disorder to the offspring

Where there is high risk of transmitting an infectious disease from the man to the woman or to the offspring

Severe rhesus isoimmunisation 5.6 Surrogacy 5.6.1 Definition: Surrogacy is a way for a childless couple to become parents, with a surrogate mother carrying their child. In traditional surrogacy, the surrogate may be the child's genetic mother i.e. her egg is fertilized using sperm from the man who wishes to raise the child. In gestational surrogacy, the pregnant woman is not biologically related to the baby. 5.6.2 Policy statement Merton CCG does not fund any element of surrogacy arrangements or associated fertility treatments and procedures. 5.6.3 Rationale: The funding of surrogacy arrangements and associated fertility treatments raises numerous legal and ethical issues which present significant risk to commissioners. These risks arise from the complexities associated with surrogate arrangements including: issues relating to the parentage of the child; change of mind by any of the parties involved in the surrogate arrangement (including termination of pregnancy or refusal to surrender child); problems arising from “unwanted baby” or genetic or congenital defects. Given that these are either unresolved and that the legal position on many of these aspects are presently unclear, the legal advice to CCGs is not to fund any element of surrogacy procedures. 5.7 Private/Self Funding Patients 5.7.1 Policy statement Patients who are undergoing treatment outside of an NHS pathway will not be funded or reimbursed for drugs or additional tests incurred as a result of self-funded/private treatment. 5.8 In vitro maturation 5.8.1 Definition: In vitro maturation involves removing immature eggs that have yet to complete their growth, and subsequently maturing these eggs in the laboratory. 5.8.2 Policy statement In vitro maturation will only be funded in exceptional circumstances. 5.8.3 Rationale There is limited evidence for the effectiveness of in vitro maturation of eggs


5.9 HIV infection and sperm washing 5.9.1 Definition: Sperm washing is a process in which individual sperm are removed from the semen then used in IUI or IVF. Its use in reducing male to female HIV transmission is based on the observation that HIV is found in the seminal fluid rather than the sperm cells. 5.9.2 Policy statement Funding of Sperm washing for the prevention of transmission HIV will be considered on an individual patient basis. 5.9.3 Rationale: Where the man is HIV positive, the risk of HIV transmission through unprotected sexual intercourse is negligible when all of the following criteria are met:

the man is complying with highly active antiretroviral therapy (HAART)

the man has a plasma viral load of less than 50 copies/ml

there are no other infections present

unprotected intercourse is limited to the time of ovulation If all of the criteria above are met, sperm washing may not further reduce the risk of infection and may actually reduce the likelihood of pregnancy. In addition, sperm washing reduces, but does not eliminate, the risk of HIV transmission 5.10 Cryopreservation and cryostorage 5.10.1 Definition Cryopreservation entails freezing of eggs, sperm and/or embryos that may be thawed for use in future IVF treatment cycles. Cryostorage entails storage of frozen eggs, sperm and/or embryos that may be thawed for use in future IVF treatment cycles. 5.10.2 Policy statement i) Merton CCG will fund sperm cryostorage, egg cryostorage and embryo cryostorage in the following circumstances:

Medical or surgical treatment that is likely to have a permanent harmful effect on subsequent sperm or egg production. Such treatment includes radiotherapy or chemotherapy for malignant disease.

Ongoing medical treatment that, whilst on treatment, causes harmful effects on sperm or egg production or has possible teratogenic effects, and in whom stopping treatment for a prolonged period of time to enable conception is not an option.

ii) Commencement of cryostorage does not entitle people to assisted conception treatments. In this circumstance and individual funding request can be applied iii) Storage:

May not exceed five (10) years.

Will not be available where a man or woman chooses to undergo medical or surgical treatment whose primary purpose is infertility, such as sterilisation;

Will not be available where a man or woman requests cryostorage for personal lifestyle reasons, such as wishing to delay trying to conceive

iv) Post-storage Treatment


Funding of assisted conception treatments would be made available on the same basis as other patients who have not undergone such storage

5.11 Surgical sperm retrieval/recovery 5.11.1 Definition: A surgical procedure to obtain sperm from the testicles in men who cannot ejaculate or have a blockage in the flow of sperm from their testicles. 5.11.2 Policy statement Surgical sperm retrieval will be commissioned in appropriately selected patients provided the azoospermia is not the result of a sterilisation procedure or the absence of sperm and the couple meets all other criteria. 5.11.3 Rationale Spermatozoa can be retrieved from both the epididymis and the testis using a variety of techniques with the intention of achieving pregnancies for couples where the male partner has obstructive or non-obstructive azoospermia. Sperm recovery is also used in ejaculatory failure and where only non-motile spermatozoa are present in the ejaculate. Surgically collected sperm in azoospermia are immature (because they have not traversed the epididymus) and have low fertilising ability with standard IVF. It is therefore necessary to use ICSI.


Appendix 1: Merton CCG Criteria for Access to Intrauterine Insemination (IUI), In Vitro Fertilisation (IVF), Intracytoplasmic Sperm Injection (ICSI) Title Criteria Rationale


Couples will be eligible for referral for treatment if they have experienced twenty four months of unexplained infertility or have an identified cause of infertility



Woman is aged 23 – 402 at the time of treatment i.e she has not had her 41st 43rd birthday

Couples will not be able to be referred from secondary to tertiary care where the women is aged over 402.5 years. This is because treatment must take place before her 41st3rd birthday and clinics will be operating an 18 week pathway The lower age limit will not apply to women accessing treatment due to clinical care that is likely to result in long-term infertility







19 – 30 kg/m2, weight to be maintained for the last 6 months prior to application.





Previous cycles

Couples will be eligible for NHS funding of one fresh cycle of IVF or ICSI. Where the couple produces more than one good quality embryo and have an elective single embryo transfer, the PCT CCG will fund 12 months of cryopreservation of the remaining embryos. If the initial embryo transfer does not result in a live birth, Merton CCG will then fund a single unstimulated frozen embryo transfer

Where couples have self-funded previous cycles, these must not exceed one.



Couples will not be eligible for treatment if they have received any previous NHS funded treatment

Women who are aged over 40 at the time of treatment will be entitled to one cycle of IVF/ICSI treatment provided that they have not undergone any previous self-funded or NHS IVF/ICSI treatment previously

Childlessness

Neither partner will have any living children from this or previous relationships (including adopted children)


Sterilisation

Treatments will not be available if either partner has undergone sterilisation.

Sterilisation is offered as an irreversible method of contraception and individuals on the NHS are made aware of this at the time of the procedure



Human Fertilisation and Embryology (HFE) Act 1990 (as amended) states:

Section 13 (5): A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting), and of any other child who may be affected by the birth.


IVF treatment will be funded for same sex couples or women not in a partnership if those seeking treatment are demonstrably subfertile and have undergone a period of expectant management. They would first need to demonstrate subfertility through 6 self-funded attempts at artificial insemination using donor sperm in a clinical setting, and undergo a period of expectant management involving up to a further 6 cycles of self or NHS-funded donor intra-uterine insemination (see policy statement 4).

Note: Men in same-sex relationships wanting a baby can either adopt or

Same-sex couples should have access to IVF on equivalent grounds to heterosexual couples. In this respect, failure to conceive after six cycles of self-funded artificial insemination has been deemed an equivalent indicator of sub-fertility, given clinical and practical considerations3.


use some form of surrogacy. The CCG will not fund surrogacy arrangements. However, when a pregnancy does not occur through surrogacy after 6 cycles of self-funded intra-uterine insemination in a clinical setting there is an increased risk of some underlying problem. In those circumstances, the man whose sperm is being used and the surrogate partner would be eligible to be referred for further clinical assessment and possible treatment4.

In the case of same sex couples where only one partner is sub fertile, clinicians should discuss the possibility of the other partner receiving treatment before proceeding to interventions involving the sub fertile partner.

The other criteria for eligibility for IVF will also apply.

All same sex couples and women not in a partnership should have access to professional experts in reproductive medicine to obtain advice on the options available

Further NHS-funded cycles of intra-uterine insemination (up to six) constitutes the period of expectant management required prior to being eligible for IVF, during which pregnancy may be achieved (based on NICE recommendation3 and advice of local clinicians).

FSH FSH levels should be checked between day 2 and 4 of the menstrual cycle, where day 1 is the first full day of menstrual bleeding, with Oestradiol level. Only women whose FSH has never exceeded a level of 11.9 iu/L or less when an oestradiol level checked on the same day is 249 pmol/l or less will be eligible for treatment with the sample timed within 6 months of date of treatment. For those with no periods the sample can be timed at any date but the same maximum levels apply. The clinic will be expected to repeat the FSH blood test if the level was checked more than 6 months prior to treatment and treatment will be withdrawn if the repeated level exceeds 11.9iu/L

Investigations The couple must have been appropriately investigated within a recognised NHS fertility clinic in secondary care. The couple can only be referred for assisted conception once all of these investigations have been completed and a proforma referral document completed . The referring clinic will check to ensure that the couple fulfil the relevant criteria and at that point will start an 18 week clock. Couples must NOT be referred for assisted conception until all other relevant procedures have been completed and the patient discharged from secondary care.


RICHMOND CCG – IVF criteria 2014/2015

Sub-fertility Investigations and Assisted Conception Policy

Summary

This summary should be read with

Appendix A-Decision tree for subfertility investigations and treatment

Appendix B-Criteria for Subfertility Investigations

Appendix C-Criteria for Assisted Conception including IVF, ICSI and IUI

Appendix D-South West London Effective Commissioning (SWLECI)criteria on Fertility

Preservation techniques

1. Richmond CCG will only fund fertility investigations and related drugs (Appendix B)

for:

a. women 45 years of age or below; and

b. who are childless or have only one living child (including adopted children)

either from this or previous relationship and

c. who are in a current long term relationship (at least one year)

2. Please refer to the appendices regarding which investigations should be carried out in

general practice. Subfertility investigations and treatment criteria are attached at

appendix A, B and C. Patient choice exists for subfertility investigation but not for

Assisted Conception i.e. IUI, IVF and ICSI. When referring patients for investigations

please consider this to avoid duplication of investigation. Please note that the ACU at

KH will always repeat the semen analysis before any assisted conception.

3. Primary Care investigations include

BMI- if >30 refer to LiveWell Richmond weight management programme.

Routine bloods – Rubella, FSH/LH (day 2 – 4) and Progesterone (day 21).

If indicated, conduct smear.

If amenorrhoea or oligomenorrhea, conduct Prolactin and TFT.

Semen analysis – if abnormal repeat after 6 – 8 weeks.

4. Specialist investigations include Hep B, HIV, and ovarian reserve; tubal and uterine

abnormalities.

5. Please do not carry out specialist investigations in Primary care (Please note this also

applies to Private clinics)

6. The referral letter to secondary care should include the following information

regarding patient’s

BMI

Smoking status

Duration of trying

Relationship status

Existing children

7. Assisted Conception i.e. IUI/IVF and ICSI is only commissioned at Assisted Conception

Unit based at Kingston Hospital.


8. Richmond CCG will only fund one fresh cycle of IVF and one frozen cycle for women

between 23 to 40 years of age and who fulfil the criteria set out in appendix C

9. Richmond CCG will only fund IUI cycles ( upto a maximum of 6 cycles) for people

(Appendix C);

a. who are unable to, or would find it very difficult to, have vaginal intercourse

because of a clinically diagnosed physical disability or psychosexual problem

who are using partner or donor sperm

people with conditions that require specific consideration in relation to methods of conception (for example, after sperm washing where the man is HIV positive)


Appendix A: Management of Subfertility


Annex B: RICHMOND CCG – Subfertility Investigations-2014/2015

Criteria Rationale


Couples will be eligible for subfertility investigations* who have tried to conceive for 12 months or where the woman is over the age of 36, have been trying to conceive for 6 months

or an identified cause of infertility1


Age of woman at the time of referral

The maximum age of the woman should be less than 46 years of age i.e. 45 years or below

2

Evidence shows that fertility drops below 5% in women over the age of 45


19 – 30 kg/m2,

weight to be maintained for the last 6 months prior to referral

3.

Higher body mass index reduces the probability of fertility and the success associated with assisted conception techniques


Both partners should have been non-smokers for atleast 6 months

3

Smoking can adversely affect fertility and the success rates of assisted reproductive techniques.

Childlessness Neither partner should have more than one living child from this or previous relationships (including adopted children)

Priority will be given to couples with the greatest need.


Sub fertility investigations will be funded for women in same sex couples if those seeking treatment are demonstrably subfertile.(This requires that same-sex female couples complete 6 cycles of artificial insemination successfully( Not NHS-funded) before being eligible for NHS sub-fertility assessment and treatment)

In the case of women in same sex couples in which only one partner is sub-fertile, clinicians should discuss the possibility of the other partner receiving treatment before proceeding to interventions involving the sub-fertile partner.

NHS funding will not be available for access to insemination facilities for fertile women who are part of a same sex partnership or those not in a partnership.

In circumstances in which women in a same sex partnership are eligible for sub-fertility treatment, the other criteria for eligibility for sub fertility treatments will also apply.

Women in same sex couples and women not in a partnership should have access to professional experts in reproductive medicine to obtain advice on the options available to enable them to proceed along this route if they so wish.


*All Assisted conception (IUI/IVF and ICSI) should only be carried out at Kingston Hospital.

References:


1. National Institute for Health & Clinical Excellence (NICE) CG156:Fertility: assessment and treatment for people with fertility problems, Feb 2013

2. Local Public Health Analysis 2013 3. SWLECI IVF Criteria2013/14

Annex C: RICHMOND CCG – Assisted Conception-IVF/ICSI/IUI-2014/2015

Richmond CCG criteria for Access to Assisted Conception, including, In Vitro Fertilisation (IVF) , Intracytoplasmic Sperm Injection (ICSI) and Intrauterine Insemination (IUI)

Criteria Rationale


Couples will be eligible for referral for treatment if they have experienced twenty four months of unexplained infertility* (this can include upto twelve months before their fertility investigations)

or an identified cause of infertility1



The age range will be between 23-39 years as per NICE Guidance. If the woman reaches the age of 40 during treatment, complete the current full cycle but do not offer further full cycles o







19 – 30 kg/m2,

weight to be maintained for the last 6 months prior to application

2.

Higher body mass index reduces the probability of fertility and the success associated with assisted conception techniques


Both partners should have been non-smokers for at least six months prior to commencement of treatment

2.


IVF** Cycles and ICSI

Couples (Women 23-39 years of age) will be eligible for one fresh and a maximum of one un-stimulated frozen cycle with or without ICSI

1. The storage cost for frozen

embryos for up to one year or until a live birth (whichever is sooner) would be paid for by the CCG

3.(Criteria at Appendix D)

Where couples have self-funded previous cycles, the self-funded cycles must not exceed TWO.

The probability of a live birth following the IVF is consistent for the first three cycles but effectiveness of subsequent cycles is uncertain. NICE Guidance 2013.

IUI Cycles** Offer IUI cycles ( upto a maximum of 6 cycles) to

1

people who are unable to, or would find it very difficult to, have vaginal intercourse because of a clinically diagnosed physical disability or psychosexual problem who are using partner or donor sperm

people with conditions that require specific consideration in relation to methods of conception (for example, after sperm

NICE Guidance 2013.


washing where the man is HIV positive)


2


Sterilisation Treatments will not be available if either partner has undergone previous sterilisation

2.




2

Human Fertilisation and Embryology (HFE) Act 1990 (as amended) states: Section 13 (5): A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting), and of any other child who may be affected by the birth. Section 2 (1) … “treatment services” means medical, surgical or obstetric services provided ... for the purpose of assisting women to carry children.


Sub fertility treatment will be funded for women in same sex couples if those seeking treatment are demonstrably sub fertile.( This requires that same-sex female couples complete 6 cycles of artificial insemination successfully before being eligible for NHS sub-fertility assessment and treatment)

In the case of women in same sex couples in which only one partner is sub fertile, clinicians should discuss the possibility of the other partner receiving treatment before proceeding to interventions involving the sub fertile partner.


In circumstances in which women in a same sex partnership or individuals are eligible for sub fertility treatment, the other criteria for eligibility for sub fertility treatments will also apply.

Women in same sex couples and women not in a partnership should have access to professional experts in reproductive medicine to obtain advice on the options available to enable them to proceed along this route if they so wish

2.


FSH FSH levels should be checked between day 1 and 4 of the menstrual cycle with an LH and Oestradiol level. Only women whose FSH has never exceeded a level of 11.9 iu/l or less when an oestradiol level


checked on the same day is 249 pmol/l or less will be eligible for treatment with the sample timed within 6 months of date of referral. For those with no periods the sample can be timed at any date but the same maximum levels apply

4

*women who have not conceived after 24 months of regular unprotected intercourse or 12 cycles of artificial insemination (where 6 or more are by intrauterine insemination). This period may be known as ‘expectant management’ or ‘watchful waiting’. **All Assisted conception i.e. IUI, IVF and ICSI should only be carried out at Kingston Hospital

References:

4. National Institute for Health & Clinical Excellence (NICE) CG156:Fertility: assessment and treatment for people with fertility problems, Feb 2013

5. South West London Effective Commissioning Initiative Criteria 2013/14;Criteria for IVF

6. South West London Effective Commissioning Initiative Criteria 2013/14; Criteria on Fertility Preservation Techniques

7. Wandsworth CCG IVF Criteria 2012

Appendix D: Fertility preservation techniques (SWLECI Criteria 2013/14)

The following preservation techniques: semen cryostorage, oocyte cryostorage, embryo cryostorage, will be routinely funded by SWL CCGs in the following circumstances:

Where a man or a woman requires medical or surgical treatment that is likely to have a permanent harmful effect on subsequent sperm or egg production. Such treatment includes radiotherapy or chemotherapy for malignant disease.

OR

Where a man or a woman requires ongoing medical treatment that, whilst on treatment, causes harmful effects on sperm or egg production, impotence or has possible teratogenic effects, and in whom stopping treatment for a prolonged period of time to enable conception is not an option.

It is important to note that the eggs are extracted for cryostorage using drugs and procedures of egg collection normally used for assisted conception; therefore the funding includes assisted conception drugs and procedures as well as the storage costs. This will not progress to IVF/ ICSI or any other assisted conception procedures to form an embryo in these cases, unless this is sought separately later through the assisted conception pathway. Note:

Women should be offered oocyte or embryo cryostorage (without simultaneous assisted conception treatment) as appropriate if they are


well enough to undergo ovarian stimulation and egg collection, provided this will not worsen their condition and that sufficient time is available.

Women preparing for medical treatment that is likely to make them infertile should be informed that oocyte cryostorage has very limited success, and that cryopreservation of ovarian tissue is still in an early stage of development.

Storage

If agreed, will be funded for five (5) years. The HFEA would grant a license to cryostore oocytes for ten years. The further extension up to ten years can still be offered to the patient but as a self-funded process.

Will not be available where a man or woman chooses to undergo medical or surgical treatment whose primary purpose is that it will render her infertile, such as sterilisation.

Will not be available where a man or woman requests cryostorage for personal lifestyle reasons, such as wishing to delay trying to conceive.

Post-storage Treatment Funding of assisted conception treatments would be made available on the same basis as other patients who have not undergone such storage. Self -funding following cessation of NHS funding Once the period of NHS funding ceases, patients can elect to self-fund for a further period, not to exceed appropriate HFEA regulations on length of storage. Embryo Cryostorage after NHS funded assisted conception Suitable embryo’s that are not transferred in IVF/ICSI cycle - Storage will be funded for a period of one (1) year.

SUTTON CCG – IVF criteria 2014

Funding Criteria Explanation

Access

Equity of access to services and choice of provider for those meeting the eligibility criteria. The constraints on NHS resources, and the impact on the financial stability for CCGs. Clauses 226 to 230 of the NHS Act 2006 focus on the statutory financial duties of Health Bodies.


It is a duty to ensure that annual expenditure does not exceed the annual allowance (as set out in accordance with the provision of the NHS Act).

Definition of a treatment cycle

A cycle of IVF/ICSI includes ovarian stimulation, egg recovery, fertilisation and single fresh embryo transfer. This includes the provision for further transfer of one frozen embryo where the initial procedure does not result in a viable pregnancy and the subsequent storage of embryo A frozen cycle is one which starts when a cryopreserved embryo is removed from storage in order to be thawed and then transferred.

Eligibility criteria

Couples will only be funded for assisted conception if they meet the eligibility criteria below and when all appropriate tests and investigations have been successfully completed in primary and secondary care in line with NICE guidelines. See appendix for list of investigations. The process for funding approval is set and should be followed.

Registration status

Both partners must be registered with a GP on the performers list in Sutton CCG

Compliance Criteria

The referring clinician must ensure that patients are aware of the implications of IVF or ICSI treatment and the commitments required before making a referral for assisted conception. Those where compliance to IVF treatment is deemed to be a problem must be referred for counselling in the first instance

Duration of Fertility

Couples who have not conceived after one year of unprotected sexual intercourse should be offered investigations in primary and secondary care as appropriate and referred for Assisted Conception if they meet other IVF access criteria and have been trying to conceive without success for at least 2 years. Investigation after 6 months may be indicated if maternal age id approaching the maternal age referral criterion.

Cause of infertility

Couples with diagnosed or known cause of infertility that precludes natural conception do not need to wait for one year before referral for AC. This includes couples who cannot achieve full sexual intercourse due to disability. Couples in whom one or both partners have been voluntarily sterilised will not be eligible for treatment under this policy.


Age of Female

IVF treatment will be funded for couples where the female partner is at least 23 years and not yet reached their 40th birthday (39 years and 34 weeks to comply with 18 weeks waiting time requirements) by the time the treatment commences as the chances of a live birth decrease with rising female age (defined as the start of the stimulating phase of the IVF cycle) It is the responsibility of service providers to ensure that eligible couples have commenced the woman’s frozen treatment before her 40th birthday.

Welfare of the child

The referrer/provider should ensure that the HFEA code of ethics is followed. Details can be found at http://www.hfea.gov.uk/index.html

Children from previous relationships

Neither partner should have any living children (including adopted children) from current or previous relationships.

Life style factors

The couple’s health and social circumstances should pose no significant risk to conception, pregnancy or the resultant child. Obesity, smoking and alcohol reduce fertility and increase risks to mother and baby during pregnancy. The woman must have a body mass index (BMI) of between 19 and 30 at the commencement of treatment. Women who are overweight or underweight will be offered referral to dieticians in order to improve their BMI before referral to AC. Women with a BMI less than 19 and greater than 30 will not be funded. Couples who smoke must be referred to smoking cessation service to support their efforts in stopping smoking. Couples should be advised that modifying their drinking habits may increase their fertility. Women should be advised not to consume more than 1-2 units of alcohol once or twice a week and avoid intoxication. Men should not consume more than 3-4 units per day. Sutton CCG will not fund IVF treatment until both partners have stopped smoking for six months. This information should be included in the referral letter to the provider. Referral for smoking cessation prior to referral will be the responsibility of the GP/hospital consultant. Sutton CCG recommends that households are encouraged to be smoke free. Advice should be given in relation to caffeine consumption and its adverse effect on success rates of assisted conception procedures including IVF treatment.

Number of cycles to be funded

Sutton CCG will fund 1 Full cycle of IVF or ICSI at the current accredited providers across SWL – The Full IVF cycle will consist of

http://www.hfea.gov.uk/index.html


one fresh cycle and one frozen embryo transfer cycle. One treatment cycle will ideally be followed by the other, but a successful fresh cycle (in terms of a live birth) would make the couple ineligible for a frozen cycle. Similarly a spontaneous conception leading to live birth while on the waiting list will make the couple ineligible for further IVF treatment. Sutton CCG will not fund IVF where a patient has received any previous full IVF or ICSI treatment cycle funded by the NHS. Sutton CCG will not fund IVF treatment where a woman has a history of 3 or more previous privately funded fresh cycles. Where a woman has previously privately funded one or two cycles, Sutton CCG will still fund one full cycle or only one fresh cycle if clinically appropriate in view of chance of success under this policy

Frozen Embryos Frozen cycles

The transfer of frozen embryos will constitute a cycle for the purpose of establishing entitlement to NHS funding under this policy. If a couple has had frozen embryos transferred as part of the earlier self-funded treatment the frozen cycles will not be counted as previous cycles when assessing eligibility for NHS funded IVF. Frozen embryos must be transferred within six months of the patient reaching their 40th birthday. Where couples have previously self-funded and frozen embryos exist, the couple must implant one or two of the previously fresh/frozen embryos, rather than undergo ovarian stimulation, egg retrieval and fertilisation again.

Abandoned cycles Abandoned cycles following known clinical complications of assisted conception treatment will not constitute a cycle for the purpose of establishing entitlement to NHS funding. Providers may only charge for the cycle if it reached the stimulating stage when treatment is stopped.

Number of embryos to be transferred

In order to comply with the HFEA’s multiple births minimisation strategy as outlined in the document ‘One Child at a Time’, Sutton CCG will require its IVF and assisted conception provider units to adhere with the following guidance; If female partner is less than 37 years and having first fresh cycle, provider units should transfer one blastocyst day 5 embryo. Sutton CCG will fund embryo transfers and freezing in order to support this single embryo transfer strategy. If the female partner is more than 37 years, provider units can transfer up to 2 embryos in the first fresh cycle. Where the female is undergoing a frozen cycle for all age groups, only one embryo (or 2 embryos where the quality of frozen embryos are judged to be poor) could be transferred. Sutton CCG will leave this


judgement to clinicians.

Gamete and Embryo storage

Sutton CCG will fund sperm banking for post-pubertal males under the age of 55 years who have not yet completed their family, and are about to undergo treatment which is likely to result in long-term subfertility. In accordance with HFEA guidance, gametes can be stored for up to 50 years. Sutton CCG will fund gamete storage for the first 12 months but subsequent annual storage charges will be the responsibility of the individual patient. Subsequent assisted conception procedures using the sperm will not be funded unless the other IVF eligibility criteria set out in this policy are met. Ovarian stimulation and embryo cryopreservation will be made available to women who are about to undergo treatment likely to cause infertility, provided they are in a stable relationship and wish to pursue this option. Oocyte (egg) preservation and ovarian tissue preservation are still experimental treatments, and will not be funded. However, the evidence will be kept under review. The procedures recommended by the Royal College of Physicians and the Royal College of Radiologists should be followed before commencing chemotherapy or radiotherapy likely to affect fertility, or management of post-treatment fertility problems. Retrieval and storage of sperm, eggs or embryos should also be in accordance with HFEA guideline

Intra Uterine Insemination (IUI)

Intra Uterine Insemination (IUI) for unexplained infertility is part of the care pathway leading to IVF/ICSI. Therefore previous treatment with IUI will not preclude access to NHS funded IVF treatment.

Egg Donation

Where the couple meet the relevant eligibility criteria Sutton CCG will fund IVF using donated eggs from UK clinics licensed by the HFEA (but not from clinics abroad) for women with premature ovarian failure due to pathological or iatrogenic cause or in order to avoid the transmission of inherited disorders to a child. Egg donation outside of these criteria will not be funded. Patients will be informed of the requirement to fund their own donor.

Sperm Donation

Sutton CCG will not fund donor sperm but will fund the associated IUI/IVF/ICSI treatment in line with the criteria in this policy providing the sperm meet the criteria laid down by the treating provider unit Patients wishing to access donor sperm treatments must make their own arrangements but are advised to check with the treating provider unit to ensure compliance with HFEA guidelines before accessing donated sperm.


Surgical sperm retrieval

Surgical sperm retrieval will be funded in appropriately selected patients, provided that the azoospermia is not the result of a sterilisation procedure as part of IVF and ICSI.

Surrogacy

DI, IUI or IVF using a surrogate mother will not be funded by Sutton CCG.

Sperm Washing

Sutton CCG will fund sperm washing for IUI/IVF/ICSI in infertile couples where the male partner is HIV positive and the female partner is HIV negative. Where there are no fertility problems, Sutton CCG will fund sperm washing and up to 3 cycles of IUI in couples where the male partner is HIV positive and the female partner is HIV negative, subject to other IVF clinical criteria being met, in order to decrease the transmission rate of HIV to an unborn child. The attending Consultant in Genito Urinary Medicine or Infectious Diseases will be required to provide written confirmation of the suitability of the couple for NHS funding.


The main aim of this policy is to assist couples with medical or physical limits to their fertility. Applying the infertility policy to same sex couples requires some flexibility from those seeking treatment and the clinical team referring or treating the couple to ensure that the over-arching aim of this policy is met. Women in same sex relationships and women not in a partnership should have access to professional experts in reproductive medicine to obtain advice on the options available to them. Same sex female couples will not have access to initial investigations for IVF without some medical evidence of six unsuccessful cycles of IUI or donor sperm use and no resultant pregnancy. Same sex male couples will not be able to access fertility treatment within their relationship but may be eligible for some assistance if there is a medical infertility issue as would be available for couples using a surrogate (e.g. women born without a uterus but have normal ovaries, premature menopause, Cancer of the ovaries, uterus etc.). Applications from women not in a partnership will be considered in line with HFEA Guidance and Code of Practice and the Human Rights of the individual. Sutton CCG will fund assisted conception treatment for same sex couples who demonstrate evidence of clinical infertility as would be required for couples in heterosexual relationships. (This is normally defined as failure to conceive after regular unprotected sexual intercourse for 2 years or where there is already known or established anatomic cause(s) of infertility, but for the purposes of this policy, couples could start investigations in primary care after 1 year of unexplained infertility).


Same sex couples will be expected to have undertaken all necessary fertility tests to exclude possible causes of treatable infertility such as an ovulation and tubal blockage in the first instance. Where fertility tests show no obvious cause of infertility, same sex couples will be required to provide evidence of failure to conceive after 6 cycles of self funded donor IUI before they become eligible for NHS funded IVF or other assisted conception treatment. In the case of women in same sex couples in which only one partner is sub fertile, clinicians should discuss the possibility of the other partner receiving treatment before proceeding to interventions involving the sub fertile partner Sutton CCG will not fund donor sperm, so same sex couples have to fund this element themselves, for either IUI or IVF. All couples will have to be in a stable relationship for at least 2 years before eligibility for NHS funded IVF or other assisted conception treatment.

Provider units All drug costs should be met by the tertiary unit as part of the commissioned service and must not be prescribed by a GP. Providers are expected to use the most clinically and cost effective drugs available. To avoid the clinical risks associated with multiple births, tertiary units must have a strategy in place to comply with the HFEA’s multiple births minimisation strategy as outlined in the document ‘One Child at a Time’ published by HFEA.(www.oneatatime.org.uk/36.htm) Where a consultant has assessed a patient and established that the likelihood of success is less than 10% (due to FSH levels or other valid clinical reasons such as previous poor response), the clinician may decide not to continue with IVF/ICSI treatment even if the patient meets the access criteria set out in this policy. In these cases, Sutton CCG will be guided by the clinician's view


WANDSWORTH CCG - IVF criteria 2013/2015

Title Criteria Rationale


Couples will be eligible for referral for treatment if they have experienced twenty four months of unexplained infertility* (this can include up to twelve months before their fertility investigations)

or have an identified cause of infertility



Woman is aged 23 – 39 years at the time of treatment

The lower age limit will not apply to women accessing treatment due to clinical care that is likely to result in long-term infertility

Women aged 40 – 42 who have experienced twenty four months of unexplained infertility*, where the following criteria are fulfilled:

o They have never previously had IVF treatment o There is no evidence of low ovarian reserve o There has been a discussion of the additional

implications of IVF and pregnancy at this age







19 – 30 kg/m2,






Previous cycles

Couples will be eligible for NHS funding of one fresh cycle of IVF or ICSI. Where the couple produces more than one good quality embryo and have an elective single embryo transfer, the CCG will fund 12 months of cryopreservation of the remaining embryos. If the initial embryo transfer does not result in a live birth, the CCG will then fund a single unstimulated frozen embryo transfer

Where couples have self-funded previous cycles, these must not exceed TWO.





Sterilisation is offered as an irreversible method of contraception and individuals on the NHS are made aware of this at the time of the procedure


Couples must comply to a Welfare of the Child assessment as described in the Human Fertilisation and Embryology Authority Code of Practice

Human Fertilisation and Embryology (HFE) Act 1990 (as amended) states: Section 13 (5): A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting), and of any other child who may be affected by the birth.


Sub fertility treatment will be funded for women in same sex couples or women not in a partnership if those seeking treatment are demonstrably sub fertile.

In the case of women in same sex couples in which only one partner is sub fertile, clinicians should discuss the possibility of the other partner receiving treatment before proceeding to interventions involving the sub fertile partner.


In circumstances in which women in a same sex partnership or individuals are eligible for sub fertility treatment, the other criteria for eligibility for sub fertility treatments will also apply.

Women in same sex couples and women not in a partnership should have access to professional experts in reproductive medicine to obtain advice on the options available to enable them to proceed along this route if they so wish.

To ensure equality of access to the service.

http://www.hfea.gov.uk/docs/Code_of_Practice_8_-_October_2013.PDF

http://www.hfea.gov.uk/docs/Code_of_Practice_8_-_October_2013.PDF


Title Criteria Rationale

FSH FSH levels should be checked between day 1 and 4 of the menstrual cycle with an LH and Oestradiol level. Only women whose FSH has never exceeded a level of 11.9 iu/l or less when an oestradiol level checked on the same day is 249 pmol/l or less will be eligible for treatment with the sample timed within 6 months of date of referral. For those with no periods the sample can be timed at any date but the same maximum levels apply

*women who have not conceived after 24 months of regular unprotected intercourse or 12 cycles of artificial insemination (where 6 or more are by intrauterine insemination). This period may be known as ‘expectant management’ or ‘watchful waiting’.

The content should demonstrably comply with all relevant legal and statutory requirements, NHS guidance and policy in force at the time of writing or reviewing the document. It should include Consultation and Equality Analysis results and any required changes to the document.


Appendix H: Classification of Pain Levels and Functional Limitations Table for Primary Hip Replacement and Oxford Hip Score

Variable Definition Pain Level

Mild

Pain interferes minimally on an intermittent basis with usual daily activities. Not related to rest or sleep. Pain controlled by one or more of the following: NSAIDs with no or tolerable side effects, aspirin at regular doses, paracetamol.

Moderate

Pain occurs daily with movement and interferes with usual daily activities. Vigorous activities cannot be performed. Not related to rest or sleep. Pain controlled by one or more of the following: NSAIDs with no or tolerable side effects, aspirin at regular doses, paracetamol.

Severe

Pain is constant and interferes with most activities of daily living. Pain at rest or interferes with sleep. Pain not controlled, even by narcotic analgesics.

Previous non-surgical treatments

Correctly Done

NSAIDs, paracetamol, aspirin or narcotic analgesics at regular doses during 6 months with no pain relief; weight control treatment if overweight, physical therapies done.

Incorrectly Done

NSAIDs, paracetamol, aspirin or narcotic analgesics at inadequate doses or less than 6 months with no pain relief; or no weight control treatment if overweight or no physical therapies done. Functional Limitations

Minor

Functional capacity adequate to conduct normal activities and self care. Walking capacity of more than one hour. No aids needed.

Moderate

Functional capacity adequate to perform only a few or none of the normal activities and self care. Walking capacity of about one half hour. Aids such as a cane are needed.

Severe

Largely or wholly incapacitated. Walking capacity of less than half hour or unable to walk or bedridden. Aids such as a cane, a walker or a wheelchair are required.


OXFORD HIP SCORE(1) TO BE COMPLETED BY THE PATIENT DURING THE PAST 4 WEEKS:

1 How would you describe the pain you usually have from your hip? (scoring None о Very mild о Mild о Moderate о Severe о 4-0)

2 Have you had any trouble with washing and drying yourself (all over) because of your hip? (scoring No trouble at all о Very little trouble о Moderate trouble о Extreme difficulty о Impossible to do о 4-0)

3 Have you had any trouble getting in and out of a car or using public transport because of your hip? (scoring No trouble at all о Very little trouble о Moderate trouble о Extreme difficulty о Impossible to do о 4-0)

4 Have you been able to put on a pair of socks, stocking or tights? (scoring Yes, easily о With little difficulty о With moderate difficulty о With extreme difficulty о Impossible to 4-0) do о

5 Could you do the household shopping on your own? (scoring Yes, easily о With little difficulty о With moderate difficulty о With extreme difficulty о All of the 4-0) time о

6 For how long have you been able to walk before pain from your knee becomes severe? (with or (scoring without a stick) 4-0) No pain/more than 30 minutes о 16-30 minutes о 5 to 15 minutes о Around the house only о

Not at all-pain severe when walking о

7 Have you been able to climb a flight of stairs? (scoring Yes, easily о With little difficulty о With moderate difficulty о With extreme difficulty о All of the 4-0) time о

8 After a meal (sat at a table), how painful has it been for you to stand up from a chair because of (scoring your hip? 4-0) Not at all painful о Slightly painful о Moderately painful о Very painful о Unbearable о

9 Have you been limping when walking because of your hip? (scoring Rarely/Never о Sometimes, or just at first о Often, not just at first о Most of the time о All of 4-0) the time о

10 Have you had any sudden, severe pain -‘shooting’, ‘stabbing’ or ‘spasms’ from the affected hip? (scoring No days о Only 1 or 2 days о Some days о Most days о Every day о 4-0)

11 How much has pain from your hip interfered with your usual work (including housework) ? (scoring Not at all о A little bit о Moderately о Greatly о Totally о 4-0)

12 Have you been troubled by pain from your hip in bed at night? (scoring No nights о Only 1 or 2 nights о Some nights о Most nights о Every night о 4-0)

OXFORD HIP SCORE USER GUIDE

System of scoring* 10 Each of the 12 questions on the Oxford hip score is scored in the same way with the score decreasing as the reported symptoms increase (ie. become worse). All questions are laid out similarly with response categories denoting least (or no) symptoms being to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0). The overall score is reached by simply summing the scores received for individual questions. This results in a continuous score ranging from 0 (most severe symptoms) to 48 (least symptoms). Score each question from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome. *New scoring system for the Oxford hip score When the Oxford knee score was originally devised, the scoring system was designed to be as simple

as possible, in order to encourage its use. Thus, in the original publication 11each question was scored from 1 to 5, with 1 representing best outcome/least symptoms. Scores from each question were added so the overall score was from 12 to 60 with 12 being the best outcome. Since then, many surgeons have found this scoring unintuitive and have adapted the scoring - leading to considerable confusion. The new scoring system is now recommended.


Appendix I: Knee Symptomatology, Radiology and Localisation and Oxford Knee Score7

Variable Definition

Mobility and Stability

Preserved mobility and stable joint

Preserved mobility is equivalent to minimum range of movement from 0to 90. Stable or not lax is equivalent to an absence of slackness of more than 5mm in the extended joint.

Limited mobility and /or stable joint

Limited mobility is equivalent to a range of movement less than 0to 90. Unstable or lax is equivalent to the presence of slackness of more than 5mm in the extended joint.

Symptomatology

Slight Sporadic pain. Pain when climbing/descending stairs. Allows daily activities to be carried out (those requiring great physical activity may be limited). Medication: aspirin, paracetamol or NSAID to control pain with no side effects

Moderate Occasional pain. Pain when walking on level surfaces(half an hour, or standing). Some limitation of daily activities. Medication: aspirin, paracetamol or NSAIDS to control the pain with few or no side effects.

Intense Pain of almost continuous nature. Pain when walking short distances on level surfaces or standing for less than half an hour. Daily activities significantly limited. Continuous use of NSAIDs for treatment to take effect. Requires the sporadic use of support systems (walking stick, crutches).

Severe Continuous pain. Pain when resting. Daily activities significantly limited constantly. Continuous use of analgesics- narcotics/NSAIDs with adverse effects or no response. Requires more constant use of support systems (walking stick, crutches).

Radiology

Slight Ahlback grade 1.

Moderate Ahlback grade II and III.

Severe Ahlback grade IV and V.

Localisation

Uni-compartmental Excluded patello-femoral isolated.

Bi-compartmental Unicompartmental plus patello-femoral.

Tri-compartmental Disease affecting all three compartments of the knee.


OXFORD KNEE SCORE TO BE COMPLETED BY THE PATIENT DURING THE PAST 4 WEEKS:

1 How would you describe the pain you usually have from your knee? (scoring None о Very mild о Mild о Moderate о Severe о 4-0)

2 Have you had any trouble with washing and drying yourself (all over) because of your knee? (scoring No trouble at all о Very little trouble о Moderate trouble о Extreme difficulty о Impossible to do о 4-0)

3 Have you had any trouble getting in and out of a car or using public transport because of your knee? (scoring No trouble at all о Very little trouble о Moderate trouble о Extreme difficulty о Impossible to do о 4-0)

4 For how long have you been able to walk before pain from your knee becomes severe? (with or without a (scoring stick) 4-0) No pain/more than 30 minutes о 16-30 minutes о 5 to 15 minutes о Around the house only о Not at all-pain

severe when walking о

5 After a meal (sat at a table), how painful has it been for you to stand up from a chair because of your knee? (scoring Not at all painful о Slightly painful о Moderately painful о Very painful о Unbearable о 4-0)

6 Have you been limping when walking because of your knee? (scoring Rarely/Never о Sometimes, or just at first о Often, not just at first о Most of the time о All of the time о 4-0)

7 Could you kneel down and get up again afterwards? (scoring Yes, easily о With little difficulty о With moderate difficulty о With extreme difficulty о No, impossible о 4-0)

8 Have you been troubled by pain from your knee in bed at night? (scoring No nights о Only 1 or 2 nights о Some nights о Most nights о Every night о 4-0)

9 How much has pain from your knee interfered with your usual work (including housework) ? (scoring Not at all о A little bit о Moderately о Greatly о Totally о 4-0)

10 Have you felt your knee might suddenly ‘give way’ or let you down? (scoring Rarely/Never о Sometimes, or just at first о Often, not just at first о Most of the time о No, impossible о 4-0)

11 Could you do the household shopping on your own? (scoring Yes, easily о With little difficulty о With moderate difficulty о With extreme difficulty о All of the time о 4-0)

12 Could you walk down one flight of stairs? (scoring Yes, easily о With little difficulty о With moderate difficulty о With extreme difficulty о All of the time о 4-0)

OXFORD KNEE SCORE USER GUIDE8

System of scoring* Each of the 12 questions on the Oxford knee score is scored in the same way with the score decreasing as the reported symptoms increase (ie. become worse). All questions are laid out similarly with response categories denoting least (or no) symptoms being to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0). The overall score is reached by simply summing the scores received for individual questions. This results in a continuous score ranging from 0 (most severe symptoms) to 48 (least symptoms). Score each question from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome. *New scoring system for the Oxford knee score When the Oxford knee score was originally devised, the scoring system was designed to be as simple as possible, in order to encourage its use. Thus, in the original publication (2) each question was scored from 1 to 5, with 1 representing best outcome/least symptoms. Scores from each question were added so the overall score was from 12 to 60 with 12 being the best outcome. Since then, many surgeons have found this scoring unintuitive and have adapted the scoring - leading to considerable confusion. The new scoring system is now recommended.


Appendix J – Lymphoedema Staging and Referral Criteria Best Practice for the management of Lymphoedema 2006 guidelines Referral Criteria

Staging of Lymphoedema


Appendix K – NHS England Policies

Previous SWL ECI procedures now commissioned and managed by NHS England, effective from April 1st 2013.

Bariatric Surgery

Bone Anchored Hearing Aids (BAHAs)

Cochlear Implants

Deep Brain Stimulation (DBS) for Parkinson’s Disease

Dental Policies:

o Apicectomy

o Dental Implants

o Orthodontic Treatment

o Wisdom Teeth

Gender Reassignment Surgery

Hyperbaric Oxygen Therapy

Revision of Hip Arthroplasty

Revision of Knee Arthroplasty

Sacral Nerve Stimulation (SNS) for Faecal Incontinence

Spinal Cord Stimulation for Neuropathic Pain


Appendix L – Governance 2014/2015 All amendments/additions to the 2014/2015 SWL ECI Document have gone through a rigorous governance process as detailed below:

Local GP’s invited to suggest new procedures for inclusion into the SWL ECI Document

Suggested procedures taken through a prioritisation process and scored (top 5/6 scoring procedures worked up for discussion by

Group)

Procedures currently included in SWL ECI Document reviewed (in line with 3-year rolling programme)

New/updated criteria discussed and agreed by the SWL ECI Group.

Consultation with clinicians from the local acute trust.

SWL ECI Group reviews feedback and updates draft criteria.

Cluster wide consultation with clinical teams.

SWL ECI Group reviews feedback and updates draft criteria.

Draft policy submitted to local CCG’s for approval.

SWL ECI Group ratify updated Document.

New/updated criteria included into local secondary care contracts


Amendments/additions to the 2014/2015 were approved by local CCGs as follows:

CCG Approving Body Date Approved

Croydon Croydon CCG Governing Body 02 September 2014

Kingston Kingston CCG Governing Body 02 September 2014

Merton Merton CCG Governing Body 250September 2014

Richmond Richmond CCG Governing Body 14 October 2014

Sutton Sutton CCG Governing Body 03 September 2014

Wandsworth Wandsworth CCG Governing Body 09 July 2014

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