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Produced by S Turner, Professional Secretary for North of Tyne Area Prescribing Committee. April 2014 of 21

Executive Summary The North of Tyne Area Prescribing Committee (APC) has continued its work of facilitating medicine related clinical decision making across the North of Tyne area during 2013-14. NETAG and NECDAG ceased to operate at the end of March 2013 and NHS England took over responsibility for Specialised Commissioning with CCGs assuming the responsibility for

non – specialised drug decision making. The

15 new products were considered by the committee. 18 products were considered for an extension of approved uses or formulations. Approx. 80% of reviews resulted in recommendations for approval. The rest were either

rejected or deferred. 4 decisions made by the North of England Specialised Commissioning Group (NESCG)

were ratified. 29 NICE Technology Appraisals were noted and the recommendations made within

them reflected in the North of Tyne Formulary. 17 miscellaneous recommendations relating to the use of drugs across the area were

made. The North of Tyne Formulary was updated regularly and made available on the APC‟s

website for public scrutiny along with minutes of meetings and decision summaries. The committee continued to look at NICE and SMC decisions as well as reviewing newly

licensed drugs and formulations. A number of shared care guidelines and information leaflets for primary care were developed by the Committee‟s Medicines Guidelines and Use Group, a subgroup which also took on responsibility for leading on specific work streams of medicines optimisation across the health economy and continued work on improving quality and generating savings relating to prescribing.

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ANNUAL REPORT April 2013 to March 2014

Background The APC was established in January 2007 with the aim of facilitating a cross-organisational approach to medicines management, clinical decision making and related commissioning issues that affect primary care, acute hospitals, mental health, learning disabilities and social care. There has been an increasing focus, in recent years, on medicines usage as well as medicines policy, particularly through the work of the APC‟s subgroups. As the NHS reforms develop it is essential that commissioners and clinicians continue to make funding decisions in a manner that is robust, rational and defensible. The commitments in the NHS Constitution reinforce the need for clinical commissioning groups (CCGs) to have in place robust arrangements for their local decision-making groups and an established APC is one of the key mechanisms used to help make local decisions about medicines for their patient populations. All NHS organisations must also ensure that drugs approved within a NICE Technology Appraisal are included in local medicines formularies and these formularies should be published online and be patient and stakeholder accessible. The APC facilitates this process for its members. This report has been compiled to inform participating organisations of the Committee‟s activities for the 12 months up to the end of March 2014. The report includes the outcomes of new drug requests, membership details, attendance figures and other relevant/significant developments, areas of interest and involvement. The challenge for 2014/15 will be to continue the excellent work of the APC at a time of significant change to member organisations, NHS architecture and, perhaps most significantly, the new arrangements for commissioning of medicines that are developing as part of NHS reform.


Membership & Terms of Reference The Area Prescribing Committee (APC) served the following participating organisations during the year:

Newcastle upon Tyne Hospitals NHS Foundation Trust (NUTH)

Northumberland, Tyne and Wear NHS Foundation Trust (NTWT)

Northumbria Healthcare NHS Foundation Trust (NHCT)

NHS Northumberland Clinical Commissioning Group (NHS NCCG)

NHS North Tyneside Clinical Commissioning Group (NHS NTCCG)

NHS Newcastle North and East Clinical Commissioning Group (NHS NNECCG)

NHS Newcastle West Clinical Commissioning Group (NHS NWCCG) Membership of the committee reflects a wide variety of professional, clinical, educational, management, commissioning and organisational backgrounds. Committee Officers The following is the list of officers of the committee and its main sub groups/committees at the end of March 2014:

APC – Chair David Campbell

APC – Vice Chair Simon Thomas

APC – Professional Secretary Susan Turner

Formulary sub-committee – Chair Simon Thomas

Formulary sub-committee – Vice Chair Alexander Dyker

Formulary sub-committee – Professional Secretary

Matthew Lowery

MGUG Group – Chair Martin Wright

MGUG Group – Vice Chair Hilary Wynne

MGUG Group – Professional Secretary Sarah Tulip

Attendance figures Between April 2013 and March 2014 there have been 6 meetings of the APC. The table below describes the attendance figures for members of the Committee.

Name Job Title Organisation Meetings

Attended Anne-Marie Bailey (deputy Janette Stephenson)

Senior Medicines Optimisation Pharmacist

NECS (supporting Newcastle CCGs)

4

Arpita Bhattachayra (AB) Consultant Community Paediatrician

NHCT 6

Mark Burdon Community Pharmacist Representative

NoT LPC 0

David Campbell (Chair) Chief Pharmacist/Clinical Director for Medicines Management

NHCT 5

Ian Campbell Assistant Director of Pharmacy

NUTH 4

Sarah Chandler (SC) Formulary and Procurement Pharmacist

NHCT 6

Helen Coundon GP and prescribing lead NHS North Tyneside CCG 4 Sue Dickinson (deputy – Monica Mason)

Director of Pharmacy RDTC 5

Tim Donaldson (deputy – Matt Haggerty)

Trust Chief Pharmacist/Associate Director of Medicines Management

NTWT 4

Alexander Dyker Consultant Physician NUTH 2 Sue Gordon Consultant in Public Health NHS England 1 Matt Grove Consultant Rheumatologist,

NTGH NHCT 2

Janet Kelly Chief Matron for Community Services

NHCT 4

Matthew Lowery Formulary and Audit Pharmacist

NUTH 6

Peter McEvedy GP representative NHS Northumberland CCG 6

Tamsin Oswald (TO) Consultant Microbiologist NHCT 2 John Ross (JR) Patient Representative 5 Wendy Ross GP and APC Representative NHS Newcastle North & East

CCG 5

Helen Seymour Senior Medicines Optimisation Pharmacist

NECS (supporting North Tyneside CCG)

6

Simon Thomas Consultant Clinical Pharmacologist

NUTH 5

Susan Turner (Professional Secretary)

Medicines Optimisation Pharmacist

NECS (supporting Northumberland CCG)

6

Neil Watson Clinical Director of Pharmacy and Medicines Management

NUTH 5

Nicola Weaver GP and Prescribing Lead NHS Newcastle West CCG 1 Steve Williamson Consultant Pharmacist in

Cancer Services NHCT/NHSE 4

Hilary Wynne Consultant Physician/Chair of NUTH D&T panel

NUTH 6

Glossary for organisations not listed on page 3

NECS North of England Commissioning Support Organisation NoT LPC North of Tyne Local Pharmaceutical Committee RDTC Regional Drugs and Therapeutics Centre


Sub groups and committees Various sub groups/committees exist to carry out specific programmes of work for the main committee. These include:

- Formulary Sub-Committee – This considers new product applications and leads the development of the shared formulary. Recommendations to approve defer or reject applications, with summaries of evidence, are presented to the APC.

- MGUG Group – The Medicines Guideline and Use Group (MGUG) makes

recommendations to the APC with regard to:

The coordination of guidelines which have substantial impact on medicine use in primary care and interfaces of care

The development, maintenance and, as far is appropriate, the management of shared care guidelines and information leaflets.

The development and maintenance of a traffic light list that classifies locally approved medicines into one of the following categories:

o RED Medicines for hospital use only, except under very exceptional

circumstances where a GP may be asked to prescribe for an individual patient.

o AMBER Medicines initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement.

o BLUE Drugs normally initiated by hospital specialist, but where the provision of an information leaflet may be appropriate to facilitate continuing treatment by GPs.

o GREEN Drugs where prescribing by GPs is appropriate. This category will include all medicines or groups of medicines approved for use in the participating Primary and Secondary care organisations that are not classified as Red, Amber or Blue.

- Antimicrobial Chemotherapy Sub-group – This looks at sharing good practice with regard to antimicrobial chemotherapy as well as developing, reviewing and maintaining Primary Care Antibiotic guidelines.

Committee’s activities/achievements During the period from April 2013 to March 2014 the committee carried out the following key activities:

Formulary - Work continued on the ongoing development and maintenance of the North of Tyne

Formulary. All NICE TAGs are automatically incorporated into the formulary within 90 days of publication and NHS England decisions are reflected in the formulary in line with their commissioning approval.

New drug applications - Applications to have new drugs or formulations added to the formulary continued to

be a large part of the committee‟s work. New products were considered by the committee and products were considered for an extension of approved uses or formulations.

- All formulary decisions are made on the basis of a detailed review of the available evidence of efficacy, safety and cost effectiveness.

- Details of these applications and the committee‟s decisions are noted in appendix 1.

Communication - The committee continued to publish details of its meetings and decisions, the North

of Tyne Formulary, finalised Shared Care Guidelines and information leaflets for primary care and other statements and guidelines for both healthcare professionals and members of the public on its website: www.northoftyneapc.nhs.uk.

Shared Care - Progress on developing shared care guidelines has occasionally been delayed by

issues relating to the funding of medications and/or associated changes in locations of care. The movement of funds from original providers to new providers of care has proved challenging and has sometimes delayed implementation. The Medicines Guidelines and Use Group has taken over responsibility for the development and updating of these guidelines and representation on that group has evolved during the year as emerging organisations become involved.

- Despite the above challenges the following Shared Care Guidelines were developed or updated:

- Atomoxetine – Children and Young people – Approved Jan 2014 - Dexamfetamine (Dexamphetamine) in the Treatment of Attention Deficit

Hyperactivity Disorder (ADHD) in children and young people – Feb 2014 - Immunosuppressive treatment following heart and lung transplants – Nov

2013 - Immunosuppressive treatment following liver transplants - Nov 2013 - Immunosuppressive treatment following paediatric renal transplantation - Jan

2014 - Immunosuppressive treatment following renal transplants – Nov 2013 - Lithium– Jan 2014 - Methylphenidate in the Treatment of Attention Deficit Hyperactivity Disorder

(ADHD) in adults – Feb 2014 - Methylphenidate in the Treatment of Attention Deficit Hyperactivity Disorder

(ADHD) in children and young people and for Giggle Incontinence in children aged 8 to 16 years – Feb 2014

- Naltrexone - Feb 2014 - 18 information leaflets were developed or updated to provide information to primary

care professionals on drugs classified as BLUE under the „traffic light‟ system. These were:

- Antipsychotic leaflet – Jan 2014 - Chorionic Gonadotrophin – Nov 2013 - Denosumab – May 2013 - Dexamfetamine – Nov 2013 - Humulin R U500 insulin – Jan 2014 - Lanreotide and Octreotide – Treatment of Adults with acromegaly or

neuroendocrine tumours Jan 2014 (v2) - Lidocaine Plasters – Nov 2013 - Melatonin – May 2013 (v2)

http://www.northoftyneapc.nhs.uk/


- Memantine – Mar 2013 - Mexiletine – Nov 2013 - Modafinil - Jan 2014 - Pramipexole – Nov 2013 - Rasagiline – Nov 2013 - Retigabine – Jan 2014 - Ropinirole – Nov 2013 (Updated) - Rosuvastatin – Jan 2014 - Rotigotine Patches – Nov 2013 - Triptorelin (Decapeptyl SR) Use in the Management of Precocious Puberty –

Jan 2014

Guidelines and statements - Guidelines to aid prescribing decisions were produced in the following areas:

- Newer Oral Anticoagulants Comparison - Oct13 - APC Guideline on Medicines that are Not Suitable for Generic Prescribing –

Jan 2014 - Blood Glucose Monitoring - Jan 2014 - Cow‟s Milk Protein Allergy (CMPA) or lactose intolerance – Jun 2013 - Guidelines for the Monitoring of Immune Modifying Drugs (IMDs) in Stable

Adult Patients (excluding post transplantation) in Primary and Secondary Care – Jan 2014

- NoT Epilepsy Guidelines – Jan 2014 - Stoma Prescribing Guidelines – Jul 2013

Newly licensed drugs and formulations - At each meeting the committee continued to review a list of drugs and formulations

which had been newly licensed since the previous meeting. This included any formulary drug which had received a license for a new indication.

NICE and SMC - The committee regularly looked at both NICE appraisals/guidance and SMC

decisions to ensure that its own decisions and work plans are robust. NICE TAG recommendations are endorsed by the committee within 90 days of publication.

Formulary compliance - Work continued on assessing compliance with the North of Tyne Formulary across

primary and secondary care.

Summary The APC continues to provide an excellent forum to bring together medicines related clinical and commissioning decision making across the North of Tyne health economy. It has had excellent primary and secondary care representation, has been well attended and delivers a significant work programme and system of governance associated with medicines use for all of the organisations involved. Recommendation The Boards of member organisations are requested to note the details of this report.


APPENDIX 1 Summary of APC Decisions April 13 to March 14 Classification of products:

R = „RED‟ drugs for hospital use only

A = „AMBER‟ drugs suitable for use under Shared Care arrangements

B = „BLUE‟ drugs initiated in secondary care where an information sheet for GPs is

recommended

T = drugs used in Tertiary Care only.

Product Decision + date of decision Comments / notes Approved Refused Deferred

1) Requests Reconsidered or Deferred from 2012 - 2013

Primasol 4mmol/l potassium

®

11/09/12

Decision: Deferred Sept 2012. Application now withdrawn.

Cinacalcet – Secondary hyperparathyroidism in ESRD change of status from red to amber.

Decision : Deferred Nov 2012 pending further information but now retained as red.

AdCal D3® caplets

8/05/12

Decision: Deferred May 2012. Application now withdrawn.

Botulinum toxin A (Botox®) – bladder dysfunction in paediatrics

u

10/9/13

R

Decision: Approved. The request for botulinum toxin A (Botox®) for use in paediatric patients with severe bladder over-activity and neuropathic bladder, who have not responded to other treatments, was approved. Its use should be in line with MHRA guidance.

Warfarin suspension 1mg/ml

12/03/13

Decision: Deferred March 2013. Resubmission to be considered in May 2014

2) New Requests

Azarga® eye drops (brinzolamide 1% / timolol 0.5%)

14/1/14

Decision: The request for Azarga® was rejected on the grounds that there are more cost effective options available on the formulary for use in this cohort of patients.


Aclidinium bromide (Eklira Genuair

®)

400 microgram inhalation powder

12/11/13

Decision: The request for aclidinium bromide was approved as an alternative for patients who are unable to tolerate or use the tiotropium bromide or glycopyrronium bromide inhaler devices. Tiotropium should still be regarded as first choice LAMA on the formulary.

BioGaia® probiotic drops

10/9/13

R

Decision: Approved. BioGaia® probiotic drops for the prevention of NEC were approved and added to the formulary in addition to Infloran®. BioGaia should initially be used only when there are supply issues with Infloran on the grounds that the evidence for Infloran is currently stronger.

Combodart® capsules (tamsulosin hydrochloride

400microgram/ dutasteride

500micrograms)

12/11/13

Decision: The request for Combodart® was rejected on the grounds that there are more cost effective options available on North of Tyne formulary for use in this cohort of patients.

DC beads - 75-150 micron

9/7/13

Decision: Approved in addition to the 100-300 micron DC beads.

Epiduo (adapalene 0.1% and benzoyl peroxide 2.5%) - acne

14/05/13

Decision: The request for Epiduo was approved subject to review of usage and if supply issues change.

Fluticasone 50 microgram / Azelastine 137 microgram (Dymista®) nasal spray

10/09/13 & 12/11/13

Dymista® nasal spray has been

requested to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis. Decision: Refused: The request for Dymista® was rejected on the grounds that more cost effective options are available for this cohort of patients.This decision was subsequently appealed but the original decision was upheld.

Granisetron 3.1mg/24 hours transdermal patches (Sancuso®)

Granisetron patches had previously been requested for use in patients to prevent chemotherapy induced nausea and vomiting in multi-day chemotherapy regimens to replace palonosetron capsules. The request for granisetron patches was deferred until the matter was discussed at the cancer network clinical group meeting in February 2014.The network group did not support addition to formularies and the applicant has since withdrawn the request.



Linaclotide (Constella®) 290 microgram capsules

10/9/13

B

Linaclotide has been requested for the symptomatic treatment of moderate-to-severe irritable bowel syndrome with constipation (IBS-C). Decision: Approved. The request for linaclotide was approved on the basis that, following initiation by a secondary care specialist, prescribing will remain with secondary care until they have confirmed that the patient has responded adequately to an initial 4 week trial. Prescribing can then be transferred to primary care. A blue information sheet, providing additional information for primary care will be produced.

Lisdexamfetamine (Elvanse®) 30mg, 50mg and 70mg capsules

10/09/13

A

Decision: Approved. Lisdexamfetamine was approved as an amber drug for third line use after inadequate response to methylphenidate. It should be initiated and reviewed by a specialist and only prescribed by GPs after at least 6 months of stable symptom control is achieved. A shared care guideline will be developed and should be in place before the transfer of patients to general practice.

Lixisenatide (Lyxumia®) 10 microgram and 20 microgram injection

10/09/13

B

Decision: Approved. Lixisenatide was approved as a treatment option alongside the other formulary GLP-1 receptor agonists. Existing patients stabilised on a GLP-1 receptor agonist do not need to be switched over.

l-lysine 2.5%, l-arginine 2.5% infusion

14/05/13

Decision: l-lysine 2.5%, l-arginine

2.5% solution will be added to the Formulary for use with lutetium 177 dotatate only.


Nalmefene (Selincro®) 18mg tablets

12/11/13

Decision: The request for nalmefene was rejected but the group would be prepared to reconsider the application if an agreed pathway supporting the psychosocial support that is needed for full benefit was in place that was supported and funded by local authority public health. The application was subsequently considered and rejected by N-TAG.

NuvaRing® vaginal delivery system

14/3/14 s

Decision: The requests for

NuvaRing® was accepted for use in patients who are unable to tolerate progesterone-only contraceptives,

have experienced skin irritation with

the transdermal patch, and are

unable to take oral contraceptives

due to allergy. Use should be

initiated by a specialist in

contraceptive services.

Tapentadol (Palexia®) - 50mg, 100mg, 150mg, 200mg and 250mg MR tablets, 50mg and 75mg IR tablets

10/9/13

B

Decision: Approved: Tapentadol was approved for specialist initiation in adults with severe pain who have been screened for a neuropathic element to their pain and are uncontrolled or experiencing GI side effects on existing therapy.

3) New Formulations & Extensions to Use

Abatacept SC (Orencia®)

125mg injection

9/7/13

Decision: Approved. The request for SC abatacept was approved and its use should be in line with the current NICE TAGs for the IV preparation.

Amphotericin 100mg/1ml suspension (unlicensed)

10/9/13

R

Decision: Approved. Amphotericin 100mg/1ml suspension was approved for use in patients with chronic mucocutaneous candidiasis.

Anakinra 100mg injection – Adult Onset Still‟s Disease

14/05/13

R

Decision: The request for anakinra for adult onset Still‟s disease with an inadequate response to methotrexate was approved.

Azithromycin tablets

10/9/13

Decision: Approved. Azithromycin tablets are currently cheaper than capsules. Capsules will remain on the formulary to allow the cheapest preparation at any point in time to be prescribed.



Calcium Acetate 667mg capsules (PhosLo®)

14/1/14

Decision: Approved. The request for PhosLo® was approved subject to it remaining cost neutral compared to Phosex®.

Ciclosporin eye drops 0.06%

14/1/14

R

Ciclosporin eye drops (0.06%) have been requested for use in patients with keratoconjunctivitis for patients who cannot tolerate the 0.2% eye ointment. Decision: Approved. The request for ciclosporin 0.06% eye drops should be approved subject to it being a red drug. The 2% eye drops will be removed from the formulary.

Colecalciferol 1000iu and 3000iu buccal spray (unlicensed)

10/9/13

R

Decision: Approved. The request for colecalciferol buccal spray was approved for paediatric parenteral nutrition patients, those with short bowel syndrome and in adults with metabolic bone disease who have vitamin D deficiency despite previous treatment. It has been requested that patients who do receive this formulation are monitored before and after treatment to determine effectiveness.

Cosopt® preservative-free eye drops

12/11/13 s

Decision: Approved. The request for Cosopt® preservative free was approved for use in patients who demonstrate a clear allergy to the preservative as demonstrated by skin or conjunctival changes. Its use should be restricted to this cohort of patients and not for general use in patients who experience stinging as an adverse event.

DC beads – 75-150 micron

14/05/13

Decision: The request was deferred pending further information to support the efficacy of 100-300 micron DC beads and the length of outstanding patents for these drug delivery devices.

Domperidone in breast feeding

12/11/13

Decision: Approved. Use of domperidone as a galactagogue: This is an unlicensed indication but is standard practice throughout the UK.


Methylphenidate MR (Medikinet XL

®) - 5mg,

10mg, 20mg, 30mg and 40mg MR capsules.

9/7/13

Decision: Approved.

Mini TT380 Slimline IUD

12/11/13

Decision: The request for the Mini TT380 Slimline IUD was approved for use in women who have a uterine length between 5cm and 6.5cm.

Minocycline – DMARD

9/7/13

Decision: Approved for the treatment of rheumatoid arthritis in patients where alternative treatments are contraindicated was approved.

Omeprazole 40mg injection

9/7/13

Decision: Approved.

Oxycodone 50mg/1ml Injection

12/11/13

Decision: Approved for use in controlled circumstances in palliative care patients in patients requiring high doses which would result in need for a significant number of ampoules or multiple syringe drivers to be used. It is the responsibility of each individual organisation to ensure appropriate risk management processes are in place.

Pregabalin (Lyrica

®) 20mg/ml

solution

9/7/13

Decision: Approved.

Rifaximin 550mg Tablets (Targaxan®)

14/1/14

R

Rifaximin 550mg tablets have recently been licensed for the prophylaxis of hepatic encephalopathy. This preparation is cheaper than the “off label” use of the 200mg tablets. It was considered appropriate to change the status from red to blue to allow for care to be transferred to GP‟s once patients had been stabilised. It was however noted that NICE are currently reviewing rifaximin for this indication. Decision: The request for rifaximin 550mg tablets was approved but the status change from red to blue to allow for prescribing in primary care will be reviewed once the outcome of guidance from NICE is known.



Triptorelin - Prostate Cancer3mg, 11.25mg and 22.5mg IM injection (Decapeptyl SR)

14/05/13

Decision: The request for triptorelin 3mg, 11.25mg, 22.5mg IM injection for the treatment of prostate cancer, locally advanced, metastatic and adjuvant to radiotherapy was approved.

4) Products considered by NESCG and decisions endorsed by APC

Aztreonam lysine (nebulised)

12/11/13

R

Decision: Approved in line with NHS England Specialised commissioning criteria.

Plerixafor for stem cell mobilisation (update)

14/3/14

R

The formulary will reflect the NHS England Specialised Services circular position.

Stribild - HIV-1 Infection in adults

12/11/13

R

Decision: Approved in line with NHS

England Specialised commissioning criteria

Trastuzumab s/c injection

12/11/13

R

Decision: Approved in line with NHS

England Specialised commissioning criteria

5)Products considered by NICE and endorsed by the APC

TA276 - Cystic fibrosis (pseudomonas lung infection) - Colistimethate sodium and tobramycin.

14/05/13

Approved. The formulary will reflect the NICE TAG.

TA277 - Methylnaltrexone for treating opioid-induced bowel dysfunction in people with advanced illness receiving palliative care

Terminated appraisal due to lack of evidence submission

Noted.

TA278 - Omalizumab for the treatment of severe persistent allergic asthma in children aged 6 and over and adults (review of TA133 and TA201).

14/05/13



TA280 - Abatacept for treating rheumatoid arthritis after the failure of conventional disease -modifying anti-rheumatic drugs (rapid review of technology appraisal guidance 234)

14/05/13


TA281 -Gout – canakinumab

Terminated appraisal due to lack of evidence submission

Noted.

TA282 - Pirfenidone for treating idiopathic pulmonary fibrosis.

14/05/13


TA283 - Macular oedema (retinal vein occlusion) - ranibizumab

9/7/13


TA284 - Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer.

9/7/13

Negative appraisal

TA285 - Bevacizumab - Ovarian, fallopian tube and primary peritoneal cancer (recurrent advanced, platinum-sensitive or partially platinum-sensitive)

9/7/13

Negative appraisal

TA286 – loxapine inhalation – Schizophrenia or bipolar disorder

9/7/13

Terminated appraisal due to lack of submission

TA287 – rivaroxaban - Pulmonary embolism and recurrent venous thromboembolism

9/7/13




TA288- Dapagliflozin combination therapy - Type 2 diabetes

9/7/13


TA289- ruxolitinib - Myelofibrosis (splenomegaly, symptoms)

9/7/13

Negative appraisal.

TA290 - mirabegron - Overactive bladder

9/7/13


TA291 – pegloticase - Gout (tophaceous, severe debilitating, chronic)

9/7/13

Negative appraisal.

TA292 - Bipolar disorder (children) - aripiprazole

10/9/13


TA293 - Thrombocytopenic purpura – eltrombopag.

10/9/13

The formulary will reflect the NICE TAG.

TA294 - Macular degeneration (wet age-related) - aflibercept (1st line).

10/9/13

The formulary will reflect the NICE TAG.

TA295 - Breast cancer (HER2 negative, oestrogen receptor positive, locally advanced or metastatic) – everolimus (with an aromatase inhibitor) – negative appraisal.

10/9/13

Negative appraisal - The formularywill reflect the NICE TAG.

TA296: Crizotinib: Lung cancer (non-small-cell, anaplastic lymphoma kinase fusion gene, previously treated)

12/11/13

Decision: Negative appraisal. The formulary will reflect that position.


TA297: Vitreomacular traction - ocriplasmin

12/11/13

R

Decision: The formulary will reflect the NICE position.

TA298:Choroidal neovascularisation (pathological myopia) - ranibizumab

14/1/14

R

Decision: The formulary will reflect

the NICE position.

TA299:Leukaemia (chronic myeloid) – bosutinib – negative appraisal

14/1/14

Decision: The formulary will reflect the NICE position.

TA300:Hepatitis C (children and young people) – peginterferon alfa and ribavirin

14/1/14

R


the NICE position.

TA301:Diabetic macular oedema - fluocinolone acetonide intravitreal implant (rapid review of TA271)

14/1/14

R


the NICE position.

TA302: Juvenile idiopathic arthritis (systemic) - canakinumab (terminated appraisal)

Noted

TA303 Multiple sclerosis (relapsing) – teriflunomide

14/3/14

R

The formulary will reflect the NICE

approval noting that this will be funded by NHS England from 23/4/14.

TA305 Macular oedema (central retinal vein occlusion

14/3/14

R


approval.

TA306 Lymphoma (non-

Hodgkin‟s, relapsed,

efractory) - pixantrone

14/3/14

R


approval.

6) Appeals against earlier decisions by the APC

Plenadren (MR Hydrocortisone)

14/05/13

Decision: Refused.

7) Miscellaneous decisions



Buccolam® (buccal

midazolam) 5mg/ml, 2.5mg,5mg, 7.5mg and 10mg prefilled oral syringes for the management of status epilepticus

9/7/13

Decision: Buccolam® was added to the formulary for use within its licensed indications as the preferred product. Epistatus will still be used for pre-sedation in secondary care for palliative care. It may also be required in some paediatric and adult epilepsy patients depending on clinical need.

Calcitonin nasal spray

14/05/13

Calcitonin nasal spray has been discontinued and will therefore be removed from the Formulary.

Desogestrel 75microgram (Cerelle®) combined oral contraceptive

14/1/14

R

Decision: An umbrella statement will be added to the formulary that will allow branded generics to be used, in accordance with APC guidance, without them being formally listed.

Fesoterodine – change of Status from Red to Blue

Decision: Fesoterodine will remain a red drug. The role of this drug is currently under review following publication of NICE CG 171

Fosfomycin 3g oral sachets

12/11/13

s

Fosfomycin 3g sachets are included on the Formulary as a red drug. Oral fosfomycin is occasionally recommended by microbiologists for patients in the community with UTIs caused by multi-resistant organisms. The status will now be changed to allow GP initiation following advice from a microbiologist. Decision: Fosfomycin oral sachets should be re-classified to allow for initiation in primary care, but only on the advice of a microbiologist.

Hydroxychloroquine tablets

14/3/14

Decision: An information sheet is to be produced andapproved to help primary care.

Ibuprofen gel 5%

14/1/14

Decision: Approved The request for ibuprofen gel was approved and piroxicam gel will be removed from formulary.

Ipratropium bromide MDI

14/3/14

Decision: Ipratropium should no longer be first choice for the treatment of COPD.


Loperamide 2mg oro-dispersible tablets

12/11/13

s

Decision: Loperamide 2mg oro-dispersible tablets are approved for use in primary care following specialist initiation for patients with high output stoma only.

Memantine 10mg/ml oral solution & Galantamine 4mg/ml oral solution

12/11/13

s

Decision: Memantine oral solution is now approved for use in primary care on the condition that it remains cost neutral with its solid dose formulations. The oral solution is included in NICE TA217 as a treatment option in addition to the other solid formulations. Galantamine oral solution was also re-classified due to its inclusion in NICE TA217. However it should only be used if no other preparation is appropriate, due to the additional cost.

Omega – 3 fatty acids CG172:Myocardial infarction: secondary prevention

Formulary to be updated to reflect that the omega-3 preparations are for hypertriglycerideamia only and no longer for myocardial infarction.

Proxymetacaine 0.5% and fluorescein 0.25% Combined Minims®

14/1/14

This product has been discontinued by the manufacturer. It has been requested that lidocaine 4% and fluorescein 0.25% Minims® be used a replacement. Decision: The request for lidocaine 4% and fluorescein 0.25% Minims® was approved.

Sildenafil – first line use in erectile dysfunction

9/7/13 &10/9/13

Following the patent expiry on sildenafil and subsequent cost savings available the APC confirmed that sildenafil will be positioned as the “first – line agent” in the formulary. Tadalafil will remain as a second line option for patients in whom sildenafil failed or where they were intolerant to sildenafil.



Generic sildenafil for pulmonary hypertension

12/11/13

R

The group discussed the off label use of generic sildenafil for patients with pulmonary hypertension (PH) instead of the licensed preparation, Revatio®, given the very significant savings this would generate for the NHS. The FSC/APC had been requested to review the safety and efficacy implications of this change. The group discussed the presented evidence and agreed with the conclusion that this change could be supported from a safety and efficacy perspective. Decision: The use of generic sildenafil for PH instead of the branded preparation, Revatio®, can be supported from an efficacy and safety perspective.

Sodium fluoride 0.05% dental rinse

14/3/14 s

Decision: Sodium fluoride 0.05% dental rinse should be approved for addition to the formulary for use within the dental hospital .

Vitamin B compound strong (nicotinamide 20mg, pyridoxine hydrochloride 2mg, riboflavin 2mg & thiamine hydrochloride 5mg per tablet)

A request for removal of this product had been submitted by commissioners as it is no longer considered appropriate use of NHS resources in the treatment of Wernicke‟s encephalopathy and Korsakoff's psychosis, especially as seen in chronic alcoholism. Decision: Vitamin B Co Strong will become a Red drug for short term use in refeeding syndrome. Use in people at high risk of developing, or with suspected, Wernicke's encephalopathy and Korsakoff's psychosis, especially as seen in chronic alcoholism , is no longer supported as these patients are best treated initially by the parenteral administration of B vitamins (Pabrinex®), followed by oral administration of thiamine in the longer term.

NICE CG173: Neuropathic pain – pharmacological management

Decision: Tramadol will be removed from the neuropathic pain section of the formulary and a statement added to the effect that carbamazepine should be used for trigeminal neuralgia only in order to reflect the NICE Guidance.

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