1

Minutes of a meeting of the Treatment Advisory Group

held on

08 April 2013 at Health House, Willerby

Gill Fox (GF) Policy Implementation and Assurance Manager CSU

Christopher Ranson (CR) Senior Pharmacist CSU

Diane Tomlinson (DT) Senior Pharmacist CSU

Sarah Abbas (SA) Pharmacist Harrogate Trust

Catherine Lightfoot (CL) Clinical Triage Lead CSU

Helen Thorpe (HT) Commissioning Pharmacist Leeds Trust

Jane Crewe (JC) Principal Pharmacist York Trust

Marie Miller (MM) Interface Principal Pharmacist Hull and East Riding Trust

Pippa Cole (PC) Assistant IFR Case Manager (minutes)

Apologies:

David Humphriss (DH) Deputy Chair of D & T York and Scarborough

Trust/Endocrinologist

Paul Jennings (PJ) Chair of D & T York and Scarborough Trust/Endocrinologist

John Hampton (JH) Formulary Pharmacist York and Scarborough Trust

Jackie Lyon (JL) Lead for Medicine Management CSU

John Hancock (JH) Head of Commissioning Specialist & Service Delivery CSU

Sonia Snowden (SS) Commissioning Policy Manager CSU

Linda Stewart (LS) Pharmacist Airedale Trust

Helen Holdsworth (HH) Deputy Chief Pharmacist (Scarborough) York and Scarborough

Trust

Dave Abbott (DA) Medicines Information Pharmacist – Leeds Trust

Jillian Sykes (JS) Assistant Director of Commissioning, York Teaching Hospital

NHS Foundation Trust

1. Welcome, apologies and conflict of interest

Members were welcomed and introductions were made.

JC declared that she had recently attended an external palliative care conference

sponsored by a variety of drug companies which was noted.

2. Minutes of the previous meeting and matters arising

The minutes of the meeting held on 25 February 2013 were ratified and reviewed as

follows:

Point4.4, p3: GF highlighted this point which states that LS had expressed concern as

to her attendance in NY & H TAG; the question was asked about which CCG Airedale,

Wharfedale and Craven have contracted with for medicines management and clarity

would be sought from JL. GF stated that she has not yet discussed this with JL but is

meeting with her next week and will discuss this further at that time.

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Point 7.1 on page 6: SA took the proposed draft policy regarding femoro-acetabular

arthroscopic surgery to Consultant Orthopaedic Surgeon, Mr Conroy, who was not in

full agreement with the proposed policy and would like further opportunity to

undertake a retrospective review of the patients previously approved and those not.

GF stated that this query has been redirected to the HaRD CCG and Mr Conroy has

been informed that the TAG is no longer responsible for making commissioning

decisions; policy decisions are now the responsibility of the CCGs and the TAG can

only act as directed by the CCGs, for example reviewing policy or assisting with

audits.

Point 7.2 on page 6: GF stated that the IAG is this week and will address some

outstanding points. The IAG has stalled recently and further discussions with JL

should resolve this matter. It was recognised that the lack of progress with this

group is largely attributable to the NHS transition phase.

Point 10: GF explained that she and Jo Gaunt (Head of Service Delivery and

Assurance) have met with seven of the eight CCGs and signed off the service

specifications for Horizon Scanning and Medicines Management, which includes the

TAG policy. GF highlighted that the TAG policy does need some revision but has been

accepted by the CCGs in the interim. Vale of York CCG is the only CCG yet to sign up

to the service specification but this was unavoidable due to time difficulties

following transition. GF summarised that it is fair to say that all the CCGs have

agreed the process and any policy modifications would be reviewed. It was

confirmed that these policies should be published on each CCG website in time.

However, it is the CSU’s responsibility to highlight the policies for publishing to each

CCG. GF highlighted the difficulties in identifying who in each CCG is responsible for

editing their websites but discussions have identified that there is an expectation

from the CCGs that the CSU should publish what is agreed at the TAG on the CCG

websites and therefore it is essential for operational purposes and good governance

to know exactly when and where a decision has been made within a CCG. MM

explained that she has tried to make this process smoother for Hull and East Riding

but it has proved extremely difficult and time consuming. GF recognised this and

confirmed that this will be discussed further when she meets with JL. GF highlighted

that all the CCGs are different and work to different timescales, some taking up to

four months to ratify policies. CR stated that each CCG needs to provide a clearly

identified contact person to send such publishing material; GF explained that a list

has been made available which will be circulated but some CCGs request certain

correspondence be sent to certain individuals only and this inevitably causes

individual difficulties which need to be overcome.

Action – GF and SS – need to obtain and circulate a definitive list of contacts

in each CCG of who receives what and who is responsible for feed back to

the CSU.

MM explained how at a recent HERPC meeting she had previously been told by the

two CCG representatives present that she was agreeing policy on behalf of the CCG

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but was then later told that the TAG is an advisory group only, not a decision making

group. In view of this confusion, MM highlighted this to JL who informed her that

HERPC decisions should always go through her. MM stated that she would rather

send the outcomes of HERPC to Julia Mizon to highlight what has been agreed and

therefore what they advise to the CCG as a commissioning position. GF stated that

Julia Mizon’s vision for this process and JL’s role in it would be clarified outside this

meeting.

3. General Discussion and Standing Items

3.1

NHS CB letter - Cancer Drugs Fund (CDF)

Sent to all Chief Executives of Provider organisations who offer

NHS treatments in the North of England region, dated 12 March

2013, stating that the NHS Commissioning Board (NHS CB) will be

responsible for the CDF for 2013/14 with a national policy and

operational framework for the CDF and IFR processes. CR stated

that a national list from the CDF was published on 05 April 2013

which appears to be a definitive list but HT highlighted that it is

only for the CDF and there is no indication of what baseline

chemotherapy/routine regime is commissioned. In the absence

of a definitive policy for standard chemotherapy regimens, MM

stated that it should be assumed that the NHS CB is working

towards what was agreed network-wide. HT highlighted previous

difficulties agreeing the tri-network baseline regimes due to such

differences and recognised that this is a massive undertaking for

the NHS CB. HT stated that the CDF clinical groups no longer exist

due to movement of staff. GF clarified that any IFRs for cancer

treatment, including the list of decommissioned treatments, now

need to be submitted to the NHS CB for consideration.

GF tabled a letter from Steve Williamson at North of England

Cancer Network enclosing a list of fourteen different drugs with

particular implications. DT queried if the North of England Cancer

Network is still in existence and stated that it was unclear if the

letter is from NHS England under the NHS CB or Steve Williamson

in his old role for the Cancer Network. It was agreed that the

letter is intended to highlight the handover for the new system

and newly decommissioned treatments.

CR/DT

3.2 NHS CB letter – IFRs

Sent to all Chief Operating Officers of Clinical Commissioning

Groups/Primary Care Trusts in the North of England region, dated

12 March 2013, stating that the NHS Commissioning Board (NHS

CB) will be responsible for the consideration of IFRs for NHS CB

prescribed services and will commission on a provider rather

than a population basis. GF and DT stated that the few

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outstanding cases of this nature from NYY PCT have been

forwarded to the NHS CB but highlighted the lack of a definitive

list for more general procedures, not just drugs. GF highlighted

the differences in geographical boundaries of the CCGs and the

loss/addition of areas previously under the jurisdiction of NYY

PCT and the implications of this for the storage of around 15,000

case files. GF confirmed the Cumbria LAT under the NHS CB as

responsible for North of England IFRs for specialised services.

MM queried what is being done to address queries regarding

drugs other than those managed by the NHS CB where it is

unclear if they are commissioned or not. GF stated that the CSU

has been in contact with Lisa Jordan (Clinical Review and

Effectiveness Specialist, Interim CDF/IFR Lead for the Cumbria,

Northumberland and Tyne & Wear NHS CB Area Team) about this

and unclear cases will need to be discussed with her upon receipt

on a case by case basis. GF explained that the CSU has issued a

standing instruction that no records are moved off site unless

safe transmission and retention can be ensured and there is also

some concern about the internal storage of records on behalf of

the CCGs which potentially poses Information Governance

difficulties. In order to address this, a list of all CCG records has

been provided individually to each CCG and continued CSU access

to the records has been requested.

HT queried if the IFR appeals process has changed and if it would

now be managed by the CCGs. DT and GF explained that the

appeal process falls under the overall IFR process, managed by

the CSU and which the CCGs have signed up to. GF stated that

one appeal process across North Yorkshire & Humber CSU would

be ideal but, in practice, two may have to be run; one for North

Yorkshire and one for Humber. GF stated that the assumption is

there would also be a similar appeals process for the NHS CB but

exactly how this works is unknown as yet. GF explained how the

entire IFR process has had to adapt to the new ways of working,

although the appeals process has largely remained the same and

been adopted by the CCGs but with different people involved. DT

highlighted that the appeals process under the CSU is currently

untested and the CCGs need to familiarise themselves with the

process. GF explained how the original vision for one IFR Panel

proved impossible and five Panels now operate, although appeals

Panels should be limited to two and may merge with

complaints/PALS.

AFTER MEETING NOTE: the four NYY CCGs have agreed to hold

further internal discussions regarding the way in which they

individually wish to see the appeals process run for their CCG.

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3.3 NHS CB – Definitive drugs list

It was highlighted that currently there is no definitive drugs list.

DT explained that she and HT have drawn up their own lists of

what they understand to be on the list but there are differences

in each list. DT highlighted that the list received recently does not

entirely reflect what is in the manual and therefore needs further

clarification. HT confirmed that clarification should be provided

by Malcolm Quailey (National Prescribing Adviser). GF highlighted

that in the interim, patients could be at risk so decisions will have

to be made quickly upon receipt of such queries. GF and CR

stated that the NHS CB timescales for responding to an IFR have

been set at 40 days but it is unclear when this timescale

commences, for example, upon submission of a request and

whether or not it includes appeal. GF understands that this

timescale applies to all NHS CB IFRs, although IFRs for cancer

treatments would trump this timescale. HT stated that it appears

the NHS CB is under the impression that they will not receive any

IFRs for cancer treatments and that their drugs list has resolved

this; GF agreed with this. HT explained that the lack of clarity

regarding an NHS CB definitive drugs list and weekly changes to

the list has resulted in clinicians passing drug requests quickly to

ensure that the drugs are available before the list changes again

and this is likely to continue for the foreseeable future. GF also

highlighted that the top slicing of funding will impact on the

CCGs, potentially resulting in less available funding and a likely

increase in more IFRs for Procedures of Limited Clinical Value.

CR/DT

3.4 Shared Care Drugs – email from Paul McManus

CR explained that an email from Paul McManus attempted to

clarify the position around drugs which are managed by the NHS

CB which are at the moment being prescribed in primary care, for

example, immunosuppressant drugs and CF drugs (currently

managed through shared care within primary care). CR explained

how it is unclear whether or not these drugs will remain in

primary care or in future be repatriated with secondary care to

manage through healthcare at home provision. HT highlighted

that this decision will be determined by the funding available

which, for the current year, has been left with the CCGs but will

be reviewed. HT highlighted a particular example regarding renal

transplant immunosuppressant drivers which the relevant clinical

group has decided should be returned to secondary care centres

from shared care. However, there was concern that this would

cause confusion with prescribing between primary and secondary

care, in addition to limited capacity in secondary care to take this

number of patients back into the system. HT therefore requested

clarification on the funding arrangements and responsibilities

which states that there are no immediate changes this year but

CR/DT

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work will take place towards putting an infrastructure in place to

develop that service. DT noted that where shared care

arrangements are already in place for certain treatments, the

CCGs may be reluctant to embark on shared care for new

treatments and new guidelines. HT highlighted that new CF drugs

represent an example of this situation and may be repatriated.

4. Feedback from CCGs

4.1 Feedback received to date

GF stated that a few recommendations have gone from the TAG to

the CCGs, although the CCGs now have very new mechanisms for

consideration of such recommendations. This position will

continue until a definitive agreement is reached with each CCG. GF

explained that CL and SS will ensure that this list is kept up to date

on the matrix and that a safe IT platform to house the matrix it is

being looked at so that the matrix is available at any given time for

any CCG. It was highlighted that decisions from the CCGs can take

3-4 months the internal consideration process. DT explained that

SS has updated draft policies into new templates and she and CR

now need to process these with the decisions and test the process

of publishing these onto websites so that they can be

communicated and finalised. GF confirmed that each of the eight

CCGs require their own logos and headers on all paperwork,

including policies, for example, all outgoing IFR letters have the

relevant CCG header on to reflect that the patient belongs to that

CCG, however, the contact details are that of the CSU since the IFR

process is managed by the CSU on behalf of the CCGs. GF

highlighted the confusion this may cause and confirmed that a

request to put the CSU heading on IFR letters has been declined.

CR/DT

4.2 Dapagliflozin (for type II diabetes)

Dapagliflozin is a first-in-class, orally-active, competitive,

reversible inhibitor of the human sodium-glucose co-transporter 2

(SGLT2) to be licensed in the UK. NICE are expected to publish the

technical appraisal at the end of June 2013. The SMC have

approved it but restricted to dual therapy in combination with

metformin only when a sulphonureas is inappropriate; the SMC

did not support use in combination with insulin. Monotherapy

clinical trials showed dapagliflozin to be more effective than

placebo but no head to head trials showed that it would be

superior to metformin. A combination of dapagliflozin with

metformin was shown to be more effective compared to either as

monotherapy. It should be noted that there small numbers of

elderly patients included in clinical trials. Dapagliflozin increases

diuresis and is not recommended in patients receiving loop

CR/DT

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diuretics. Safety concerns relate to increase risk of UTIs and

genital infections. FDA is also looking into a potential increase risk

of breast and bladder cancer. SPC states the following warnings:

o Not recommended with CrCl<60ml/min.

o Not recommended in over 75s.

o Monitoring of renal function – baseline then yearly and if

approaching moderate/ severe renal impairment then

consider every 2-4 times a day.

o Not recommended with loop diuretics

o Risk of falls in combination with ant-hypertensives or

elderly with history of hypotension.

o Not recommended with pioglitazone.

o Not studied in combination with DPP-4 inhibitors and GLP

analogues.

CR summarised that feedback has been received from

Scarborough and Harrogate. Scarborough’s position was that they

would be unlikely to use it due to the side effect profile and other

risks highlighted. Harrogate agreed with the draft

recommendation proposing it as a second line treatment in

addition to metformin for patients with completely normal renal

function and in line with what the SMC agreed or third line

treatment in addition to other treatment, although there were

some concerns around patients with potentially poor renal

function or patients who are not identified as being renally

impaired due to the contraindications/cautions already

highlighted. Harrogate also felt there was an option for its use in

addition to insulin as an insulin-sparing agent and flagged up some

of the risks highlighted above but did highlight the potential

benefit for weight loss in some patients. CR also highlighted that

the SPC recommends that renal function is checked before

considering the treatment and any patients with mild renal

dysfunction would require regular monitoring and would result in

the need for switching drugs if further deterioration was detected.

JC explained that the clinicians at York felt it appropriate to await

NICE guidance and, whilst it may be worth having available for a

small minority of patients, did not elaborate as to who those

patients would be. Further feedback from York referred to the

treatment as a last resort for an obese type II diabetic patient and,

where other agents may have worse effects like weight gain, there

may be a need to recommend a trial and because it is

predominantly a primary care product there is no reason to rush it

through their D&T yet. MM referred to the algorithm from Hull

and East Riding which is pending NICE guidance although it will

probably go to their D&T in May 2013 for specialist initiation only

for a short term agreement until NICE guidance is issued. MM

identified that there may be a small cohort of obese patients to

consider its use but does not expect that their clinicians would

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agree that it is a primary care drug and suggested that the patients

for whom it is prescribed would have already been in contact with

a specialist. JC suggested their clinicians may not want to continue

prescribing; rather they might commence the treatment and

monitor its effect in addition to monitoring renal function. GF

suggested deferring recommendation until after NICE guidance is

issued and noted that LPG submission could be expected around

May 2013. CR highlighted the debate regarding how much this

issue continues to be pushed in primary care and explained that

one Harrogate specialist had stated that he did not think he would

see these patients at the point where they would potentially be

prescribed so this would have implications for restrictions in

secondary care. JC highlighted the potential scenario where the

drug might be prescribed in the interim but then not fulfil what

guidance NICE issues although it was clarified that treatment in

this scenario would continue. MM reiterated that none of the Hull

and East Riding consultants were overwhelmed by the drug but

recognised that there might be a small number of patients for

whom it would be suitable and therefore it is useful to have

available in these instances. DT stated that there does not appear

to be any desire to use the drug until NICE guidance is issued and

would therefore be inclined to position dapagliflozin as not

routinely commissioned, taking into account the safety issues,

with a view to reconsidering it upon NICE guidance and

establishing its position then. The members agreed with this

position.

Recommended position - not routinely commission.

5. New policy recommendations

5.1 Tadalafil for benign prostatic hypertrophy

Treatment licensed for treatment of signs and symptoms of

benign prostatic hyperplasia in adult males. Evidence shows that

tadalafil may improve lower urinary tract symptoms associated

with benign prostatic hyperplasia but is no more effective than

the standard treatments recommended by NICE for this

indication. It is unlikely that this treatment would be shown to be

cost effective compared to standard treatment such as alpha

blockers and 5-alpha reductase inhibitors. Tadalafil may be

beneficial in patients who suffer from both benign prostatic

hypertrophy and erectile dysfunction. Drug treatments for the

management of erectile dysfunction can be provided on the NHS

for the following conditions: diabetes, multiple sclerosis,

Parkinson’s disease, poliomyelitis, prostate cancer,

prostatectomy, radical pelvic surgery, renal failure treated by

dialysis or transplant, severe pelvic injury, single gene

CR/DT

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neurological disease, spinal cord injury, spina bifida (Ref HSC

1999/148). Both NICE and SMC are unable to provide guidance

due to none submission by manufacturer. CR summarised

comments from primary care that some urologists are referring

patients for treatment of this indication. NICE clinical guidelines

(97) outlines treatment for this particular indication in the first

instance an alpha blocker should be offered for moderate to

severe condition and also to consider an alpha blocker plus a 5-

alpha reductase inhibitor. CR highlighted that the issue regards

the evidence of relatively small trials compared to the standard

treatment which shows tadalafil to be no better than the

standard treatment. CR also noted that the cost implications are

significantly more expensive than that of the standard treatment.

On this indication alone, ignoring the issue regards erectile

dysfunction, this treatment does not provide any extra benefit to

patients with this particular indication than the standard

treatment. The treatment of patients with benign prostatic

hyperplasia who also suffer erectile dysfunction is where the drug

is being pushed; however, within the national guidance this

indication specifically does not come under the criteria for which

the NHS would support its use. CR explained that, based on the

evidence available, it could be concluded that tadalafil is unlikely

to be considered cost effective specifically for benign prostatic

hyperplasia but may be beneficial for the proportion of those

patients who also suffer erectile dysfunction. The members

agreed to recommend that the drug should not be routinely

commissioned.

Recommended position - not routinely commission.

5.2 Aflibercept for wet age related macular degeneration (ARMD)

Aflibercept is a newly licensed treatment that is licensed for the

management of wet AMD, the second agent to be licensed for

this indication (Lucentis being the other). The initial dose is

monthly injections x3 followed by treatment every 2 months

(with no requirement to monitor between treatments). After 12

months the license suggests that it is up to clinicians’ judgement

to whether to extend the schedule of monitoring/ treatments

dependent on VA. NICE is due to report in August 2013 and the

SMC is expected to report April 2013. CR outlined the evidence

from the VIEW studies which shows aflibercept 2mg administered

monthly for 3 months, followed by 2mg every two months up to

one year, followed by PRN dosing between 1-3 monthly is as

effective as ranibizumab. At present the predicted number of

injections over the first two years is likely to be similar in clinical

practice but there is scope with aflibercept to extend the period

between injections which may result in some patients needing

fewer injections; this in turn could result in a reduction in

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administration associated adverse events. Overall patients will

need less monitoring appointments with aflibercept compared to

ranibizumab; this will have a positive impact on clinical capacity

and may prove more preferable to patients. There has been

interest from clinicians to also consider this treatment for

patients who have lost response to ranibizumab in wet AMD and

those who are resistant or refractory to treatment with

ranibizumab in wet AMD. CR stated that the cost impact of

aflibercept and Lucentis are both subject to a confidential PAS. CR

highlighted one of the main potential benefits of aflibercept is

that patients will not need to attend hospital as often as they

would be required for Lucentis therefore reducing tariff costs for

outpatient appointments . However, CR highlighted that the eight

CCGs commission the current service differently so there will

need to be some local assessments regarding how it compares.

HT queried if savings would actually be made or if more patients

will simply be pushed through the system. DT and CR

acknowledged this and explained that there are currently issues

around capacity due to the use of ranibizumab for DMO and

therefore the use of aflibercept is initially attractive in reducing

capacity, particularly for new patients. DT highlighted a further

consideration regarding the frequency of follow up and the

impact of this on perceived and actual savings. CR and DT

acknowledged that a proportion of patients would not be treated

in accordance with the original clinical trials. CR highlighted the

issues to emerge from Harrogate are in relation to patients not

being treated with Lucentis as it was hoped because monthly

follow up is not possible and they also have a high proportion of

patients (around 40%) who are receiving monthly Lucentis

injections, therefore treatment with aflibercept may reduce the

frequency at which these patients would be treated. CR also

highlighted that there has already been a noticeable increase in

IFRs for aflibercept where patients have previously been treated

with Lucentis but where the patient has now lost response to

Lucentis or where they are within the NICE criteria for cessation

of Lucentis. CR noted that there is currently no evidence to

support the use of aflibercept where Lucentis has failed, apart

from a few case series, and these patients would comprise a new

cohort of patients requiring new funding allocation. DT

summarised that the spec for aflibercept is more complex than it

initially seems and HT highlighted that the drug cannot be

commissioned without discussions around pathways and

therefore a spec is required. HT further highlighted that there is a

regional tender going through which has not yet been awarded

but is looking favourable for Lucentis which would result in a

positive move away from the national costing scheme, however,

aflibercept has not submitted to the tender. The regional tender

is led by Phil Deedey which may conflict with CCG commissioning

responsibilities and drive for savings. HT highlighted the benefits

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of aflibercept around pathways and capacity and the potential for

making funding available for another service for another cohort

of patients. DT highlighted the difficulty of advising a

commissioning position regarding aflibercept because it is only

known that it is attractive for new patients in year 1 but the

benefit and savings beyond that is unknown. It was agreed that a

decision regarding recommendation to commission or not

commission aflibercept needs careful consideration in view of the

outcome of regional tender which is due at the end of April and

could impact on the discussions of the TAG, although the

clinicians are not bound by the tender outcome. DT also noted

that the confidential nature of the PAS creates difficulty for the

CCGs being aware of what they are paying for and they should

therefore be having discussions in relation to regional proposals

and savings in order to make an informed decision. CR suggested

that the TAG is unable to make a decision at this time before each

CCG undertakes a local assessment. CR summarised that the

evidence currently available demonstrates that aflibercept is as

effective as Lucentis as a first line treatment but there is less

evidence for other cohorts of patients. DT also noted that there

are currently no cost-effectiveness models and whilst these

should be available from the SMC by the end of the day and it

would not have been submitted to NICE if it was not cost

effective, it is important to recognise this alongside clinical

efficacy in addition to considering affordability and associated

pathways. DT and GF noted the need for different models for

each of the local eight CCGs and queried how and by whom these

would be drafted, for example, by the CSU or by CCGs with their

local providers. GF highlighted that the commissioning position of

each CCG is likely to be very different in view of the outcome of

regional tender and SMC. CR suggested that each individual CCG

should decide whether to take this forward or not once the

various issues have been highlighted to them with targeted

information relating to each CCG. It was confirmed that the

regional tender is across Yorkshire and Humber and whilst the

outcome may not provide a definitive answer, it does need taking

into account.

6. Excluded devices and technologies

6.1 Exogen

CL explained the commissioning recommendation for this will be

discussed further at the next TAG meeting once NICE guidance is

published. GF highlighted difficulties with a PAS in place for

Exogen whereby funding can be returned if the treatment does

not work after three months but there is no definition of what

would be considered a failed response to treatment. GF also

CL

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noted that Exogen had previously been used for the non-union of

long bones only but it is now increasingly being used for a range

of non-unions. DT suggested that until clarification regarding the

PAS scheme is received, this cannot be considered further.

6.2 Subfertility services fact sheet

GF referred to the subfertility services fact sheet dated February

2013 received from the NHS Commissioning Board and

summarised the previous commissioning position of NHS North

Yorkshire & York whereby subfertility services in tertiary care

were not routinely commissioned, other than in cases of

exceptional clinical need. NICE guidance currently recommends

up to three cycles of IVF. GF attended a recent board meeting of a

local CCG where it was highlighted that whilst they would wish to

commission subfertility services, limited funding means that it

cannot be commissioned and GF understands that for the present

financial year the four NYY CCGs will be adopting the policy to not

routinely commission subfertility services. GF highlighted that the

NHS Commissioning Board has extended the age range for the

transfer of eggs from 39 years and 6 months up to 42 years based

on three additional criteria which, whilst minimal for this cohort

of patients, could significantly impact on NYY patients within this

age range. GF stated that the fact sheet was tabled for

information only but noted that the new NICE guidance could

generate some changes at secondary care which may result in

savings elsewhere but it is highly unlikely that this would make

available enough funding for tertiary care services. GF reiterated

that it appears the four NYY and one of the North Lincolnshire

CCGs will not routinely commission subfertility services; the other

North Lincolnshire CCG commissions one cycle and it is not yet

known if the Humber CCGs will commission it or not.

CL

7. NICE guidance and technical appraisals

7.1 Apixaban for stroke prevention (TA)

CR stated apixaban is another treatment option for stroke

prevention within the same criteria as dabigatran and

rivaroxaban. There is no cost impact reported given it is

favourably costed against the two other available treatments. CR

highlighted that the CCGs may wish to have it available as a

treatment option and may therefore wish to discuss this further

with regards to which treatment they would favour as first line in

conjunction with their local providers.

CR highlighted other NICE guidance recently published relating to

Lucentis for DMO and the potential for a significant cost impact

CR

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for each individual CCG which they need to aware of and which

may impact capacity around management of the service. NICE

has recommended Lucentis as the treatment option for patients

with DMO only where the eye has a central retinal thickness of

400 micrometres or more and that the manufacturer provides it

at a discount. NICE predicts in its cost model that around 26% of

patients with DMO would be eligible for treatment although did

set a range of between 26-52% so the exact figure is unknown. DT

stated that it has been highlighted to the CCGs to investigate

their local populations to ascertain a more realistic understanding

of what local providers perceive as their eligible population with

regards to cost.

7.2 Colistimethate sodium and tobramycin dry powder inhalers for

cystic fibrosis

CR confirmed that the NICE guidance sets out the criteria for use

and stated that a regional policy was previously in place under

NHS NYY. CR highlighted that the products are subject to a

manufacturer PAS to bring them in line with the cost of nebuliser

treatments and it was therefore felt at the time that these would

be “red drugs” because the discounted rate is not available within

primary care and suspects that this will continue. DT noted that

these treatments are now NHS CB commissioned and

recommended with the PAS scheme therefore this cannot be

managed in primary care. MM queried if the saving under the PAS

could be returned to the CCGs but this would not be possible

where it is prescribed on an FP10 as the full list price would be

charged. It was noted that the practicalities of implementation

are not part of NICE’s agenda which causes difficulties. DT

confirmed that the previous commissioning policy remains and it

should be re-communicated that the drug stays as a hospital only

drug on the basis of the PAS.

CR

7.3 Methylnaltrexone for treating opioid-induced bowel dysfunction

in people with advanced illness receiving palliative care

(terminated appraisal)

CR stated that the appraisal was terminated as the company did

not put forward a submission to NICE. NHS NYY previously

reviewed this treatment and had a regional commissioning policy

of routinely commissioned for treatment of opioid-induced

constipation when optimal maximal laxative combinations have

been exhausted and restricted its use to palliative care specialists

only. DT highlighted that the commissioning of methylnaltrexone

does not have a significant impact and should be maintained until

the CCGs advise otherwise.

CR

14

8. AOB

It was noted that the last IAG did not go ahead due to the on-going reorganisation

within the NHS. However, GF highlighted that Jo Gaunt is keen that the IAG is re-

established and works closely with the TAG to assist the CCGs with knowledge

management. GF stated that CL and SS are working on knowledge management but

further support is needed for this via the IAG to control the information flow to the

CCGs. GF highlighted the difficulties of knowledge management in view of the

volume of information available but confirmed that this is one service purchased

from the CSU by the CCGs and therefore needs pursuing. CL explained that she has

been liaising with Oliver Tipper in Communications regarding including TAG and IAG

information in the newsletter which is circulated to the CCGs and which could be

published on their websites. GF noted that the CCGs are currently unclear on what

information they require and therefore there needs to be a system whereby

information of significance is clearly highlighted to them.

9. Date of next meeting

? July 2013