Milton keynes, oxfordshire, berkshire east, berkshire west & buckinghamshire (mobbb) priorities committee

Southampton, Hampshire, Isle of Wight & Portsmouth
Priorities Committee

Minutes of meeting held on Friday 09 July 2010, Southampton City PCT, Oakley Road,
Southampton, SO16 4GX
Present:
Committee Members
Public Health Consultant – Isle of Wight PCT Consultant in Public Health, Southampton City PCT Chair, Area Professional Advisory Committee (North and East) – Hampshire PCT Director of Finance & Services – Southampton City PCT Head of Medicines Management – Portsmouth City Teaching PCT Medical Advisor, South Central Specialised Commissioning Group Director of Commissioning – Isle of Wight PCT Director of Medicine Management and Pharmacy Portsmouth Hospitals NHS Trust Clinical Director (and GP), Portsmouth City Teaching PCT South Central Priorities Support Unit
Health Policy Business Administrator, PSU In Attendance
Lipidologist, Southampton General Hospital Professor of Endocrinology, University of Southampton Consultant Congenital Cardiologist, SUHT PSU is delivered by Solutions for Public Health 

THIS MEETING WAS QUORATE

SECTION A – MATTERS ARISING
A1
Apologies
Steve Bolam, Tom Dent, Jeremy Hogg, Cathy Price, Richard Samuel
A3
Declarations
interest
None Declared

A4
Draft minutes of the Hampshire and Isle of Wight Priorities Committee
The minutes of the meeting held on 11 June 2010 were approved with no amendments.

Action:
A5 Neurosurgery for Cerebral Metastases
DS presented the draft policy to the committee.
The committee endorsed the policy and noted that clinical audit is essential. The Priorities
Committee may be asked to comment on the details of the audit proposal. Members recognised
the need to capture both retrospective and prospective data and requested that this be included in
the final paragraph.
Agreed:
The committee approved the policy with the above amendment. TD to amend and pass to SF to distribute policy to Committee members A6 DPP-4 inhibitors (Gliptins) in the treatments of type 2 diabetes
DS presented the draft policy to the committee.
The committee requested that the word ‘committees’ was changed to ‘committee’ in the first
sentence.
The committee wanted a definition of the phrase ‘high body weight’ and requested that the PSU
check whether the NICE guideline defines this phrase, in which case the PSU will include the
definition in the final policy.
At the previous meeting, after discussing the DPP-4 inhibitors paper, the committee had
requested that the PSU consult Diabetes UK. However the PSU is not resourced to undertake
such consultations, and previously the PCTs have decided that it is their responsibility to
undertake engagement with patients, patient groups and the wider public if appropriate. The
Priorities Committee agreed that its policies constitute advice to commissioners on the basis of
evidence and the ethical framework. It is not currently the role of the PSU or Priorities Committee
to undertake patient and public consultation.

Agreed:
The committee approved the policy with the above amendments FF to look for a definition as outlined above and amend the policy. SF to distribute final policy to Committee members
A7 Da Vinci Robotic prostatectomy
DS presented the draft policy to the committee.

Agreed:
The committee approved the policy with no amendments SF to distribute policy to Committee members
THIS MEETING WAS QUORATE


A8
Fenestrated
DS presented the draft policy to the committee.

Agreed:
The committee approved the policy with no amendments SF to distribute policy to Committee members

SECTION B - POLICY REVIEW/NEW PROPOSALS

B1
Pharmaceutical treatment of pulmonary arterial hypertension in adults
Dr Veldtman, Dr Limbrey, Mr Pennington and Mr Armstrong attended for this item. All present were asked to introduce themselves and state any conflicts of interest. Dr Limbrey noted that she had received manufacturer sponsorship to attend educational meetings. No other conflicts of interest were declared. The PSU had been asked: 1. For which drugs is there sufficient evidence of clinical and cost-effectiveness to justify use as single agents to treat adult patients with pulmonary arterial hypertension? 2. Is there new evidence for clinical and cost-effectiveness of treating adults with combination therapies in pulmonary arterial hypertension, to justify changing the current priorities recommendations for South Central PCTs? DS summarised the paper as follows: Pulmonary hypertension is a rare and life threatening condition. Drug treatment is available. Most of the available evidence for these drugs relates to patients with idiopathic pulmonary arterial hypertension. The treatment of pulmonary hypertension is a specialised service, commissioned by specialised services commissioning groups (SCGs). The SCGs have agreed a national commissioning policy. NICE is not planning to provide overall guidance for pulmonary hypertension services. South Central Priorities Committees reviewed the evidence of clinical and cost-effectiveness of a number of treatments for patients with pulmonary hypertension in 2009, with particular attention to patients who were not included in the national commissioning policy. The South Central Specialised Commissioning Group’s commissioning team has concerns about the evidence base and cost effectiveness of some of the drugs included within the national policy, and believes there may be opportunities for disinvestment. It has therefore requested this 2010 review to examine recent evidence for the clinical and cost-effectiveness of a number of single agents for pulmonary arterial hypertension. In addition, this review includes recently published evidence to update the 2009 review. There is evidence that sildenafil, tadalafil, sitaxentan, ambrisentan, bosentan, iloprost and epoprostenol are effective in improving haemodynamic parameters and exercise capacity. Most evidence relates to idiopathic pulmonary arterial hypertension in functional class III. There is little evidence of effectiveness in pulmonary arterial hypertension secondary to specific underlying diseases, although a number of studies have shown no significant difference between outcomes for patients with different underlying pathologies. This may therefore represent lack of evidence of differential effectiveness rather than evidence of lack of differential effectiveness. There is insufficient or contradictory evidence that these treatments prolong survival for any category of patients. THIS MEETING WAS QUORATE “Sildenafil, tadalafil, sitaxentan, ambrisentan and bosentan are probably cost-effective by usual thresholds for treating patients with idiopathic pulmonary arterial hypertension. Iloprost and epoprostenol are probably not”.fficient evidence of cost-effectiveness in any other categories of pulmonary hypertension. This review has identified two guidelines that recommend the use of sildenafil in patients with functional class II pulmonary hypertension, but little published research to support this. However, a number of studies have demonstrated that in populations of mixed functional class sildenafil has similar effectiveness to other treatments, and there is little evidence of different effectiveness between patients in functional categories II and III. In addition, there is one study that supports the combination of sildenafil with epoprostenol. The views of the priorities committees in South Central will be forwarded as recommendations to the South Central Specialised Commissioning Group. Sally Nelson explained why the priorities committees had been asked to look at this topic: Treatment of pulmonary hypertension is defined as a specialised service and there is a national interim policy that has been agreed by the Specialised Services Commissioning Groups (SCGs) for England. The South Central SCG’s commissioning team is concerned about the evidence base and cost effectiveness of some of the drugs included within the national policy, and believes there may be opportunities for disinvestment. It has therefore requested this 2010 review to examine recent evidence for the clinical and cost-effectiveness of a number of single agents for pulmonary arterial hypertension. The National Institute for Health and Clinical Excellence (NICE) was undertaking a multiple technology assessment (MTA) of epoprostenol, iloprost, bosentan, sitaxentan and sildenafil for the treatment of pulmonary arterial hypertension in adults. The appraisal consultation document (ACD) was released in March 2008, but the appraisal was subsequently abandoned. The technology assessment commissioned by NICE to inform this MTA was published in October 2009 (Chen 2009 Currently, PCTs and specialist commissioners are receiving increasing numbers of individual requests for funding treatments for pulmonary hypertension – some of which are outside the scope of the agreed interim national commissioning policy. The Priorities Committees have therefore been requested to re-examine the evidence for effectiveness and cost-effectiveness of specific treatments for pulmonary hypertension. The attendees from PHAUK contributed the following points: • The evidence base in this orphan area does not allow meaningful comparisons or robust economic modelling. There is certainly insufficient RCT type evidence to make broad policy decisions. Within certain parameters treatment decisions should be left to experts in the therapy area. • The prevalent population is largely already receiving treatment and the therapies under review have effectively become standard of care, endorsed by NICE and English SCGs via the national policy. • Equity of access is improving via this policy and any move to local decision-making in an area covered by collective specialised commissioning arrangements is a retrograde step and a move towards postcode prescribing. • This disease is severe and devastates patients’ lives. • The PHA UK spent over £150,000 to ensure they could effectively take part in the NICE review discussed extensively in this paper. Had they failed to find these resources then the patient voice would not have been as clearly heard. PHAUK then provided the £90,000 to ensure that the PH national database could be developed and rolled out in the UK. • Quality of life is more important to patients than extension of life. • 88% of 600 patients surveyed said these drugs were effective • Audit data will be available in the next few years • Some of the current treatments including flolan (epoprostenol) will be coming off patent soon and their prices can be expected to drop significantly The Dr Veldtman & Dr Limbrey commented as below: • Trying to look at trials and cost effective data in such small patient groups is difficult • Treatment improves quality of life as well as overall survival • There is no evidence that one treatment is more effective than another • Patients need to be able to move from one treatment to another depending on their • Patients with congenital heart disease are the largest patient group – 5% • Integrated services are absolutely necessary • There is a form of clinical classification more recent than the Venice classification
The Committee discussed the following points:
It was not appropriate for the committee to consider option 5 (support for the national policy), as
this is a matter for the SCG to consider.
1. Overall, the Priorities Committee recommends that, there is insufficient evidence at this time
to justify deviation from the current national commissioning policy on target therapies for pulmonary hypertension. 2. In particular, there is insufficient evidence of clinical effectiveness or cost-effectiveness to justify introducing target therapies for patients with pulmonary hypertension in Functional Class II. 3. However, the Priorities Committee considers that the quality of the published evidence is insufficient to justify the current national commissioning policy and therefore recommends that
the national policy should be reviewed to ensure that services and patient pathways are
based on robust evidence that can be verified by service commissioners. In particular:
3.1. The published evidence base does not directly relate to current clinical practice, which appears to have progressed beyond the published evidence. 3.2. Some oral treatments (particularly sildenafil and tadalafil) appear on the basis of published evidence to be cost-effective and affordable. Others (particularly bosentan, ambrisentan and sitaxentan) may be cost-effective on the basis of the current prices of alternatives. 3.3. Intravenous agents appear not to be cost-effective or affordable on the basis of published 3.4. Evidence suggests that long-term use (i.e. not just used for rescue of acutely unstable patients) of intravenous therapy at current prices is not cost effective and should be
classified as LOW PRIORITY.
3.5. There is currently insufficient evidence of clinical effectiveness and no evidence of cost- effectiveness to justify combination therapy. The Committee agreed that overall, there is insufficient evidence at this time to
justify deviation from the current national commissioning policy on target therapies
for pulmonary hypertension. However – they noted the above points.

THIS MEETING WAS QUORATE

Action:
DS to draft a summary table for presentation at the next meeting in August. Cascade testing for familial hypercholesterolemia
Professor Bryne, Dr Abu and Debbie Hilder attended for this item. The PSU had been asked: Which approach to cascade testing for familial hypercholesterolemia (FH) should be followed? CCL summarised the paper as follows: • Familial hypercholesterolemia is an inherited disorder of cholesterol metabolism which can • Treatment of the raised cholesterol level in the blood reduces this risk, so finding and treating affected people early in life is advantageous. • On average, half of relatives of affected people have familial hypercholesterolemia too. Affected relatives can be identified by cascade testing, and there are different strategies that can be followed. • In South Central, most people with the condition are undiagnosed and most of those who are diagnosed have not had cascade testing offered to family members. • Two approaches to cascade testing were proposed. One is recommended in a clinical guideline from the National Institute for Health and Clinical Excellence (NICE); the other was developed by the Public Health Resource Unit as a lower cost alternative. • NICE’s recommended approach has a cost per quality-adjusted life-year of £1376, and would cost about £1 million across South Central in the third year of operation, less if the price of atorvastatin falls when its patent expires in 2011. By the tenth year, it costs only £23,000 per year. • The alternative costs about £200,000 in the third year, but identifies fewer people for treatment. Its cost-effectiveness is likely to be less than NICE’s recommended approach.
The clinicians tabled a third option for the committee to consider as follows:
Primary Care Diagnosis
Refer for cascade genetic testing if the following criteria are present
Possible FH
• Total LDL >5.5 mmol/l in adult AND a triglyceride concentration less than 4.0 mmol/l (measurements either pre-treatment or highest on treatment) (i)Family history of myocardial infarction before age 50 in 2nd degree relative or before age 60 in 1st degree relative (ii)family history of raised total cholesterol concentration above 8.0 mmol/l in 1st or 2nd degree relative
Definite FH
• The above criteria plus Tendon xanthomata (or evidence of these in 1st or 2nd degree • And /or DNA-based evidence of an LDL receptor mutation, familial receptor defective apo- B100, or a PCSK 9 mutation in patient or 1st or 2nd degree relative
Note Consider the diagnosis if LDL cholesterol substantially elevated (i.e.>6.0 mmol/l) even in the
absence of a personal or family history of coronary disease.
THIS MEETING WAS QUORATE The clinicians in attendance contributed the following: • Having familial hypercholesterolemia (FH) gives you a much higher risk of vascular events than just happening to have high cholesterol. • If someone does have FH, there is a 50% chance of first degree relatives (parent, sibling, child) having FH. If a first degree relative has the relevant genetic test and does not have FH, his/her children are no more likely to have FH than the general public and therefore don’t need to be tested. If he/she does have FH, his/her children each have a 50% chance of having FH. • Cascade testing is about CASE-FINDING not population screening. • The tabled 3rd option restricts the numbers who would be sent for genetic testing and therefore increases the SPECIFICITY of the overall testing process. This will reduce the number of people who have genetic tests and are found not to have familial hypercholesterolemia. • The COST of genetic testing is incidental compared to the COST of treatment (£50-£200 • The current recommendations are to use atorvastatin to treat people with FH to reduce the risk of vascular events (probably because the majority of studies have used atorvastatin). However 40mg of simvastatin are likely to be just as effective in most patients and cheaper at the moment. • For patients where 40mg of simvastatin are insufficient to reduce cholesterol, 80mg of simvastatin can be used, but there is a higher risk of the side-effect rhabdomyolysis (an unpleasant, painful condition in which muscles are damaged) compared to the equivalent dose of atorvastatin. • Atorvastatin is currently much more expensive than simvastatin, but its patent will expire soon and the price is likely to fall to a similar level. The clinicians proposed: Option 3 (as above) with the suggested levels of cholesterol and triglycerides as indicators to offer genetic testing. Treat patients identified with FH with simvastatin until the price of atorvastatin falls then swap them to atorvastatin. The committee discussed the below points: • The models presented are all low cost per QALY and therefore cost effective • This is a good invest to save opportunity • Both models are cost effective but there is a need to establish which is more affordable. • There is a wide variation/inequality in practice. • It is important to establish where patients will go for the end services to help establish • The committee were interested in option three and its potential benefits compared to  
Agreed:
The PSU was asked to model the impact on numbers and costs of the tabled option 3 and bring back to he next meeting. PSU to model the proposed option 3 and take to the next meeting in August. This item was deferred to the next meeting in August
THIS MEETING WAS QUORATE

SECTION C – POLICY & PROCEDURE
SECTION D
D1
programme
SECTION E – ANY OTHER BUSINESS
E1 PCT Case Review Summaries
For information
Other business

Dabigatran
At its last meeting, the OWG had agreed the need for an interim action to contain the use of
Dabigatran on the grounds that it would be unethical to put a huge financial strain on the NHS. It
was agreed that as there is an alternative treatment in place Dabigatran should be Low Priority
until a full evidence review is undertaken and presented at priorities committees in November.
The committee did not however want this in the form of a policy, rather a minute that would be
distributed to PCT leads for action.
Date and time of next meeting:
Friday 10 September 2010, 9.30-12.30pm
Southampton PCT HQ, Oakley Road, Southampton, SO16 4GX


i Chen Y-F et al. Clinical and cost-effectiveness of epoprostenol, iloprost, bosentan, sitaxentan and sildenafil
for pulmonary arterial hypertension within their licensed indications: a systematic review and economic
evaluation. Health Technology Assessment 2009; Vol. 13: No. 49

Source: http://www.sph.nhs.uk/ebc/sph-files/ship-minutes/SHIP%20Minutes%20-%2009July2010.pdf