Scottish Medicines Consortium

Transcription

1 Scottish Medicines Consortium Mr Fergus D Cochrane Clerk to the Public Petitions Committee Directorate of Clerking and Reporting TG.01 The Scottish Parliament Edinburgh EH99 1SP Date 4 April 2008 Enquiries to Rosie Murray Direct Line rosie.murray@nhs.net Dear Mr Cochrane Thank you for your letter of 5 th March On behalf of the Scottish Medicines Consortium (SMC) I endeavour below to answer those of the Committee s questions on which the Scottish Medicines Consortium has information or views and will be happy to expand upon any of these answers or discuss other areas at the oral evidence meeting on Tuesday 29 th April. In an effort to facilitate our response I have repeated below the Committee s question before giving our answer to it. 1. Whether the roles fulfilled by local area drug and therapeutic committees, the Scottish Medicines Consortium, NHS Quality Improvement Scotland and the National Institute for Health and Clinical Excellence are clearly defined when undertaking clinical, scientific and cost effectiveness assessment on the use of cancer treatment drugs for the guidance that is subsequently issued to NHS Boards and clinicians? SMC believes that the roles of the individual organisations are clearly defined and well understood within the NHS in Scotland and that both overlap and duplication of effort are minimal. In respect of new cancer medicines, SMC reviews all of these as close as possible to the time of launch as part of its assessment of all new medicines coming to the market place. The National Institute for Health and Clinical Excellence (NICE), as part of a NICE Multiple Technology Appraisal (MTA) process, reviews only some medicines (including only some cancer medicines) coming to the market place. The outcome of these reviews is at least 18 months after the SMC advice is made available. Where NICE (MTA) advice is issued for a drug or group of drugs, this advice is assessed by NHS Quality Improvement Scotland and, in general, made applicable to Scotland, superseding any prevailing SMC advice. Our Area Drug and Therapeutics Committee (ADTCs) then concentrate on the local implications of the output from SMC (and NICE MTA), often involving local expert clinicians in deciding whether a drug, which has been accepted for use by SMC, will in fact be used locally or whether other therapeutic approaches would be preferred. With cancer drugs, these decisions will involve consultation with the relevant Regional Cancer Network. The roles and responsibilities of each of the agencies are clearly defined. NICE Single Technology Assessment (STA) has no status in Scotland. SMC was established in May 2002 and looks at all medicines (approximately 100 per year) whereas NICE STA was established in June

2 and looks at approximately 12 new medicines per year. The NICE STA basically mirrors the SMC process in content, but there is often a significant time delay with the issue of NICE STA advice, unlike SMC advice which is usually issued within 3-4 months of a new medicine becoming available.. 2. In terms of the number and roles that these bodies play; o Do any anomalies or contradictions exist and is there any duplication of roles? o Are resources being used constructively and efficiently and are there inefficiencies as a result of all these bodies? o How is effective communication maintained across and amongst these bodies? As noted above there are no serious anomalies or contradictions amongst the bodies concerned and minimal duplication of roles. The SMC is a particularly lean organisation given the large number of assessments is undertakes and the very tight timelines that these are undertaken. The introduction of the Scottish Medicines Consortium was precisely to avoid duplication of new drugs assessment by individual ADTCs, and evidence from a recent consultation process with ADTCs shows that they no longer undertake individual assessments of new drugs but rely on advice from the Consortium. While ADTCs will have a role in developing local formularies they also have many other roles e.g. in monitoring prescribing, drug safety, safe systems of work, etc so the development of SMC has served to lighten the burden on hard-pressed ADTCs. SMC communicates its decisions regularly to all relevant individuals and has excellent working relationships with NHS Quality Improvement Scotland, including the Scottish Intercollegiate Guidelines Network. Regular interactions take place and, where any possible problems are identified, these can be resolved through discussion. As a Consortium of ADTCs every SMC agenda has a space for ADTC Feedback at which time the representatives of local ADTCs can bring to the SMC table any local issues and concerns. It was apparent from the recent consultation exercise that our constituent ADTCs regard the SMC as an extremely useful venture in helping manage the introduction of new medicines. SMC additionally has a horizon scanning function for all new drugs, including cancer drugs, allowing the NHS prior knowledge of new therapies in the drug development pipeline and giving the service time to plan for their introduction. This function, developed in the last 3 years, is already perceived by NHS Boards as essential in their planning processes. 3. Do any anomalies exist in terms of the roles played by these bodies when considering drug treatments for other life threatening and terminal conditions and how can such anomalies be resolved? As noted above, SMC does not believe there are any significant anomalies in the roles played by the various bodies. Responsibilities are clear and overlap is minimal. 2

3 4. What action and steps need to be taken to streamline the roles played by these bodies and the processes involved and why are these not being taken? SMC does not believe that changes to streamline the roles are required. The only possible overlap could be with NICE STA. This is not an issue at present as NICE STA has no status in Scotland. If it were proposed that NICE STAs were made valid in Scotland then duplication could occur. However the number of reviews (100 for SMC versus 12 for NICE STA) and the difference in timing of the issue of advice (as noted above) mean that clinicians in Scotland have expressed the view that the SMC should continue to undertake a lead role in medicines assessment for Scotland. A later NICE MTA review (again only undertaken for a minority of cancer medicines) or SIGN Guideline will usually see data not available at the time of initial drug launch and thus complements the more rapid, early SMC assessment. 5. What requirement is there for an NHS Board to adhere to advice and guidance issued by the Scottish Medicines Consortium and NHS Quality Improvement Scotland (which recommends NICE guidance to the NHS in Scotland and which supersedes SMC guidance) on the approval and use of cancer treatment drugs? SMC is a Consortium of Area Drug and Therapeutics Committees and there is an understanding that membership of the Consortium brings with it responsibility to stand by the Consortium s decisions. SMC advice is advisory but we would anticipate that Health Boards would, except in unusual circumstances, make available SMC approved drugs where clinicians and patients wish to use them in line with SMC advice. 6. Is implementation of guidance across NHS Boards variable and if so, what checks and balances are in place to address this? SMC is not presently in a position to assess the uptake of its advice across the NHS in Scotland. This is a particular problem for drugs predominantly used in secondary care (e.g. most cancer medicines) where centralised electronic prescribing and administration systems are not yet in place. Even were headline data to be available, this would require very close scrutiny and interpretation as differences in uptake of medicines may reflect individual clinician and/or patient preferences, peculiarities of geography and indeed existing custom and practice in individual therapeutic areas. It is too simplistic to simply observe differences in headline uptake of drugs and interpret these as necessarily detrimental to patient care. 7. What assessment is done of how individual clinicians apply such guidance? It is not within the role of the Scottish Medicines Consortium to assess the response of individual clinicians to its guidance. Individual Health Boards will have processes in place to monitor medicine usage, particularly for high cost medicines. 3

4 8. Do any anomalies exist in terms of the implementation of guidance on cancer treatment drugs and guidance on drug treatments for other life threatening or terminal illnesses and how can such anomalies be resolved? As noted above, SMC is not able to answer this question from a position of knowledge. We have no reason to believe that variability of local uptake of guidance will be any different for cancer medicines than for other medicines and will reflect differences in local circumstances. 9. What views and suggestions have been offered by (a) clinicians and (b) patients on the procedures involving making cancer treatment drugs available? SMC is fully engaged with clinicians across Scotland in its processes and indeed engages with expert clinicians in the field of cancer when assessing each new cancer drug. Input from such experts is vital to our understanding of the therapeutic area and to our overall assessment process. Clinicians in general respect and feel involved in SMC s decision making process. Obviously they will be disappointed when an individual drug which they wish to use is not recommended for use in the NHS in Scotland but most appreciate that difficult decisions do have to be made and that the SMC goes about its work in a robust, transparent and inclusive fashion. Patients are also heavily involved in the SMC process with three patient and public members sitting on the SMC, a Patient and Public Involvement Group trying to encourage wider patient involvement and the frequent submission of information from patient interest groups as part of the SMC decision-making process. These patient submissions can often supply useful additional perspectives on new drug therapies and they are very helpful in guiding SMC s conclusions. A number of observers from patient interest groups have sat in on SMC meetings. Feedback from them has always indicated that they are impressed by the detailed discussion and debate of the SMC decision-making process and by the fact that SMC, in all its deliberations, remains focussed on the needs of patients. As with clinicians there is obviously some disappointment when a new drug is not recommended but observers have indicated that they can understand the circumstances in which individual medicines may not be recommended and that they would be satisfied that the decision-making was robust and objective. 10. Whether there are any cancer treatment drugs available in some NHS Boards and not in others? This is not information which SMC has readily to hand or could readily obtain. As noted above, the decision not to use a new cancer drug may simply be because local clinicians feel that existing therapies are satisfactory and the new drug does not offer any specific benefit for the patients in that area. 4

5 11. What criteria are applied by NHS Boards when considering whether to fund a cancer treatment drug not recommended by the SMC? 12. What are the conditions and criteria set by NHS Boards to use exceptional prescribing circumstances and is any guidance provided to patients? 13. Whether it is ethical and appropriate that patients should self fund and prove the merit of being prescribed a particular drug and to what extent does ECHR apply in the decision making process when an NHS Board is considering a funding request? 14. What is the reasoning behind the position whereby a person cannot be treated as a private patient and an NHS patient for one condition during a single visit to an NHS organisation? 15. Does the availability of cancer treatment drugs across NHS Boards fit in with the Scottish Governments cancer strategy and are there any contradictions between availability and the overarching policy? These are not areas of SMC knowledge and expertise and would be better answered by local Heath Boards or the Scottish Government Health Department. 16. Are there any particularly unique issues or considerations that apply in terms of the availability on the NHS of cancer treatment drugs that do not apply in relation to other drugs for terminal illnesses? SMC does not believe that the assessment of new cancer medicines is different from the assessment of other drugs for terminal illnesses or indeed other drugs for the prolongation or improvement of human life. The principle of trying to ensure that NHS resources are used most effectively, having regard to the underlying premise that the NHS has limited resources which can only be spent once, underpins all our assessments. 17. The criteria and basis of the formula used to measure both the quality and the quantity of life lived, as a means of quantifying in the benefit of a medical intervention (QALYs). The use of the quality adjusted life year (QALY) is an effort to capture, in a single measure, the fact that medicines aim to prolong life, improve the quality of life or do both of these. For most drugs in cancer, we would hope to see both an improvement in quantity of life (= increased survival) and also some improvement in quality of life, although on occasion the increased quantity of life may come at the expense of quite significant drug side effects which might actually reduce life quality. There is not a single simple formula to bring together quality and quantity of life and this is often the subject of considerable health economic modelling. I do not believe that an attempt to describe this approach in great detail in this letter would be very helpful and this might be something more easily addressed at the oral evidence session. If the committee would be interested in seeing some further written information on the QALY approach then I would be happy to supply this separately before the oral evidence meeting. 5

6 The QALY approach is widely used world-wide and, while it undoubtedly has its detractors, there is no real evidence of a better approach to try to encompass the twin domains of quality and quantity of life. In terms of the anti-cancer drugs that the SMC has looked at, a cost per QALY approach has been used in all cases. 18. What consideration is being given to the availability of cancer treatment drugs as part of the Scottish Governments national discussion on the future of cancer care? This is not an area of SMC s expertise and would be more appropriately answered by the Scottish Government Health Department. I hope the above answers will be helpful to the Public Petitions Committee in its deliberations. As noted I would be happy to expand on this written response in any specific areas where the Committee would seek additional information and I will look forward to appearing before the committee to give further oral evidence at the meeting on Tuesday 29 th April. If the Committee wishes to explore in more detail the whole QALY approach (Q17) then I will arrange that one of our expert health economists accompanies me to the oral evidence session; I will await advice from you on this point. Yours sincerely Dr Kenneth R Paterson Chairman 6