Select Committee on Health Minutes of Evidence

Memorandum by GlaxoSmithKline (NC 120)


  GSK strongly endorses the goals of NICE in promoting faster and more equitable access to modern treatments and the need to address postcode prescribing.

  GSK agrees that NICE can play an important role in achieving these goals. NICE has provided a mechanism to appraise the value of new and existing technologies within the NHS, and hence provided a potentially clear central focus for decision making. However it does not, and should not have a role in assessing the affordability of technologies, which is a matter for Government.

  Individual Primary Care Groups (PCG's) and Trusts (PCT's) are still making judgements regarding the implementation of NICE guidance. This has lead to clear variations in implementation throughout the country and suggests that NICE has not yet achieved one of its main objectives. GSK trusts that this may be improved by the recent Government announcement to direct the implementation of NICE guidance. However it must be ensured that appropriate levels of funds are made available for implementation. Until then we reserve judgement. We are also concerned with the potential impact of this direction, as funds may be diverted from those areas not reviewed by NICE to fund the implementation of NICE guidance. This makes it critically important to review the process for the selection of products for appraisal.

  Since its inception NICE has worked with its stakeholders, including industry, to improve its processes. Some improvements have been made to these evolutionary processes although they are still not applied entirely consistently or reliably. GSK believes it is important to continue to drive for change and monitor improvement. GSK encourages and supports further development in the field of clinical guidelines, which although in its infancy, has the potential to achieve more equitable access for patients to treatments in the NHS.

  GSK has committed considerable resource to providing the relevant evidence in the full appraisals that the company has been directly involved in, working in partnership with NICE and the assessment teams to reach final guidance. As the experience of all parties involved has increased this process has become somewhat easier. However we are concerned that on occasions final guidance has still lacked clarity. We would welcome improvements in this area.

  GSK hopes that there would be a full debate before any decision is made to make NICE completely independent. It is vital that Ministers are accountable to the public for decisions that NICE makes and therefore we would suggest that it is appropriate that NICE continues to report to the Department of Health.


  1.1  GlaxoSmithKline (GSK), is one of the world's leading research-based pharmaceutical and healthcare companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GlaxoSmithKline is proud to be a UK-Headquartered company employing over 100,000 people across the world and approximately 25,000 in the UK. GSK annually invests £2.5 billion in Research and Development, over 40 per cent in the UK alone, at the cutting edge of pharmaceutical discovery in order to bring new medicines to patients across an extensive portfolio of disease areas, including those of the developing world. GSK takes its corporate social responsibilities very seriously and our programme supports scientific education, medical research, healthcare charities, and the environment with donations totalling over £5 million in the UK alone.

  1.2  GSK has been involved in six full NICE health technology appraisals, of which four are complete and two approaching completion. GSK is also a stakeholder in the development of six NICE guidelines. In addition, GSK has regularly submitted opinion into the consultation process on a number of NICE processes including guidelines for manufacturers and sponsors, processes for development of NICE appraisals and guidelines and contributed to ABPI positions on NICE.


  2.1  GSK has been involved in four full appraisals of our products to date. In all cases we have committed considerable resource to providing the relevant evidence, and to working with NICE and the Assessment teams to reach final guidance. As experience of all parties involved has increased the process has become somewhat easier. However it has been more problematic in specialist areas such as cancer and reflects the critical importance of incorporating appropriate clinical expertise in evidence assessment and the appraisal process.

  2.2  Since its inception NICE has worked with its stakeholders to review and improve its processes. Although they are still not applied entirely consistently or reliably, improvements have been made and these should be acknowledged. GSK is pleased to have had the opportunity to input into these developments and would welcome continued involvement, as it is important to continue to monitor progress and make further improvements.

  2.3  GSK considers that issues still remain with the wording of guidance, which can lack clarity. For example with Avandia for the treatment of diabetes, we have anecdotal evidence that the wording is unclear and this may be a contributing factor to the variable uptake of this medicine across England and Wales (see graph below). We would therefore welcome improvements in this area.


  3.1  NICE has made considerable progress towards this aim as it has provided a mechanism to make decisions which, whether they are agreed with or not, previously did not exist. However, individual primary care groups (PCG's) and trusts (PCT's) are still making judgements regarding whether or not to implement NICE guidance, and in some cases have re-reviewed the evidence at a local level. This constitutes a clear duplication of activity, and reduces the impact of NICE as a single national focus.

  3.2  GSK trusts that the recent Government announcement to direct PCG's and PCTs to implement NICE guidance may avoid this activity. However we reserve judgement until we have witnessed the practical application.


  4.1  Individual decisions are still being made locally. The Avandia data above demonstrates unacceptably large differences in prescribing across PCG/T's and although we accept that there might be other reasons for these differences it would indicate that guidance is not being implemented in a consistent way across England and Wales. As stated previously, this may change when implementation of NICE guidance is compulsory.


  5.1  NICE has made decisions on how and when treatments are to be used based on evidence of clinical and cost effectiveness to which NICE applies its own criteria. However we have had concerns about the variable quality of some of the evidence assessments and their utilisation of evidence provided by stakeholders, particularly with regards to health economics, and trust that the recently revised guidelines will improve consistency. It is also important to note that the guidance is in the context of use within the NHS and therefore cannot be transferred to other health care systems.

  5.2  NICE has only made decisions on some technologies. Therefore other technologies which may be less effective may continue to be used simply because they have not been considered. Alternatively, funds may be diverted away from treatments which would be clinically and cost-effective simply because NICE has not had the opportunity to assess them. GSK believes that either outcome is far from ideal and will result in NICE failing to meet its overall objectives.

  5.3  The current process of selection is lacking in transparency. The membership of the Technology Advisory Group (TAG) that advises Ministers on which technologies to review lacks clarity. It is also unclear why some products are reviewed as appraisals, whereas others are only looked at as part of guidelines. Although broad categories are provided as the basis for selection it is not clear why individual products are reviewed and others not. Given the importance of NICE guidance to an individual product in a cash limited environment where PCG/Ts are obligated to implement NICE guidance, and the problems of planning for the considerable work involved in preparing a submission to NICE, we would recommend that improvements are made to the selection process. This could involve broadening and publicising the membership of TAG with full consideration of the benefits of industry representation; full disclosure of the minutes of TAG meetings; the listing of products being considered with reasons for inclusion or exclusion made public, and publication of clear timelines for the process.

  5.4  GSK does not have any specific evidence about NICE guidance providing faster access. However there is a potential conflict between the availability of good evidence and faster access. At launch it is unlikely that all the evidence would be available. However if an appraisal is delayed then there is a danger that patients will be denied that technology at a local level until NICE guidance is available (the concept of "blight"). One way around this is to have a transparent discussion about the optimum time for a review that is likely to vary depending on the technology and the disease area involved. If an appraisal at launch is identified by all parties as being the best approach then it is important that the appraisal committee has a realistic expectation of the evidence that is likely to be available, and should not limit access to new technologies inappropriately.

  5.5  GSK believes that it is disingenuous to continue to assert that NICE allows patients to have faster access to treatments known to work. By its own admission, in the much-publicised beta-interferon decision, NICE is rejecting treatments that have clinical benefit but are not deemed to be sufficiently cost effective. It is critical that this point is made clear to patients and the general public. NICE should not be used to disguise political decisions. GSK would like the Committee to consider recommending to the Government to engage more fully with the electorate in order to ensure that patients are clear on the choices that are being made on their behalf. This would enable healthcare funding judgements to more accurately reflect the choices of society.


  6.1  GSK is confident that if the suggested changes outlined in this submission were to be adopted by the Government it would create a more transparent process and improvements in the selection process.

  6.2  GSK suggests that there should be a full debate before making NICE completely independent. It is vital that Ministers are accountable to the public for decisions that NICE makes and therefore we would suggest that it is appropriate that NICE continues to report to the Department of Health. In addition we support NICE's own view that to remove it from the NHS is only likely to distance it further from the end user.

January 2002

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