Select Committee on Health Minutes of Evidence

Memorandum by Professor Tom Walley (NC 104)

  1.  I should like to point out to the Committee my particular standpoint in preparing this Memorandum of Evidence. These are as follows:

    (a)  I am an academic with a longstanding interest in prescribing issues, both in primary and secondary care: in clinical effectiveness and cost-effectiveness: and policy matters related to the provision and use of medicines. I have also carried out some personal research into the influences of NICE within the past six months.

    (b)  I work extensively in educational matters with prescribing advisers at health authority, primary care trust and practice level and am therefore aware of issues they face.

    (c)  I am the leader of one of the units which is contracted through the National Co-ordinating Centre for Health Technology Assessments to provide technology assessment reviews on which NICE will in part base its appraisals of new technologies.

    (d)  I am Chairman of a hospital Drugs and Therapeutics Committee and therefore have responsibility both in my own hospital and more widely through local health authority and PCT committees to support the implementation of NICE guidance.

    (e)  I am a consultant physician and prescriber, and therefore have personal responsibility to implement NICE guidance in relation to my own patients.

  2.  I will confine myself to considering aspects of the appraisal of new technologies undertaken by NICE and the guidance that results from them, and will take the perspective of the NHS. I will not consider guidelines or some of the other aspects of NICE's activities.

  3.  I fully support the principals set out in a First Class Service for the activities of NICE. The NHS requires clear and credible guidance: the existence of "postcode prescribing" was divisive and inappropriate: the NHS needs to take on board those technologies which represent a true clinical advance and which are cost effective by comparisons with other available treatments, as quickly as possible. Conversely the NHS needs to specifically prevent the uptake of technologies which do not meet these criteria, ie not merely ineffective therapies (which are surely rare) but less effective therapies. Such decisions should be taken at a national level so as to ensure equity of access across the NHS.

  4.  There are a number of issues to be considered in relation to NICE—I will group these under two broad headings, of Principles and of Practice.


  5.  It should be realised that there may be contradictions inherent in some of these criteria: for instance it may be that a new therapy is uniquely effective but constitutes very poor value for money, i.e. a conflict between effectiveness and cost effectiveness. Whether it should be funded is therefore a matter for judgement or appraisal, to include the financial, social, ethical and legal implications of its use or non-use. The rules or values for such appraisal are not clear. We require open debate about how we value such trade-offs. An example is beta interferon for multiple sclerosis.

  6.  It is said to be essential that such a body undertaking this work should be independent of government. However, this can never be entirely the case, since NICE must consider resources available to the NHS and the possible alternative use of those resources, in making its appraisals. It is not clear to what extent the resources or their alternative uses are considered.

  7.  The extent of resources available to the NHS is a political decision, outside the remit of NICE. Prof Rawlins stated in Feb 2001 (BMJ 2001; 322:489) that with regard to guidance from the ministers on resources "the institute has not yet received any such guidance". If so, it seems to me that the government has abrogated its key role in deciding NHS priorities and has delegated its role in NHS rationing, or has decided that the NHS can have unlimited resources and that rationing is unnecessary. The recent directive from the Dept of Health to health authorities and PCTs on making resources available to meet NICE guidance suggests that use of NHS resources should be directed by NICE. This needs to be made explicit. It also effectively converts NICE guidance into mandates for the NHS.

  8.  Rationing carries unpleasant connotations of reduction in services. However, to my mind this is a misuse of the term which should instead imply the best use of limited resources to ensure adequate and equitable care for a population. This limitation of resources and the need to use them to best advantage is inevitable in any health service where the technical abilities go beyond the financial resources available to deliver them. Only in a health service with limitless access to funds can health care not be rationed.

  9.  If NICE is the priority setter, then we must consider how wide a view NICE takes in coming to its decisions. For instance in considering a drug such as sibutramine, has NICE considered whether NHS resources might be better spent in providing better dietetic advice? If it has only considered sibutramine and its effectiveness in isolation, then it allows itself to be driven by the technology and the submissions of the manufacturers rather than taking a broader view of the needs of the NHS.

  10.  Does NICE advice carry with it added resources to the NHS, or as seems to be the case, redistribution of existing resources? If this latter is the case, then all possible alternative uses of the resources need to be considered and a review confined to a single therapeutic area or technology is inadequate. A broader approach is necessary, to cover a wide range of, or even all NHS activities.

  11.  These issues of principle need clarification.


  12.  There have been many practical problems with the work of NICE, which I believe have limited its effectiveness.

  13.  The timing of NICE guidance. Some NICE guidance has tended to come too late to be of true practical value, not being available at the time of the launch of a technology. This will improve with time, but will remain a problem to some extent, particularly when NICE processes become more involved and requirements for evidence seem to increase.

  14.  There has to date been no ring fenced funding for the implementation of NICE guidance. This has led to an inability or reluctance of health authorities to provide the resources for NICE guidance implementation (which could seriously disrupt other services). There has been a raising of patient expectations which could not be fulfilled by the clinicians, eg in my own area, around the lack of resources to fund alpha interferon and ribavirin for hepatitis C patients. Recent government guidance might seem to resolve this, but may in fact cause other problems, as outlined below.

  15.  An alternative is the approach suggested by the Royal College of Physicians in 2000 in the document "The Prescribing Of Costly Medicines" where is advocated that there should be central funding for high cost medicines so as to ensure equity of access across the country.

  16.  The requirement that health authorities/PCTs will provide funding for NICE guidance removes local discretion and should abolish postcode availability of treatments. However it may only transfer the inequity from a visible technology to other, less visible services; ie by requiring commissioners to fund NICE guidance from the same pot as other services and with a priority over other services. This may mean that there is for instance more money available for an appraised drug therapy at the expense of unappraised community nursing services.

  17.  This will also cause problems in planning services—a requirement to provide such funding within a short space of time will either force commissioners to keep a large contingency fund or will disrupt other services in year.

  18.  The funding of NICE priorities therefore has an adverse effect on other services. If NICE priorities were truly NHS priorities, this might be appropriate. There is a distinct impression that some of the priorities of NICE as documented by the issues in which they give guidance are more priorities for perhaps their commercial sponsors than for the NHS. As an example, consider the guidance on such agents as sibutramine or orlistat. This is not to deny the importance of obesity to the NHS, but how important is the supply of a drug therapy to treat it?

  19.  This may constitute a charter for the producers of such technologies to direct NHS funding.

  20.  NICE processes are changing and evolving, and this is to be expected. However, some of the changes are not desirable. My impression is that the process has become excessively adversarial and antagonistic with, on the one hand the industry and sometimes patient pressure groups, and in the other a somewhat beleaguered NICE. This has led to an increase in the amount of documentation required for NICE appraisals and complexity in the conduct of the appraisals, as the appraisals need to be legally as well as medically robust.

  21.  This has been considerable pressure on NICE to accept therapies that are, perhaps marginal, either in their benefits or their importance to the NHS. The extent to which NICE has given in to such pressure is unclear but some of the loss of credibility described below is related to a perception of this.

  22.  It is not clear to what extent NHS organisations (eg primary care and zanamivir) are consulted about their ability to deliver or appropriateness of NICE guidance at the time the appraisal is undertaken. There is certainly no right of appeal from within the NHS against NICE guidance in contrast to the rights of appeal of the industry or of patient groups.

  23.  Some greater degree of transparency in justifying the decisions it has made would be welcomed, but one should be cautious about allowing excessive transparency before this: it risks exposing NICE to inappropriate political or commercial pressure.

  24.  Another practical problem is the way in which NICE guidance is read, with blurring of the important detail. The guidance itself may be relatively restrictive, but this is not how it is applied eg widespread use of Cox II inhibitors, justified based on the basis of NICE advice, but which is in reality contrary to the detail of this advice. Better means of implementing the important detail are essential—computer decision support in prescribing may be one such way.

  25.  NICE has some problems with credibility. The reasons for this are:

    (a)  Some of the appraisals seem to be perverse in light of the evidence available, for instance that recommending glycoprotein IIb/IIIa inhibitors or the inclusion of such drugs as meloxicam and etodolac in the guidance on cox II inhibitors.

    (b)  The reversal of the decision around zamanivir without strong clinical evidence has been particularly damaging to the credibility of NICE in the eyes of general practitioners. Has this decision served the NHS, patients or the pharmaceutical company?

    (c)  The use of NICE as a marketing device by some pharmaceutical companies.

    (d)  The apparent driving of NICE priorities by commercial rather than NHS needs.

    (e)  The difficulties of the NHS to move fast enough to deliver all of NICE guidance makes it seem remote from NHS practice and leads to "guidance weariness".

    (f)  Concern about its perceived lack of independence from government and uncertainty over the extent to which it should be independent, as described above. There is an impression that NICE guidance is the victim of "spin" by the government—if not in its content, then in its dissemination.

    (g)  Decisions made by the government have not assisted NICE's credibility:

      (i)  the confusion over NICE's role and the extent to which NICE should take the availability of resources into account.

      (ii)  the recent proposed to make available beta-interferon and other drugs for multiple sclerosis throughout the country in a "trial" of dubious scientific value, seems to be a means of bypassing NICE advice.

      (iii)  The Department of Health has decided to fund imitanib for patients who participated in trials, now that this drug is licensed. It is not due to be considered by NICE for some months. In this particular case, the decision was forced on the Department of Health by the rapidity of the licensing process, which has taken NICE and the Department of Health by surprise. However the external appearance is damaging and the use in patients other than those in trials is expanding as a result. Here was a case for an urgent appraisal.

  26.  The Committee will be aware that there is currently a review of the implementation of NICE guidance underway by the University of York but this is unlikely to be completed for a further 18 months.


  27.  I strongly support the principles under which NICE was founded. I have some concerns that the internal tensions within these principles have not been fully considered.

  28.  There have been many practical problems that have undermined the credibility and effectiveness of NICE. These criticisms have come both internally from within the NHS and externally from industry and patient groups. The Committee will be aware of the selective interests of all of these parties. These problems are not insurmountable, but they require the clear support of the House of Commons Committee in tackling them. There is a need for a rapidly responsive source of guidance for the NHS, but also for a body to take a broader view of NHS priorities: this seems to be beyond NICE in its present form.

  29.  The issue of the limitation or not of NHS resources needs resolution: a decision either way would change the nature of NICE.

  30.  NICE is a brave start which will evolve but which needs regular detailed review. Its current direction is in my view flawed.

January 2002

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