Select Committee on Health Written Evidence


Evidence submitted by Dr Chris Hyde (NICE 76)

EXECUTIVE SUMMARY

  In circumstances where the total price of new health care innovations exceeds growth in health care budgets, scrutiny of value for money is essential. If NICE is performing this role in Technology Appraisal successfully, highlighting even a minority of innovations where the additional costs do not seem to be matched by the demonstrable health benefits, will bring it into conflict with both the public and drug manufacturers. The committee must thus take care not to judge the value of NICE by its popularity.

  Scrutiny should instead be directed at whether the balance between benefits, harms and costs in cases which NICE has not supported make sense to the Committee. The Committee will need support with this because quantifying health benefit, side-effects and cost is often complex. Despite this it should be possible for the main elements of the argument for or against a health technology being cost-effective to be presented in a way where the Committee can make their own judgement on whether the conclusions reached by NICE are reasonable.

  In my experience the decisions by NICE are reasonable and generally give the benefit of the doubt to the health technology being appraised.

  Greater resources should be devoted to explaining the nature of the evidence underpinning NICE's Technology Appraisal systems more widely.

INTRODUCTION

  1.  I have worked in health care for 20 years. During that time I have acquired a variety of experience which is potentially relevant to my evidence. I am a medically qualified Doctor and worked in hospitals for several years. I have also trained in public health and have worked in health authorities helping to commission health care for local populations.

  2.  Currently I am a researcher who helps provide the summaries of evidence which feed into the decisions which NICE makes. The university I am employed by receives funding from the NHS Health Technology Assessment Programme for developing these summaries, however my post is not dependent on this funding. I have attended NICE appraisal committee meetings and appeals, but I am not part of NICE and am not involved in the final decisions it makes. Finally I am a parent of young children and have been a carer.

EVIDENCE

  3.  The Committee posed a series of questions. My evidence consists of reflections on each of these.

Why are NICE's decisions increasingly being challenged?

  4.  My understanding is that NICE has a number of roles and that it is mainly the decisions of Technology Appraisal arm which are contentious and subject to challenge. My perception is that the advice NICE offers in the form Clinical Guidelines and Interventional Procedures Guidance although not immune from criticism, is rarely formally contested.

  5.  Two things set the Technology Appraisal arm apart. First it is the stream of guidance which specifically sanctions use of specific new technologies. Second it is the only stream which considers value for money in which the benefits, side-effects and costs are weighed against alternative approaches. This is essential in a situation where the total price of new health care innovations exceeds growth in health care budgets.

  6.  Both factors suggest why NICE's decisions in Technology Appraisal are challenged, both because it is required to make decisions which prevent a new technology being made widely available and because it uses a criterion (cost relative to benefit) which is not universally accepted as one which should govern decisions about availability of health care. Unfortunately it is self evident to those aware of the true costs of health care, which the NHS rightly protects most patients from, and the scale of health innovations, that such decisions must be made.

  7.  The only way NICE could avoid conflict with patients and drug companies, is if it made no negative decisions, thus NICE's growing unpopularity might be regarded as a marker of success rather than failure. One would certainly be suspicious if it was popular.

  8.  Concerning the apparent increase in decisions being challenged, I suspect this is due to the fact that negative decisions take years to achieve because appeals can be mounted, and the nearer the end of the appeal process the greater the volume of criticism.

  9.  Greater clarity borne of a number of years of experience, could also explain an increase in negative initial decisions made by NICE, as could random fluctuation in the cost effectiveness of new health care products being introduced, as the licencing system is primarily aimed ensuring that drugs meet minimum criteria of safety and effectiveness, allowing marked variation in the extent of effectiveness and cost-effectiveness.

Is public confidence in the Institute waning, and if so why?

  10.  This is difficult to gauge because it may not be clear to many members of the public exactly what NICE's role is. Given this the contention that NICE has ever had true public confidence is open to question.

  11.  However, irrespective of this it is inevitable that if NICE is performing this role successfully, highlighting even a minority of innovations where the additional costs do not seem to be matched by the demonstrable health benefits, it will be brought into conflict with the public. This in turn could be interpreted as waning of public confidence, whereas more truthfully it might just reflect that as the number of negative decisions rises over time, the more people are directly affected by the unpopular decisions NICE has to make.

  12.  One issue is clear is that NICE does not have the capacity to counter media campaigns supported by drugs companies. Whether NICE should try to do so is debatable, but what is certain is that greater coverage of views reflecting the drug manufacturers perspectives will inevitably make it appear that public confidence is waning. How much of media coverage on a particular topic is inspired or supported by drug companies may be amenable to measurement.

Are any particular groups disadvantaged by NICE's evaluation process?

  13.  Having observed the evaluation process relatively independently, I would suggest that no group is greatly disadvantaged.

  14.  Relatively however, although NICE have tried hard to solicit and incorporate patient views, the technical complexity of the submissions and the debate often make it challenging for truly representative patient perspectives to be incorporated into their decisions.

  15.  Greater resources devoted to facilitating understanding of the available evidence by patients and patients groups could be valuable. There is certainly no funding to translate the summaries of evidence we provide to NICE into lay language, so the feasibility of this could again be usefully explored.

Speed of publishing NICE guidance?

  16.  In my experience the slow progress with the guidance, although frustrating, is usually commensurate with the complexity of the decisions being made. Delays are usually to allow greater opportunity for consultation.

  17.  Speed of guidance is often as much compromised by filibustering techniques by drug manufacturers as delay attributable to NICE's processes.

  18.  Concerning the time taken to produce the systematic reviews and health economic models, these are produced much more quickly than would normally be achieved if the same summaries of research were produced in normal academic practice where contracts would usually be between one and two years. In the NICE process, the usual period to produce the technology appraisal is six months.

  19.  Recently NICE has tried to streamline procedures in the Single Technology Appraisal (STA) process. Experience with this is still limited so it is unclear whether it will actually achieve quicker guidance, especially where a negative decision is made by NICE.

  20.  There is also concern that time saved by not having an independent academic report on effectiveness and cost-effectiveness may lead to important issues being overlooked in the appraisal process. Again only greater experience with the new STA process will allow an accurate assessment of this to be made.

The appeal system

  21.  I have attended appeal hearings on three topics. In all cases the process appeared to me to be on balance fair.

  22.  The unlimited resources which appellants can invest in preparation for the appeals procedure more than outweighs any possible bias in the way the procedures are organised and conducted.

Comparison with the work of the Scottish Intercollegiate Guidelines Network (SIGN)?

  23.  This is a highly respected system of developing clinical guidelines in Scotland.

  24.  However, as indicated in B3, comparing the work of SIGN with the component of NICE's advice which attracts most criticism, the Technology Appraisal component, is inappropriate.

  25.  SIGN would most reasonably be compared with the Clinical Guidelines produced by NICE, which rarely attract adverse comments, and would thus externally be judged to perform to the same high standard as SIGN

  26.  As a corollary, it should be noted that SIGN to do not sanction use of specific new technologies or not, nor do the SIGN guidelines make any recommendations based on information about value for money—are the costs of the new technology justified relative to the demonstrable health benefits?

Implementation of NICE guidance

  27.  A key problem with implementation is that specific funds are not made available to match each decision. A favourable decision to make a technology available must be funded by diverting resources from another area of health care. This will inevitably lead to variation in the extent and speed with which a new recommendation is implemented in different PCTs depending on the amount of flexibility in the health budget in a given locality at a given point in time

  28.  Support at a local level to explain and educate about the nature of the decisions made by NICE may improve implementation. This is for the same reasons the patient groups may struggle to understand the evidence considered by the NICE appraisal process (see 14).

  29.  However, given sufficient support I believe it is possible for non-experts to understand the key features of the arguments which lead NICE to concluding that some new technologies may be considered cost-effective and others not.

C.  RECOMMENDATIONS

  30.  The success of NICE should not be judged by its popularity.

  31.  Generally it performs its functions well and it should continue to be strongly supported.

  32.  However, there should be more resources to explain the nature of the evidence to patients, the public and health care workers both during the NICE process and as part of the dissemination of the decisions.

Dr Chris Hyde

March 2007





 
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