The Royal College of Physicians of Edinburgh is pleased to respond to the House of Commons Health Committee on its Inquiry on the National Institute for Health and Clinical Excellence (NICE).

Why NICE's decisions are increasingly being challenged

  The College understands the perception that NICE's decisions are being challenged, but questions whether this is evidence based. Clearly, there has been considerable media attention to the decisions taken by NICE, and some recent concerns from patient support groups and the pharmaceutical industry eg drugs for Alzheimer's disease and multiple sclerosis. Such dissent may arise from concern about the fact that NICE generally takes an NHS perspective, and so is not able to take into account necessarily all the potential benefits that may come from an intervention, such as those to carers and associated with getting patients back to work.

  Another concern, not now so often expressed, is that because NICE has its work programme defined by the Department of Health and the Welsh Assembly, it is influenced significantly by government. Health economists are core members of the NICE guideline development groups and cost effectiveness analysis is always undertaken, using the available economic data irrespective of quality. This may feed the view that NICE is there to ration healthcare rather than to evaluate the clinical effectiveness of healthcare interventions and comment on the resource implications.

  NICE appraisals are carried out by methodologists, whose conclusions are reviewed or supported by healthcare professionals. This, coupled with concerns about the applicability of cost effectiveness data, may reinforce a perception that NICE decisions can be influenced unduly by government or special interest groups.

  Over the years that NICE has been in operation, there has been a view that the organisation does not always interact constructively with the pharmaceutical industry, and certainly NICE keeps the industry very much at arm's length. This difficult relationship may have led to some of the criticism from industry. In addition, there has been concern from industry, and more recently by some well-informed patient support groups, that the Health Technology Appraisal (HTA) process, and the models used, are not completely transparent and are not open to external scrutiny.

  Finally, high profile successful challenges, based on what may appear to be minimal additional evidence, will encourage more to follow the same path, as will a growing understanding of NICE methodologies.

Whether public confidence in the issue is waning and, if so, why?

  It is not clear that public confidence is waning, although the high profile media response to certain decisions might sway opinion. It is clear that there are some concerns about the delay with which decisions are arrived at by NICE on important new drugs. One reason for the delay is that the Department of Health sets the agenda, and usually only does this some time after a new drug is licensed. In addition, the process at NICE for Health Technology Assessment takes over 12 months to complete, which means that decisions at NICE on new drugs often come in anywhere between 18 months and four to five years after decisions are made on similar medicines in Scotland by the Scottish Medicines Consortium (SMC). The media attention to such delays may have stimulated the recent creation of the rapid appraisal process at NICE called NICE Single Technology Assessment (STA).

  Another concern about NICE is that its decisions, though intended to be binding in England and Wales, are not always well implemented and there are continuing allegations of a "postcode lottery" for some treatments. Whatever the extent to which these concerns are real, there is little doubt that they have been substantially amplified by the media.

NICE's evaluation process, and whether any particular groups are disadvantaged by the process

  The process of NICE guidance is delivered from an NHS perspective, and primarily focuses on NHS costs. In this regard, there has no doubt been a concern that additional societal costs may not have been taken into account and, in particular, the costs associated with unemployment, the reduction in quality of life that may occur for other family members of someone with a severe illness, and the burden or carers or social services. Clearly, these issues are important in Alzheimer's disease and multiple sclerosis and have been a major focus of attention.

  There has been a concern expressed that those who are older, where the ability to gain long-term QALYs is more difficult, may have been disadvantaged. However, this is denied by NICE and there is no clear evidence of age discrimination. Others have argued that those with substantially life-threatening conditions, such as cancer and heart failure, may gain a particular benefit from even short periods of additional life. An additional three months of life to somebody who is likely to live 10 or more years may be very different from an additional three months of life for somebody who has only three months to live. There is a concern that QALYs do not adequately capture the benefit of medicines that extend life under these circumstances.

  The process itself can introduce an unintended but nonetheless systematic bias towards treatment in areas where there are existing funds available to demonstrate effectiveness (eg a new drug) at the expense of other areas for which there is little evidence. Similarly, conditions with a small number of patients may be disadvantaged as NICE gives priority to common diseases.

The speed of publishing guidance

  As explained above, NICE MTA is a slow process that usually only begins after a drug is licensed and runs for a period of at least 12 months, even if there are no appeals against the decision. This delay, sometimes called "NICE blight", is a well recognised problem in England and Wales that has been less of a problem in Scotland since the creation of the Scottish Medicines Consortium (SMC). The comparison between SMC and NICE has shown the latter in a bad light, and has attracted significant media attention. Indeed, the pressure has become so great on NICE in relation to cancer drugs that NICE has introduced a new process called NICE Single Technology Assessment (STA) to allow decisions to be made earlier. So far, this has only produced a relatively small number of outputs and it is not clear yet whether this new development, very much modelled on the SMC approach, will deliver the early decisions that are needed.

  The quality of Health Technology Appraisal at NICE is unquestionable, and has been recognised in the recent OFT Market Report on the Pharmaceutical Price Regulation Scheme (PPRS), as has the quality of work by SMC. It is clear that the early appraisal process is an important model for the future. Later appraisal of multiple technologies for a single disease offers a complementary approach to reviewing the treatment of a disease area at a time that a substantially larger evidence base is available, some time after drug licensing when more clinical trials have been published, and both clinical and cost-effectiveness are likely to be clearer.

The appeal system

  The appeal system is attractive for its transparency and inclusiveness, but extends the process substantially and therefore means that decisions are delayed. Also, and as stated above, it appears that decisions can be overturned on appeal with minimal additional evidence. It would seem that the appeal system may not be fit for purpose and could be telescoped in some way to the benefit of all parties.

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

  It is interesting that the Health Committee draws particular comparison with SIGN, given that most public disquiet has been in comparison to the work of the Scottish Medicines Consortium (SMC) in relation to Health Technology Appraisal. This College (Royal College of Physicians of Edinburgh) created the SIGN network and continues to support its work following the transfer of the Executive staff to NHS Quality Improvement.

  There are benefits to both systems. NICE clinical guidelines have been more willing to include assessment of both clinical effectiveness and cost effectiveness, and identify those treatments which provide good value for money. An example would be the NICE clinical guideline on hypertension, prepared with the British Hypertension Society, which gives a clear view on both clinical effectiveness and the cost effectiveness of different hypertension treatments and the order in which they should be introduced to achieve best value for money. However, the College understands that NICE Collaborating Centres work to their own rules and methodologies, which can be confusing for clinicians. Also, NICE does not have a robust method for ensuring all relevant stakeholders are engaged in guideline development and this may influence public and professional confidence.

  SIGN focuses on clinical effectiveness and involves healthcare professionals fully in the development process, whether as members of the guideline development or participants in national meetings before the guidelines are completed. SIGN's programme of work is selected according to clinical priorities and the availability of evidence and agreed with the Health Department. This builds professional and public confidence in the resulting guidelines and assists implementation.

  NICE documents can be unwieldy and difficult to digest where SIGN documents are succinct and supported by quick reference guides for clinicians. However, there is significant overlap in the work of both and the College would be keen to see continuing collaboration over such issues as topic selection or sharing evidence

The implementation of NICE guidance, both technology appraisals and clinical guidelines (which guidance is acted on, which is not and the reasons for this)

  Health Technology Appraisals from NICE are mandatory within the NHS in England and Wales, whereas the clinical guidelines are not. On this basis, the clinical guidelines provide helpful advice whereas Health Technology Appraisal should dictate treatment. One would expect that NICE Health Technology Appraisal would be better implemented than the clinical guidelines, though both are generated with the intention of improving patient treatment. The College is unable to comment of the effectiveness of implementation of NICE appraisals and guidelines. An important next step would be an audit of implementation of NICE guidance to provide the evidence on which to base any decision about how effective such guidance has been in moulding the behaviour of the NHS in England and Wales and their impact on clinical outcomes.

  Guidelines perhaps provide a more significant implementation challenge, as they are designed to support clinical decision taking and there are often several competing (and sometimes conflicting) guidelines available to doctors and patients.

Royal College of Physicians of Edinburgh

March 2007