Select Committee on Health Minutes of Evidence

Memorandum by Professor David B Barnett, Chairman, Appraisals Committee NICE (NC 9)


  I have been the chairman of the appraisals committee for NICE since its inception in April 1999. I am also an academic Clinical Pharmacologist and Honorary Consultant Physician with a special interest in cardiovascular disease. Since taking on the role as chairman I have found the work both fascinating and challenging. The workload has increased dramatically over the last 2 years and has exceeded the initial expectations by many fold. This is in part due to the increasing complexity of the technology appraisals themselves but also due to the steep and continuous learning curve for the committee regarding the appraisal process itself. This submission addresses a number of issues of general importance regarding specifically the technology appraisals programme from my perspective as chairman of the appraisals committee and following many discussions with committee members.

  1.  The technology appraisals process is unique worldwide. It is obvious to all those involved that the guidance produced is scrutinised, discussed and for the most part respected internationally. This is particularly for the following reasons:

  (a)  The transparency of the process both in its written documentation and the nature of its full, open and wide consultations during the development of the guidance.

  (b)The bringing together of issues of both clinical and cost effectiveness which are not addressed in this way by HTA programmes elsewhere in the world. Frequently cost effectiveness issues are not even referred to in the national decision making processes of other health care systems

  (c)  The direct feeding of the results of deliberations of the committee into health care policy decision making

  (d)  The Committee is dedicated to produce guidance that is in the interests of the NHS users as a whole. They must therefore take account of the needs of both the patients for whom a particular technology is directed as well as those who may be disadvantaged if decisions result in directing limited funds away from other health care areas

  2.  The involvement of the wide spectrum of "stakeholders" in the production of guidance adds immeasurably to both its credibility and long-term acceptability. This is particularly notable in the involvement of professionals and patient and carer organisations as expert "witnesses" both in writing and verbally in person for the committee meetings.

  Frequently the evidence base available for the appraisal is limited to little more than that which is used for licensing purposes and the important issues of clinical and cost effectiveness in real life practice have not been investigated sufficiently. In particular the evidence base usually does not fully capture the patient experience. The health care professional and patient/carer view is essential to help fill this evidence gap.

  However, often the patient perspective has not been, to date, given the credence it should and may seem to be disadvantaged relative to the weight of scientific, clinical and health economic data provided from other sources. This is an area, which has progressively been taken up by the committee and the NICE executive and is to be addressed more fully within future revisions of the process. This will be helped by the planned development of a more all encompassing Patient Impact Assessment document which will hope to draw together the rather disparate and poorly focussed patient/carer submissions we have had to date and will run alongside the academic HTA report.

  In addition the process for selection of experts (professional and patients) to help with the committee deliberations although transparent is still an area for concern and requires further improvements to ensure confidence of all stakeholders. These issues are presently being addressed.

  3.  The process of selection of topics for appraisals has been a cause of concern. For the most part the topics selected have been pharmaceuticals. Although this reflects the major input of health technology in the NHS it is not necessarily a reflection of those aspects of health care that matter most to patients.

  The selection of topics also needs to be more transparent and to reflect ownership by the NHS as a whole. A devolvement of the procedure for selection of topics to be appraised to NICE itself would enhance public and professional confidence in the process.

  4.  The timing of appraisals is critical. This is particularly an issue with new drugs. Too early in the drug's development and the evidence for clinical and cost effectiveness on which the appraisal is made may be sparse. However leaving the appraisal until some time after launch of the drug may lead to difficulties with entrenched professional and patient attitudes towards the clinical experience with the drug, which are anecdotal and yet frequently substantially outweigh the published evidence base that exists.

  A balance must be struck between these two and will require the development of a research approach by the pharmaceutical industry which provides early evidence of the drugs effectiveness that is of use to the NICE appraisals process. In particular issues of quality of life for patients and careful assessments of cost effectiveness are often overlooked in the rush to license and market new drugs.

  5.  Finally with regard to ownership by the NHS it is essential that the technology guidance is seen to be sensible, practical and capable of implementation. The committee whilst not directly concerned with affordability, has increasingly addressed issues of implementation. The nature of resources (financial and human) that are required for training and development of staff as well as practical aspects of the workload concerns for health care professionals that would need to change in order to effectively implement a recommended technology are examples of these issues.

  These matters are not directly relevant to the appraisal of the clinical effectiveness of a technology but are of significance in helping to create the necessary confidence in the guidance from professionals and patients.

  This should in time ensure that although the guidance may not always be agreeable to all involved it will become acceptable as a gold standard in the NHS because of the robustness and openness of the process of its development.

  It has been a privilege to be involved in the development of the NICE appraisals process and represents for me and I believe for all of my colleagues on the Committee a real chance to place quality and equity at the forefront of the NHS agenda.

  NICE and the technology appraisals programme have begun well and continues to develop. I believe that it is welcomed by all health care professionals who would wish to see it succeed.

3 January 2002

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