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