APPENDIX 27
Memorandum by Aventis Pharma Ltd (NC 122)
Aventis Pharma Ltd is the UK pharmaceutical
company of Aventis SA. Aventis Pharma is dedicated to treating
and preventing human disease through the discovery, development,
manufacture and sale of innovative pharmaceutical products aimed
at satisfying unmet medical needs. Aventis Pharma focuses on important
therapeutic areas such as cardiology, oncology, infectious diseases,
arthritis, allergies and respiratory disorders, diabetes and the
central nervous system disorders. Aventis Pharma has its corporate
headquarters in Frankfurt, Germany.
Aventis Pharma Ltd has had wide experience of
NICE. Six of our products have been the subject of eight technology
appraisals by NICE. A further five evaluations by the Institute
are in progress.
We welcome the opportunity to submit the following
evidence and our suggestions for improvement of the processes
of NICE to the Select Committee for consideration. Should the
Committee want additional clarification or expansion of any point
raised in this submission please contact Dr Anna Sorman, Head
of Government Affairs.
This submission is structured as requested in
the Guide to Submitting Evidence, dated 23 November 2001. In order
to further help the Committee, our recommendations are presented
after each point to which they refer and collectively below.
1. CRITERIA FOR
ASSESSMENT
1.1 The Institute, in concert with interested
parties, should develop and publish a clear set of criteria for
both the clinical and the health economic dimensions of assessment
for each specific type of technology or therapy area prior to
its assessment.
1.2 There should be an open consultation
process between stakeholders and the Institute to agree the relevant
criteria to use for a specific technology assessment.
2. PROCESS DURATION
2.1 A clear and short timeline is needed
for each assessment marked with clear milestone events. We contend
that this should be no longer than 180 days, with the provision
for "clock-stop" periods if necessary.
2.2 We recommend that in the long run, the
Institute should resource itself adequately in order to be able
to conduct its own appraisals rather than commission third-party
organisations of varying quality.
2.3 In the short run, and if it is also
necessary in the long run for the Institute to continue to use
third-party assessment organisations, they should use the same
organisations to assess similar technologies. We contend that
this will improve self-learning by NICE and its third-party contractors
with benefits accruing to the quality of assessment and hopefully
the speed as well.
2.4 A mechanism for the provision of interim
guidance needs to be established to ensure that patients are not
denied access to treatments that they and their doctors consider
of benefit when the Institute has been either tardy or negligent
or both.
3. TRANSPARENCY
OF APPRAISAL
COMMITTEE DATA
USE AND
DECISION MAKING
3.1 Introduce a consultative mechanism for
stakeholders to be able to address the Appraisal Committee in
the early stage of their work and after the first draft of the
Appraisal Determination has been issued.
3.2 Introduce a mechanism for the Appraisal
Committee to explain its decisions by publishing the reasons for
decisions and inviting oral questions with answers, in public,
as part of the consultation process.
4. THE DEPTH
AND BREADTH
OF EXPERT
OPINION AVAILABLE
TO THE
APPRAISAL COMMITTEE
4.1 Publish the list of expert opinion that
the Appraisal Committee will refer to prior to the start of the
appraisal of the data and submissions by the Committee; inviting
additions and challenges to the experts selected.
4.2 As the Institute clears its backlog
of appraisals it will increasingly appraise cutting edge technologies.
Expert opinion should not be limited to UK experts but include
experts irrespective of their place of abode or clinical or scientific
practice.
4.3 The breadth and depth of expert view
should not be arbitrarily limited by number of experts but only
be limited by predefined scope of opinion required to achieve
a sound decision.
5. INDEPENDENT
APPEALS PROCESS
5.1 Establish an appeals process for Final
Appraisal Determinations and NICE Guidance that is independent
of the NICE executive.
5.2 Appeals should be possible on the merits
and substance of the decision and not limited to Wednesbury unreasonable:
"perverse".
6. CLARIFY THAT
THE OUTPUT
OF NICE IS
GUIDANCE NOT
DICTUM
6.1 A clear footnote must be written into
all published guidance setting out that the document is only guidance
and that no patient should be disadvantaged by this guidance if
sound clinical reasons for deviating from it can be made by their
attending physician.
6.2 The nature of the content and process
to establish reasonable justification for using a treatment that
is not the subject of positive NICE guidance should not be so
onerous as to act as an effective barrier to the patient receiving
the treatment.
| 
