Memorandum by GlaxoSmithKline (NC 120)
EXECUTIVE SUMMARY
GSK strongly endorses the goals of NICE in promoting
faster and more equitable access to modern treatments and the
need to address postcode prescribing.
GSK agrees that NICE can play an important role
in achieving these goals. NICE has provided a mechanism to appraise
the value of new and existing technologies within the NHS, and
hence provided a potentially clear central focus for decision
making. However it does not, and should not have a role in assessing
the affordability of technologies, which is a matter for Government.
Individual Primary Care Groups (PCG's) and Trusts
(PCT's) are still making judgements regarding the implementation
of NICE guidance. This has lead to clear variations in implementation
throughout the country and suggests that NICE has not yet achieved
one of its main objectives. GSK trusts that this may be improved
by the recent Government announcement to direct the implementation
of NICE guidance. However it must be ensured that appropriate
levels of funds are made available for implementation. Until then
we reserve judgement. We are also concerned with the potential
impact of this direction, as funds may be diverted from those
areas not reviewed by NICE to fund the implementation of NICE
guidance. This makes it critically important to review the process
for the selection of products for appraisal.
Since its inception NICE has worked with its
stakeholders, including industry, to improve its processes. Some
improvements have been made to these evolutionary processes although
they are still not applied entirely consistently or reliably.
GSK believes it is important to continue to drive for change and
monitor improvement. GSK encourages and supports further development
in the field of clinical guidelines, which although in its infancy,
has the potential to achieve more equitable access for patients
to treatments in the NHS.
GSK has committed considerable resource to providing
the relevant evidence in the full appraisals that the company
has been directly involved in, working in partnership with NICE
and the assessment teams to reach final guidance. As the experience
of all parties involved has increased this process has become
somewhat easier. However we are concerned that on occasions final
guidance has still lacked clarity. We would welcome improvements
in this area.
GSK hopes that there would be a full debate
before any decision is made to make NICE completely independent.
It is vital that Ministers are accountable to the public for decisions
that NICE makes and therefore we would suggest that it is appropriate
that NICE continues to report to the Department of Health.
1. INTRODUCTION
TO GLAXOSMITHKLINE
1.1 GlaxoSmithKline (GSK), is one of the
world's leading research-based pharmaceutical and healthcare companies,
and is committed to improving the quality of human life by enabling
people to do more, feel better and live longer. GlaxoSmithKline
is proud to be a UK-Headquartered company employing over 100,000
people across the world and approximately 25,000 in the UK. GSK
annually invests £2.5 billion in Research and Development,
over 40 per cent in the UK alone, at the cutting edge of pharmaceutical
discovery in order to bring new medicines to patients across an
extensive portfolio of disease areas, including those of the developing
world. GSK takes its corporate social responsibilities very seriously
and our programme supports scientific education, medical research,
healthcare charities, and the environment with donations totalling
over £5 million in the UK alone.
1.2 GSK has been involved in six full NICE
health technology appraisals, of which four are complete and two
approaching completion. GSK is also a stakeholder in the development
of six NICE guidelines. In addition, GSK has regularly submitted
opinion into the consultation process on a number of NICE processes
including guidelines for manufacturers and sponsors, processes
for development of NICE appraisals and guidelines and contributed
to ABPI positions on NICE.
2. IS NICE PROVIDING
CLEAR AND
CREDIBLE GUIDANCE?
2.1 GSK has been involved in four full appraisals
of our products to date. In all cases we have committed considerable
resource to providing the relevant evidence, and to working with
NICE and the Assessment teams to reach final guidance. As experience
of all parties involved has increased the process has become somewhat
easier. However it has been more problematic in specialist areas
such as cancer and reflects the critical importance of incorporating
appropriate clinical expertise in evidence assessment and the
appraisal process.
2.2 Since its inception NICE has worked
with its stakeholders to review and improve its processes. Although
they are still not applied entirely consistently or reliably,
improvements have been made and these should be acknowledged.
GSK is pleased to have had the opportunity to input into these
developments and would welcome continued involvement, as it is
important to continue to monitor progress and make further improvements.
2.3 GSK considers that issues still remain
with the wording of guidance, which can lack clarity. For example
with Avandia for the treatment of diabetes, we have anecdotal
evidence that the wording is unclear and this may be a contributing
factor to the variable uptake of this medicine across England
and Wales (see graph below). We would therefore welcome improvements
in this area.
3. HAS NICE ENDED
CONFUSION BY
PROVIDING A
SINGLE NATIONAL
FOCUS?
3.1 NICE has made considerable progress
towards this aim as it has provided a mechanism to make decisions
which, whether they are agreed with or not, previously did not
exist. However, individual primary care groups (PCG's) and trusts
(PCT's) are still making judgements regarding whether or not to
implement NICE guidance, and in some cases have re-reviewed the
evidence at a local level. This constitutes a clear duplication
of activity, and reduces the impact of NICE as a single national
focus.
3.2 GSK trusts that the recent Government
announcement to direct PCG's and PCTs to implement NICE guidance
may avoid this activity. However we reserve judgement until we
have witnessed the practical application.
4. IS NICE PROVIDING
GUIDANCE THAT
IS LOCALLY
OWNED AND
ACTED ON
IN THE
RIGHT WAY?
4.1 Individual decisions are still being
made locally. The Avandia data above demonstrates unacceptably
large differences in prescribing across PCG/T's and although we
accept that there might be other reasons for these differences
it would indicate that guidance is not being implemented in a
consistent way across England and Wales. As stated previously,
this may change when implementation of NICE guidance is compulsory.
5. IS NICE ACTIVELY
PROMOTING INTERVENTIONS
WITH GOOD
EVIDENCE OF
CLINICAL AND
COST-EFFECTIVENESS
SO THAT
PATIENTS HAVE
FASTER ACCESS
TO TREATMENTS
KNOWN TO
WORK?
5.1 NICE has made decisions on how and when
treatments are to be used based on evidence of clinical and cost
effectiveness to which NICE applies its own criteria. However
we have had concerns about the variable quality of some of the
evidence assessments and their utilisation of evidence provided
by stakeholders, particularly with regards to health economics,
and trust that the recently revised guidelines will improve consistency.
It is also important to note that the guidance is in the context
of use within the NHS and therefore cannot be transferred to other
health care systems.
5.2 NICE has only made decisions on some
technologies. Therefore other technologies which may be less effective
may continue to be used simply because they have not been considered.
Alternatively, funds may be diverted away from treatments which
would be clinically and cost-effective simply because NICE has
not had the opportunity to assess them. GSK believes that either
outcome is far from ideal and will result in NICE failing to meet
its overall objectives.
5.3 The current process of selection is
lacking in transparency. The membership of the Technology Advisory
Group (TAG) that advises Ministers on which technologies to review
lacks clarity. It is also unclear why some products are reviewed
as appraisals, whereas others are only looked at as part of guidelines.
Although broad categories are provided as the basis for selection
it is not clear why individual products are reviewed and others
not. Given the importance of NICE guidance to an individual product
in a cash limited environment where PCG/Ts are obligated to implement
NICE guidance, and the problems of planning for the considerable
work involved in preparing a submission to NICE, we would recommend
that improvements are made to the selection process. This could
involve broadening and publicising the membership of TAG with
full consideration of the benefits of industry representation;
full disclosure of the minutes of TAG meetings; the listing of
products being considered with reasons for inclusion or exclusion
made public, and publication of clear timelines for the process.
5.4 GSK does not have any specific evidence
about NICE guidance providing faster access. However there is
a potential conflict between the availability of good evidence
and faster access. At launch it is unlikely that all the evidence
would be available. However if an appraisal is delayed then there
is a danger that patients will be denied that technology at a
local level until NICE guidance is available (the concept of "blight").
One way around this is to have a transparent discussion about
the optimum time for a review that is likely to vary depending
on the technology and the disease area involved. If an appraisal
at launch is identified by all parties as being the best approach
then it is important that the appraisal committee has a realistic
expectation of the evidence that is likely to be available, and
should not limit access to new technologies inappropriately.
5.5 GSK believes that it is disingenuous
to continue to assert that NICE allows patients to have faster
access to treatments known to work. By its own admission, in the
much-publicised beta-interferon decision, NICE is rejecting treatments
that have clinical benefit but are not deemed to be sufficiently
cost effective. It is critical that this point is made clear to
patients and the general public. NICE should not be used to disguise
political decisions. GSK would like the Committee to consider
recommending to the Government to engage more fully with the electorate
in order to ensure that patients are clear on the choices that
are being made on their behalf. This would enable healthcare funding
judgements to more accurately reflect the choices of society.
6. HOW INDEPENDENT
IS NICE?
6.1 GSK is confident that if the suggested
changes outlined in this submission were to be adopted by the
Government it would create a more transparent process and improvements
in the selection process.
6.2 GSK suggests that there should be a
full debate before making NICE completely independent. It is vital
that Ministers are accountable to the public for decisions that
NICE makes and therefore we would suggest that it is appropriate
that NICE continues to report to the Department of Health. In
addition we support NICE's own view that to remove it from the
NHS is only likely to distance it further from the end user.
January 2002
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