RESPONSES TO THE QUESTIONS RAISED BY THE
HEALTH SELECT COMMITTEE
1. IS NICE PROVIDING
1.1 ABPI believes that the majority of NICE
guidance should take the form of best practice guidelines on the
overall treatment of clinical conditions; where guidance on individual
technologies is issued, this should only be given when there is
mature evidence upon which to base reliable conclusions.
1.2 ABPI recognises that the NHS needs information
on new medicines at launch. The National Prescribing Centre provides
high-quality, objective information on new medicines and we would
recommend this as a model. Information (rather than guidance)
at launch should include the licensed indications, the summary
of product characteristics, a summary of the available evidence,
the product's proposed position in treatment, and an estimate
of budget impact based upon licensed use and clinical practice.
1.3 New medicines (ie those that have been
launched within the last two years) constitute only 0.3
per cent of the total NHS budget. The approach above does not
run counter to the DH's need to manage NHS resources effectively,
and offers the benefits of improved evidence and greater confidence
in the quality of NICE guidance when it is ultimately given.
2. HAS NICE ENDED
2.1 Historically, the NHS has had the option
to choose guidance from a wide variety of sources, and in many
cases NHS organisations have developed their own guidance. There
is little evidence that this situation has changed: local committees
still exist at many levels, and if anything, with the advent of
PCOs, the number of bodies used to filter national, or develop
local, guidance has increased. NICE guidance is also being interpreted
differently in different locations. There is still, therefore,
considerable variation in clinical practice on the ground.
2.2 NICE itself has "double vision"
in examining technology appraisals and clinical guidelines. Completely
different experts are used for each process, and guidelines groups
are not allowed to comment on draft guidance issued for technology
appraisals. Quoting specific examples, the scope of the clinical
guideline for multiple sclerosis, which is under development,
does not include reference to any disease modifying therapies,
and is focused only on palliative care. Another example is the
scope of the clinical guideline for falls, which does not include
treatments that prevent or treat osteoporotic fractures, a major
cause of disability in the elderly.
2.3 There remains room for improvement in
coordination between the creation of NICE clinical guidelines
and the broader issues considered by such policy areas as National
Service Frameworks (NSFs). For example, Standard 6 of the NSF
for Older People covers both falls and fractures as priority areas
of clinical need to reduce visits to Accident & Emergency
Departments. The scope of the NICE guideline for falls excludes
any consideration of fractures. Achieving cohesion is a challenging
task, and illustrates the complexity and difficulty in getting
the scoping right for NICE's technology appraisals and clinical
3. Is NICE providing guidance that is locally
owned and acted on in the right way?
3.1 As stated earlier, even once NICE guidance
is issued, implementation is poor. ABPI has undertaken a detailed
analysis of uptake of medicines appraised by NICE, and Annex 2
to this document gives some extracts from this work. The work
There are still wide variations in
uptake of medicines that have been appraised by NICE: postcode
prescribing still persists.
Increases in uptake have rarely resulted
from NICE guidance.
The Annex quantifies the continuing
problem of low uptake by the NHS by analysing expenditure on medicines
for which NICE guidance up to October 2000 had been available
for a full year. NICE's own estimates of increased uptake in its
guidance predicted a total annual addition of £93 million.
This figure compares with an actual increased uptake of, at most,
£32 million, ie only a third. There is also evidence that
predicted savings accruing from NICE decisions have not been realised.
3.2 The Government's recent announcement
requiring HAs and PCOs to fund NICE recommendations is implicit
confirmation that they not currently being implemented satisfactorily.
While we very much welcome this move as a step in the right direction,
we would contend that additional sufficient funding needs to be
made available to enable such compliance.
4. IS NICE ACTIVELY
Annex 3 shows that many patients are still failing
to benefit from faster access. Measures to promote and fund best
practice through the issuing of NICE guidance are not yet sufficient
to the task.
5. THE INDEPENDENCE
5.1 NICE's work programme is decided by
Ministers. NICE has developed its structure and processes in a
concerted attempt to involve a broad range of stakeholders who
can give a broad perspective on its activities. Perceptions prevail
among many stakeholders that NICE is not independent of Ministerial
intervention, and is not yet perceived as a genuine force for
improving the quality of NHS care rather than as a tool to control
5.2 Currently, NICE is a Special Health
Authority and is constituted to receive directions from Ministers
on technologies subject to review. The process for appointments
to NICE bodies is with the agreement of Ministers. ABPI believes
that NICE has the best opportunity to achieve its objectives if
it remains part of the NHS family. However, we also believe that
whilst it should remain linked to the DH, it should be independent
of Ministers in the conduct of its technology appraisals and its
development of guidance and guidelines.
5.3 NICE is an organisation that has the
potential to have significant effects on patients, clinicians,
the health of the nation, and on the industries that provide new
solutions to unmet clinical need. It is important therefore that
it be publicly accountable for its activities and the impact these
have on the quality of NHS care and on its stakeholders.
5.4 The objectives of NICE are not yet being
met. The future status of NICE is under some discussion; currently
as a Special Health Authority it is subject to quinquennial review.
Our concern is that such a review process is inadequate in view
of NICE's state of evolution and essential role in the setting
of standards and improving NHS care, and we support a two yearly
review by an independent body.