Memorandum by Professor Tom Walley (NC
1. I should like to point out to the Committee
my particular standpoint in preparing this Memorandum of Evidence.
These are as follows:
(a) I am an academic with a longstanding
interest in prescribing issues, both in primary and secondary
care: in clinical effectiveness and cost-effectiveness: and policy
matters related to the provision and use of medicines. I have
also carried out some personal research into the influences of
NICE within the past six months.
(b) I work extensively in educational matters
with prescribing advisers at health authority, primary care trust
and practice level and am therefore aware of issues they face.
(c) I am the leader of one of the units which
is contracted through the National Co-ordinating Centre for Health
Technology Assessments to provide technology assessment reviews
on which NICE will in part base its appraisals of new technologies.
(d) I am Chairman of a hospital Drugs and
Therapeutics Committee and therefore have responsibility both
in my own hospital and more widely through local health authority
and PCT committees to support the implementation of NICE guidance.
(e) I am a consultant physician and prescriber,
and therefore have personal responsibility to implement NICE guidance
in relation to my own patients.
2. I will confine myself to considering
aspects of the appraisal of new technologies undertaken by NICE
and the guidance that results from them, and will take the perspective
of the NHS. I will not consider guidelines or some of the other
aspects of NICE's activities.
3. I fully support the principals set out
in a First Class Service for the activities of NICE. The
NHS requires clear and credible guidance: the existence of "postcode
prescribing" was divisive and inappropriate: the NHS needs
to take on board those technologies which represent a true clinical
advance and which are cost effective by comparisons with other
available treatments, as quickly as possible. Conversely the NHS
needs to specifically prevent the uptake of technologies which
do not meet these criteria, ie not merely ineffective therapies
(which are surely rare) but less effective therapies. Such decisions
should be taken at a national level so as to ensure equity of
access across the NHS.
4. There are a number of issues to be considered
in relation to NICEI will group these under two broad headings,
of Principles and of Practice.
5. It should be realised that there may
be contradictions inherent in some of these criteria: for instance
it may be that a new therapy is uniquely effective but constitutes
very poor value for money, i.e. a conflict between effectiveness
and cost effectiveness. Whether it should be funded is therefore
a matter for judgement or appraisal, to include the financial,
social, ethical and legal implications of its use or non-use.
The rules or values for such appraisal are not clear. We require
open debate about how we value such trade-offs. An example is
beta interferon for multiple sclerosis.
6. It is said to be essential that such
a body undertaking this work should be independent of government.
However, this can never be entirely the case, since NICE must
consider resources available to the NHS and the possible alternative
use of those resources, in making its appraisals. It is not clear
to what extent the resources or their alternative uses are considered.
7. The extent of resources available to
the NHS is a political decision, outside the remit of NICE. Prof
Rawlins stated in Feb 2001 (BMJ 2001; 322:489) that with regard
to guidance from the ministers on resources "the institute
has not yet received any such guidance". If so, it seems
to me that the government has abrogated its key role in deciding
NHS priorities and has delegated its role in NHS rationing, or
has decided that the NHS can have unlimited resources and that
rationing is unnecessary. The recent directive from the Dept of
Health to health authorities and PCTs on making resources available
to meet NICE guidance suggests that use of NHS resources should
be directed by NICE. This needs to be made explicit. It also effectively
converts NICE guidance into mandates for the NHS.
8. Rationing carries unpleasant connotations
of reduction in services. However, to my mind this is a misuse
of the term which should instead imply the best use of limited
resources to ensure adequate and equitable care for a population.
This limitation of resources and the need to use them to best
advantage is inevitable in any health service where the technical
abilities go beyond the financial resources available to deliver
them. Only in a health service with limitless access to funds
can health care not be rationed.
9. If NICE is the priority setter, then
we must consider how wide a view NICE takes in coming to its decisions.
For instance in considering a drug such as sibutramine, has NICE
considered whether NHS resources might be better spent in providing
better dietetic advice? If it has only considered sibutramine
and its effectiveness in isolation, then it allows itself to be
driven by the technology and the submissions of the manufacturers
rather than taking a broader view of the needs of the NHS.
10. Does NICE advice carry with it added
resources to the NHS, or as seems to be the case, redistribution
of existing resources? If this latter is the case, then all possible
alternative uses of the resources need to be considered and a
review confined to a single therapeutic area or technology is
inadequate. A broader approach is necessary, to cover a wide range
of, or even all NHS activities.
11. These issues of principle need clarification.
12. There have been many practical problems
with the work of NICE, which I believe have limited its effectiveness.
13. The timing of NICE guidance. Some NICE
guidance has tended to come too late to be of true practical value,
not being available at the time of the launch of a technology.
This will improve with time, but will remain a problem to some
extent, particularly when NICE processes become more involved
and requirements for evidence seem to increase.
14. There has to date been no ring fenced
funding for the implementation of NICE guidance. This has led
to an inability or reluctance of health authorities to provide
the resources for NICE guidance implementation (which could seriously
disrupt other services). There has been a raising of patient expectations
which could not be fulfilled by the clinicians, eg in my own area,
around the lack of resources to fund alpha interferon and ribavirin
for hepatitis C patients. Recent government guidance might seem
to resolve this, but may in fact cause other problems, as outlined
15. An alternative is the approach suggested
by the Royal College of Physicians in 2000 in the document "The
Prescribing Of Costly Medicines" where is advocated that
there should be central funding for high cost medicines so as
to ensure equity of access across the country.
16. The requirement that health authorities/PCTs
will provide funding for NICE guidance removes local discretion
and should abolish postcode availability of treatments. However
it may only transfer the inequity from a visible technology to
other, less visible services; ie by requiring commissioners to
fund NICE guidance from the same pot as other services and with
a priority over other services. This may mean that there is for
instance more money available for an appraised drug therapy at
the expense of unappraised community nursing services.
17. This will also cause problems in planning
servicesa requirement to provide such funding within a
short space of time will either force commissioners to keep a
large contingency fund or will disrupt other services in year.
18. The funding of NICE priorities therefore
has an adverse effect on other services. If NICE priorities were
truly NHS priorities, this might be appropriate. There is a distinct
impression that some of the priorities of NICE as documented by
the issues in which they give guidance are more priorities for
perhaps their commercial sponsors than for the NHS. As an example,
consider the guidance on such agents as sibutramine or orlistat.
This is not to deny the importance of obesity to the NHS, but
how important is the supply of a drug therapy to treat it?
19. This may constitute a charter for the
producers of such technologies to direct NHS funding.
20. NICE processes are changing and evolving,
and this is to be expected. However, some of the changes are not
desirable. My impression is that the process has become excessively
adversarial and antagonistic with, on the one hand the industry
and sometimes patient pressure groups, and in the other a somewhat
beleaguered NICE. This has led to an increase in the amount of
documentation required for NICE appraisals and complexity in the
conduct of the appraisals, as the appraisals need to be legally
as well as medically robust.
21. This has been considerable pressure
on NICE to accept therapies that are, perhaps marginal, either
in their benefits or their importance to the NHS. The extent to
which NICE has given in to such pressure is unclear but some of
the loss of credibility described below is related to a perception
22. It is not clear to what extent NHS organisations
(eg primary care and zanamivir) are consulted about their ability
to deliver or appropriateness of NICE guidance at the time the
appraisal is undertaken. There is certainly no right of appeal
from within the NHS against NICE guidance in contrast to the rights
of appeal of the industry or of patient groups.
23. Some greater degree of transparency
in justifying the decisions it has made would be welcomed, but
one should be cautious about allowing excessive transparency before
this: it risks exposing NICE to inappropriate political or commercial
24. Another practical problem is the way
in which NICE guidance is read, with blurring of the important
detail. The guidance itself may be relatively restrictive, but
this is not how it is applied eg widespread use of Cox II inhibitors,
justified based on the basis of NICE advice, but which is in reality
contrary to the detail of this advice. Better means of implementing
the important detail are essentialcomputer decision support
in prescribing may be one such way.
25. NICE has some problems with credibility.
The reasons for this are:
(a) Some of the appraisals seem to be perverse
in light of the evidence available, for instance that recommending
glycoprotein IIb/IIIa inhibitors or the inclusion of such drugs
as meloxicam and etodolac in the guidance on cox II inhibitors.
(b) The reversal of the decision around zamanivir
without strong clinical evidence has been particularly damaging
to the credibility of NICE in the eyes of general practitioners.
Has this decision served the NHS, patients or the pharmaceutical
(c) The use of NICE as a marketing device
by some pharmaceutical companies.
(d) The apparent driving of NICE priorities
by commercial rather than NHS needs.
(e) The difficulties of the NHS to move fast
enough to deliver all of NICE guidance makes it seem remote from
NHS practice and leads to "guidance weariness".
(f) Concern about its perceived lack of independence
from government and uncertainty over the extent to which it should
be independent, as described above. There is an impression that
NICE guidance is the victim of "spin" by the governmentif
not in its content, then in its dissemination.
(g) Decisions made by the government have
not assisted NICE's credibility:
(i) the confusion over NICE's role and
the extent to which NICE should take the availability of resources
(ii) the recent proposed to make available
beta-interferon and other drugs for multiple sclerosis throughout
the country in a "trial" of dubious scientific value,
seems to be a means of bypassing NICE advice.
(iii) The Department of Health has decided
to fund imitanib for patients who participated in trials, now
that this drug is licensed. It is not due to be considered by
NICE for some months. In this particular case, the decision was
forced on the Department of Health by the rapidity of the licensing
process, which has taken NICE and the Department of Health by
surprise. However the external appearance is damaging and the
use in patients other than those in trials is expanding as a result.
Here was a case for an urgent appraisal.
26. The Committee will be aware that there
is currently a review of the implementation of NICE guidance underway
by the University of York but this is unlikely to be completed
for a further 18 months.
27. I strongly support the principles under
which NICE was founded. I have some concerns that the internal
tensions within these principles have not been fully considered.
28. There have been many practical problems
that have undermined the credibility and effectiveness of NICE.
These criticisms have come both internally from within the NHS
and externally from industry and patient groups. The Committee
will be aware of the selective interests of all of these parties.
These problems are not insurmountable, but they require the clear
support of the House of Commons Committee in tackling them. There
is a need for a rapidly responsive source of guidance for the
NHS, but also for a body to take a broader view of NHS priorities:
this seems to be beyond NICE in its present form.
29. The issue of the limitation or not of
NHS resources needs resolution: a decision either way would change
the nature of NICE.
30. NICE is a brave start which will evolve
but which needs regular detailed review. Its current direction
is in my view flawed.