Evidence submitted by Dr Chris Hyde (NICE
76)
EXECUTIVE SUMMARY
In circumstances where the total price of new
health care innovations exceeds growth in health care budgets,
scrutiny of value for money is essential. If NICE is performing
this role in Technology Appraisal successfully, highlighting even
a minority of innovations where the additional costs do not seem
to be matched by the demonstrable health benefits, will bring
it into conflict with both the public and drug manufacturers.
The committee must thus take care not to judge the value of NICE
by its popularity.
Scrutiny should instead be directed at whether
the balance between benefits, harms and costs in cases which NICE
has not supported make sense to the Committee. The Committee will
need support with this because quantifying health benefit, side-effects
and cost is often complex. Despite this it should be possible
for the main elements of the argument for or against a health
technology being cost-effective to be presented in a way where
the Committee can make their own judgement on whether the conclusions
reached by NICE are reasonable.
In my experience the decisions by NICE are reasonable
and generally give the benefit of the doubt to the health technology
being appraised.
Greater resources should be devoted to explaining
the nature of the evidence underpinning NICE's Technology Appraisal
systems more widely.
INTRODUCTION
1. I have worked in health care for 20 years.
During that time I have acquired a variety of experience which
is potentially relevant to my evidence. I am a medically qualified
Doctor and worked in hospitals for several years. I have also
trained in public health and have worked in health authorities
helping to commission health care for local populations.
2. Currently I am a researcher who helps
provide the summaries of evidence which feed into the decisions
which NICE makes. The university I am employed by receives funding
from the NHS Health Technology Assessment Programme for developing
these summaries, however my post is not dependent on this funding.
I have attended NICE appraisal committee meetings and appeals,
but I am not part of NICE and am not involved in the final decisions
it makes. Finally I am a parent of young children and have been
a carer.
EVIDENCE
3. The Committee posed a series of questions.
My evidence consists of reflections on each of these.
Why are NICE's decisions increasingly being challenged?
4. My understanding is that NICE has a number
of roles and that it is mainly the decisions of Technology Appraisal
arm which are contentious and subject to challenge. My perception
is that the advice NICE offers in the form Clinical Guidelines
and Interventional Procedures Guidance although not immune from
criticism, is rarely formally contested.
5. Two things set the Technology Appraisal
arm apart. First it is the stream of guidance which specifically
sanctions use of specific new technologies. Second it is the only
stream which considers value for money in which the benefits,
side-effects and costs are weighed against alternative approaches.
This is essential in a situation where the total price of new
health care innovations exceeds growth in health care budgets.
6. Both factors suggest why NICE's decisions
in Technology Appraisal are challenged, both because it is required
to make decisions which prevent a new technology being made widely
available and because it uses a criterion (cost relative to benefit)
which is not universally accepted as one which should govern decisions
about availability of health care. Unfortunately it is self evident
to those aware of the true costs of health care, which the NHS
rightly protects most patients from, and the scale of health innovations,
that such decisions must be made.
7. The only way NICE could avoid conflict
with patients and drug companies, is if it made no negative decisions,
thus NICE's growing unpopularity might be regarded as a marker
of success rather than failure. One would certainly be suspicious
if it was popular.
8. Concerning the apparent increase
in decisions being challenged, I suspect this is due to the fact
that negative decisions take years to achieve because appeals
can be mounted, and the nearer the end of the appeal process the
greater the volume of criticism.
9. Greater clarity borne of a number of
years of experience, could also explain an increase in negative
initial decisions made by NICE, as could random fluctuation in
the cost effectiveness of new health care products being introduced,
as the licencing system is primarily aimed ensuring that drugs
meet minimum criteria of safety and effectiveness, allowing marked
variation in the extent of effectiveness and cost-effectiveness.
Is public confidence in the Institute waning,
and if so why?
10. This is difficult to gauge because it
may not be clear to many members of the public exactly what NICE's
role is. Given this the contention that NICE has ever had true
public confidence is open to question.
11. However, irrespective of this it is
inevitable that if NICE is performing this role successfully,
highlighting even a minority of innovations where the additional
costs do not seem to be matched by the demonstrable health benefits,
it will be brought into conflict with the public. This in turn
could be interpreted as waning of public confidence, whereas more
truthfully it might just reflect that as the number of negative
decisions rises over time, the more people are directly affected
by the unpopular decisions NICE has to make.
12. One issue is clear is that NICE does
not have the capacity to counter media campaigns supported by
drugs companies. Whether NICE should try to do so is debatable,
but what is certain is that greater coverage of views reflecting
the drug manufacturers perspectives will inevitably make it appear
that public confidence is waning. How much of media coverage on
a particular topic is inspired or supported by drug companies
may be amenable to measurement.
Are any particular groups disadvantaged by NICE's
evaluation process?
13. Having observed the evaluation process
relatively independently, I would suggest that no group is greatly
disadvantaged.
14. Relatively however, although NICE have
tried hard to solicit and incorporate patient views, the technical
complexity of the submissions and the debate often make it challenging
for truly representative patient perspectives to be incorporated
into their decisions.
15. Greater resources devoted to facilitating
understanding of the available evidence by patients and patients
groups could be valuable. There is certainly no funding to translate
the summaries of evidence we provide to NICE into lay language,
so the feasibility of this could again be usefully explored.
Speed of publishing NICE guidance?
16. In my experience the slow progress with
the guidance, although frustrating, is usually commensurate with
the complexity of the decisions being made. Delays are usually
to allow greater opportunity for consultation.
17. Speed of guidance is often as much compromised
by filibustering techniques by drug manufacturers as delay attributable
to NICE's processes.
18. Concerning the time taken to produce
the systematic reviews and health economic models, these are produced
much more quickly than would normally be achieved if the same
summaries of research were produced in normal academic practice
where contracts would usually be between one and two years. In
the NICE process, the usual period to produce the technology appraisal
is six months.
19. Recently NICE has tried to streamline
procedures in the Single Technology Appraisal (STA) process. Experience
with this is still limited so it is unclear whether it will actually
achieve quicker guidance, especially where a negative decision
is made by NICE.
20. There is also concern that time saved
by not having an independent academic report on effectiveness
and cost-effectiveness may lead to important issues being overlooked
in the appraisal process. Again only greater experience with the
new STA process will allow an accurate assessment of this to be
made.
The appeal system
21. I have attended appeal hearings on three
topics. In all cases the process appeared to me to be on balance
fair.
22. The unlimited resources which appellants
can invest in preparation for the appeals procedure more than
outweighs any possible bias in the way the procedures are organised
and conducted.
Comparison with the work of the Scottish Intercollegiate
Guidelines Network (SIGN)?
23. This is a highly respected system of
developing clinical guidelines in Scotland.
24. However, as indicated in B3, comparing
the work of SIGN with the component of NICE's advice which attracts
most criticism, the Technology Appraisal component, is inappropriate.
25. SIGN would most reasonably be compared
with the Clinical Guidelines produced by NICE, which rarely attract
adverse comments, and would thus externally be judged to perform
to the same high standard as SIGN
26. As a corollary, it should be noted that
SIGN to do not sanction use of specific new technologies or not,
nor do the SIGN guidelines make any recommendations based on information
about value for money—are the costs of the new technology
justified relative to the demonstrable health benefits?
Implementation of NICE guidance
27. A key problem with implementation is
that specific funds are not made available to match each decision.
A favourable decision to make a technology available must be funded
by diverting resources from another area of health care. This
will inevitably lead to variation in the extent and speed with
which a new recommendation is implemented in different PCTs depending
on the amount of flexibility in the health budget in a given locality
at a given point in time
28. Support at a local level to explain
and educate about the nature of the decisions made by NICE may
improve implementation. This is for the same reasons the patient
groups may struggle to understand the evidence considered by the
NICE appraisal process (see 14).
29. However, given sufficient support I
believe it is possible for non-experts to understand the key features
of the arguments which lead NICE to concluding that some new technologies
may be considered cost-effective and others not.
C. RECOMMENDATIONS
30. The success of NICE should not be judged
by its popularity.
31. Generally it performs its functions
well and it should continue to be strongly supported.
32. However, there should be more resources
to explain the nature of the evidence to patients, the public
and health care workers both during the NICE process and as part
of the dissemination of the decisions.
Dr Chris Hyde
March 2007
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