7 Conclusions |
346. Healthcare budgets in England as elsewhere are
limited. Difficult decisions have to be made about priorities.
Patients cannot expect to receive every possible treatment. In
other words rationing is essential. Dr Imogen Evans echoed the
views of many witnesses when she stated, "the cost of healthcare
weighs heavily on all national economies, and the need to set
priorities is inescapable". Moreover, it would be sensible
if any choices to be made were based on robust evidence, with
the aim of offering patients the best available treatments. In
this context NICE evidently has a key role to play.
347. The evidence we received indicated that since
it was established in 1999 NICE has achieved much. Its work has
led to a greater concentration on cost- as well as clinical effectiveness.
Its evaluation processes are generally robust, and are well-regarded
worldwide. However, there are failings.
348. The evaluation process was criticised on a number
- The speed of publication of
guidance is a major problem; licensed medicines are often not
prescribed while PCTs and clinicians wait for NICE to make a decision.
Delayed access to products later found to be both cost and clinically
effective harm both patients and the NHS.
- Topic selection is also unsatisfactory. Selecting
topics for assessment is appropriate for clinical and public health
guidance, but not for technology assessments. While there needs
to be an assessment of all new drugs, it is very important not
to skew spending to expensive secondary care at the expense of
public health and other clinical guidance. There is also far too
little emphasis on disinvestment. Here we found NICE's responses
to our questions disingenuous. While few older treatments may
do no good at all, many will not be cost-effective.
- The wider benefits of treatment to society, for
example to carers, are not included in NICE's cost : benefit analyses;
- NICE often does not have all the information
it needs to make a full assessment. It does not have access to
all the information the MHRA uses and clinical trials are usually
designed without NICE's work on cost-effectiveness in mind.
improve the evaluation process, we recommend that:
- All drugs
be assessed at the time of licensing, so that clinicians can prescribe
useful and cost-effective products as soon as they are launched;
- There be more emphasis on disinvestment;
- Our last report on NICE recommended
that the legislation be changed to accommodate the need to ensure
that assessments of products take account of the wider benefits
to society; we make the same recommendation here;
- NICE have access to the same
material used by the licensing body, clinical trials be registered
and there should be closer working between NICE and the industry
to enable these early assessments to take place.
affordability of NICE guidance and the range, measured in cost-per-QALY,
it uses to decide whether a treatment is cost-effective is of
serious concern. The threshold it employs is not based on empirical
research and is not directly related to the NHS budget, nor is
it at the same level as that used by PCTs in providing treatments
not assessed by NICE, which tends to be lower. Some witnesses,
including patient organisations and pharmaceutical companies,
thought NICE should be more generous in the cost per QALY threshold
it uses, and should approve more products. On the other hand,
some PCTs struggle to implement NICE guidance at the current threshold
and other witnesses argued that a lower level should be used.
However, there are many uncertainties about the thresholds used
by PCTs. Accordingly we cannot authoritatively at this stage recommend
a change in NICE threshold. Nevertheless, we recommend that it
be reviewed. We do recommend that an independent body determine
the threshold used when making judgements of the value of drugs
to the NHS.
351. The implementation of non-mandatory guidance
is variable. This is due to a variety of causes, including the
threshold used by NICE for determining cost-effectiveness, lack
of clarity about the status of guidance, lack of involvement of
PCTs in the development of guidance, clinicians' disagreement
about the worth of some NICE guidelines. This is a particular
problem when clinicians believe that NICE has not used the right
experts or when different guidelines from other organisations
are published about the same time as NICE guidance.
352. To improve
the implementation of NICE guidance we recommend:
- More help
for PCTs to implement guidance;
- Better assessment of the level
- That PCTs should play a larger
role in the development of guidance;
- Better use of experts in the
development of guidance;
- A change in the terminology
used by NICE, to clarify to patients what they can and cannot
expect by right from their local NHS organisation; and
- That some elements of clinical
guidelines be made mandatory.
353. Changes to the system of medicines pricing may
follow the OFT's report on the PPRS. NICE should be involved in
any new system, and to ensure full involvement in any such process,
NICE should be adequately resourced.
354. We recommend
that risk-sharing schemes be used with caution. They should not
be used as a catch-all in cases of uncertainty over a drug's benefit.
Uncertainty would be better addressed by the careful design and
performance of a publicly funded randomised controlled clinical
trial. Better use should be made of NICE's 'only in research'
recommendation in this regard.
355. NICE does a vital job in difficult circumstances.
The development of more and more health technologies and procedures,
coupled with rising patient expectations and the ageing population,
is going to make it even more difficult in the future. NICE can
improve and we have recommended improvements. In the past it has
changed and we are sure it can do so again. Given the difficult
environment, NICE requires the backing of the Government. Ministers
must support NICE, not seek to undermine it. NICE must not be
left to fight a lone battle to support cost- and clinical effectiveness
in the NHS.