Memorandum by The NHS Confederation (NC
1.1. The NHS Confederation welcomes the
establishment of the National Institute of Clinical Excellence
(NICE) and acknowledges that it has produced high quality guidance
that is useful to the service.
1.2. However, there are concerns about the
wider policy environment and what effects it has on NICE's work.
1.3. The Confederation is concerned that
mandatory guidance may distort local priorities. By redirecting
resources to NICE prescribed variations may be produced elsewhere.
1.4. The Confederation has some concerns
about the overly simplistic approach to clinical guidelines. NICE
appraisals should take into consideration the possible clinical,
demographic and other conditions and issues affecting implementation
at the local level.
1.5. There is little in-year flexibility
for NHS organisations as resource allocation takes place on an
1.6. The Confederation welcomes NICE's independence
but believes that it must sustain and strengthen links with the
NHS. This will enhance the development of its work programme;
the appraisal process and the final guidance to the service.
2. WHO WE
2.1. The NHS Confederation is the voice
of NHS management. Our members include the majority of NHS trusts,
primary care trusts (PCTs) and health authorities in England;
trusts, health authorities and local health groups in Wales; trusts
and health boards in Scotland; and health and social services
trusts and boards in Northern Ireland.
2.2. For information about the work of the
NHS Confederation across the UK you can visit our website: www.nhsconfed.net
3. THE EVIDENCE
3.1. The views and recommendations in this
paper have been formulated from views expressed by the Confederation's
virtual policy networks in England. The Confederation would like
to thank all its members that have helped in the preparation of
4. NICE OPERATION
4.1. The Confederation welcomes the establishment
of NICE and acknowledges that NICE has produced high quality guidance
that is useful to the service. The existence of NICE has reduced
the replication of effort in reviewing the evidence in multiple
NHS organisations to varying standards. NICE has raised the public
understanding of the need to consider treatments according to
4.2. Our members do not question the quality
of the technical appraisal of new technologies, however, there
are a number of aspects of the way that NICE is currently required
to operate that do cause some concern.
4.3. The publication of NICE appraisals
throughout the year does not fit with the annual allocation of
resources to NHS organisations. The requirements to fund NICE
treatments may lead to in-year financial pressures as contingency
flexibility becomes increasingly limited. The timing of NICE appraisals
causes very significant difficulties for Health Authorities and
PCTs as they are required to estimate the likely result of NICE's
determination, the timing of the announcement and the scale of
its effect at the start of the financial year.
4.4. The estimates of the financial impact
by NICE appear to be of dubious quality. This is not a criticism
of NICE as the data on which they have to work is poor but it
compounds the problem referred to in 4.3.
4.5. NICE has concentrated on decisions
about whether to start using new technologies and much less on
which treatments could be stopped. The dissemination and implementation
of guidance needs more thought.
4.6. Some important areas that could have
been referred to NICE have not been. Perhaps the most striking
of these was the decision by the Department of Health to require
the use of disposable instruments for tonsillectomy operations
because of the theoretical risk of transmitting nvCJD. The costs
of this were very high and the result has been one very real avoidable
5.1. The government recently announced that
it would require Health Authorities and PCTs to fund the decisions
made by NICE. This is likely to have very serious unintended consequences
unless the way that NICE operates is changed.
5.2. At present NICE only examine individual
treatments or technologies referred to them by the Department
of Health's Advisory Group. The assessment of cost effectiveness
does not generally make any judgements about the relative effectiveness
of the treatment against the available alternatives. The assessment
is made difficult by a lack of good quality cost effective data.
Even where it may do this there is no judgement made about how
best to allocate limited resources to the new treatment. Many
of the treatments that NICE have examined have been at the margins
of cost effectiveness. As a result the paradox arises that the
government will mandate the funding of a marginally cost effective
drug and local NHS organisations may have to achieve this by not
supplying drugs which are very much more effective and would benefit
5.3. The argument that this is good for
patients or that it eliminates post code prescribing is spurious.
By definition insisting on funding a less cost effective treatment
will be at the expense of other patients who would have benefited
more. It may eliminate post cost prescribing in the treatment
that NICE have examined but, as the funding government provides
for NICE decisions is in general allocations and not earmarked,
different NHS organisations will find the money in different ways
producing variation elsewhere. Earmarking would not be possible
for reasons explained in 4.3 above.
5.4. A very disturbing example of the perverse
and unintended consequences of mandated funding is beginning to
be apparent in the case of atypical anti-psychotics (which is
currently at final appraisal stage). To fund the implications
of the NICE decisions reductions will need to be made in the already
stretched staffing of mental health trusts which will mean poorer
care overall for patients.
5.5. The mandating of funding is good news
for those companies fortunate enough to have their drugs assessed
by NICE. They are provided with a very useful marketing tool.
6. FUTURE DIRECTION
6.1. NICE was not intended to assess the
entire range of treatments, technologies and interventions available.
There are still many difficult decisions about the relative priorities
that need to be made. PCTs will need to make challenging decisions
on where to invest resources and this will not just be made on
cost effectiveness data, but is a balanced decision which will
take account of a number of factors including ethical values and
the views of the community. Just because a treatment is found
to be cost effective does not mean that it would be wise or a
good use of resources to fund it if there are more pressing priorities
locally. It is difficult to compensate for a more expensive replacement
treatment with possible hidden implementation costs in an existing
largely inflexible budget. The government's policy of shifting
the balance of power to front line decision makers recognises
the importance of these decisions being taken as close to the
patient as possible. The policy of mandating the funding of a
certain number of marginal treatments seems to directly contradict
the intention to shift the balance of power.
6.2. There needs to be a further debate
on the way that NICE fits into the current system of resource
allocation and local decision making. One suggestion is that it
should be asked to prioritise its recommendations within a fixed
technology growth budget. NICE could increase the budget by suggesting
possible disinvestment. Alternatively NICE could be asked to look
at relative priorities within particular programmes of care and
to assess how a new treatment or intervention scored against the
cost effectiveness of existing treatments. This could also be
in the context of an agreed budget for technology growth. PCTs
would find the information produced in this sort of exercise of
6.3. PCTs will need to make challenging
decisions on where to invest resources and this will not just
be made on cost effectiveness data, but is a balanced decision
which will take account of a number of factors including ethical
values and the views of the community.
6.4. NICE guidance needs to be available
as a high quality resource to inform local decision-making. It
should be considered whether there needs to be a differentiation
between what is absolutely funded after NICE consideration and
those technologies which are most appropriately considered locally.
For example, a PCT might be guided on the use of taxanes for breast
cancers but decide to invest in secondary prevention for coronary
heart disease rather than fund glycoprotein 11b/111a inhibitors.
7. WORK PROGRAMME
7.1. The NHS Confederation welcomes NICE's
independence. Its present system of inviting suggestions for work
programmes has focused more on new technologies than existing
ones. The most effective method of appraisal should cover range
of technologies for a particular condition. This system would
cover both new and old drugs and interventions.
7.2. Given the importance of NICE's work
and particularly since the government have mandated the funding
of NICE appraisals, very much more thought needs to be given to
how the areas that NICE should be examining are chosen. At present
these are not transparent and it is not clear how expert opinion
is canvassed. More sophisticated methods to identify areas for
study are required.
8.1. The NHS Confederation supports the
role of NICE and with the exception of the rather disappointing
work in the area of referral guidelines, is broadly happy with
the way that it has conducted its work. We are less happy with
the way that topics are chosen for study, the consideration of
technologies in isolation from alternatives or with the potentially
serious implications for allocative efficiency of mandating the
funding of treatments that may be less cost effective than others
that NICE have not reviewed. The timing of guidance and the extent
to which it is consistent and supports local implementation and
is sensitive to local issues also needs consideration.
8.2. The problem of how new technologies
and treatments can be afforded and prioritised still needs a solution.
Professor Alan Maynard and colleagues from York University have
offered some interesting proposals about how NICE could contribute
to this in their recent BMJ article and these should be debated.
Simply instructing a lower level of the NHS to find the money
does not solve the fundamental problem that difficult resource
allocation decisions need to be made. NICE does not provide sufficient
information to allow this and was not intended to fulfil this
role. The balance achieved in the National Service Frameworks
of national standards based on gold standard evidence and key
milestones combined with local implementation offers a useful
way forward. This would also allow some of the more contested
and controversial decisions to be made locally after a proper
debate with patient groups, the public and local professionals.