The focus, organisation and implementation
of NICE's work
141. The concept of NICE guidance has been broadly
welcomed by the NHS. However, some of our witnesses felt that
the reality of NICE had raised difficulties, many of which were
outside NICE's direct control. Difficulties surrounding the timing
of NICE guidance and the focus of its work programme can be traced
to the variety of competing aims NICE has faced from its inception:
- the need for guidance on specific controversial
treatments, balanced against the need for comprehensive clinical
guidelines on treatment of conditions as a whole
- the need for appraisals of new treatments, balanced
against the need for appraisals of existing treatments that may
be ineffective or suffer from inequitable provision
- the need for guidance to be timely, balanced
against the need for that guidance to be of the highest scientific
standard
142. While none of these aims are mutually exclusive,
it would not be reasonable to expect NICE to have achieved all
of them in such a short timeframe, or within the confines of its
current structure or capacity. Drawing on the concerns raised
in our evidence, we have therefore recommended that the Government
should refocus NICE's efforts in several respects.
143. Firstly, we have recommended that a significantly
increased proportion of NICE's resources should be devoted to
NICE's clinical guideline development programme, which should
be extended to cover all major causes of morbidity and mortality,
as identified by a new, more inclusive and more transparent topic
selection process. These changes in focus are supported by NICE,
and are broadly supported by government. However, we are concerned
at NICE's ability to deliver them without a significant increase
in capacity, and therefore we recommend that the Government should
extend NICE's funding to fully support these activities.
144. Alongside this, we have recommended that
rapid 'interim' appraisals of all selected new treatments should
be published to coincide with the launch of the relevant technology,
with a proviso for later review where necessary. For a number
of years there will clearly be a continuing need for NICE to appraise
the backlog of existing treatments and interventions which suffer
from inequitable provision, or are of questionable cost or clinical
effectiveness. This function should be distinct from NICE's "new
technology" function in order to ensure that both activities
are occurring concurrently, and to raise confidence in the NHS
that NICE is achieving a balance between them, and should be carried
out as part of NICE's main clinical guidelines function.
145. To improve the clarity and impact of this refocused
work programme, we have also recommended that NICE should develop
clearer cross-referencing between technology appraisals and guidelines,
clearer links with NSFs, and that the legal status of NICE technology
appraisals and guidelines should be clearly communicated to the
NHS by the Government.
146. The success of NICE's endeavour is critically
connected to the thorough and systematic implementation of its
guidance, which is again outwith NICE's direct remit. While the
impact of the Government's recent directive in this area is not
yet known, it is clear from our evidence that monitoring of implementation
has not been rigorous. We have therefore recommended that the
Government ensures that CHI (and later CHAI) is able to conduct
appropriate monitoring of the implementation of NICE guidance.
NICE in its wider context
147. Many of the issues raised by this inquiry reach
beyond the specific role of NICE, focusing on NICE's relationship
with the Government and its place in the wider debates on funding
and prioritisation within the NHS. Considerable confusion currently
surrounds the role NICE plays in assessing the affordability of
treatments in the NHS, and to this end we have recommended that
the Government ensures that there is clarity about its own role
in settling issues of affordability. NICE's methodology is obviously
still evolving, and we hope it will continue to be subject to
regular review and 'fine-tuning' by NICE itself. Cost-effectiveness
is an issue subject to the difficult combination of being both
emotive and little understood, and we feel that our evidence reveals
a need for greater clarity about both the determinants of cost-effectiveness,
and the attendant value-judgements these necessitate. We have
therefore recommended a full-scale review of NICE's methodology,
followed by the publication of clear criteria.
148. The Government's decision to fund further research
on beta interferon under a scheme of risk-sharing following NICE's
negative appraisal of the drug has also raised concern and confusion,
pointing to the need for further clarification and development
of the relationship between the Government and NICE. We have therefore
recommended that the Government ensures that all its work on health
technology research and pricing takes full account of NICE's work,
and that any subsequent government decisions which could appear
to run contrary to NICE recommendations are issued in collaboration
with NICE to minimise the potential risk to NICE's credibility.
149. In addition to the clear value of its guidance
to clinicians, patients and commissioners of care, NICE has generated
great interest in its work because of the central position it
holds in the highly charged debate about prioritisation within
the NHS. NICE's role in prioritisation has come under even greater
scrutiny since the Government directed that implementation of
NICE's recommendations will be a mandatory requirement for health
authorities, which means that NICE's decisions may now have a
direct impact on spending priorities in local health economies.
This makes the process through which topics are selected for NICE's
work programme doubly critical. We have recommended that the transparency
and inclusiveness of the Government's topic selection process
is improved, and that topic selection should be informed by the
total health benefit to all patients.
150. The mandatory funding of NICE recommendations
also raises the question of how the NHS should value other competing
calls on its resources which will not be assessed by NICE, including,
for example, nursing services. While NICE has served as a focus
for these difficult issues, we do not feel that this is a debate
NICE is qualified, or should be expected, to lead unsupported,
and we have therefore recommended that the Government should work
to establish a broad framework of values to guide the NHS in its
consideration of spending priorities. These values should also
inform the Government's prioritisation of topics for NICE appraisal
and guidance.
