Memorandum by the Department of Health
Clear and credible guidance
Single national focus
Guidance is locally owned and acted on
Faster access to clinically and cost effective
Origins and objectives
1. The National Institute for Clinical Excellence
(NICE) was formally established in February 1999. The broad aims
for the Institute were first described in December 1997 in the
White Paper The new NHS: Modern Dependable , and were set out
in more detail in the discussion papers A first class service:
quality in the new NHS  and Faster access to modern treatment
. These aims can be summarised as promoting
(i) common standards across the NHS by providing
a national source of clinical guidance,
(ii) faster uptake of treatments with evidence
of clinical and cost effectiveness, and
(iii) more effective use of NHS resources
by focussing on treatments which work best for patients.
NICE is a key part of the Government's agenda for
improving quality in the NHS.
It was set up to help eradicate inequity of
access to care. The Institute identifies cost effective medicines
and treatments, and helps to spread their use quickly and evenly
through the NHS.
2. NICE is a Special Health Authority. Its
work is governed by three key documents:
(i) the Establishment Order  which defines
its overall objective as "the promotion of clinical excellence
and the effective use of available resources in the health service";
(ii) Directions from Department of Health
(DH) Ministers and the National Assembly for Wales (NAW)  which
define more closely the functions of the Institute and, in very
broad terms, how it is to carry out those functions;
(iii) The Framework Document , which sets
out the details of the Institute's arms' length relation with
DH and NAW. The Framework Document includes an annex, originally
published in July 1999 as a self-standing Memorandum of Understanding,
describing the broad expectations of the processes and methodology
applying to NICE's appraisal guidance.
3. NICE's agenda is determined by DH and
NAW Ministers, in response to proposals from many sources including
(i) new technologies identified by the National
Horizon Scanning Centre, a unit of the University of Birmingham;
(ii) topics suggested by professional and
patient groups and by the wider NHS;
(iii) proposals from the National Clinical
Directors and other DH or NAW policy branches;
(iv) completed research carried out under
the auspices of the National Health Technology Assessment programmee.
All topics are carefully assessed against criteria
which include the potential benefit for patient care, the likely
impact on NHS resources and the potential for NICE to "add
value" by issuing guidance. The criteria are set out in full
at Annex A.
4. DH and NAW have recently been reviewing
the arrangements for selection of topics for appraisal in order
to ensure that interested parties are fully aware of the opportunities
for proposing topics. A consultation paper will shortly be issued,
and the Department will provide copies to the Committee as soon
as it is available.
5. NICE issues three main forms of guidance:
(i) Guidance on the clinical and cost effectiveness
of particular health interventions including new treatments such
as pharmaceuticals, diagnostic procedures, health promotion activities
(ii) Guidance on best practice for treating
particular clinical conditions (clinical guidelines), in some
cases also including guidance on the service arrangements needed
to secure best practice (service guidelines);
(iii) Guidance on how clinicians can compare
their current standards with best current practice (clinical audit).
The Committee will wish to note that, as part
of its response to the Bristol Royal Infirmary Inquiry, the Government
proposes to transfer responsibility for managing national audits
from NICE to the Commission for Health Improvement.
This memorandum therefore does not cover clinical audit.
6. NICE has to date issued 31 sets of technology
appraisal guidance and 4 sets of clinical guidelines, with a further
44 appraisals and 31 clinical guidelines in its forward programme.
The guidance published so far covers a wide range of disease areas
including cancer, coronary heart disease, diabetes and long-term
conditions as shown in Table 1 below.
| Clinical area/specialty
||Number of appraisals
||Number of clinical guidelines
|Coronary heart disease||5
|Mother and children services||2
(1) Some topics could be placed in more than one category.
The table is therefore only an approximate guide to the spread
between major clinical areas.
(2) The Institute's forward programme includes a number
of items of guidance in the mental health field.
7. In examining whether the Institute has produced clear
guidance, the Department believes it is useful to distinguish
between the clarity of presentation on the one hand, and the strength
of the recommendations on the other. While the presentation should
always be clear, the strength of recommendationsand therefore
their impact on clinical practicewill depend on the evidence
with which the Institute has to work.
8. On the first aspect, the Department believes that
some of the early appraisal documents did not set out clearly
the links between the evidence and the conclusions drawn by the
Institute. The result was that, even though the Institute's Appraisal
Committee may have had good reasons for its judgements, these
were not evident to the reader. The Institute has now rectified
this shortcoming and every appraisal determination now includes
a section headed "Considerations" which explains the
significant factors influencing the Committee in that case.
9. On the second aspect, since NICE's guidance is derived
from the clinical and economic evidence, it follows that its strength
depends on the quality of the available evidence. In the majority
of the appraisals so far published, NICE has been able to come
out with a more or less clear-cut recommendation relating to the
intervention being considered. Table 2 below places the guidance
into three simple categories.
SUMMARY OF TECHNOLOGY APPRAISAL GUIDANCE
|Recommendation||Number of appraisals
|Recommended for routine use||7
10. However, more detailed analysis of NICE's guidance
shows many shades of recommendation. In some cases, eg the appraisal
of taxanes in ovarian cancer, NICE recommends clearly the use
of the treatment in all appropriate cases (ie for all patients
who can tolerate chemotherapy). In other cases, such as gemcitabine
for pancreatic cancer, NICE recommends only that the treatment
should be considered as one of the therapeutic options for the
condition. Where the evidence does not at present permit a firm
recommendation for one option over anotheras for instance,
with different treatments for woundsthe guidance has made
11. Where the available evidence does not justify the
use of a new technology which is more expensive than currently
available treatments, NICE in general recommends against use except
in the context of clinical research, preferably a randomised controlled
trial. This helps to protect patients from as yet unproven treatments
while promoting as far as possible the conditions in which further
research can take place. There is however a fine balance to be
struck when considering innovative technologies which promise
substantial clinical benefit, especially where there is evidence
of some clinical benefit but as yet no firm evidence on
the size of the treatment effect.
12. In the Department's view, NICE's guidance is usually
as clear as the evidence permits. Where the evidence is not definitive,
the Institute has sought to ensure that its guidance to the NHS
is as helpful as possible, either by promoting further research
or by encouraging clinicians to consider use of the intervention
as one of a range of available therapeutic options.
13. NICE's credibility with its stakeholders will only
emerge over a number of years, just as it took several years before
the role of medicines regulation became fully accepted both by
clinicians and by industry. However, the Department believes that
the Institute has put in place procedures which enable it to produce
authoritative guidance. It has developed exhaustive processes
for scoping its work, gathering evidence, consulting on draft
guidance and hearing appeals against its conclusions.
14. NICE is responsible for determining its own methodology,
within the broad requirements of the Framework Document. Following
extensive consultation, the Institute has recently issued a series
of publications describing the processes and methodology to be
used for the development of its appraisal guidance and clinical
guidelines. We assume that the Committee will be seeking advice
directly from NICE on these documents and on the thinking behind
them. However, it might be reasonable to summarise NICE's approach
as being based on three fundamental principles:
(i) systematic application of evidence on clinical
effectiveness. Wherever possible, NICE's guidance involves
an independent review, using explicit criteria for selecting and
combining sources, of the available evidence on clinical effectiveness;
(ii) application of the principles of health economics
(cost effectiveness or cost utility analysis). The Institute's
legal framework clearly places on it the responsibility for promoting
the effective use of NHS resources, ie of assessing not merely
the clinical effectiveness of health interventions but
also their cost effectiveness;
(iii) extensive consultation with interested parties.
NICE's processes allow for consultation with patients and patient
groups, professional groups, NHS management, and healthcare companies.
This allows all relevant sources of evidence to be taken into
account, including unpublished evidence and perspectives which
are not easily captured by conventional approaches to clinical
and cost effectiveness.
15. Since its inception, NICE has been the foremost body
charged with providing authoritative guidance to the NHS in the
form of clinical guidelines and technology appraisals. The Government
has made clear that, where NICE guidance is available, the NHS
is expected to look to this as the primary basis of its clinical
and funding policies.
16. This position has been underlined by the recent Direction
, effective from 1 January 2002, which requires health authorities
and trusts to ensure that funding is available for all positive
recommendations contained in NICE's appraisal guidance. This is
a key part of the government's strategy to end postcode prescribing
and fulfils a commitment in the 2001 manifesto commitment. It
will mean that every patient can know that, if their doctor makes
a clinical decision within the terms of NICE guidance, no one
will block the decision on grounds of alleged lack of funding.
In general, NHS bodies have three months to provide funding to
underpin NICE recommendations. We will prepare special directions
on a case by case basis if NICE recommends a longer implementation
period on specific guidance.
17. The Government response to the Bristol Royal Infirmary
report states that NICE's focus as the main standard setting body
for the NHS will be sharpened in line with Professor Kennedy's
recommendations. NICE guidance will form the clinical core for
the National Service Frameworks (NSFs). NSFs are a key part of
the Government's agenda to drive up standards and reduce unacceptable
variations in health and social services. NSFs have already been
developed for mental health, coronary heart disease, the national
cancer plan, and older people. Further NSFs are being developed
for diabetes, renal services, children and long-term conditions.
Each NSF sets out a programme of action and reforms to set standards
and deal with variations in service provision.
18. The Institute will also take over responsibility
for the Safety and Efficacy Register of New Interventional Procedures
(SERNIP) which categorises new surgical treatments according to
their safety and efficacy. Furthermore, the Government is considering
whether there are other forms of guidance which are currently
developed outside NICE but which might more appropriately fall
within NICE's remit.
19. Although NICE will be the pre-eminent body in setting
clinical standards, it cannot be the only setter of standards.
Bodies such as the Medicines Control Agency, the Medical Devices
Agency and the National Patient Safety Agency will continue to
have responsibility for standards in their own fields. The Royal
Colleges and professional associations also provide guidance to
their members. Advice from professional bodies which goes beyond
NICE guidance will be regarded as aspirational and the Government
does not have the expectation that this will necessarily form
the basis of local NHS policies.
20. A distinction needs to be drawn between national
monitoring of compliance with NICE guidance, which is inevitably
broad brush, and the detailed audit which is possible at local
21. At the national level, the quarterly monitoring returns
made by Health Authorities to the Department now include a question
about individual items of NICE guidance. Health Authorities are
asked whether their local health economy is implementing specified
guidance, and to provide an explanation if action is not being
taken. As an aid to implementation the National Prescribing Centre
has produced a practical handbook for professionals, "Implementing
NICE Guidance" . The handbook has been widely distributed
throughout the NHS.
22. The Department does not yet have routine access to
data about the hospital use of medicines, although it hopes shortly
to agree terms with a market research company for the provision
of this information. Such data will enable the Department broadly
to monitor hospital prescribing following NICE guidance. However,
there is some evidence from primary care data that NICE guidance
is having a significant impact on GP prescribing. The graphs at
Annex B highlight this effect for anti-obesity drugs, riluzole
for motor neurone disease, glitazones for diabetes, and drugs
for Alzheimer's disease.
23. Health bodies will, however need to audit in more
detail their implementation of NICE guidance. To assist them in
this task, all technology appraisal guidance initiated after October
2000 includes specific audit advice and measurable criteria to
be used in local reviews. A similar approach is being adopted
for clinical guidelines.
24. The Commission for Health Improvement (CHI) is monitoring
the implementation of NICE guidance as part of its regular cycle
of inspections. Specifically CHI will take action to ensure that
NHS organisations have mechanisms in place to:
know when NICE guidance is published
document the reasons why NICE guidance is not
followed in patient records
review and collect data
develop suitable organisational and financial
monitor at Board level.
25. Where new treatments are referred promptly to NICE,
and where NICE finds good evidence of clinical and cost effectiveness,
a positive recommendation from NICE should ensure a faster and
more uniform uptake across the NHS than has been common in the
past. The previous section has offered some evidence that this
is already occurring. The recent Direction requiring NHS bodies
to arrange funding for positive NICE recommendations, generally
within 3 months, will reinforce this trend.
26. A key issue in this connection is the timing of referral
of new treatments to NICE. The Association of the British Pharmaceutical
Industry has argued that, for many new pharmaceuticals, there
is inadequate evidence to form a robust view on clinical and cost
effectiveness at the time of launch. In the Government's view,
the presumption should continue to be that significant new medicines
are appraised at time of launch. This is in the best interests
of both the NHS (which must form some judgements at that time)
and patients who may otherwise see slower uptake of important
new medicines. However, the Department recognises that this ideal
may not be feasible in all cases because there may be good reasons
why relevant data are not available at launch. These issues will
be explored in some detail in the consultation document mentioned
above at paragraph 4.
27. NICE has, from its outset, enjoyed a very large measure
of independence from Government and from other interests. As a
Special Health Authority NICE can operate at arm's length from
Government while being part of the NHS. We believe that it is
this relationship with the NHS that gives it authority and credibility
with those who implement its recommendations.
28. Particular examples of NICE's de facto independence
include the following:
(i) as already noted above, NICE is free to determine
its methodology and processes within the very broad guidance set
out in the Framework Document;
(ii) although NICE's Directions allow Ministers to give
it specific guidance in relation to particular appraisal topics,
Ministers have made clear in Parliament that they do not expect
to use these powers other than very exceptionally, and have so
far never used them at all;
(iii) similarly the provision for the Department of Health/National
Assembly for Wales to issue "management guidance" to
the NHS have been used only very sparingly (in relation to the
guidance on removal of wisdom teeth, taxanes in ovarian and breast
cancer, and zanamivir); and in each case the management guidance
has reinforced NICE's guidance;
(iv) the rights of the Department of Health and of the
National Assembly for Wales to comment on draft NICE guidance
are no different from those of other interested parties. Comments
are either limited to detailed technical or clinical issues, or
seek to clarify aspects of the draft guidance. (Although the DH/NAW
comments are not routinely published we would be very happy to
provide copies in relation to any completed appraisals if the
Committee would find this helpful.)
29. However, although NICE currently operates with considerable
independencecritically itself determining the standards
it setsMinisters consider that this could be further strengthened.
The Government response to the Kennedy report proposes the following
removing the requirement for approval from the
Secretary of State for Health and the National Assembly for Wales
for disseminating NICE guidance. Ministers have never used this
power of veto but believe that its removal will reinforce NICE's
ability to issue guidance direct to the NHS;
enabling NICE to determine its own committee structure
and to appoint committee members without reference to the Secretary
of State or the National Assembly for Wales.
The Department of Health will provide the Committee with
a copy of the full response to the Kennedy report. The Committee
may find this helpful in setting the Institute's work in the broader
context of standards of clinical care.
Department of Health
1. The new NHS: Modern Dependable. Cm 3807 December 1997.
2. A First Class Service: Quality in the new NHS. Published
by Department of Health, June 1998.
3. "Faster access to modern treatment": how
NICE appraisal will work. A discussion paper. January 1999.
4. The National Institute for Clinical Excellence (Establishment
and Constitution) Order 1999. SI 1999 No. 220, as amended by S.I.
5. Directions to the National Institute for Clinical
Excellence August 1999. (These Directions are at Annex A to the
Institute's Framework Document). There were later Directions to
NICE covering the Delegation of Land Acquisition and Transaction
6. The National Institute for Clinical Excellence Framework
7. The Directions are posted on the following websites:
8. Implementing NICE Guidance: a Practical Handbook for
Professionals. National Prescribing Centre, Radcliffe Medical
Press July 2001. Can also be obtained on website:
The National Confidential Enquiries will however remain with
the Institute. Back