Select Committee on Health Minutes of Evidence

Memorandum by the Department of Health (NC 1)



  Clear and credible guidance

  Single national focus

  Guidance is locally owned and acted on

  Faster access to clinically and cost effective treatments



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 [1], and were set out in more detail in the discussion papers A first class service: quality in the new NHS [2] and Faster access to modern treatment [3]. 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 [4] 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) [5] 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 [6], 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 (appraisals);

    (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.[1] 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.

Table 1

Clinical area/specialty
Number of appraisals
Number of clinical guidelines
Coronary heart disease
Long-term conditions
Mother and children services


  (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 recommendations—and therefore their impact on clinical practice—will 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.

Table 2


Number of appraisals
Recommended for routine use
Selective use
Research only

  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 another—as for instance, with different treatments for wounds—the guidance has made this clear.

  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.


General position

  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 [7], 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 level.


  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" [8]. 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

    —  know who is affected

    —  document the reasons why NICE guidance is not followed in patient records

    —  review and collect data

    —  develop suitable organisational and financial arrangements

    —  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 independence—critically itself determining the standards it sets—Ministers consider that this could be further strengthened. The Government response to the Kennedy report proposes the following measures:

    —  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

January 2002


  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. 199/2219.

  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 Responsibilities.

  6.  The National Institute for Clinical Excellence Framework Document.

  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:

1   The National Confidential Enquiries will however remain with the Institute. Back

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