House of Commons - Health - Minutes of Evidence

Select Committee on Health Minutes of Evidence

Memorandum by National Institute for Clinical Excellence (NC 62)

EXECUTIVE SUMMARY

I. The Institute has developed rapidly in a very short time. Since its formation, it has built an organisation, developed, consulted on and published methodologies for its work programmes, constructed a network of contributors, including six National Collaborating Centres, produced 36 separate guidance documents and completed nine audit and effectiveness projects. It has reviewed and reorganised the national confidential enquiries.

II. The Institute is rightly an integral part of the NHS, funded by and accountable to the Department of Health and the National Assembly for Wales. It has established robust processes which guarantee that its guidance is independent of any vested interests. NICE is seen to be independent in relation to its assessment of clinical and cost effectiveness.[1] There are further measures that could be taken to enhance the Institute's independence, and these are set out in paragraph 2.10.

III. The Institute's guidance is prepared by independent advisory groups composed of experts (including those who speak on behalf of patients) in their field. These groups scrutinise the evidence with the utmost care to formulate guidance that is in the best interests of patients. There is overwhelming national and international opinion that NICE guidance is credible, appropriate and produced to an exacting standard.

IV. There is no other body in England and Wales capable of producing clinical practice guidance of the quality and range achieved by NICE. In addition, no other body producing clinical advice operates in a manner that is as inclusive and transparent. The Institute would welcome the opportunity to increase its capacity to enable it to produce guidance on all the major causes of morbidity and mortality as quickly as possible.

V. By involving, in its preparation, those who will have responsibility for implementing the guidance, the Institute is doing as much as it can, within its remit, to promote and achieve local ownership of its work. Individual clinicians, NHS and patient bodies, professional organisations and manufacturers all share responsibility for the implementation of clinical practice guidance. NICE has worked, and will continue to work, with them all to secure local adoption of its guidance.

VI. With the Institute's guidance patients and health professionals now have clear statements on the appropriate use of over 30 interventions and on four areas of clinical practice. There is increasing evidence that, whilst some NHS organisations and some individuals have not responded as quickly as the Institute would have liked, it is the case that its advice is being applied across the NHS in England and Wales. The opportunity now exists—and is being taken—to use the guidance that NICE has produced to secure for patients, wherever they live, care of a consistent and high standard. Earlier referral of new technologies will enable the Institute to extend this opportunity.

1. INTRODUCTION

1.1 High-quality care and the efficient use of resources are objectives shared by healthcare systems throughout the world. Whilst there are, in most developed countries, schemes that try to ensure patients receive the highest possible quality of care, there are few that take account of both clinical and cost effectiveness. The National Institute for Clinical Excellence (NICE) is unique among those that do because of its broad scope and its position within the NHS.

1.2 A First Class Service: Quality in the NHS,[2] proposed a series of initiatives (for England and Wales) that would promote, for NHS patients, the highest attainable quality of clinical care. These included:

— the setting of national clinical standards (through National Service Frameworks and NICE);

— the delivery of these standards (through clinical governance and professional self-regulation); and

— the monitoring of standards (by the Commission for Health Improvement, and through the National Framework for Assessing Performance and the National Survey of Patient and User Experience).

1.3 NICE was therefore conceived as one part of a strategy to enhance the quality of care for NHS patients, and to eradicate inappropriate variations in clinical performance.

1.4 NICE was established as a Special Health Authority in April 1999, with the statutory purpose of promoting clinical excellence and the effective use of resources within the NHS. The Institute achieves this by developing and disseminating advice to patients and health professionals, primarily in the form of:

— guidance on the appropriate use of selected technologies (from appraisals of medicines, devices, procedures, diagnostics and health promotion);

— clinical guidelines for the treatment of specific diseases and conditions; and

— appropriate clinical audit methods.

All NICE guidance is based on evidence of both clinical and cost effectiveness; its production involves patient/carer organisations, health professionals and manufacturers.

1.5 NICE is accountable to the Secretary of State for Health in England and to the National Assembly for Wales. The Department and the Assembly commission guidance from the Institute. The relationship between the Institute and the Department and the Assembly is described in the Framework Document.[3]

1.6 NICE was established in April 1999 with a budget of £10,112,000, largely derived from pre-existing funding. Its recurring allocation in the financial year 2001/2002 is £12,575,000.

1.7 The Institute was founded on the principle that it would be likely to work most effectively by maintaining a small central team and creating a network of relationships with professional, academic and NHS organisations from which it could seek expertise and advice. A core of 40 people now work at NICE's offices in London, but the "virtual" Institute involves individuals and organisations across England and Wales.

1.8 NICE is supported by the Partners Council, the whose members of which are drawn from organisations representing the key stakeholder groups, including patient/carers, the health professions (the Royal Colleges and professional bodies and associations), academics, NHS service interests and the healthcare industries. The experience, skill and knowledge of its members mean that it has become an invaluable source of individual and collective advice on a range of issues, and it provides a forum for exchange of ideas and the development of strategy.

1.9 Over the coming months, the Institute will establish a Citizens Council to ensure that the judgements that underpin its evaluation of clinical and cost effectiveness reflect, more clearly, the values held by people living in England and Wales. The Council will be drawn from people living in England and Wales who neither work for, nor supply, the NHS. The views of the Citizens Council will inform the deliberations of the Board and its advisory committees

1.10 The Institute has ensured that patient/carer organisations are routinely engaged in its governance and in the development of its guidance. The Board includes two non-executive directors with substantial experience of patient and carer advocacy. One-quarter of the membership of the Institute's Partners Council represents patient and carer interests. All the Institute's advisory committees and guideline development groups include individuals with experience of patient or carer advocacy. The Institute has also created a patient and carer support unit, in association with the College of Health, to help representatives of patient and carer organisations contribute to guideline development groups.

1.11 The Institute published its first routine guidance in March 2000. Since then it has embarked on the largest programme of original clinical guidance development ever attempted by a national healthcare system. In particular, it has:

1.11.1 developed, consulted on and published methodologies for its guidance and guideline programmes;[4][5]

1.11.2 established independent advisory committees to formulate its guidance. Members of these committees, whose expertise is recognised both in the UK and internationally, are are drawn from the NHS, patients/carer organisations, and academia;[6][7]

1.11.3 published 31 technology appraisals, with a further 43 in development;[8]

1.11.4 published four clinical guidelines, with a further 32 clinical guidelines in development;[9]

1.11.5 completed nine national audit projects, commissioned seven national audit projects, and developed practical advice, A Guide to Principles for Best Practice in Clinical Audit, which will be published in Spring 2002;[10]

1.11.6 commissioned, piloted and published a set of guidelines for health professionals, on good practice for referring patients to specialist care, covering 11 common conditions;[11]

1.11.7 reviewed the four national Confidential Enquiries to better enable their work to improve the quality of care.

1.12 In addition the Institute has:

1.12.1 Established six multidisciplinary National Collaborating Centres.[12] These centres bring together groups of health care professionals, patient/carer representatives and academics that develop clinical guidelines and audit advice for the NHS in England and Wales. The six Centres cover acute care, chronic disease, nursing and supportive care, mental health, primary care, and women and children's health. Their creation is an indication of the commitment that the organisations representing health professionals working in the NHS, including the Royal Colleges, have made to the Institute and its work.

1.12.2 Reviewed the methodology used by the Sowerby Centre to develop guidance for PRODIGY (a prescribing decision support system used to assist treatment decisions in primary care) and has ensured that the Institute's guidance is available within it.

1.12.3.Reviewed the national publications transferred to the Institute, (MeReC Bulletins, Effectiveness Bulletins and Prescribers Journal). The Institute continues to fund the MeReC Bulletins and the Effectiveness Bulletins.

1.12.4 Provided a forum, through its annual conference, for health professionals, patient/carer organisations, academics, the healthcare industries, and other NHS organisations, such the Commission for Health Improvement and the Modernisation Agency, to share examples of good practice and ideas for quality improvement. These conferences are attended by, on average, 1,800 people.

1.12.5 Established its approach to dissemination, including a web site[13] with disability-access features, patient/carer versions of its guidance and guidelines and Welsh language texts. In September 2001, the Institute has commissioned a review of its approach to dissemination for all stakeholder groups.

1.12.6 Commissioned a research project through the methodological section of the National R&D Programme to evaluate the impact of NICE guidance on clinical and managerial practice. A team led by Professor Trevor Sheldon from York University has been appointed to carry out this project following a European-wide open-tendering process. The team will use a combination of postal questionnaires, interviews and data analysis to identify any barriers to implementing NICE guidance and to highlight factors that facilitate its implementation. The initial results will be available in the summer of 2002.

2. THE INDEPENDENT ROLE OF NICE

2.1 The Institute's work programme is ultimately, determined by the English and Welsh health Ministers. Once the work programme has been agreed, the development of the subsequent advice is entirely the responsibility of the Institute.

2.2 The Institute follows open and structured processes in the development of its guidance.[14][15] Inevitably, its advice is not always received with universal approval. Many of the topics referred to NICE represent areas of genuine uncertaintly or disagreement. The decisions NICE makes are sometimes difficult, and the Institute will seldom satisfy every possible interest. Nevertheless, it is essential, in a truly national healthcare system, for there to be a single source of guidance to act a reference for patients and health professionals alike.

2.3 The Institute's guidance is prepared by the independent expert members of its advisory committees,[16] and the guideline development groups that operate through the National Collaborating Centres.[17] Although the Institute seeks the views of the relevant professions, patient/carer organisations, manufacturers and government, the work of its advisory committees is independent of any vested interests. All members are required to declare interests and any declarations are made public.[18] Where there are potential conflicts of interest, members withdraw from discussions. Full details of the Institute's committees and guideline development groups are published on the Institute's web site together with the minutes of their meetings.

2.4 Although there are methodological differences in the processes followed for the development of technology appraisal guidance and clinical guidelines, the Institute has taken care to ensure that each process is transparent, objective, inclusive, and offers adequate opportunity for consultation. This includes the submission of evidence from all stakeholder groups and the publication of preliminary versions of guidance on the Institute's public web site. Once completed, the Institute issues its guidance directly to the NHS and patients.

2.5 The Secretary of State's Directions to the Institute include a reference that ".. the Institute should have regard to any guidance from the Secretary of State or the National Assembly for Wales on the resources likely to be available and on other such matters as they see fit".[19]

The Institute has never received any such guidance but should any such advice be given its nature would be publicly available.

2.6 The Institute's processes are, of necessity, evolutionary. Within weeks of its establishment, the Institute had prepared Interim Guidance for Manufacturers and Sponsors for the Technology Appraisal Programme (December 1999), with the clear understanding that these this would be revised in the light of its early experience. In February 2001, the Institute's Board approved revisions to the appraisal process. The changes were developed following extensive public consultation and included:

— the addition of an initial "scoping" exercise, that involving involves all relevant stakeholders, to define the precise extent of the topic;

— improved guidance to stakeholders on the nature of the evidence they should submit;

— increased time for the preparation of evidence and for appeals;

— publication of the Appraisal Committee's preliminary and final conclusions.

2.7 The Institute has also improved the clarity of the Appraisal Committee's decision-making process by incorporating a "Consideration" section within its consultation and guidance documents. This acts as the link between the evidence quoted in the guidance document and the guidance itself.

2.8 The Institute holds all its formal Board meetings in public. They now take place in towns and cities across England and Wales, and attract an average of around 50 observers. The agenda and papers for the meetings are published on the Institute's web site and members of the audience are given an opportunity to comment, or ask questions, between each agenda item.

2.9 The Institute is accountable to the Secretary of State for Health and to the Secretary of the Health and Social Service Committee in Wales. The relevant ministers appoint the chairman and non-executive directors. The Report of the Public Inquiry into Children's Heart Surgery at the Bristol Royal Infirmary 1984-1995 (Kennedy Report) suggested that the Institute should become a non-departmental public body (analogous to the Food Standards Agency) and independent of the Department of Health and the National Assembly for Wales. Whilst the Board supports the majority of the Report's recommendations, it does not believe that this particular measure would be appropriate. The Board is proud to be part of the NHS, and believes that its formal status as an NHS body has considerable benefits. First, the Board believes that remaining part of the NHS is critically important to the continuing confidence of health professionals and patient/carer groups in the Institute. Second, it enables the Institute to secure more readily the commitment and goodwill of NHS personnel involved in the development of NICE's guidance. Third, it allows the Institute to be closely aligned to the implementation of the advice it gives. What is most important, in securing the Institute's independence, is for its advice to be insulated from inappropriate stakeholder influence. The Institute and its advisory bodies firmly believe that this is the case.

2.10 Recommendations

Whilst the Institute seeks to remain part of the NHS, there are measures that would enhance the Institute's independence, and improve its efficiency.

2.10.1 The Board wishes its work programme to be constructed in a more open and inclusive manner. In particular, there is insufficient opportunity for NHS staff to propose either appraisal or clinical guideline topics. This is important because clinicians and those who work with them will often be the best judges of where the need for guidance is greatest.

2.10.2 The appointment of the Chief Executive is subject to prior ministerial agreement. The Institute suggests that responsibility for appointment to this post be devolved to the Board. The appointment of non-executive members must, of course, continue to remain with Ministers.

2.10.3 Powers to establish, or disestablish, committees of the Institute should (with the exception of those necessary to comply with NHS corporate governance arrangements) rest solely with the Institute's Board.

2.10.4 At present, the members of the Partners Council and the Appraisal Committee are subject to approval by the Secretary of State and the National Assembly for Wales. Although to date, no such agreement has been withheld, the Institute believes that the responsibility for these appointments should be devolved to the Board.

2.10.5 The Institute considers that its independence would be further enhanced if it was to be required to make an annual report to Parliament. This would be in addition to its existing annual report and accounts.

3. PROVIDING CLEAR AND CREDIBLE GUIDANCE[20]

3.1 The Institute's guidance is prepared by the independent expert members of its advisory committees and guideline development groups. Members are drawn from the NHS, patients/s and carers, and from academia, and although they seek the views of the Institute's stakeholders (the professions, patient and carer organisations, manufacturers and government) their advice is independent of any vested interests. Additional experts, nominated by patient/carer and professional bodies, inform individual technology appraisals.

3.2 The evidence used by the Appraisal Committee is formed from submissions received from patient/carer organisations, professional bodies and manufacturers in addition to a systematic review of the published literature and appropriate unpublished data. An independent academic group, commissioned by the National Coordinating Centre for Health Technology Assessment, prepares this systematic review for the committee. The Coordinating Centre is a part of the NHS Research and Development programme. The independence and objectivity of this systematic review supports the integrity and credibility of the Institute's guidance.

3.3 Although there are differences in the development of technology appraisal guidance and clinical guidelines, the Institute has taken care to ensure that each process is transparent, objective, inclusive, and offers adequate opportunity for consultation. This includes the submission of evidence from all stakeholder groups and the publication of preliminary versions of guidance on the Institute's public web site.,[21][22]

3.4 NICE has also established two units to support the work of the National Collaborating Centres:

— The National Guidelines and Audit Patient Involvement Unit, which provides advice on patient/carer involvement, and support and training for patients and carers involved in guideline and audit development. The Institute intends to extend the remit of the unit to cover the technology appraisals programme.

— The National Guidelines Support and Research Unit, which provides advice on methodological issues, training and education for the National Collaborating Centres, and undertakes research to increase understanding of methodological aspects of guidelines.

3.5 The Institute's guidance is based, primarily, on clinical need (in relation to the nature and prognosis of the underlying condition, and the effectiveness of current treatment options) and on the best available evidence of clinical and cost effectiveness. Evidence of clinical effectiveness is, ideally, derived from the results of randomised clinical trials but other approaches are necessary where such data is are lacking. Considerations of cost effectiveness are derived from estimates of increased longevity or improved quality of life. The Institute's approach to interpreting evidence is considered robusts[23] The balance between clinical and cost effectiveness is, necessarily, based on the judgements of the Institute's advisory committees and NICE has deliberately avoided defining a cost effectiveness "threshold".

3.6 Although the Institute's guidance is intended only for the NHS, it has become clear that it the Institute's guidance is being used as a benchmark by organisations providing private care. The Board is also aware that NICE's work is watched, assiduously, by many health care providers in Europe, North America and Australia. The Institute is also aware that the medical defence organisations place considerable weight on the status of its guidance.

3.7 NICE currently disseminates its guidance to the NHS, and stakeholders, using a variety of methods, including paper-based systems, electronic media and partnerships with stakeholder organisations. The strategy is to send key information to those with a responsibility to deliver the Institute's guidance, allowing more detailed information to be drawn as required from the Institute's web site.

3.7.1 Publication and distribution of conventional printed material is currently the Institute's principal method of dissemination. Each item of guidance is published with corresponding patient text,[24] and a summary compilation (currently published bi-annually) is produced.[25] In 2000-01 more than 1.5 million documents were printed and circulated to the NHS in England and Wales and to patient/carer organisations. The Institute's guidance is included in summary form in standard clinical reference texts and is available free of charge from the NHS response line. In addition, the Institute's copyright arrangements are such that publications may be freely reproduced for educational purposes within the NHS.

3.7.2 From the outset the Institute recognised the importance of web technology and there are around 15,000 visits per day to its web site.[26] This rises to 30-40,000 visits per day when guidance of special interest is issued. During the past 12 months, over 500,000 copies of the Institute's guidance have been downloaded. NICE's web site is fully searchable, it provides access for Braille readers, translation devices and auto-readers, and a text-only facility ensures that high-visibility, on-screen requirements are met. There is also a Welsh language framework and Welsh versions of patient/carer documents are available.

3.7.3 NICE guidance is also available from NHS Direct Online and the National Electronic Library for Health, through PRODIGY and in other standard clinical reference texts. A number of NHS intranets host copies of the Institute's guidance, and many commercial, public and private sector sites provide links to NICE guidance. NICE is in discussion with the NHS Direct Digital TV pilot to determine the most appropriate way to disseminate guidance through this medium.

3.7.4 The Institute has sought to achieve significant, and accurate reporting of its guidance by the media. This includes the professional press (UK and international), public media sources, and specialist health and general lifestyle magazines.

3.7.5 A recent survey[27] conducted for the pharmaceutical industry revealed that:

— 70 per cent of doctors rated the clarity of NICE appraisals above the mid-point (5) in a 9-point scale where 1 was "not at all clearly" and 9 was "very clearly".

— 60 per cent of doctors scored above the mid-point scale when asked to rate their personal understanding of NICE appraisals (where 1 was "not at all well" and 9 was "very well").

3.8 The Institute's work has gained an international reputation and the organisation has been visited by government agencies and academic institutions from all over the world. What marks NICE out as different from most, if not all, comparable organisations is the strength of its association with its home health care system and the robustness and openness of its processes. To date, 17 companies, in 10 countries (from Europe, the Middle East, Australasia, the Americas, and the Far East) have purchased over 100,000 reprints of the Institute's guidance for use by health professionals. In addition, the Institute is regularly approached to provide international copyright clearance on its guidance and process documents. These approaches are from government, clinical, academic and commercial organisations.

3.9 The Institute's senior team devotes substantial time to speaking at international, national, regional and local events, to a range of stakeholders. These events include conferences, meetings and other educational activities. NICE guidance is used in continuing professional development activities and the Institute is reviewing the extent to which its guidance forms a part of the undergraduate and postgraduate syllabuses of health professionals and how this might be developed.

3.10 NICE is perceived as being the cutting edge of health technology assessment, and it is expected that international agencies might adopt NICE recommendations. The NICE website (http://www.nice.org.uk) is a highly-visible, well-designed, and informative mode of dissemination.[28]

4. PROVIDING A SINGLE NATIONAL FOCUS

4.1 At the time NICE was established, there was no single national focus for clinical guidance in the NHS. Individual health authorities and trusts and regional bodies undertook health technology assessments and came to divergent conclusions, often giving rise to variations in service provision and referred to as "post-code prescribing". A number of groups, including professional organisations (some with support from the Department of Health), produced clinical guidelines of variable quality and without, in most instances, any attempt to incorporate cost effectiveness. Although it is not the only source of guidance, NICE is the only body with the credibility, resources, professional networks, and robust methodologies to provide a single national focus for developing clinical standards for the NHS.

4.2 The six National Collaborating Centres established by NICE follow the same rigorous methodology in the development of each piece of guidance. The Institute's contract with the Centres ensures compliance with an agreed process, which ensures that the guidance produced is of a consistent quality.

4.3 The Institute has brought together the work of PRODIGY, the National Centre for Clinical Audit, the National Guidelines Programme and Professional Audit Programme, and the publications of the National Prescribing Centre, Liverpool and the Centre for Reviews and Dissemination at York University.[29]

4.4 Recommendations

NICE currently is currently only able to cover, in its technology appraisals and its clinical guidelines programmes, a proportion of emerging and established health technologies and clinical conditions. The Institute strongly endorses the proposal, in the Kennedy Report, that NICE should be given the task of extending its programmes to cover the major areas of morbidity and mortality. The Board believes that a comprehensive suite of guidelines will secure for patients the quality of care they deserve. Such a programme will require several components if it is to be achieved:

4.4.1 The Institute would need to be provided with an increase in its funding. This will need to cover both the initial development of a "suite" of NHS guidelines and also their regular revision.

4.4.2 The Institute would have to embark on developing an increased national capacity for robust guideline construction. At present, expertise in all the elements of clinical guidelines is limited and, particularly in the area of cost effectiveness.

4.4.3 Whilst the Board believes that the responsibilities of the National Screening Committee, the Safety and Efficacy Register of New Interventional Procedures (SERNIP) and the Joint Committee on Vaccination and Immunisation should fall within the scope of the Institute, some areas that will need to remain with other agencies which issue guidance to clinicians (eg Medicines Control Agency, Medical Devices Agency, Human Fertility and Embryology Authority). Nevertheless, the Institute would need to ensure that consistent advice is provided for NHS health professionals and their patients.

5. PROVIDING LOCALLY OWNED GUIDANCE ACTED ON IN THE RIGHT WAY

5.1 Getting nationally developed clinical guidelines in use at a local level requires cooperation right across the health system and a number of conditions need to exist for it to occur successfully. Some are within the Institute's remit and some are not. The main conditions are:

5.1.1 an acceptance of the value of clinical practice guidance by health professionals and therefore a desire to use them;

5.1.2 a commitment by the health system to use clinical guidelines and technology appraisals as a formal standard-setting mechanism;

5.1.3 local systems to actively lead and support implementation;

5.1.4 sufficient resources (funds, people, facilities and equipment) for the guidance to be implemented;

5.1.5 credible and robust guidance, based on the best available evidence, that has involved, in its development, representatives of the people for whom it has been written;

5.1.6 clear presentation and effective dissemination.

The Institute has a deep interest in promoting the first four of these but direct responsibility only for the last two. Some of the ways in which NICE is tackling these two responsibilities are set out below and in section 3 of this document.

5.2 In the technology appraisals programme, two health authorities (and, following the re-organisation in April 2002, two primary care organisations) are invited to act as consultees for each appraisal. They are therefore involved in the initial "scoping" phase, as well as formally commenting on the Appraisal Consultation Document and the Final Appraisal Determination. Over time, all primary care organisations and hospital trusts will have the opportunity to become involved. A similar arrangement will ensure that local NHS bodies are involved in the development of clinical guidelines. Additionally, primary care organisations and hospital trusts involved in the development of guidelines will be asked to act as implementation pilots, enabling the Institute to gather information on the implementation challenge that its guidelines will present to the NHS. This will help NICE to develop local implementation protocol templates (point 5.5 below).

5.3 In the technology appraisals programme, local geographical ownership is also accomplished to some extent by striving to ensure regional representation amongst the membership of the Appraisal Committee.

5.4 Professional ownership of NICE guidance is provided, in the technology appraisal programme, by inviting relevant organisations to act as formal "consultees" and invited to nominate clinical experts to join the Appraisal Committee; and by ensuring that the membership of the Appraisal Committee is comprised of experts in whom health professionals have full confidence.

5.5 Local geographical ownership of the clinical guidelines programme is being accomplished by encouraging the development of "integrated care pathways". Thus, whilst a clinical guideline will advise on what measures should be adopted in the management of a particular condition, the locally -constructed pathway offers flexibility in how the guideline's goals can best be best achieved (eg which health professionals should undertake each specific task). To facilitate this, model integrated care pathway "templates" will be prepared by NICE for each clinical guideline.

5.6 Professional ownership of NICE clinical guidelines is further supported by the Institute's policy of devolving responsibility for guideline construction to the relevant National Collaborating Centre. That these multi-disciplinary organisations are collaborations of appropriate professional bodies should heighten confidence in the guidance they produce.

5.7 Some forms of the Institute's advice, such as the recently published "Referral Advice,[30]" have been deliberately developed to be the subject of local adaptation to ensure appropriate flexibility in their implementation.

5.8 The extent to which NICE guidance is appropriately implemented is of obvious concern to the Institute. Guidance that is either not implemented, or not implementable, is clearly valueless. Whilst there is evidence that some of the Institute's technology appraisal guidance has been rapidly been adopted by clinicians, there have been instances where NICE's advice has been implemented more slowly. In most cases, this has been because some health authorities or trusts, have been reluctant to make the necessary resources available. The Institute therefore welcomes the recent direction to health authorities in England to ensure that funding arrangements to be put in place within three months of the dissemination of NICE technology appraisal guidance.

5.9 The Institute has sponsored (through the National Prescribing Centre) the production and publication of A Guide to Implementing NICE Guidance[31]. This text, developed following extensive discussions with a wide range of experienced health professionals in health authorities and NHS trusts, has been warmly welcomed by clinical governance leads across England and Wales.

5.10 Much of what is said about the way in which the NHS has responded to the Institute's guidance is anecdotal. A number of limited surveys have been conducted on specific pieces of guidance, but only the Institute itself has launched substantial and independent formal research into the implementation of its work. This is the York University project, which is led by Professor Trevor Sheldon. Until the York project team reports, in summer 2002, the only public sources of data available to monitor how the NHS has responded to the Institute's guidance are, generally, insufficiently specific to enable accurate tracking of changes in the use of individual technologies. The Department of Health does ask NHS organisations whether they have implemented NICE guidance and it is understood that the response is overwhelmingly positive. Some of the results of the surveys and other work on the implementation of NICE guidance are quoted elsewhere in this submission and set out in Appendix K.[32]

5.11 An independent survey[33] of health authorities in England and Wales, commissioned by CancerBACUP, suggests the following.

5.11.1 The majority of health authorities (80 per cent) have a written policy for assessing the clinical and financial implications of implementing NICE guidance; 65 per cent have a written policy for disseminating NICE guidance locally, whilst others follow existing national dissemination practice. Just under half, 47.5 per cent, have a policy for monitoring compliance with NICE guidance.

5.11.2 NICE guidance on the use of taxanes for breast and ovarian cancer, issued in the summer of 2000, is being funded and implemented more fully than guidance issued more recently on a number of other treatments. More than 90 per cent of suitable patients with breast cancer are offered the option of treatment with a taxane. Nearly 90 per cent of suitable ovarian cancer patients are offered treatment with paclitaxel. Ring-fenced funds have been made available for these treatments by the majority of health authorities.

5.11.3 In the case of treatments other than taxanes for breast and ovarian cancer, the majority of health authorities have not set aside specific funds for treatments recommended by NICE. A minority of health authorities do not know whether patients are being offered these treatments.

6. PROVIDING (PROMOTING) FASTER ACCESS TO TREATMENTS

6.1 There is a substantial body of evidence to show that, for a variety of reasons, patients are denied access to treatments of proven clinical and cost effectiveness both in the United Kingdom and in other developed countries. NICE cannot, on its own, provide faster access to treatments but the Institute does have responsibility to promote effective treatments so that NHS patients benefit from the results of medical research. Between March 1999 and December 2001, NICE has published 31 technology appraisal guidance documents (reference Table 1) covering more than 87 researchable subjects. It has been independently argued that, generally, where NICE recommends the use of a technology it will lead to faster and more uniform access to these technologies rather than to a deny denial of access.[34]

Table 1

REVIEW OF COMPLETED APPRAISALS MARCH 2000—DECEMBER 2001

	Total Appraisals	Routine Use	Selective Use	Research use only	Appeals
Pharmaceuticals	21	6	15	0	5
Devices	5	1	4	0	3
Diagnostics	1	0	0	1	0
Procedures	4	0	2	2	1
Health Promotion	0	0	0	0	0
Total	31*	7	21*	3	9*

* Includes review of taxanes for breast cancer.

6.2 In the future, in order to ensure that "post-code" variation in availability does not re-emerge and that patients have early access to new important technologies, NICE is anxious to publish appraisals of significant novel health technologies as soon as possible after licensing (eg within three months). For pharmaceuticals and medical devices, this would involve starting the appraisal process around the time of submissions for marketing authorisation.

6.3 The pharmaceutical industry has expressed concerns that NICE would find it difficult to appraise new medicines until these had been licensed for two to three years. The Institute does not, in general, accept this.

6.3.1 Delays in appraising new technologies generally, and pharmaceuticals in particular, deny NHS patients access to significant novel remedies, creates confusion amongst NHS organisations about how they should respond to their introduction and leads to the re-emergence of post-code prescribing.

6.3.2 The Institute's experience over the past 20 months also shows that the pharmaceutical industry's fears are unfounded. During this period NICE has published appraisals of 12 pharmaceutical products licensed within the previous two to three years (Table 2). In all cases it was possible to evaluate their clinical and cost effectiveness; in only two instances did a manufacturer appeal against the Final Appraisal Determination; and for at least six products the result of the Institute's appraisal has been used in manufacturers' promotional literature.

Table 2

APPRAISALS CONDUCTED ON PHARMACEUTICALS WITHIN 2 YEARS OF LICENSING

Drug	Appeal	Use of NICE guidance in Company Marketing
Ribavirin	No	Not known
Zanamivir	No	Not known
Tirofiban	No	Not known
Eptifibatide	No	Not known
Rosiglitazone	No	Yes
Galantamine	No	Yes
Pioglitazone	No	Yes
Temozolamide	No	Not known
Celecoxib	Yes	Yes
Relicoxib	Yes	Yes
Topetecan	No	Not known
Sibutramine	No	Yes

6.3.3 The pharmaceutical industry has also expressed concerns that the appraisal process will lengthen the development time for new medicines. Technology appraisals take, overall, about 12 months (including the time for preparation of submissions by consultees, and the additional time for possible appeals). This period is essential for consultees to be given adequate time to produce their submissions, for gathering evidence, for the Appraisal Committee to consider the evidence, and for all parties to have an opportunity to comment on the Committee's emerging conclusions. Indeed, under the revised appraisal procedure, the time-scales for appraisals have been increased at the request of stakeholders who have engaged in the appraisal process, including the pharmaceutical industry.

6.3.4 Early appraisals will, however, sometimes be controversial. There is, in Britain, a degree of therapeutic conservativism that has already been manifest in relation to some of NICE's completed appraisals (eg zanamivir, glycoprotein IIb/IIIa inhibitors, sibutramine). The conclusions of the Appraisal Committee depend, ultimately, on the collective judgement of its members. The Board, however, believes that the Appraisal Committee should invariably draw conclusions that are in the best interests of patients.

— In the case of zanamivir, the Committee was persuaded that, whilst the evidence was not overwhelming, it was sufficient to indicate that the serious complications of influenza in elderly people and others at risk would be lessened by early treatment. This would not only prevent some deaths but also obviate the need for admission to hospital during a time when the secondary sector is fully stretched.

— With the glycoprotein IIb/IIIa inhibitors, some commentators concluded the advice to be premature (despite support for the Appraisal Committee's conclusions from professional organisations). More recent studies have confirmed that the Committee's conclusions were, indeed, correct.

Drug and Therapeutics Bulletin

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6.4 Recommendations

6.4.1 The Institute should be routinely commissioned to undertake reviews of technologies at an early stage in their development to enable guidance to be issued to the NHS at or shortly after they become available for use in the NHS.

January 2002

1 Raftery, J. BMJ 2001;323:1300-1300. 01.12.01. Back

2 Department of Health. September 1998. Back

3 Framework Document (Appendix A. Back

4 Technology Appraisal Process Series (Appendix B). Back

5 The Guidelines Development Process Series (Appendix C). Back

6 Membership of Advisory Committees (Appendix D). Back

7 Code of C conduct (Appendix E). Back

8 Topics of Technology Appraisal Guidance published & in progress (Appendix F). Back

9 Topics of Clinical Guidelines published & in progress (Appendix G). Back

10 Audit projects-complete and in progress. (Appendix H). Back

11 Referral Advice-A guide to appropriate referral from general to specialist services (Appendix I). Back