The National Institute of Clinical Excellence (NICE) was established as a Special Health Authority in April 1999 to promote clinical excellence and the effective use of resources within the NHS.

It is part of the NHS, but an independent organisation responsible for providing national guidance on treatments and care for people using the NHS in England and Wales.

Guidance is developed using the expertise of the NHS and the wider healthcare community including NHS staff, healthcare professionals, patients and carers, academics and industry. NICE encourages interested parties to register as stakeholders for the development of clinical guidelines and health technology appraisals.

Clinical guidelines
NICE guidelines are recommendations on the appropriate treatment and care of people with specific conditions or diseases. They can also be used to develop standards to assess the clinical practice of health care professionals, to educate and train medical staff and to help patients make informed decisions.

How does NICE develop its clinical guidelines?
The Secretary of State for Health and the Welsh Assembly Government refer guideline topics to NICE. These topics are published on NICE’s website and stakeholder organisations are invited to register their interest in individual guidelines.

NICE has established a number of National Collaboration Centres (NCCs) to utilise the expertise of the Royal Medical Colleges, professional bodies and patient/carer organisations when developing guidelines. There are currently seven National Collaboration Centres. The NCC for Acute Care is based at the Royal College of Surgeons; the NCC for Cancer is based at the Velindre NHS Trust in Cardiff; the NCC for Chronic Conditions is based at the Royal College of Physicians in London; the NCC for Mental Health is jointly led by the British Psychological Society and the Royal College of Psychiatrists; the NCC for Nursing and Supportive Care is based at the Royal College of Nursing; the NCC for Primary Care is based at the Royal College of General Practitioners; and the NCC for Women’s and Children’s Health is based at the Royal College of Obstetricians and Gynaecologists.

NICE commissions the appropriate NCC to develop the guideline. The NCC develops a scope - a document outlining what the guideline will or will not cover - and invites comments from registered stakeholders. The NCC then establishes a guideline development group (GDG) comprising healthcare professionals, lay representatives and technical experts. The GDG assesses the evidence available and makes recommendations. These form the core of the guideline.

Once a draft guideline has been developed, registered stakeholders have two opportunities to comment. They have the opportunity to comment on the draft guidance for the NHS (a shortened version of the guideline) and on the full guideline containing all the evidence considered. The Guideline Review Panel also reviews the guideline to ensure comments by stakeholders have been addressed. These panels have been set up by NICE and are aligned with one of the NCCs. They are responsible for validating the full guideline.

Following the consultation period, the GDG finalises the recommendations and the NCC produces the final version of the guideline. The NCC then submits the guideline to NICE for formal approval. NICE formally approves the guideline and issues its guidance. It takes NICE between 18 and 24 months to develop a guideline.

Technology appraisals
Technology appraisals are recommendations on the use of new and existing medicines and treatments within the NHS in England and Wales, such as medicine, medical devices, surgical procedures and health promotion activities. Since January 2002, the NHS has been legally obliged to provide funding and resources for medicines and treatments recommended by NICE as a part of its technology appraisals programme.

How does NICE develop technology appraisals?
The Secretary of State for Health and the Welsh Assembly Government formally refer a technology to NICE. NICE then invites registered stakeholders and other appropriate organisations to participate. These include national groups representing patients and/or carers, organisations representing healthcare professionals and manufacturers of the technology. Registered stakeholders are invited to submit evidence during the appraisal and to comment on the appraisal documents.

NICE commissions an independent academic centre through the NHS Research and Development Health Technology Assessment Programme to assess the published evidence on the technology and prepare an assessment report. Stakeholders and other appropriate organisations are then invited to comment on the report. The assessment and comments received are then put together along with the written submissions of evidence into an evaluation report.

An independent Appraisal Committee - composed of healthcare professionals working in the NHS and representatives of patient/carer organisations - meets to consider the evaluation report and verbal evidence from nominated clinical experts and patients and/or carers. The Committee produces preliminary recommendations based on the evidence in an Appraisal Consultation Document (ACD). Stakeholders and other appropriate organisations are invited to comment. The Committee considers comments received on the ACD and prepares its final recommendations (Final Appraisal Determination, FAD) for approval by NICE. NICE publishes the FAD on its website. Stakeholders and other appropriate organisations are entitled to appeal against the final recommendations contained in a FAD. If no appeals are received, the final recommendations are formally approved by NICE and become the basis of guidance for the NHS.

The BGS’ Role
The Society became a registered stakeholder organisation of NICE in 2001. Since then the Society has registered its interest in 36 clinical guidelines and 26 health technology appraisals. The Society has enjoyed mixed success in getting members on GDGs. It has been able to get members on GDGs developed by the NCC for Chronic Conditions, NCC for Primary Care and NCC for Nursing and Supportive Care. The Society has not been able to get members on GDGs developed by other NCCs. To date eight GDGs had BGS representation. A number of BGS members are also members of Appraisal Committees. Five BGS members have been invited by NICE to give expert evidence. The BGS’s work with NICE is co-ordinated by the BGS office, but is predominantly carried out by the SIGs and Sections. The Bladder and Bowel SIG, Cardiovascular Section, Cerebral Ageing and Mental Health SIG, Diabetes SIG, Drugs and Prescribing Section, Falls and Bone Health Section, Gastroenterology and Nutrition SIG, Parkinsons’ Disease and Respiratory Sections have all contributed to the development of guidelines and health technology appraisals.

Annette Guerda-Fischer
BGS London Office