National Institute for Health and Clinical Excellence

Overview
The National Institute for Health and Clinical Excellence or NICE is a Special Health Authority of the National Health Service in  England and Wales. It was set up as the "National Institute for Clinical Excellence" in 1999, and on 1 April 2005 joined with the Health Development Agency to become the new "National Institute for Health and Clinical Excellence" (still abbreviated as NICE).

NICE publishes clinical appraisals of whether particular treatments should be considered worthwhile by the NHS. These appraisals are based primarily on cost-effectiveness.

NICE was established in an attempt to defuse the so-called postcode lottery system of healthcare in England and Wales, where treatments that were available depended upon the NHS Trust area in which the patient happened to live. However its role in rationing treatment has led to NICE becoming a very controversial body.

The Scottish equivalent (formed earlier in 1993) is SIGN: the Scottish Intercollegiate Guidelines Network. NICE and SIGN often work together, to avoid duplicating guidelines.

Technology appraisals
Since January 2005 the NHS in England and Wales has been legally obliged to provide funding for medicines and treatments recommended by NICE's technology appraisal board. This is at least in part as a result of well-publicised "postcode lottery" scandals in which certain treatments are funded in one part of the UK but not in another.

If a technology is to be appraised by NICE then it must be referred to them by the Secretary of State for Health. Once this has been done NICE works with the Department of Health to draw up the scope of the appraisal.

NICE then invite "consultee" and "commentator" organisations to take part in the appraisal. A consultee organisation would include patient groups, organisations representing health care professionals and the manufacturers of the product undergoing appraisal. Consultees submit evidence during the appraisal and comment on the appraisal documents. Commentator organisations include the manufacturers of products to which the product undergoing appraisal is being compared. They comment on the documents that have been submitted and drawn up but do not actually submit information themselves.

An independent academic centre then draws together and analyses all of the published information on the technology under appraisal and prepares an assessment report. This can be commented on by the Consultees and Commentators. Comments are then taken into account and changes made to the assessment report to produce an evaluation report. An independent Appraisal Committee then looks at the evaluation report, hears spoken testimony from clinical experts, patient groups and carers. They take their testimony into account and draw up a document known as the appraisal consultation document. This is sent to all consultees and commentators who are then able to make further comments. Once these comments have been taken into account the final document is drawn up called the final appraisal determination. This is submitted to NICE for approval.

The process aims to be fully independent of government and lobbying power, basing decisions fully on clinical and cost-effectiveness. There have been concerns that lobbying by pharmaceutical companies to mobilise media attention and influence public opinion are attempts to influence the decision making process. A fast-track assessment system has been introduced to reach decisions where there is most pressure for a conclusion.

Clinical guidelines
NICE carries out assessments of the most appropriate treatment regimes for different diseases. This must take into account both desired medical outcomes (i.e. the best possible result for the patient) and also economic arguments regarding differing treatments.

NICE have set up several National Collaborating Centres who draw up the boundaries of the guideline, i.e. what it will cover. The National Collaborating Centre then appoints a Guideline Development Group whose job it is to work on the development of the clinical guideline. This group will consist of medical professionals, representatives of patient and carer groups and technical experts. They work together to asses the evidence for the guideline topic (e.g. clinical trials of competing products) before preparing a draft guideline.

There are then two consultation periods in which stakeholder organisations are able to comment on the draft guideline. After the second consultation period an independent Guideline Review Panel reviews the guideline and stakeholder comments and ensures that these comments have been taken into account.

The Guideline Development Group then finalises the recommendations and the National Collaboration Centre produces the final guideline. This is submitted to NICE who then formally approve the guideline and issues this guidance to the NHS.

Criticism
The work that NICE is involved in attracts the attention of many groups, including doctors, the pharmaceutical industry, and patients. Some health sector workers have come up with an alternative meaning: National Institute for Clinical Economy, in reference to the businesslike working practices or National Institute for Cutting Expenses referring to its perceived refusal to sponsor expensive treatment during the NHS budget crisis circa 2006-.

NICE is often associated with controversy, because the need to make decisions at a national level can conflict with what is (or is believed to be) in the best interests of an individual patient, and because there is an inherent need for rationing in the NHS. From an individual's perspective it can sometimes seem that NICE is denying access to a potentially life-saving treatment.

NICE has been criticised for its over-reliance on evidence-based medicine, which it is argued privileges certain kinds of econometrically derived types of studies over others. NICE has also been criticised for being too slow to reach decisions.

Some of the more controversial NICE decisions have concerned beta-interferon for multiple sclerosis, imatinib (Glivec) for leukaemia, and trastuzumab (Herceptin) for breast cancer.