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How NICE makes decisions on treatments and drugs

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Author Kathryn Godfrey, BSc, is clinical editor, Nursing Times.

NICE recommendations can be controversial. Kathryn Godfrey explains why NICE was originally set up and its role in making decisions about individual drugs and treatment.

The National Institute for Health and Clinical Excellence, commonly known as NICE, has the job of deciding which drugs and treatments can be provided on the NHS in England and Wales. Using the expertise of doctors, nurses, patients and carers, it also produces evidence-based guidance that is designed to help healthcare professionals promote good health and prevent and treat ill health.

NICE was established in 1999 with one of its main aims being to tackle the ‘postcode lottery’ of healthcare, that is, when the availability of treatment is dependent on where the patient happens to live. Originally set up as the National Institute for Clinical Excellence, it merged with the Health Development Agency in 2005. NICE is a special health authority, which is accountable directly to the NHS chief executive and the health secretary. Its chairperson is a clinical pharmacologist, Professor Sir Michael Rawlins, and the chief executive is former trust chief executive, Andrew Dillon.

Although specifically focused on England and Wales, NICE does have indirect influence on the rest of the UK. In 2006 the Department of Health, Social Services and Public Safety (HPSS) in Northern Ireland decided to link to NICE. The HPSS now studies any guidance issued by NICE and decides if it should be accepted for Northern Ireland.

In Scotland the equivalent body is the Scottish Medicines Consortium (SMC), which conducts appraisals of new drugs. It tends to report more quickly than NICE, whose appraisals are more in depth. If a later appraisal by NICE comes to a different conclusion than that of the SMC then the NICE guidance will usually be adopted in Scotland.

With regard to producing clinical guidelines, the Scottish equivalent is the Scottish Intercollegiate Guidelines Network (SIGN). In order to avoid duplicating guidelines, the two bodies – NICE and SIGN – work together.

Areas of activity
NICE has four main areas of activity in the NHS in England and Wales. The first, and the one that causes the most controversy, is producing guidance on the use of new and existing treatments in the form of technology appraisals. The appraisals look at the evidence regarding the clinical and cost effectiveness of a treatment and recommend whether, and in what circumstances, it should be used in the NHS. The appraisals mainly cover drugs but they do also cover other areas such as procedures, medical devices and screening.

The second is to produce guidance on the care and treatment of specific conditions in the form of clinical guidelines.

The third area covered is interventional procedures that consider whether particular diagnostic or treatment procedures are safe and effective for routine use.

NICE also produces guidance on the promotion of good health and the prevention of ill health but these only apply in England.

Anyone can propose a subject for all of the NICE work programmes. Healthcare professionals and members of the public can email suggested topics to NICE, although the final decision about what it addresses is determined by the Department of Health and the Welsh Assembly.

Technology appraisals
Each technology appraisal takes around 12–18 months and is undertaken by a committee of some 15–20 experts, which includes clinicians, academics, researchers, managers and patient representatives.

When developing guidance NICE takes into account both clinical evidence and cost effectiveness. As part of the process, the committee asks
for expert advice and opinion from health professionals, patients and patient organisations, as well as from pharmaceutical companies.

Who should use the guidance Healthcare professionals are expected to take NICE guidance into account when deciding how patients should be cared for. This was not the case in the early years of NICE – at this time the situation was unclear, with some trusts continuing to argue that they could not afford those treatments recommended by NICE, thereby continuing the postcode lottery.

However, since January 2002, trusts in England and Wales have been expected to provide funding for treatments recommended in technology appraisals within three months of the guidance bring published. Despite this target, there is still some variation in the speed of implementation.

Doctors can go against NICE recommendations if they feel that an individual case warrants it. The Medical Defence Union advises its members that the guidance can be rejected if the decision taken is ‘reasoned and reasonable’ and advises that the rationale should be documented in the patient’s notes.

Controversial decisions
In the past a major criticism of NICE has been that it takes too long to approve new drugs and treatments and, for some patients, particularly those with life-threatening or terminal disease, that delay is unacceptable. More recently NICE has started fast-tracking appraisals of specific treatments. It now looks at some drugs while they are still in the licensing stage, rather than waiting until after they are licensed. This enables NICE to make a decision shortly after a drug has been licensed.

The NHS does not have limitless resources and NICE is involved in the management of these by considering the cost-effectiveness of various treatments. Inevitably patient groups feel strongly and lobby hard when treatments are not made available. This occurred with one of NICE’s earliest decisions in 2000 when it decided not to recommend beta-interferon for patients with multiple sclerosis.

In 2002 another treatment received media coverage: NICE draft guidance suggested that the drug imatinib would be limited to people in the advanced stages of chronic myeloid leukaemia. However, by the time the full guidance came out its use had been extended to all stages of the disease.

The trastuzumab (Herceptin) case is the one that has had the most press coverage. After heavy lobbying by patients and pharmaceutical companies, the then health secretary Patricia Hewitt announced during the appraisal process that Herceptin would be made available to women with early breast cancer who could benefit from it. NICE went on to recommend Herceptin in August 2006.

NICE has only made an outright decision not to recommend a treatment on a handful of occasions. Most recommendations from technology appraisals provide a restricted yes, allowing drugs or treatment to be used for a specific subset of patients.

However, although many may feel that NICE guidance is excluding them from the treatments they need, a recent report suggests that NICE may, in fact, be allowing more treatments through than the NHS can afford.

In evidence that was submitted to the House of Commons select committee enquiry on NICE this year (Appleby et al, 2007) a joint report by City University and the King’s Fund said that the body may be judging value for money at too high a level, compared with other treatments within the NHS. NICE uses a variety of economic equations in order to judge whether a treatment is cost-effective, including a Quality Adjusted Life Year (QALY), which indicates the benefits gained from treatments and drugs in terms of quality of life and survival. The report authors suggest that NICE may be setting its QALY level too high.

NICE has to make some controversial decisions about funding treatments. These may not be popular with the public but its remit is to provide guidance as to the best possible care based on current evidence.

Nurses need to be aware of this function when they are implementing guidance, talking to patients about their care and also when they are reviewing their practice against NICE guidance. This supplement will explore how nurses can become involved in the development of NICE guidance or implementing guidance to assess, improve and challenge existing practice.

Appleyby, J. et al (2007) NICE’s cost-effectiveness threshold. British Medical Journal; 335: 358–359.

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