NICE: guessing is not guidance. (Viewpoint).(National Institute for Clinical Excellence)

A preliminary assessment of the extent to which the National Institute for Clinical Excellence (NICE) has achieved its goals within cardiovascular medicine is presented. NICE is a government sponsored agency operating in the UK which attempts to assess the value of medical therapies, devices, and surgery for a wide range of medical and surgical problems. Its recommendations determine whether a particular therapy can be adopted in the National Health Service.

The creation of the National Institute for Clinical Excellence (NICE) was a timely initiative, setting up a body which would make recommendations to those working in the National Health Service and elsewhere on the effective use of current treatments. Treatments were to include drugs, devices, and interventional procedures including surgery. Until now the use of drugs or devices has been largely controlled by the Committee for the Safety of Medicines (CSM), the Medicines Control Agency (MCA), and the Medical Devices Agency (MDA). Pharmaceutical companies submitted evidence, usually from clinical trials, to these bodies whose role was to assess the benefit to patients before approving a drug and granting a licence. Device companies followed a somewhat similar procedure. The introduction of new surgical techniques or innovative operations was not overseen and was in effect managed by the medical profession itself. An objective of NICE was to move away from the simple demonstration of efficacy (effects in clinic al trials) towards effectiveness (effects in clinical practice within the community) and to efficiency (cost effectiveness). That was and is a laudable objective.

NICE (www.nice.org.uk) criticises published guidelines arguing that they vary in quality and can be opinionated, biased, and contradictory and take little account of effectiveness or efficiency. NICE states: "NICE guidelines are based on the best available research evidence and expert professional advice. They take into account both clinical effectiveness and cost effectiveness, and must be practical and affordable." On the back of the cover page of documents entitled "Technology appraisal guidance" it is stated: "This guidance represents the view of the Institute's Appraisal Committee . . .. Health professionals are expected to take it fully into account when exercising their clinical judgement ... This guidance does not however override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer."

NICE has now issued 16 technology appraisal guidance documents (15 numbered plus the first on Zanamivir in October 1999). Three of these documents are relevant to cardiovascular medicine, namely those on stents (document 4), implantable cardioverter-defibrillators (ICDs) (document 11), and glycoprotein IIb/IIIa inhibitors (document 12). A preliminary assessment of the extent to which NICE has achieved its goals within cardiovascular …