Commentary: A clinical challenge

The creation of the National Institute for Clinical Excellence (NICE) in 1999 put the English NHS in a leading role in setting healthcare priorities.1 Although Australia, New Zealand, and Canada have systems that judge the cost effectiveness of drugs,2–4 they do not assess other health technologies. Bodies similar to NICE are reportedly being established in other countries, notably Germany5 and France.6 By April 2005, NICE had published 86 guidances on the use of health technologies and 39 guidelines on the treatment of diseases. It has received several generally favourable reviews from independent agencies including the House of Commons Health Committee,7 the World Health Organization,8 and independent academics.9 NICE appraises the clinical and cost effectiveness of health technologies referred to it by the Department of Health. This is different from a scientific assessment and synthesis of the evidence, which is subcontracted to independent academic groups. The two NICE committees appraise this often incomplete evidence. The committees rely on the judgments of their members, who comprise clinicians, health scientists, managers, and patient representatives. NICE's recommendations are issued in the form of mandatory guidance to the NHS.10 It started controversially by recommending against the use of zanamavir, an antiviral drug for flu. However, reviews of the guidances issued in the first years show that few recommendations can be classified as simply yes or no.11–14 Despite suggestions to the contrary,11 13 15 NICE has repeatedly stated that it does not have a threshold at which cost effectiveness becomes unacceptable. However, it has clarified that when the cost per quality adjusted life year (QALY) is above £20 000 (€29 000; $37 000), “Judgements about the acceptability of the technology as an acceptable use of NHS resources are more likely to make …