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Introduction
The National Institute for Clinical Excellence (NICE) offers health professionals in England and Wales advice on providing NHS patients with the highest attainable standards of care. 1 NICE gives guidance on individual health technologies, the management of specific conditions, and the safety and efficacy of interventional diagnostic and therapeutic procedures. Guidance is based on the best available evidence. The evidence may not, however, be very good and is rarely complete. Those responsible for formulating the NICE's advice therefore have to make judgments both about what is good and bad in the available science (scientific value judgments) and about what is good for society (social value judgments). In this article we focus on the scientific and social judgments forming the crux of the institute's assessment of cost effectiveness. Scientific value judgments and those relating to clinical effectiveness are considered elsewhere. 2
NICE's approach to economic evaluation
On its own, clinical effectiveness is insufficient for maintaining or introducing any clinical procedure or process. Cost must also be taken into account. When good evidence exists of the therapeutic equivalence between two or more clinical management strategies, the cheaper option is preferred (box 1).
Incremental cost effectiveness ratio
However, in most instances NICE is confronted with a clinical management strategy that is better than current standard practice but which costs more. NICE must then decide what increase in health (compared with standard practice) is likely to accrue from the increase in expenditure. This is the incremental cost effectiveness ratio. Such ratios can be expressed in many ways. NICE's preferred measure is the cost per quality adjusted life year (QALY), but if appropriate data on quality of life are not available, it uses alternatives such as the cost per life year gained.
Box 1: Cost minimisation
Oral and intravenous fludarabine are equivalent as second line treatments for chronic lymphatic leukaemia. 3
The total (acquisition plus administration) costs over four cycles are £3000 (£2700+£300) for oral administration and £5300 (£2700+£2600) for intravenous administration. Thus using oral fludarabine rather than intravenous saves £2300 over four cycles and the oral formulation is preferred.
NICE rejects the use of an absolute threshold for judging the level of acceptability of a technology in the NHS for four reasons:
There is no empirical basis for...