JRSM >
Volume 96, Number 8 >
Pp. 372-373
LSE Health, Houghton Street, London WC2A 2AE, UK
1 London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E
7HT, UK
Hard choices have to be made about how the National Health Service spends its limited budget. The Government established the National Institute for Clinical Excellence (NICE) to examine interventions and advise on whether and to what extent they should be made available. The approach is explicitly technical with the recommendation depending on health gain, measured where possible as the number of quality adjusted life years (QALYs), in relation to the cost. However, as Smith has noted, there is more to rationing than simple technical considerations.2 Values also play a part, as they did in 1999 when a previous Health Secretary, faced with the potential consequences of the anti-impotence drug Viagra (sildenafil) for the allocation of funds in the NHS, issued guidance that it could only be prescribed for men with a specified list of disorders or after specialist assessment. This action was highly controversial.3 The European Union Transparency Directive4 says that any exclusion of a drug from a national health system requires a statement of reasons based on objective and verifiable criteria. Viagra's manufacturer, Pfizer Ltd, successfully challenged this decision in the English High Court.5 The court ruled on the basis of European law that a breach of the Transparency Directive had occurred as the Health Secretary had given no reasons based on objective and verifiable criteria. The court also expressed concern about the implications of the decision for clinical freedom.
In response to the ruling the Health Secretary issued new advice, which effectively restated the earlier restrictions but emphasized that they were simply advisory. This conceded that there were limits to the power of the Health Secretary to determine what the NHS would cover where, as with Viagra, detailed assessments of cost utility had not been undertaken. However, even this more limited position was challenged by Pfizer, again on the basis of the Transparency Directive. Pfizer argued that decisions about what to fund could be made on the basis of comparative cost-utility analysis, comparisons of health gain from interventions in different disease areas, and even specified a method for assessing utilities (contingent valuation). While this may at one level be seen simply as an attack on the basis for the Health Secretary's decision, it has wider ramifications because it indicates that the pharmaceutical industry may have conceded the value of the so-called fourth hurdle to which it had previously been opposed—namely, the requirement to show that new products are more cost-effective than existing ones.6 Although NICE appears to have adopted a benchmark whereby an intervention is likely to be recommended if it can deliver one QALY for less than about £30 0007 it has so far avoided explicit comparisons. The thrust of Pfizer's argument was that failure to undertake such an analysis precluded the Health Secretary from acting.
In November 2002 the Appeal Court ruled in favour of the Health Secretary,8 and in doing so established several important principles. The court held that the criterion of a ‘treatment's affordability in the context of competing priorities’ is a sufficiently objective and verifiable criterion on which to decide what should be funded, without the requirement to undertake a detailed technical analysis. It accepted that, while assessment of QALYs may assist in determining which treatments are cost-effective—showing, for example, whether a treatment for a particular condition that has a higher price is actually more cost-effective than a cheaper treatment because it is more efficacious—QALYs cannot ‘assist the Secretary of State in deciding which diseases or conditions should be regarded as the higher priorities in the NHS’. This is very important because the court has reiterated the point (noted by the House of Commons Health Committee9) that what should be paid for by the NHS is a political rather than a technical matter. The court also noted that the values underpinning such a decision could be made more explicit, referring to the Commons Health Committee's recommendation that the Government should specify a set of ethical and rational values to allow the ‘relative costs and benefits of different NHS spending to be comparatively assessed in an informal way’.9 However, it emphasized that this could be achieved only in the long term and, until this happened, NHS priorities should continue to be established on a political basis.
Successive governments have tried to distance themselves from decisions about what the NHS should pay for, sheltering behind complex technical arguments. It would be surprising if the present government wished this position to change; therefore, ministers may hope that the court's ruling will remain largely unnoticed. However, the court's will is clear and action will be required sometime. Other countries have achieved consensus about the values underpinning the provision of healthcare,10 so the task is possible. In view of the methodological challenges and the lack of consensus on how to resolve them, now is a good time to start.
Acknowledgments
We thank Professor Alistair McGuire and Professor Jack Dowie for advice.
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