Economic evaluation of pharmaceuticals: science or marketing?

The increased pressures on health care budgets have emphasised the need to demonstrate the value for money from health technologies. Most major pharmaceutical companies have therefore commissioned cost-benefit or cost-effectiveness analysis of their products. There is an assumed analogy between clinical trains, which are required for product licensing, and economic evaluations, which would help in justifying price and securing reimbursement. In most countries it is the responsibility of the pharmaceutical companies to provide adequate data on efficacy and safety, which is monitored by government. Cost-effectiveness data is only required by government in a few countries, although in others, including the United Kingdom, the pharmaceutical industry is being encouraged to provide such data for its products. Although clinical trial data are used in the marketing of products, they are usually perceived as scientific data in support of licensed implications. It is not clear whether the same is true for economic evaluation data, which may be more open to interpretation. This paper explores the extent to which the analogy between clinical trials and economic evaluation really applies. It considers whether there is a greater potential for bias in economic evaluations, whether the use of economic evaluations for price setting raises any ethical concerns, whether clinical endpoints are any ‘harder’ than economic endpoints and whether there is a need to set methodological standards for economic evaluation and to develop methods for scrutinizing the results of studies. It is concluded that, in principle, there should be no more bias in a well-conducted economic evaluation than in a clinical trial. However, economists need to improve the methodological standards of economic evaluations. Priority should be given to basing studies on good medical evidence, making measurements rather than assumptions where feasible, applying conventional tests of statistical significance and improving methods of quality of life measurement. Pharmaceutical sponsors should view economic evaluations as science, although, given the increased interest in value for money, such studies will also be useful in marketing and in encouraging a rational diffusion and use of medicines.