THE EMERGING GOVERNMENT REQUIREMENT FOR ECONOMIC-EVALUATION OF PHARMACEUTICALS

With the advent of government guidelines for the provision of cost-eff ectiveness data, economic evidence has been elevated to a status simil ar to that of evidence of efficacy and safety, which is required befor e licensing of pharmaceutical products. Whilst the precise nature of g overnment requirements is likely to vary from place to place, they pos e a number of practical problems for pharmaceutical companies, in the funding of studies and in the need to modify the clinical trials progr amme to facilitate economic data collection. Economic evaluation requi rements have been viewed by various parties as a basis for pricing and reimbursement, as a form of cost containment and as a way of securing more value for money in the healthcare system. It is unlikely that ec onomic evidence could ever form the sole basis for setting price, sinc e both industry and government often seek to introduce other factors i nto the price negotiations. Requirements for economic evidence may als o be an inefficient form of cost containment, compared with other meth ods such as budgetary caps. These offer some potential as a way of sec uring more value for money, but they should be applied equally across all health technologies. In the future there needs to be much more cla rity of purpose in government guidelines, and methodological standards for economic analysis need to be refined.