The emerging government requirement for economic evaluation of pharmaceuticals.

With the advent of government guidelines for the provision of cost-effectiveness data, economic evidence has been elevated to a status similar to that of evidence of efficacy and safety, which is required before licensing of pharmaceutical products. Whilst the precise nature of government requirements is likely to vary from place to place, they pose a number of practical problems for pharmaceutical companies, in the funding of studies and in the need to modify the clinical trials programme to facilitate economic data collection. Economic evaluation requirements 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 economic evidence could ever form the sole basis for setting price, since both industry and government often seek to introduce other factors into the price negotiations. Requirements for economic evidence may also be an inefficient form of cost containment, compared with other methods such as budgetary caps. These offer some potential as a way of securing more value for money, but they should be applied equally across all health technologies. In the future there needs to be much more clarity of purpose in government guidelines, and methodological standards for economic analysis need to be refined.