Focusing pharmacoeconomic activities: reimbursement or the drug life cycle?

The purpose of this paper is to consider the role of pharmacoeconomic activities in the drug life cycle and not just as activities to support reimbursement applications and market entry. These activities are important in establishing the value case for a drug product to both internal and external audiences. Unless these activities are fully integrated into establishing the business case for a product from the pre-phase I period of drug discovery, manufacturers run the risk of establishing a unit price for the product and claims for cost-effectiveness which are inconsistent with achieving reimbursement. Importantly, manufacturers need to consider at an early stage the evidentiary and analytical needs for product evaluation under formulary submission guidelines (AMCP; NICE) and the integration of pharmacoeconomic activities over the life cycle. These activities include justifying assumptions for business opportunity assessments and an early commitment to developing a mock reimbursement submission at post-phase II. The integration of pharmacoeconomic activities in the drug cycle is not only an antidote to excessive clinical optimism but also provides the basis for an effective assessment of the likely performance of new products in the health-care market place at a price and formulary position acceptable both to the manufacturer and the reimburser.