The Role of Pharmacoeconomics provides an overview of the role and scope of pharmacoeconomic analyses in terms of the different audiences for pharmacoeconomic evaluations. Three audience groups are identified: the drug manufacturer, reimbursers (and insurers) and managers and clinical directors in health care systems. These audiences are important are particular stages in the product life cycle: the drug manufacturer in the process of drug development and market entry; the reimburser (and insurer) audience in the post-marketing approval formulary submission process, and managers and clinical directors within health care systems (e.g., physician practice groups, hospitals, clinics) in the post-formulary listing period of market entry and consolidation of a market position.
Pharmacoeconomic analyses have focused on meeting the needs of the reimbursers (insurers) and managers and clinical directors in health care systems : (i) on providing an input to formulary submissions where a pharmacoeconomics and budget impact assessment is mandated by the agency and (ii) to meeting the perceived needs of clinical directors and other health care decision makers in the adoption and placement of new therapies. In both cases the typical contribution is the development of a cost-effectiveness (and sometime cost-utility) modeling study. This is usually seen as an adjunct to the clinical case presented for the drug and is expressed in the form of a decision model. Just as in the case of pivotal clinical trial results, there is a long standing concern with the generalizability of such results to specific treating situation and, more recently, with how such models are translated into budget impact and patient risk management terms for the health care system.