Formularies, therapeutics, and outcomes: new opportunities.

The increasing prominence of drug therapies in health care and their rapidly rising costs have led to a dramatic escalation of interest in the use of outcomes data for therapeutics and formulary decisions. The expanded use of formulary submission dossiers, effectiveness data, health outcomes analysis, and pharmacoeconomic modeling has created an urgent need for outcomes research to investigate topics especially relevant for health plan drug therapy coverage decisions. This article examines the evolving use of outcomes data on drug formulary and other therapeutic decisions, and outlines several priority areas for outcomes research. These include research into surrogate measures of long-term health and economic outcomes, evaluations of new formulary submission programs, and research on the impact of pharmaceutical cost-sharing arrangements on health outcomes. The article also discusses the importance of evaluating patient compliance and health outcomes after implementation of a Medicare prescription drug benefit, and the need for new types of clinical trials that can respond to changing demands of pharmacy and therapeutics committees and providers