AMCP Guidance for Submission of Clinical and Economic Evaluation Data to Support Formulary Listing in U.S. Health Plans and Pharmacy Benefits Management Organizations

Abstract

This paper reports on the Academy of Managed Care Pharmacy's (AMCP's) suggested process for pharmaceutical manufacturers to submit a uniform, evidence-based dossier for each product submitted for formulary approval. The process requires that manufacturers provide clinical and economic evidence and an economic model that projects the potential economic consequences and impact of product coverage on health outcomes. This formulary-submission process is designed to achieve two main goals: (1) improve the timeliness, scope, quality, and relevance of information provided to pharmacy and therapeutics (P&T) committees; and (2) streamline the process of acquiring data and reviewing products for health plan staff pharmacists. In time, it is hoped; this process will lead to progressive improvements in the quality of formulary submissions and provide P&T committees with evidence that previously was often unavailable.