PURPOSE: The aims of this workshop are (1) to provide an overview of the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions (version 2.1, April 2005), the WellPoint Health Technology Assessment (HTA) Guidelines (revised October 2008), and the RegenceRx Medication Value Appraisal Principles (revised September 2007); (2) to discuss the goals met by these guidelines from payers' perspectives; and (3) to discuss lessons learned from the industry and consultant agency perspectives in coordinating the preparation of dossiers to meet the needs of diverse health plans and payers.
DESCRIPTION: The AMCP Format is the primary guideline used by manufacturers to prepare submissions for US payers. Both WellPoint and RegenceRx require more comprehensive information for formulary submissions. To achieve broad formulary placement, manufacturers planning to market a product in the US may want to understand how to meet AMCP dossier standards while addressing the needs of large health plan payers. Manufacturers also need to manage the logistical challenges of dossier preparation, as it is resource-intensive and requires integration of disease burden and product labeling information, as well as comprehensive clinical and economic evidence—all ideally by product launch. This workshop will begin by providing a broad overview of the AMCP Format, the WellPoint HTA Guidelines, and the RegenceRx Medication Value Appraisal Principles. Representatives from WellPoint and RegenceRx will then discuss the rationale for requesting the information from manufacturers noted in the guidelines, as well as how this information is ultimately used. Representatives from industry and from a consultant agency also will discuss lessons learned from coordinating the preparation of dossiers to meet the standards of multiple formulary submission guidelines. Other topics, such as the appropriate organization, depth, and breadth of information provided in particular sections from the perspectives of the discussion leaders also will be discussed.
