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AMCP Format and Dossiers
Session Chair(s)
Ivy Chang, PharmD
Principal Therapeutic Area Lead, Medical Information
Genentech, A Member of the Roche Group, United States
The Academy of Managed Care Pharmacy (AMCP) developed the AMCP Format for Formulary Submission as a template and guidance that has become one of the most widely recognized standards for requesting and receiving clinical and economic evidence from manufacturers. The Format is used to evaluate the value of pharmaceutical products, tests, and devices and can help healthcare decision-makers make population-based, formulary, coverage, policy, and reimbursement decisions. In late 2019, AMCP’s Format Executive Committee released the sixth revision of the AMCP Format: Version 4.1. This update aligns with the June 2018 final guidance from FDA on manufacturers’ communication of information about unapproved products and unapproved uses of approved products to payers, formulary committees, or other similar entities. This session will provide a brief historical perspective on the AMCP Format with a focus on the recent updates proposed in Format Version 4.1. In addition, the session will discuss common challenges faced by manufacturers in the development of product dossiers.
Learning Objective :
At the conclusion of this session, participants should be able to:
- List the type of information that may be included in a dossier for an unapproved product and an unapproved use of an approved product
- Discuss why product dossiers developed according to the AMCP Format is important to formulary decision makers
- Identify three challenges that manufacturers face in the development and communication of product dossiers within their organizations
Speaker(s)
Speaker
Iris Tam, PharmD
United States
Senior Vice President and Head, Medical Affairs and HEOR