For Public Comment: AMCP's Updated Format for Formulary Submissions

The Academy of Managed Care Pharmacy today released for public comment an updated draft version of its Format for Formulary Submissions, a framework that outlines evidence requirements used by biopharmaceutical manufacturers that are responding to an unsolicited request from health care decision-makers to support coverage, reimbursement, and/or formulary placement of new and existing drugs, tests, or devices or class of drugs, tests, or devices.

According to AMCP, Format Version 4.0 incorporates “updated considerations related to fostering rigorous, relevant, and ongoing scientific dialogue between manufacturers and health care decision makers as it relates to assessing the safety, efficacy, and value of new health technologies.” It also addresses “evolving considerations in the health care environment, including considerations related to biosimilars, medical devices, comparative effectiveness research, and specialty pharmaceuticals, among other topics.”

Format Version 4.0, which will be released in April 2016 at the AMCP Managed Care & Specialty Pharmacy Annual Meeting in San Francisco, focused on issues and concerns identified in previous versions of the Format and other topics based on AMCP membership and public feedback. To guide and validate its work, AMCP’s Format Executive Committee and its work groups are seeking additional public input.

The draft Format Version 4.0 is available on AMCP’s website. Comments should be submitted by email to Susan Oh, AMCP Assistant Director of Pharmacy Affairs, at [email protected], no later than January 8, 2016.