AMCP Format Expands Evidence Requirements for U.S. Payers
April 22, 2016
The Academy of Managed Care Pharmacy (AMCP) released a new Format for Formulary Submissions at the AMCP annual meeting this week in San Francisco, with revised requirements for manufacturers seeking coverage, reimbursement, and/or formulary placement of new drugs, tests, or devices.
Important changes in the new Format include:
- Guidelines for pre-approval dossiers that manufacturers may provide to payers prior to FDA approval
- New standards for reporting evidence about the value of diagnostic tests and medical devices
- Additional, more stringent requirements that raise the bar for evidence review
Below are links providing additional information regarding the new Format.
Learn more about implications of the new Format
The AMCP Format Version 4.0