AMCP Format Expands Evidence Requirements for US 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.