Determining coverage, or placing a medicine on a formulary list, requires numerous conversations and exchanges of clinical and economic information between biopharmaceutical manufacturers and population health care decision-makers. To ensure these discussions meet the Food and Drug Administration’s (FDA) strict regulations about the kinds of information that can be shared, manufacturers use a format developed by the Academy of Managed Care Pharmacy (AMCP) to allow biopharmaceutical manufacturers to respond to unsolicited requests for information about existing and new products. This week, as part of its ongoing efforts to align with new federal guidance, AMCP released an updated draft for public comment, Format for Formulary Submissions Version 4.1: Guidance on Submissions of Post-approval and Pre-approval Clinical and Economic Information and Evidence.
The AMCP’s new draft aligns with the FDA’s final guidance on Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities. Specifically, the updated Format clarifies the communication of health care economic information to payers regarding approved drugs and approved/cleared devices. It also outlines key information that can be shared with payers in a pre-approval information and evidence dossier before a treatment, or a new indication for an existing treatment, is approved by the FDA, enabling health care decision-makers to budget and forecast in advance of a medicine reaching the market. AMCP is seeking public comments on the draft Format by June 17, with a final version to be released in October at the AMCP Nexus 2019 meeting.
The National Pharmaceutical Council plans to submit comments, as we have done with previous Format revisions, given our longstanding research, comments, partnerships and activities related to communicating evidence and information.