AMCP Format for Formulary Submissions — Guidance on Submission of Pre-Approval and Post-Approval Clinical and Economic Information and Evidence, Version 4.1
Revisions Proposed as of June 1, 2023
AMCP is proposing revisions to the Format for Formulary Submissions — Guidance on Submission of Pre-Approval and Post-Approval Clinical and Economic Information and Evidence, Version 4.1.
The key areas of focus include:
- Digital therapeutics
- Health disparities
- Incorporating brevity to streamline dossiers
- Guidance on PIE Decks
The public comment period was June 1–30, 2023, and is now closed.
The revised AMCP Format will be available no later than 2024.
Read the full Format 4.1 in the PDF below.
The evidentiary recommendations and guidelines outlined in the AMCP Format for Formulary Submissions are intended for use by manufacturers to communicate clinical and economic evidence and information to health care decision-makers (HCDMs) who make or influence formulary, coverage, policy, and reimbursement decisions for new and existing medical products. The AMCP Format is a guidance, not a mandate. Manufacturers have final discretion on how to communicate information for HCDMs’ consideration.
The AMCP Format supports the informed review, assessment, selection, and payment of medical products by:
- Identifying the evidence needed for evaluating the clinical and economic value of medical products.
- Standardizing the synthesis and organization of the evidence and information in a concise living document, known as the “AMCP dossier” or “product dossier,” that evolves with the life cycle of the product, from the pre-approval phase through the post-approval period.
- Establishing a framework for the provision of objective, credible clinical and economic information needed by HCDMs.
- Recommending economic analyses and models to project the budgetary and cost impact on the HCDM’s organization and its patient or member population as well as to assess the cost-effectiveness and economic value of a product (assessments of economic value apply only to Approved Product Dossiers).
- Encouraging a clear and transparent, bidirectional communication and sharing process between manufacturers and HCDMs.
Get easy access to current product information, e-dossiers, and other resources to help you in formulary development.