AMCP Format for Formulary Submissions — Guidance on Submission of Pre-Approval and Post-Approval Clinical and Economic Information and Evidence, Version 4.1

Originally posted on JMCP on March 31, 2024.

The evidentiary recommendations and guidelines outlined in the AMCP Format are intended for use by manufacturers to communicate clinical and economic evidence and information to HCDMs who make or influence formulary, coverage, policy, and reimbursement decisions for new and existing products. The AMCP Format is guidance, not a mandate. Manufacturers have final discretion on how to communicate information for consideration by HCDMs.

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 and credible clinical and economic information needed by HCDMs.
• Recommending economic analyses and models to project the cost-effectiveness and budgetary impact on the HCDM’s organization and its patient or member population, as well as to assess the overall economic value of an approved product.
• Encouraging a clear and transparent bidirectional communication and sharing process between manufacturers and HCDMs.

Additional Resources

• FormularyDecisions.com
  Get easy access to current product information, e-dossiers, and other resources to help you in formulary development.

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