The AMCP Dossier 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.
   

Format 6.0 was released in October 2026 after being revised to include guidance for cell and gene therapies and biosimilars. Looking ahead, AMCP will continue efforts throughout 2027 to modernize the Format, with a focus on modular content, interoperability, lifecycle updates, machine-readable data, and the integration of real-world evidence and patient experience data.

View Format on JMCP