Presentation (CTI)

OBJECTIVES: To review the progression of updates in the AMCP Format from Version 4.0 to Version 5.0, examining structural, content, and strategic modifications, and their implications for market access communications and payer engagement.
METHODS: The AMCP Format for Formulary Submissions supports evidence-based payer decisions in the US. Since the release of Version 4.0 in 2016, the format has undergone updates; Version 4.1 in 2020, and most recently, Version 5.0 in 2024. These reflect increasing payer expectations for real-world evidence (RWE), digital integration, and value-based care, aligning with ever evolving healthcare landscape. A targeted evaluation of AMCP guidance documents (4.0, 4.1, 5.0) was conducted, supported with industry commentaries and professional forums. The review explored changes in dossier design, modular structure, digital compatibility, RWE integration, and alignment with changing payer demands.
RESULTS: Version 4.0 (2016) reflected a major revision, emphasizing clinical and cost-effectiveness evidence, but remained comparatively text-heavy and less modular. Version 4.1 introduced refinements for digital use and inclusion of RWE. Version 5.0 introduced streamlined and strategic changes: greater brevity, visual formatting, emphasis on underrepresented populations and health disparities, early pre-approval information exchange (PIE), and real-time adaptability. A separate AMCP guidance on digital therapeutics (DTx) complements Version 5.0 principles. These updates conform to evolving payer expectations about data comprehensibility, real-time flexibility, early engagement, and budget impact.
CONCLUSIONS: AMCP Format Version 5.0 signifies a paradigm shift towards evidence-based, equity-focused, and payer-relevant communication. Adapting to this evolution is crucial for formatting dossiers that meet evolving market access expectations.