AMCP Published Format 6.0 for US Formulary Submissions in October 2026

The AMCP Format for Formulary Submissions sets out a standard structure for the clinical and economic evidence that manufacturers provide to US health care decision makers when products are considered for formulary inclusion. AMCP describes the Format as advisory and not mandatory, and states that manufacturers have final discretion over how they communicate information to decision makers.

Version 5.0 was released in spring 2024 and was the first update since 2020. It placed greater emphasis on early engagement and pre-approval information exchange between manufacturers and payers, aligned its guidance with recent legislation, acknowledged the growing role of real-world evidence, particularly for under-represented populations, and added guidance on evidence for digital therapeutics.

Dossiers prepared under the Format are typically used by health care decision makers to evaluate the clinical, economic and real-world evidence for a product. Because the Format is widely recognised, a dossier that follows its structure is easier for reviewers to navigate, and manufacturers frequently prepare both pre-approval and post-approval versions of the dossier as evidence develops.

AMCP opened a public comment period on proposed revisions on 17 March 2026, which closed on 22 April 2026. The request for comment proposed revisions in three areas: biosimilars, gene and cell therapies, and the economic value and modelling report in section 4.0B. The draft noted that, although gene and cell therapies are regulated through established FDA pathways, decision makers may need information beyond what is typically supplied for conventional drugs. AMCP reported that comments came from industry, payers, academia, consultants and professional associations.

The final version was published in October 2026 in a supplement to the Journal of Managed Care and Specialty Pharmacy. According to AMCP, version 6.0 adds a streamlined submission framework for biosimilars, new guidance for cell and gene therapies, and revised economic modelling recommendations. The detailed wording of the final modelling section could not be compared with the March 2026 draft for this brief and should be checked in the published document.

AMCP opened public comment on the proposed revisions on 17 March 2026, and the comment period closed on 22 April 2026. The final version 6.0 was published in October 2026 as a supplement to the Journal of Managed Care and Specialty Pharmacy. Version 5.0, which it replaces, was released in spring 2024 after a public comment period that opened in June 2023.

Because the Format is advisory, there is no formal compliance date. Manufacturers can adopt version 6.0 for new dossiers immediately and may choose to update existing dossiers at their next scheduled revision, for example when new clinical data, a new indication or updated economic analyses become available.

For biosimilar manufacturers, a streamlined framework may reduce the volume of material needed where evidence focuses on biosimilarity rather than on new clinical claims. For developers of cell and gene therapies, the new guidance signals that payers expect additional information to support decisions on high-cost, potentially durable treatments, which may include evidence on long-term outcomes and on uncertainty.

All manufacturers using the Format for economic models should review the revised recommendations for section 4.0B before preparing new or updated dossiers. Teams should also consider how pre-approval information exchange, introduced more fully in version 5.0, fits with their engagement plans. Pubrica’s summary is informational and is not affiliated with or endorsed by AMCP.

The areas chosen for revision correspond to product types that AMCP identified as needing specific guidance. Cell and gene therapies are a clear example: the draft noted that decision makers may need information beyond what is typically supplied for conventional drugs. Guidance on presenting evidence for these product types is intended to help decision makers compare information consistently across manufacturers.

The revised economic modelling recommendations may be particularly relevant for products where budget impact and long-term outcomes drive formulary decisions. Manufacturers that maintain global value dossiers should consider how the US model inputs, time horizons and perspectives described in the Format relate to those used for HTA bodies in other countries, so that differences can be explained to reviewers.