AMCP Format for Formulary Submissions, Version 4.1, Includes New Dossiers for Submitting Evidence on Unapproved Medicines and Unapproved Indications Submitted for FDA Approval

Alexandria, Va., Jan. 8, 2020 — AMCP has released Version 4.1 of the AMCP Format for Formulary Submissions, which includes two new dossier types for biopharmaceutical manufacturers to share evidence on unapproved products and new indications that are under review by the U.S. Food and Drug Administration (FDA).

The first version of the AMCP Format was launched in 2000, and it has since become the primary tool manufacturers use to share safety, efficacy, and value data with health care decision makers (HCDMs) as they consider products for coverage and formulary placement. Changes in the AMCP Format 4.1 are a direct response to growing information needs due to the complex and costly therapies coming to market each year.

“Payers and health care decision makers have been calling for mechanisms to obtain information sooner on innovative products, such as biologics and gene therapies, as they plan and design their covered benefits for the subsequent year,” said AMCP CEO Susan A. Cantrell, RPh, CAE. “For two decades, the AMCP Format has been the gold standard for evaluating evidence when making coverage decisions. This latest version will allow payers to provide faster access to the valuable, yet often expensive, therapies once they become available.”

AMCP Format 4.1 was developed by the AMCP Format Executive Committee, made up of leaders from diverse sectors of managed care pharmacy, including academia, biopharmaceutical manufacturers, and payers. This version supports the concept of pre-approval information exchange (PIE), which expedites product coverage decisions and allows for more accurate forecasting and allocation of health care resources. AMCP Format 4.1 also aligns with the FDA’s June 2018 Final Guidance, “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities,” which describes the sharing of certain non-promotional information with payers and other HCDMs prior to a drug’s approval.

Specifically, AMCP Format 4.1 includes guidance and templates, or dossiers, for submitting information during distinct phases during a drug product’s lifecycle: unapproved products, approved products, and unapproved uses. According to the new sections on unapproved product and unapproved use dossiers, the types of information that HCDMs need include:

• Product name
• Drug class
• Anticipated indication
• FDA special designations, if applicable
• Prevalence and annual incidence of condition in the United States
• Information about phase 2 and 3 trials completed or in progress
• Anticipated route and location/settings for product administration
• Product pricing information, which can be expressed as a price range
• Anticipated patient support programs
• Anticipated distribution strategy
• Status of product development and anticipated timeline, including dates of FDA submission, advisory committee meetings, and anticipated product launch date, if known.

Consistent with the FDA guidance, Format 4.1 advises that manufacturers should not make claims about an unapproved product or unapproved use, nor may they provide characterizations or conclusions regarding the safety or effectiveness of the unapproved product or use.

As with previous versions, AMCP Format 4.1 is not a mandate and instead serves as guidance to describe information needs of HCDMs. Development and use of dossiers is at the discretion of the manufacturer and is subject to their individual legal and regulatory compliance policies.

For more information and to access AMCP Format 4.1, visit www.amcp.org/format.