Since 2000, the AMCP Format for Formulary Submissions has served as the gold standard for providing industry with guidance on the communication of medical product information to healthcare decision makers for the purpose of formulary, coverage, and reimbursement decision making. In its 6th revision, the AMCP Format was updated to Version 4.1 and published in December 2019. Version 4.1 provides new guidance on the two-way communication between industry and payers regarding evidence and information about unapproved products and unapproved uses of approved products for which FDA approval is being sought. The new guidance represents a substantial step forward in meeting the evidentiary and informational needs of payers well before FDA approval. While this new environment creates important opportunities to advance evidence review, formulary decision-making, and more importantly, patient access to effective, new therapies, challenges remain that require clear understanding and thoughtful execution by both industry and payers.
Register to hear about updates to the AMCP Format from members of the AMCP Format Executive Committee.
The goals of the forum were to develop recommendations to:
- Explain the rationale for updates included in the AMCP Format Version 4.1.
- Describe the evidentiary and information recommendations for an Unappproved Product Dossier and an Unapproved Use Dossier.
- Discuss some of the key challenges in the development and communication of unapproved use and unapproved product dossiers that industry and payers should consider.