Categories
Deliverable Market Access

AMCP and Value Dossiers

What are AMCP and Value Dossiers?

Payers around the world require data on product clinical trials, disease state burden, health economics, and other relevant information as part of the process of evaluating whether or not to cover a drug for reimbursement- this information is often shared in the form of a compendium (or dossier) developed by the manufacturer seeking reimbursement. Dossiers are a standard launch deliverable and are created and shared by manufacturers depending on the processes and laws in a given country. They are often a good starting point for the payer to get oriented to a drug or disease space and may lead to follow-up questions on specific data.

Payers may also ask for updated dossiers periodically as new data emerge or new decisions have to be made. HEOR teams in pharma work on these dossiers as part of a product launch and update them throughout the product life cycle as new data emerge. In the United States, the standard format is that set forth by the Academy for Managed Care Pharmacy (AMCP) and the deliverable is known as an AMCP dossier. There are separate formats for unapproved product AMCP dossiers and approved product dossiers in the US. For country submissions outside the US, HEOR teams tends to develop broader value dossiers so that affiliates can modify them as relevant for local submissions.

The official AMCP format can be found on their website and is updated periodically: https://www.amcp.org/Resource-Center/format-formulary-submissions/AMCP-Format-for-Formulary-Submissions-4.1

Value dossiers may also be called core value dossiers or global value dossiers outside of the US.

Robert Navarro gives a broad overview of Managed Care in his book.