AMCP Format v4.1: New Guidance on Evidence Requirements for Unapproved Products and Unapproved Uses

NPC Vice President for Comparative Effectiveness Research Jennifer Graff, PharmD, will participate in a Jan. 23 webinar hosted by the Academy of Managed Care Pharmacy (AMCP) about its updated Format for Formulary Submissions.

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.

There is no charge for AMCP members; the price for non-members is $69.

Following this webinar, attendees will be able 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.


  • Phil Bongiorno
    VP, Policy & Government Relations


  • Iris Tam, PharmD, FAMCP
    Chair, AMCP Format Executive Committee and
    Senior Director, HEOR, Patient Access & Value
    Coeus Consulting Group

  • Jennifer S. Graff, PharmD
    Member, AMCP Format Executive Committee and
    Vice President, Comparative Effectiveness Research
    National Pharmaceutical Council

** IMPORTANT: AMCP webinars are limited to the first 500 that join the webinar.  AMCP will provide a link to the recording and slides to all registrants within one week from the webinar date. 

For individuals from the media/press who are interested in attending, please contact Neal Learner at for more information.