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

Webinar Recorded on Jan. 23, 2020 

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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.

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.

Moderator:

• Phil Bongiorno
  VP, Policy & Government Relations
  AMCP

Faculty:

• 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
• Jeff White, PharmD, MS
  Member, AMCP Format Executive Committee and
  Staff Vice President, Clinical Pharmacy Services
  IngenioRx