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On DEMAND - Communicating Value to Payers Pre-Approval in the US
Session Chair(s)
Sissi Pham, PharmD
Chief Executive Officer
AESARA, United States
The FDA Payer Guidance released in 2018 has provided some clarity to industry and payers. The FDA explicitly noted the important difference between information required for medical product approval and what is needed by payers to make decisions about population-based coverage and reimbursement. The FDA Payer Guidance is largely pragmatic regarding HCEI communications and advances industry’s proactive dialogue with payers. In addition to clarifying the amendments to the Section 502(a) of Food Drug and Cosmetic Act about, the FDA provided an opportunity to further communicate about unapproved products and uses as it relates to Title 21 of the Code of Federal Regulations. However, there remains much uncertainty around pre-approval communication to payers. A panel composed of the relevant stakeholders will have an open dialogue on the intention of the guidance, the practical challenges with interpretation and operationalizing aspects of the guidance, the remaining informational needs of payers from industry to inform access decisions pre-approval.
Learning Objective : Discuss how to proactively and compliantly communicate during pre-approval phase relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.
Speaker(s)
Baking the PIE: The Recipe for Expedient Payer Decisions - How Early Data Sharing Can Improve Patient Access
Susan A Cantrell, RPh
Academy of Managed Care Pharmacy (AMCP), United States
Chief Executive Officer
Regulatory Considerations for Pre-Approval Communications with Payers
Denise Sanchez, JD, MA, MS
Opus Regulatory Inc., United States
Principal Consultant
Considerations for Pre-Approval Dossiers
Cosmina Hogea, PhD, MS
GlaxoSmithKline, United States
Director, Value, Evidence, and Outcomes
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