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FDA Payer Communication Guidance, Twenty Years in the Making: Now What?
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. However, there remains areas of uncertainty within the guidance. A panel composed of the relevant stakeholders will have an open dialogue on the intention of the guidance, the challenges with developing a guidance for industry and payers, the practical challenges of operationalizing aspects of the guidance, the remaining informational needs of payers from industry to inform access decisions.
Learning Objective : Discuss how to decrease the anxiety in proactively communicating relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.
Speaker(s)
FDA Perspective
Sheila Ryan, MPH, RAC
FDA, United States
Acting Director, ODSIR, Division of Supply Chain Integrity, OC, CDER
Panelist
Chris Leo Pashos, PHD
Independent Consultant , United States
Panelist
Mitchell Higashi, PHD
GeneDx, United States
Senior Vice President, HEOR
Panelist
Denise Sanchez, JD, MA, MS
Opus Regulatory, United States
Principal Consultant