DIA 2020 Global Annual Meeting

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.