Addressing Evidence Gaps in the Expedited Programs: Payer Perspectives - Proceedings from the AMCP Partnership Forum
The U.S. Food and Drug Administration's (FDA) expedited programs provide important mechanisms to make treatments for serious conditions with high unmet needs available to patients sooner. However, limitations exist due to the difference between FDA requirements for products approved through an expedited pathway and payer evidence needs for these often high-investment or high-risk safety profile medications. This is particularly true for products approved through the accelerated approval pathway, which allows the use of surrogate endpoints to predict clinical benefit, posing challenges to payers' need to pay for value.
To support payer needs related to the FDA's Accelerated Approval and maintain patient access to critical medications, AMCP held a multi-stakeholder Partnership Forum in Alexandria, Va., Nov. 18-19, 2021. The Partnership Forum included 37 experts from payers, pharmacy benefit managers, integrated delivery systems organizations along with patient advocates, academicians, and other key stakeholders from managed care settings. Together the group:
-
Identified gaps between the FDA Accelerated Approval requirements and treatment outcomes valued by payers.
-
Discussed opportunities for an evidence ecosystem to close those gaps.
-
Evaluated policy options to facilitate communication of payer needs, reduce financial uncertainty, and potentially decrease the time between FDA approval or clearance and coverage decisions.
Moderator:
Jennifer Graff, PharmD
Sr. Director, Professional Affairs
AMCP
Speakers:
Vivien Chan, PharmD
Director, Costco Health Solutions
Lilian Ndehi-Rice, PharmD, MBA, BCPS
Associate Vice President, Pharmacy Clinical and Specialty Strategies
Humana, Inc.
