PURPOSE: This panel seeks to discuss performance-based risk-sharing agreements (PBRSA) for medical technologies (MedTech); to identify whether taxonomies of PBRSAs for pharmaceuticals are applicable for MedTech; and, through discussion, develop a nascent set of best practices for device-specific PBRSA.

Mark Sculpher will present a taxonomy based on the the nature of the decisions taken by health systems and the type of evidence needed to support these. Susan Garfield, a consultant active in the area of PBRSA, will bring the industry perspective and provide insights the challenges of planning, execution, and evolution of these plans, and Payam Abrashimi will serve as a representative of a payer perspective into how PBRSA can address the needs of payers and procurement bodies; Richard Charter will moderate and provide an overview of PBRSA.

DESCRIPTION: Procurement bodies have increasingly sought rigorous evidence before accepting premium price products. Recent pandemic challenges have accelerated these trends of more cautious evaluation of MedTech prior to procurement. Yet, regulatory agencies in many instances allow for the commercialization of devices without rigorous trials providing the evidence sought by procurement. In the absence of such data, evidence development through performance-based risk-sharing agreements (PBRSA) have recently generated increased interest, development, and emergent use.

This panel seeks to discuss recent years’ growing interest in PBRSA for MedTech and the roles, opportunities, and challenges within this landscape of procurement bodies, governments, health technology assessment (HTA) entities, and payers. Topics for discussion include how to deliver PBRSA, what is the role of health economics and outcomes research in reducing the clinical and economic uncertainty, and the role of real-world evidence in risk-share agreements.

Each speaker will speak for approximately 15 minutes. The audience is encouraged to bring their experience to the discussion; open questions highlighted during the panel will be tested with audience polling.