PERFORMANCE-BASED RISK SHARING AGREEMENTS – OPPORTUNITIES AND CHALLENGES FOR MEDICAL DEVICES

Author(s)

Susan Garfield, DrPH, Ernst & Young, Boston, USA; Bruce Gingles, BA, Cook Medical, Bloomington, USA; Carla Zema, PhD, Precision Health Economics, Los Angeles, USA

How feasible are performance-based risk sharing arrangements (PBRSAs) for medical devices? How do PBRSAs for medical devices differ from those for pharmaceuticals? Are there unique opportunities/challenges that exist for PBRSAs for medical devices? How does this differ for devices that are reimbursed vs procured? There has been increasing interest over the past several years in PBRSA. Significant work has been done to develop frameworks that capture the varying types of arrangements as well as case studies to understand best practices and opportunities for improvement. However, most of this work has focused on pharmaceuticals. On one hand, some devices have the potential to alleviate some of the barriers such as availability of data since many devices collect rich data that can be used for PBRSAs. On the other hand, other barriers exist with devices that do not exist with drugs. Finally, there is significant diversity in the types of devices. Most devices do not go through typical payer reimbursement and are procured directly by the provider or even the patient in some instances. Therefore, the feasibility of PBRSAs could potentially differ significantly depending on the type of device. This panel will debate these questions using the Walker et al. (2012) Framework for Coverage Decisions from the perspective of a manufacturer of a procured device (Sanjoy Roy), the manufacturer of a reimbursed device (Carla Zema), and payers and health systems (Susan Garfield).

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Code

F7

Topic

Health Policy & Regulatory, Medical Technologies

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