RE1 Performance-Based Risk-Sharing Arrangements in Diagnostics and Devices in the United States

Abstract

Performance-based risk sharing agreements (PBRSAs), defined as linking coverage and reimbursement to the future performance of medical products, have continued to emerge and evolve over the last two decades. In the U.S., most arrangements and publications have focused on pharmaceuticals. Our aim was to assess the current status and trends of the uptake of PBRSAs for diagnostics and devices in the U.S. We reviewed publicly available PBRSAs for diagnostics and devices leveraging the University of Washington Performance Based Risk Sharing Database®. We augmented the review using PubMed, Google, and payer and industry websites. Key words including “outcomes-based”, “value-based”, “coverage with evidence development”, “performance-based”, “risk-sharing” were used in combination with “device” or “diagnostic”. To characterize arrangements in terms of product and market attributes, we extracted data for each product including arrangement descriptions, arrangement type, year, therapeutic area, product manufacturer, payer, and product type. Arrangements were analyzed using descriptive statistics. 53 arrangements were identified between the years 2001 and 2019, with 31 (58.5%) for devices and 22 (41.5%) for diagnostic tests. Among these, 23 (43.4%) were coverage with evidence development (CED) - only in research, 18 (34.0%) were performance linked reimbursement (PLR), and 12 (22.6%) were CED - only with research. The majority of arrangements for devices were developed in cardiology (13, 41.9%), endocrinology (4, 12.9%), and radiology (3, 9.7%). While most of arrangements for diagnostic tests identified were in oncology (17, 77.3%) and some in neurology (2, 9.1%). Over time, there has been a trend towards increasing adoptions of PLR and CED – only with research since 2013. This is the first study to comprehensively review PBRSA arrangements for diagnostics and devices in the U.S. Our findings showed that the pace of PBRSA adoption appears to be increasing, with more types of arrangements.