Academic journal article Applied Health Economics and Health Policy

Current Status and Trends in Performance-Based Risk-Sharing Arrangements between Healthcare Payers and Medical Product Manufacturers

Academic journal article Applied Health Economics and Health Policy

Current Status and Trends in Performance-Based Risk-Sharing Arrangements between Healthcare Payers and Medical Product Manufacturers

Article excerpt

Published online: 25 March 2014

© Springer International Publishing Switzerland 2014

Abstract Our objective was to identify and characterize publicly available cases and related trends for performance-based risk-sharing arrangements (PBRSAs). We performed a review of PBRSAs over the past 20 years (1993-2013) using available databases and reports from colleagues and healthcare experts. These were categorized according to a previously published taxonomy of scheme types and assessed in terms of the underlying product and market attributes for each scheme. Macro-level trends were identified related to the timing of scheme adoption, countries involved, types of arrangements, and product and market factors. Our search yielded 148 arrangements. From this set, 65 arrangements included a coverage with an evidence development component, 20 included a conditional treatment continuation component, 54 included a performance-linked reimbursement component, and 42 included a financial utilization component. Each type of scheme addresses fundamental uncertainties that exist when products enter the market. The pace of adoption appears to be slowing, but new countries continue to implement PBRSAs. Over this 20-year period, there has been a consistent movement toward arrangements that minimize administrative burden. In conclusion, the pace of PBRSA adoption appears to be slowing but still has traction in many health systems. These remain a viable coverage and reimbursement mechanism for a wide range of medical products. The long-term viability and growth of these arrangements will rest in the ability of the parties to develop mutually beneficial arrangements that entail minimal administrative burden in their development and implementation.

1 Introduction

Performance-based risk-sharing arrangements (PBRSAs; also known as patient access arrangements, market access arrangements, and managed entry arrangements, among others) have continued to emerge and evolve since their initial introduction and re-emergence over the past decade. Defined broadly, these are arrangements between a payer and a pharmaceutical, device, or diagnostic manufacturer where the price level and/or nature of reimbursement is related to the actual future performance of the product in either the research or 'real world' environment rather than the expected future performance [1]. Compared to a historical risk-sharing equilibrium, these arrangements alter or shiftthe distribution of risks among the parties [2]. The benefits of these arrangements for payers can be cost containment, efficiency (i.e., improved value for money), and/or improved outcomes for their covered population. The key benefits for product manufacturers relate to earlier market access and pricing efficiency, especially in a world with external reference pricing and parallel trade [3]. There are a variety of arrangement types, which reflects the various product and market uncertainties as well as the varied health systems and countries where they are being implemented.

The marketplace for PBRSAs continues to evolve as payers and product manufacturers gain experience and insight into their application and related risks and rewards. In addition, enthusiasm for these arrangements continues to expand beyond first movers, prompting additional health systems and countries to experiment and adopt such arrangements. With the observed volume and pace of change it is important for payers, manufacturers, and policy makers to be aware of the shifting landscape and emerging trends. We previously published a review and taxonomy of arrangement types, which has been repeatedly cited and alternately revised in subsequent discussions about PBRSAs [1, 4, 5]. Here we provide an up-to-date review of the field that includes the identification of key trends and a country-level view of the adoption of various arrangements. Understanding current trends can facilitate further innovation, help to optimize the risks and benefits for payers and manufacturers, and ensure that new medical products are introduced in a manner that helps to resolve important uncertainties that all parties-payers, manufacturers, and patients-have at initial launch. …

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