OBJECTIVES : As global spending on medicines continues to escalate, healthcare markets are experiencing increased pressure to improve patient access to highly effective, yet costly therapies. Outcomes-based contracts (OBCs) have been implemented as a sustainable solution to the rising cost of healthcare. Variation in healthcare system infrastructure, market priorities and the existence of formal health technology assessment bodies, may account for the differences in approaches to outcomes-based contracting between the US and EU. This abstract aims to better understand the trends and characteristics associated with OBCs in the US and EU.

METHODS : We assessed all publicly available OBCs within the US and EU. The analysis focused on deals from 2015 to 2019 and reviewed 135 implemented agreements. Each agreement was analyzed to consider the type of contract, outcome measure, therapeutic area, duration, and applicability to combination products or indication expansions.

RESULTS : In total, Europe has implemented 75 publicly disclosed contracts compared to 60 in the US, which is a contrast to 5 years prior (60 vs.14). In Europe, the most common agreements developed were for oncology therapies (75%). OBCs in oncology have only just begun in the US (27%), and as a result they expand numerous therapeutic areas, with the majority targeting cardiovascular indications. The types of contracts differed between the markets. Payment by result contracts were the most prevalent type of risk-sharing agreement executed in the US, as compared to coverage with evidence development contracts in Europe.

CONCLUSIONS : Despite the high-level of interest and growing implementation of value-based risk-sharing agreements globally, European markets largely lead the development of innovative arrangements. Given the heterogeneity in the number, type, and therapeutic areas defining these contracts in the EU and US, it is crucial to continue to monitor and analyze contracting approaches to determine the key characteristics facilitating successful value-based arrangements that best balance affordability and access.