OBJECTIVES: To evaluate themes in contract structures of value-based contracts (VBC) for pharmaceutical products across the US and Europe.

METHODS: VBCs in the US and select European nations (UK, Italy, Netherlands, and Spain) were extracted from the University of Washington Performance-Based Risk Sharing Agreement database (1997-2019). Contracts were categorized by the terms of reimbursement (rebate on product, reimbursement for disease sequelae, or coverage with evidence development), and endpoints (clinical, economic, or humanistic (i.e., QALY) with or without patient compliance). Preliminary results for the US and UK are reported.

RESULTS: There were 40 US-based and 21 UK-based VBCs. Most common therapeutic areas for US-based VBCs were endocrinology (32.5%), cardiology (25%), and oncology (20%). The majority of UK-based VBCs were in oncology (48%) and neurology (24%). The majority of US-based contracts were rebates (88%), whereas the majority of UK-based contracts were coverage with evidence development (52%). Outcomes-based assessments were stipulated in the majority of US-based contracts (90%), but not in the UK (42%). Of these, the most frequently utilized endpoints were clinical in the US (62.5%) and both clinical and humanistic (20%, respectively) in the UK. Humanistic outcomes were not mentioned in US-based contracts. 25% of US-based contracts also stipulated components of patient compliance, compared to 1 UK-based contract.

CONCLUSIONS: In an environment of rising prices, VBCs are becoming a cost containment strategy. However to date, only 61 VBCs were noted in the US and UK over 2 decades, which could be driven by lack of contracts and/or transparency in reporting. The lack of contracts could be driven by the challenges of data collection and analysis, which will likely be mitigated by the development of RWE methods for VBCs. More research and transparency is needed on the structure and successes of VBCs and how RWE can improve VBCs.