Presentation (CTI)

OBJECTIVES: Outcomes-based risk-sharing agreements (OBRSAs) are contractual arrangements between payers and manufacturers that link the reimbursement of healthcare interventions to real-world clinical or economic outcomes. As the US healthcare system is a multi-payer system, differences in preferences for OBRSAs may yield misaligned incentives between stakeholders, further complicating their adoption. This research aimed to explore trends for the adoption of OBRSAs in the US.
METHODS: A scoping review was conducted in PubMed using Nested Knowledge’s artificial intelligence capabilities with terms for “US” and “OBRSAs” and related synonyms (2015-2024). Supplemental searches were conducted using Google and the ISPOR website. Key trends and themes were synthesized.
RESULTS: Included studies reviewed trends in OBRSAs, such as agreement types, efficacy of individual programs, and economic impact, and often focused on Medicare and Medicaid data. Surveys of US payers indicated that >50% had implemented ≥1 OBRSA. OBRSAs were primarily used for new products, relying on claims-based outcomes for practicality. While OBRSAs offered benefits to payers, manufacturers, and patients, the number of agreements remained stagnant due to misaligned priorities and challenges in implementation. Stakeholder perspectives differed, with some evidence suggesting that payers considered OBRSAs a lesser priority than manufacturers due to operational challenges, including data collection and analysis. Social risk and equity were noted as areas of concern. Recent policy initiatives have aimed to incentivize Medicaid OBRSAs; however, states have faced infrastructure challenges. Despite these barriers, hypothetical models suggest that OBRSAs can enhance market access and increase manufacturer reimbursement while reducing payer costs, though savings may not fully offset drug costs.
CONCLUSIONS: OBRSAs show promise in aligning stakeholder interests but face challenges, including administrative burden, data limitations, and misaligned priorities. Policy changes may expand their use, but collaboration and equity remain critical for broader adoption and impact in the US.