Performance-Based Risk-Sharing Agreements in Healthcare

Performance-based risk-sharing agreements align reimbursement for health technologies with observed clinical outcomes or utilisation metrics in real-world settings. These arrangements aim to balance rapid patient access to innovative treatments with mitigation of payer uncertainty regarding therapeutic value and budget impact. By linking payments to predefined performance targets—such as response rates, treatment persistence or health-economic endpoints—stakeholders can share financial risks, generate real-world evidence and adjust coverage or pricing in light of emerging data. Globally, such agreements have grown in oncology, rare diseases and advanced therapies, reflecting pressures on health systems to deliver cost-effective care. Practical implementation typically involves data‐collection infrastructure, governance frameworks to oversee outcome assessment and contractual clauses that stipulate payment corrections or treatment continuation criteria. While administrative complexity and data governance pose challenges, successful schemes have demonstrated improved alignment between price and value, fostered collaborative evidence generation and informed subsequent health-technology assessment decisions.

Research from Nature Portfolio

No recent Nature Portfolio content available.

Performance-Based Risk-Sharing Agreements in Healthcare publication trend

The graph below shows the total number of articles in performance-based risk-sharing agreements in healthcare across all publications each year (not limited to Nature Index journals).

Technical terms

Performance-based risk-sharing agreement: A contractual arrangement that links payment for a health technology to observed clinical or utilisation outcomes.

Outcomes-based contract: A subtype of performance-based agreement where reimbursement is contingent on predefined real-world treatment outcomes.

Spread payment: A financing mechanism that distributes the cost of a high-cost therapy over time, potentially adjusted for outcome performance.

Managed entry agreement: A formal arrangement between a payer and manufacturer to manage uncertainty around a technology’s value through financial or performance conditions.

Real-world evidence: Data on health outcomes and resource use collected outside traditional clinical trials, often via registries or electronic health records.

References

1. Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future. Frontiers in Pharmacology (2017).
2. Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries. Orphanet Journal of Rare Diseases (2013).
3. What principles should govern the use of managed entry agreements?. International Journal of Technology Assessment in Health Care (2011).
4. Risk-sharing agreements, present and future. Ecancermedicalscience (2018).
5. Outcomes-Based Contracting Experience: Research Findings from U.S. and European Stakeholders.. Journal of Managed Care & Specialty Pharmacy (2017).
6. Barriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative Therapies. Frontiers in Pharmacology (2020).
7. The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy. Frontiers in Pharmacology (2021).