Perceptions of risk sharing agreements in South Korea from the viewpoints of key stakeholders: a convergent parallel mixed approach.

Objectives: In 2013, South Korea introduced risk-sharing agreements (RSAs) as a new reimbursement mechanism to enhance access to new medicines and to manage pharmaceutical expenditures. This study evaluates RSAs in South Korea from the viewpoints of key stakeholders.

Methods: In 2022, a survey and semi-structured interviews were conducted. Study participants were recruited from academia (n = 3), domestic (n = 4) and foreign (n = 6) manufacturers, and government agencies (n = 6) using a purposive sampling method.

Results: Key stakeholders perceived the objective of RSAs to be 'access to medicines' and understood RSAs to manage uncertainty about 'expenditures.' They responded that financial- and performance-based RSAs address uncertainty about 'expenditures' and 'clinical effectiveness,' respectively. All stakeholders agreed that RSAs have increased the likelihood that new medicines will be listed and have reduced out-of-pocket expenditures for patients. However, foreign manufacturers insisted that the benefits of RSAs are marginal, while the administrative burden on manufacturers is high.

Conclusion: The gaps in perception between stakeholders could be narrowed by conducting a comprehensive evaluation. Financial- and performance-based RSAs need to be clearly distinguished and aligned to address the uncertainties of a new medicine in health systems.