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

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