OBJECTIVES: In Korea, the risk-sharing system was introduced in December 2013 as a complementary system to the positive listing system, which is applies to anticancer drugs and treatments for rare diseases with high clinical requirements, aiming to enhance coverage of serious diseases and improve patient access. The purpose of this study is to analyze the types of risk-sharing systems in Korea over the past decade.

METHODS: Drugs evaluated by the Drug Benefit Evaluation Committee of the Health Insurance Review and Assessment Service were included. The risk-sharing systems were categorized as finance-based schemes (total expenditure cap, refund, utilization cap per patient) and outcome-based schemes (performance-based).

RESULTS: A total of 80 substances have been evaluated under risk-sharing agreements, mainly anticancer drugs and treatments for rare diseases. Since its introduction in 2013, 70.5% (55/78) of anticancer drugs and 32.8% (20/61) of treatments for rare diseases have been recommended for reimbursement under risk-sharing agreements. With the exception of one substance, 79 substances (98.8%) have been covered by finance-based schemes, with 6 substances (7.5%) also implementing outcome-based schemes. Since the introduction of the economic evaluation exemption in 2015, the risk-sharing agreements for drugs has increased. From 2019 onwards, outcome-based risk-sharing mechanisms have been applied, primarily focusing on treatments for rare diseases. Particularly, following the introduction of one-shot treatment Kymriah, patient outcome-based pricing for ultra-high cost drugs has been adopted to balance patient access and financial sustainability through performance-based rebates. Time to reimbursement has generally decreased since system implementation, with evaluations conducted within a similar timeframe over the past three years.

CONCLUSIONS: The implementation of risk-sharing agreements has enhanced patient access to high-cost drugs. Moreover, the shift from predominantly finance-based to recent outcome-based or hybrid risk-sharing approaches not only sustains patient accessibility but also strengthens management of uncertainty regarding effectiveness, alongside financial considerations.