Presentation (CTI)

OBJECTIVES: In South Korea, drug reimbursement decisions are determined by the Health Insurance Review & Assessment Service (HIRA), utilizing multiple assessment criteria outlined in national guidelines. These criteria include clinical benefit, cost-effectiveness, budget impact, reimbursement status in reference countries, and the presence of risk-sharing agreement (RSA). This study aimed to evaluate the practical impact of these factors by analyzing their influence on the accepted incremental cost-effectiveness ratios (ICERs) of new drugs.
METHODS: A retrospective analysis was conducted on 43 indications for new drugs (22 oncology, 14 non-oncology, 7 orphan diseases) that underwent pharmacoeconomic evaluation and were reviewed for reimbursement by HIRA between 2017 and 2024. Key assessment factors examined included the availability of therapeutic alternatives, designation as a life-threatening disease, estimated patient population size, reimbursement status in reference countries, and the application of RSA. Associations between these factors and accepted ICER levels were assessed using independent t-tests and multivariate linear regression analyses. Statistical significance was determined at p < 0.05.
RESULTS: T-tests revealed statistically significant differences in ICER levels based on the availability of alternatives, designation as a life-threatening disease, and the presence of RSA. Regression analysis demonstrated that designation as a life-threatening disease, smaller patient population size (<200), and the use of RSA were significantly associated with higher accepted ICERs. Notably, drugs subject to RSA exhibited an average ICER increase of approximately USD 8,260 per QALY. Reimbursement status in reference countries did not show a significant association with ICER outcomes.
CONCLUSIONS: South Korea’s drug reimbursement system employs a flexible, multi-criteria decision-making framework rather than adhering to a fixed ICER threshold. Higher ICERs have been accepted in cases involving life-threatening conditions, limited patient populations, or RSA, indicating that broader clinical and societal values are actively integrated into reimbursement decisions.