Analysis of Oncology Drugs Reimbursement in Korea Over the Last Decade (2015-2024): Comparison of Clinical Value and Drug Price Levels

OBJECTIVES: This study aims to analyze the clinical value and drug price levels of anticancer drugs evaluated by the Health Insurance Review and Assessment Service over the past decade.

METHODS: New anticancer drugs for solid tumors evaluated from 2015 to 2024 were included. The clinical benefit of each drug was assessed using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS), and the association between clinical value and reimbursement status was examined. Using cost-effectiveness evaluation methods (economic evaluation; EE, economic evaluation exemption procedure; EEEP), we analyzed the cost per 4 weeks and the level of drug price compared with the adjusted price of A8 countries (France, Germany, Italy, Switzerland, UK, USA, Japan, and Canada).

RESULTS: In total, 54 drugs with 72 indications were included. Fifty indications were reimbursed, while 22 were not. Indications with substantial benefit received reimbursement in 85.7% of cases, compared to 54.1% for indications with nonsubstantial benefit. A significantly higher proportion of indications with substantial benefit were reimbursed (p<0.05). Among reimbursed indications, 60% showed substantial benefit, compared to 22.7% among non-reimbursed indications (p<0.05). ESMO-MCBS scores were higher for indications evaluated under EE compared to EEEP, though the difference was not statistically significant. The cost per 4 weeks was significantly higher under EEEP compared to EE (p<0.05). The level of the drug price compared to the A8 lowest adjusted price was approximately 22.8% higher under EEEP compared to EE (p<0.05).

CONCLUSIONS: Our study demonstrates that indications with substantial benefits according to ESMO-MCBS were more likely to be reimbursed. There is an association between clinical value in reimbursement assessments and the use of ESMO-MCBS, suggesting it can be a reference in such evaluations. Additionally, EEEP tended to show lower clinical benefits and higher drug prices compared to EE, indicating a need for supplementation in the EEEP system.