Presentation (CTI)

OBJECTIVES: Following the introduction of the Positive List System in 2006, South Korea implemented diverse cost-effectiveness evaluation methods to improve patient access to new drugs. This study aims to understand the operational status of the National Health Insurance (NHI) coverage system by analyzing trends in drug reimbursement listing rates and evaluation durations across different methods from 2007 to 2025.
METHODS: A retrospective analysis was conducted using data on drugs reviewed by the Pharmaceutical Benefit Coverage Assessment Committee (PBCAC) of the Health Insurance Review & Assessment Service (HIRA) from January 2007 to December 2025. The cost-effectiveness evaluation methods were classified as (1) weighted average pricing (WAP), (2) pharmacoeconomic evaluation (PE), (3) pharmacoeconomic evaluation exemption (PEE), (4) clinically essential drugs (Rule of Rescue), and (5) others. Key outcomes included reimbursement listing rates and evaluation and listing durations.
RESULTS: A total of 742 drugs were evaluated, of which 514 (69%) were listed for reimbursement. Mean evaluation and listing durations were 110 and 264 days (medians: 107 and 231), respectively. WAP was the most common method (329/514 cases, 64%), followed by PE (120, 23%), PEE (50, 10%), others (9, 2%), and clinically essential drugs (6, 1%). By therapeutic area, WAP dominated among general (77%) and orphan drugs (59%), while PE led in anticancer drugs (40%), followed by PEE and WAP (29% each). The mean reimbursement listing rates for WAP, PE, and PEE were 72%, 71%, and 77%, respectively. While no clear temporal trends were observed in evaluation or listing durations across methods, WAP demonstrated shorter durations than the others.
CONCLUSIONS: This study analyzed drug reimbursement evaluations by assessment type in South Korea (2007-2025), quantifying listing rates and durations. These findings provide an overview of the current status of pharmaceutical assessment and may serve as objective data for evaluating the NHI reimbursement system and assessment processes.