Presentation (CTI)

OBJECTIVES: South Korea transitioned from Negative List System (NLS) to Positive List System (PLS) in December 2006 to improve efficiency in pharmaceutical spending and ensure reimbursement of medicines with therapeutic and economic value. Since its implementation, multiple policy refinements have been introduced to improve patient access while maintaining sustainability. This research aims to review the 20-year achievement of South Korea’s PLS and evaluate its impact on reimbursement decision-making, patient access, and pharmaceutical benefit management.
METHODS: A descriptive retrospective review of reimbursement policies and outcomes was conducted using data from the Health Insurance Review and Assessment Service (HIRA) (2007-2025). Key indicators included the reimbursement recommendation rates, assessment timelines, and major policy reforms.
RESULTS: Between 2007 and 2025, HIRA conducted 742 pharmaceutical reimbursement assessment, of which 576 (78%) received a positive recommendation from Pharmaceutical Benefit Coverage Assessment Committee (PBCAC). The reimbursement recommendation rate has generally increased since the introduction of PLS (67% in 2007, 94% in 2025). Mean reimbursement assessment time from submission was 109 days, excluding the time required to prepare additional information. The duration of reimbursement assessment was similar across drug categories; however, time to listing was longer for anticancer drugs (339 days) and rare disease treatments (291 days) than for other drugs (257 days). Pharmaceutical expenditure remained stable at approximately 24% of total healthcare expenditure between 2020 and 2025. Policy expansion particularly benefited oncology and rare disease treatments through application of risk-sharing agreements (RSA), pharmacoeconomic evaluation exemptions (PEE) and flexible ICER threshold.
CONCLUSIONS: Over time, PLS in South Korea has developed into a mature HTA-based reimbursement framework that balances patient access with financial sustainability. Recent policy reforms are expected to introduce an expedited reimbursement pathway incorporating real-world evidence (RWE) and a flexible pricing scheme.