Presentation (CTI)

OBJECTIVES: Treatments for rare and severe diseases have limitations in patient access because it is difficult to secure sufficient clinical evidence at the time of insurance listing, given their characteristics of being primarily developed through single-arm clinical trials for a small number of patients.. To resolve this, we aim to report the operational status and key results of the drug performance evaluation management system, which was established for the purpose of efficient post-listing management and resolving evidence uncertainty of high-cost drugs.
METHODS: As of April 2026, HIRA is managing a total of 14 drugs subject to drug performance evaluation and has analyzed the results for 11 drugs as of 2025.
RESULTS: By expanding the drugs subject to performance evaluation to 11 (previously 7 in 2024), coverage was provided to a total of 1,048 patients, thereby reducing national medical expenses by approximately 70 billion KRW that citizens would have borne if not covered. In addition, 18.9 billion KRW was recovered for cases where treatment failure was confirmed after drug administration. To ensure objectivity, data collection methods were applied differently according to drug characteristics, and an internal collaboration system within HIRA was established to enhance efficiency and reliability.
CONCLUSIONS: This drug performance evaluation system functions as a core mechanism for guaranteeing patient treatment access and the right to life by systematically managing the clinical uncertainty of high-cost medicines. Through detailed analysis of Real-World Evidence (RWE) in the future, it will play a pivotal role in further increasing the objectivity of post-management and supporting the sustainable reimbursement listing of expensive new drugs.