OBJECTIVES: This study aims to analyze the time period from regulatory approval (RA) to reimbursement of the drugs through risk sharing agreement (RSA) scheme with or without cost-effectiveness analysis (CEA) in Korea.

METHODS: The analysis considered all RSA drugs of which reimbursement started since 2014. The data were derived from the official websites of the National Health Authorities in Korea. The time difference between marketing authorizations and the start of national reimbursement has been evaluated.

RESULTS: Until Jan 2020, total 42 drugs have been considered eligible for RSA pathway. Among them, 21 drugs were categorized as “expenditure cap”, 12 drugs as “refund”, and 9 drugs as other types under RSA. In the beginning years of the Korean RSA system (2014-2016, n=13), time from RA to actual reimbursement was about 40 months but it decreased to 27.3 months in 2017 (n=15), 22.6 months in 2018 (n=7), and 17 months in 2019 (n=7). In particular, 24 out of 42 drugs have been listed under the waiver of CEA. New drugs that utilized the waiver of CEA tended to have a shorter lag time than drugs that performed through CEA. The average listing period for drugs using the waiver of CEA was 26.7 months in 2017 (n=8), 19.2 months in 2018 (n=5) and 16.4 months in 2019 (n=5). Meanwhile, the lag time for drugs which performed CEA was 29.7 months in 2017 (n=7), 31.0 months in 2018 (n=2), and 18.5 months in 2019 (n=2) respectively.

CONCLUSIONS: The Korean government introduced RSA and waiver of CEA schemes to improve patient access to medicines. Since the implementation of RSA in Korea, the lag time has been decreasing. The waiver of CEA drugs had shorter duration than that of the CEA performed drugs. This study highlights the improvements to patients’ access to drugs within RSA in Korea.