OBJECTIVES : The risk sharing agreement (RSA) was applied to anticancer and rare disease drugs as a policy to improve patient accessibility in Korea. The purpose of this study is to analyze the achievement of the implementation and the status of system operation since the implementation of RSA.

METHODS: 422 drugs evaluated from 2009 to 2018 by the Pharmaceutical Benefits Committee were analyzed. We divided the period into before and after the introduction of RSA (2009 ~ 2013 vs. 2014 ~ 2018) and compared the reimbursement recommendation rate and the time required for evaluation at HIRA focused on anticancer and rare drugs. In addition, the ratio, type, and characteristics (improvement of clinical usefulness, renewal of contract, etc.) of RSA applied drugs were analyzed among the listed drugs within five years.

RESULTS: Anticancer and rare disease drugs have increased their recommendation rate(51.7%→74.2%, 73.2%→83%, respectively) and review period was shortened after the introduction of the system. 17 drugs have been listed through RSA for 5 years, which accounted for 20% (17/87) of the listed anticancer and rare disease drugs (N=87). Most of the RSA applied drugs were reviewed as economic evaluation (N=15) because of the improvement in their clinical usefulness, accounting for 51.7% (15/29) of the total economic evaluation drugs over the same period. As for the RSA types, there were refund (N=12), utilization cap (N=4) and coverage with evidence development (N=1). After the listing, some changes occurred like the termination of contracts for the development of evidence (N=1) or listing of alternative drugs (N=3).

CONCLUSIONS: After the implementation of RSA, patients have better accessibility to medicines with the improvement in reimbursement recommendation rate and shortened review period. It especially seems to have had a positive impact on improving the accessibility of drugs with improved effects.