OBJECTIVES: After the reimbursement listing of one-shot treatments in 2022, KYMRIAH and ZOLGENSMA, the Korean government has announced policies on the listing of high priced treatments. In this study, we analyzed this newly announced policy based on a review of the KYMRIAH and ZOLGENSMA listing precedents.

METHODS: We reviewed the key policies of the reimbursement method for high priced treatments announced by the Korean government in 2022, and analyzed the P&R scheme applied to KYMRIAH and ZOLGENSMA.

RESULTS: “High priced treatments” as defined by the Korean government are those that expect long term efficacy based on a single treatment (one-shot therapy) or has an annual treatment cost of at least KRW 300,000,000 per person (ultra-high priced new drug). The policy directive is separated into short term (2022) and long term (2023 and beyond) policies, which introduce specific schemes based on the following three main objectives: (1) increased patient access (expedited listing and performance based risk-sharing agreement (RSA) per patient), (2) strengthened monitoring of treatment efficacy and safety (data collection system for post-listing effectiveness monitoring) and (3) strengthened reimbursement management (reimbursement approval prior to treatment). KYMRIAH and ZOLGENSMA were listed by applying a combination of various schemes such as refund, performance based RSA, expenditure cap and prior approval. As of June 2023, KYMRIAH and ZOLGENSMA are reimbursed at 85% and 77%, respectively, of the average price of the A8 countries (UK, US, Italy, France, Germany, Swiss, Japan and Canada) referenced by the Korean government. ZOLGENSMA’s prior approval rate since its listing is at 80%.

CONCLUSIONS: With the continuous launch of high priced drugs, the Korean government has announced high priced drug P&R policies aimed at increasing health insurance efficiency and patient access. Continued assessment on whether the government can indeed achieve these two policy objectives by strengthening post-listing management (rather than delayed listing) is necessary.