Presentation (CTI)

OBJECTIVES: Alongside its generous national health insurance (NHI) coverage for prescription drugs, Japan has adopted a convoluted price control system constraining public spending on pharmaceutical products. Japan’s cost-effectiveness assessment (CEA) repricing scheme was officially introduced in FY2019, and the first CEA results were completed in 2021. Since then, the expansion of the CEA repricing scheme has been highlighted on the Ministry of Health, Labour and Welfare’s (MHLW’s) reform agenda, as the price reduction results were seen to be insufficient by the ministry. This research aims to understand the trend in price reductions based on CEA.
METHODS: CEA results published by the Center for Outcomes Research and Economic Evaluation for Health (C2H) before April 2026 were examined. For the reviewed drugs and for their comparators which underwent CEA price review, and for which new NHI prices were confirmed by the MHLW before May 2026, the CEA results and NHI price changes were examined based on the MHLW documents and GlobalData’s POLI database.
RESULTS: A total of 49 drugs underwent CEA price reviews in the designated timeframe, resulting in an average price reduction rate of 4.02%. The NHI prices were maintained for 12 drugs. Among the 37 drugs receiving price reduction, the average price reduction rate was 5.32%. Leqembi (lecanemab) received the highest price cut - 15%, under a special CEA rule. The annual average price reduction rate due to CEA repricing increased incrementally, from 1.5% in 2021 to 7.43% in 2025.
CONCLUSIONS: The growth in annual average price cuts following CEA reviews suggests that the influence of such a price control framework is likely to be increasingly significant. This is likely to be a result of the combined impact of more high-cost drugs subjected to CEA reviews, the MHLW’s CEA reform, and the new special CEA model introduced in 2025.