Presentation (CTI)

OBJECTIVES: Japan operates a centralised, publicly funded healthcare system with universal coverage. The Ministry of Health, Labour and Welfare (MHLW) and the Central Social Insurance Medical Council (Chuikyo) lead reimbursement decisions and set pricing. Since 2019, Japan has formalised a health technology assessment (HTA) system that uses cost-effectiveness analysis (CEA) to reassess prices of high-cost drugs and devices post-launch. The Center for Outcomes Research and Economic Evaluation for Health (C2H) coordinates economic evaluations that inform Chuikyo-led pricing adjustments.We aim to summarise Japan’s current market access process, and evaluate how cost-effectiveness analyses (CEA) influence post-launch pricing for oncology therapies listed in the C2H database.
METHODS: We performed a two-part analysis. First, we compiled a descriptive overview of Japan’s market access pathway, laying out the sequence from regulatory approval to NHI reimbursement and the role of post-launch CEA. Second, we reviewed oncology therapies with completed CEAs in the C2H database. Using public Chuikyo records, we identified whether pricing changed based on CEA outcomes. We extracted data on incremental cost-effectiveness ratios (ICERs), QALY gains, and final pricing decisions.
RESULTS: Japan’s pricing system allows premium pricing at launch, with repricing based on cost-effectiveness evaluations or market expansion. Eight oncology therapies (Kymriah, Epikinly, Cabometyx, Retevmo, Enhertu, Polivy, Darzquro, Padcev) have completed HTA reports published on the C2H platform. All except Darzquro have publicly available pricing adjustment information. Among the seven therapies with available pricing data, Cabometyx retained its price, while others underwent price reductions between 0.2% and 15%, reflecting CEAs or market expansion repricing.
CONCLUSIONS: Japan’s HTA system actively uses CEA to reassess high-cost oncology drugs. Although several products faced price revisions, the scope and consistency of these impacts vary. Manufacturers must understand the evolving regulatory, reimbursement, and HTA interplay to navigate Japan’s market successfully.