Presentation (CTI)

OBJECTIVES: Japan’s ‘drug lag’—delayed or absent launches of innovative therapies versus the US and Europe—stems from disruptive policies like annual repricing of patented drugs. To address this, Japan's Chuikyo introduced a pricing reform in April 2024 to accelerate access to National Health Insurance-listed medicines. This research assessed the impact of the reform by comparing regulatory and reimbursement timelines and list price trends in Japan versus the US and key markets (France, Germany, and the UK) pre- and post-reforms.
METHODS: We conducted a descriptive statistical analysis comparing median regulatory approval, reimbursement timelines, and ex-factory list prices at launch and over time. Innovative drugs, defined as those granted an innovativeness/usefulness premium by Japan’s Ministry of Health, Labour and Welfare (MHLW) between January 2021 and May 2025 were stratified into pre-reform (January 2021-April 2024) and post-reform (May 2024-May 2025) cohorts. Data were extracted from publicly available regulatory (Pharmaceuticals and Medical Devices Agency (PMDA), US Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Health Technology Assessment, and pricing databases.
RESULTS: 23 innovative drugs were analysed. Pre-reform, MHLW approval was granted later than the FDA and EMA by a median of 3.8 and 3.3 years, respectively. Post-reform, this lag was reduced to 3.2, 2.0 and 1.8 years compared to the FDA, EMA and MHRA, respectively. Before 2024, time to reimbursement in Japan exceeded the EU average by 137 days. After 2024, timelines were comparable. Japan had the lowest average launch prices and the highest post-launch price reduction compared to US and EU at all times, at 29% and 18% respectively.
CONCLUSIONS: Early trends indicate improvements in both regulatory and reimbursement timelines. However, Japan’s lower launch prices and pronounced post-launch price erosion reflect strong influence of cost-containment policies on market access.