TRENDS IN JAPAN’S DRUG PRICING SYSTEM REFORMS FROM 2008 TO 2026...
Author(s)
Yoshie Onishi, RPh, DrPH1, maaz rafique, MM2, Mariko Nomoto, MBA3, Grace Kiyabu, PhD3, Clement Francois, MSc, PhD4, Shunya Ikeda, MSc, PhD, MD5.
1Director, Japan operation, Putnam (Creativ-Ceutical K.K.), Tokyo, Japan, 2Putnam, london, United Kingdom, 3Putnam (Creativ-Ceutical K.K.), Tokyo, Japan, 4Putnam, Paris, France, 5International University of Health and Welfare, Narita, Japan.
1Director, Japan operation, Putnam (Creativ-Ceutical K.K.), Tokyo, Japan, 2Putnam, london, United Kingdom, 3Putnam (Creativ-Ceutical K.K.), Tokyo, Japan, 4Putnam, Paris, France, 5International University of Health and Welfare, Narita, Japan.
OBJECTIVES: Japan’s drug pricing system has undergone continuous reform to balance pharmaceutical innovation, healthcare cost optimization, and sustainable drug supply. This study aimed to examine the evolution of Japan’s drug pricing system, with particular attention to structural reforms, policy transitions, and the growing use of policy-based pricing measures.
METHODS: This study reviewed the official Japanese drug pricing rules (“Yakka Santei no Kijun”) issued from 2008 to 2026 by the Ministry of Health, Labour and Welfare (MHLW). Major categories analyzed included new drugs, long-listed drugs, generics, biosimilars, repricing systems, Health Technology Assessment (HTA), and supply stability measures. Changes in pricing methodologies and policy-based pricing rules were examined.
RESULTS: The reforms progressively expanded premium systems for innovative medicines through measures. The Price Maintenance Premium introduced in FY2010 and was subsequently revised. Many reforms accumulated as additional policy layers rather than replacing existing measures, resulting in a progressively more complex pricing structure. Long-listed drugs underwent stepwise repricing under G1/G2 framework, accelerating generic uptake. Policies for generics and biosimilars increasingly emphasized lower pricing and broader utilization, while recent reforms incorporated evaluation of supply stability. Revisions to foreign average price adjustments and cost-accounting methodologies strengthened price optimization. HTA was fully implemented in FY2019, strengthening the link between value assessment and price adjustment. Innovation-supportive pricing measures also expanded in scope. Sakigake-related premiums had been applied to 11 products, while the rapid introduction premium, introduced in FY2024, had been applied to 7 products as a recent policy tool to encourage earlier introduction of innovative drugs.
CONCLUSIONS: Between 2008 and 2026, Japan’s drug pricing system evolved from a framework focused on healthcare cost optimization into a broader policy-oriented system promoting innovation, generic utilization, supply stability, and value-based healthcare. The increasing number of products covered by innovation-oriented pricing measures suggests that reform substantially expanded policy support for innovative medicines.
METHODS: This study reviewed the official Japanese drug pricing rules (“Yakka Santei no Kijun”) issued from 2008 to 2026 by the Ministry of Health, Labour and Welfare (MHLW). Major categories analyzed included new drugs, long-listed drugs, generics, biosimilars, repricing systems, Health Technology Assessment (HTA), and supply stability measures. Changes in pricing methodologies and policy-based pricing rules were examined.
RESULTS: The reforms progressively expanded premium systems for innovative medicines through measures. The Price Maintenance Premium introduced in FY2010 and was subsequently revised. Many reforms accumulated as additional policy layers rather than replacing existing measures, resulting in a progressively more complex pricing structure. Long-listed drugs underwent stepwise repricing under G1/G2 framework, accelerating generic uptake. Policies for generics and biosimilars increasingly emphasized lower pricing and broader utilization, while recent reforms incorporated evaluation of supply stability. Revisions to foreign average price adjustments and cost-accounting methodologies strengthened price optimization. HTA was fully implemented in FY2019, strengthening the link between value assessment and price adjustment. Innovation-supportive pricing measures also expanded in scope. Sakigake-related premiums had been applied to 11 products, while the rapid introduction premium, introduced in FY2024, had been applied to 7 products as a recent policy tool to encourage earlier introduction of innovative drugs.
CONCLUSIONS: Between 2008 and 2026, Japan’s drug pricing system evolved from a framework focused on healthcare cost optimization into a broader policy-oriented system promoting innovation, generic utilization, supply stability, and value-based healthcare. The increasing number of products covered by innovation-oriented pricing measures suggests that reform substantially expanded policy support for innovative medicines.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
HPR34
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas