Application of England's Severity Weighting to Cost-Effectiveness Evaluations in Japan
Author(s)
Shunya Ikeda, MSc, PhD, MD1, Mia Kobayashi, RN, PhD2, Kensuke Moriwaki, BS, MS, PhD3, Takeru Shiroiwa, MPH, PhD4, Takashi Fukuda, PhD4;
1International University of Health and Welfare, Department of Public Health, Narita, Japan, 2Yamanashi University, Kofu, Japan, 3RItsumeikan University, Kusatsu, Japan, 4National Institute of Public Health, Wako, Japan
1International University of Health and Welfare, Department of Public Health, Narita, Japan, 2Yamanashi University, Kofu, Japan, 3RItsumeikan University, Kusatsu, Japan, 4National Institute of Public Health, Wako, Japan
OBJECTIVES: In Japan, a cost-effectiveness evaluation system was introduced in 2019 to adjust the pricing of drugs and medical devices. For standard items, prices are reduced if the incremental cost-effectiveness ratio (ICER) exceeds 5 million JPY/QALY. However, treatments for rare diseases with limited alternatives, pediatric conditions, and anti-cancer drugs receive special consideration, raising the threshold to 7.5 million JPY/QALY.
In contrast, England applies QALY shortfall as a basis for severity modification. This study examines whether items evaluated in Japan meet England’s severity modification criteria.
METHODS: 74 evaluations of 32 items subject to Japan’s cost-effectiveness evaluation system, with published results as of the end of December 2024 were reviewed. Using data from reports submitted by companies or prepared by public analysis groups, Absolute Shortfall (AS) and Proportional Shortfall (PS) were calculated based on Japan’s life tables and QOL population norm values. Analyses where AS and PS could not be calculated, such as those applying cost-minimization due to the absence of additional benefit or those lacking disclosed age information, were excluded.
RESULTS: Among company-submitted analyses, AS and PS calculations were possible for 34 cases. Of these, 10 met England’s severity modification criteria, but 3 did not qualify for special consideration in Japan.
For 27 cases reassessed by public groups, 11 met England’s criteria, but 2 did not qualify for special consideration in Japan. Notably, no items meeting Japan’s criteria for special consideration failed to meet England’s severity modification criteria.
CONCLUSIONS: The limited availability of publicly disclosed information in many studies restricts the comprehensiveness of this analysis. However, Japan’s criteria for threshold modification appear more stringent than England’s. Prioritization of diseases and treatments reflects cultural and societal values, emphasizing the need for further research to establish culturally relevant and evidence-based criteria for cost-effectiveness evaluations in Japan.
In contrast, England applies QALY shortfall as a basis for severity modification. This study examines whether items evaluated in Japan meet England’s severity modification criteria.
METHODS: 74 evaluations of 32 items subject to Japan’s cost-effectiveness evaluation system, with published results as of the end of December 2024 were reviewed. Using data from reports submitted by companies or prepared by public analysis groups, Absolute Shortfall (AS) and Proportional Shortfall (PS) were calculated based on Japan’s life tables and QOL population norm values. Analyses where AS and PS could not be calculated, such as those applying cost-minimization due to the absence of additional benefit or those lacking disclosed age information, were excluded.
RESULTS: Among company-submitted analyses, AS and PS calculations were possible for 34 cases. Of these, 10 met England’s severity modification criteria, but 3 did not qualify for special consideration in Japan.
For 27 cases reassessed by public groups, 11 met England’s criteria, but 2 did not qualify for special consideration in Japan. Notably, no items meeting Japan’s criteria for special consideration failed to meet England’s severity modification criteria.
CONCLUSIONS: The limited availability of publicly disclosed information in many studies restricts the comprehensiveness of this analysis. However, Japan’s criteria for threshold modification appear more stringent than England’s. Prioritization of diseases and treatments reflects cultural and societal values, emphasizing the need for further research to establish culturally relevant and evidence-based criteria for cost-effectiveness evaluations in Japan.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR165
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas