Comparative Analysis of HTA Guidelines on Indirect Costs and Caregiver Utilities: Japan vs. Four European Countries
Author(s)
Radoslaw Skowron, MSc1, Mariko Nomoto, MBA2, Grace Kiyabu, PhD, MPH3, Yoshie Onishi, DrPH, RPh2, Clement Francois, MSc, PhD4, Shunya Ikeda, MSc, PhD, MD5.
1Putnam, Krakow, Poland, 2Putnam, Tokyo, Japan, 3Putnam, San Francisco, CA, USA, 4Putnam, Paris, France, 5International University of Health and Welfare, Ōtawara, Japan.
1Putnam, Krakow, Poland, 2Putnam, Tokyo, Japan, 3Putnam, San Francisco, CA, USA, 4Putnam, Paris, France, 5International University of Health and Welfare, Ōtawara, Japan.
OBJECTIVES: This study compares the preferences of Japan and four European Health Technology Assessment (HTA) bodies regarding the inclusion of indirect costs and caregiver burden in health economic evaluations (HEEs) used to support drug reimbursement decisions.
METHODS: Official guidance documents were identified through a targeted review of HTA agency websites in Japan (Center for Outcomes Research and Economic Evaluation for Health, C2H), Germany (IQWiG), France (HAS), Sweden (TLV), and the UK (NICE). Each was analysed for its approach to incorporating indirect costs and caregiver utilities in HEEs.
RESULTS: C2H and three European HTA bodies (NICE, IQWiG, HAS) allow the inclusion of indirect costs in supplementary analyses but not in the base case. C2H guidance is more restrictive, permitting only productivity losses directly attributable to the evaluated intervention, and only when supported by Japanese data. In contrast, TLV mandates a societal perspective, requiring all relevant indirect costs in base-case analyses. All five HTA bodies permit caregiver utilities, but under different conditions. In Japan, caregiver utilities may be included only from an extended public payer perspective, while NICE requires them if caregiver impact is deemed clinically relevant.
CONCLUSIONS: While all HTA bodies reviewed accept the inclusion of indirect costs and caregiver utilities, Japan adopts a notably more conservative and prescriptive stance. The C2H’s strict limitations—particularly the requirement for Japanese data and narrow definitions of allowable indirect costs—highlight the need for localized evidence planning. For global manufacturers, this underscores the importance of early engagement and tailored modelling to meet Japan’s specific expectations, ensuring submissions are both compliant and compelling in a highly structured HTA environment.
METHODS: Official guidance documents were identified through a targeted review of HTA agency websites in Japan (Center for Outcomes Research and Economic Evaluation for Health, C2H), Germany (IQWiG), France (HAS), Sweden (TLV), and the UK (NICE). Each was analysed for its approach to incorporating indirect costs and caregiver utilities in HEEs.
RESULTS: C2H and three European HTA bodies (NICE, IQWiG, HAS) allow the inclusion of indirect costs in supplementary analyses but not in the base case. C2H guidance is more restrictive, permitting only productivity losses directly attributable to the evaluated intervention, and only when supported by Japanese data. In contrast, TLV mandates a societal perspective, requiring all relevant indirect costs in base-case analyses. All five HTA bodies permit caregiver utilities, but under different conditions. In Japan, caregiver utilities may be included only from an extended public payer perspective, while NICE requires them if caregiver impact is deemed clinically relevant.
CONCLUSIONS: While all HTA bodies reviewed accept the inclusion of indirect costs and caregiver utilities, Japan adopts a notably more conservative and prescriptive stance. The C2H’s strict limitations—particularly the requirement for Japanese data and narrow definitions of allowable indirect costs—highlight the need for localized evidence planning. For global manufacturers, this underscores the importance of early engagement and tailored modelling to meet Japan’s specific expectations, ensuring submissions are both compliant and compelling in a highly structured HTA environment.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD151
Topic Subcategory
Reproducibility & Replicability
Disease
No Additional Disease & Conditions/Specialized Treatment Areas