Pharmacoeconomic Guidelines: Japan

Country/Region: Japan
PE Guidelines
Guideline for preparing cost-effectiveness evaluation to the central social insurance medical council (version 3.0 2022)
PDF in English
Additional Information:
Shiroiwa T, Fukuda T, Ikeda S, et al. Development of an Official Guideline for the Economic Evaluation of Drugs/Medical Devices in Japan. Value Health 2017;20(3):372-8.

Information current as of Saturday, August 13, 2022

Key Features

Type of Guidelines PE Guidelines
Title and year of the document Guideline for preparing cost-effectiveness evaluation to the central social insurance medical council (version 3.0, 2022)
Affiliation of authors Prepared by: Study Team for “Establishing Evaluation Methods, Data Standardization, and Assessment Systems Toward the Application of Economic Evaluation of Healthcare Technologies to Governmental Policies” (Team Leader: Takashi Fukuda); Supported by Health and Labour Science Research Grants (Strategic Integrated Scientific Research Project)
Purpose of the document This guideline presents methods of analysis to prepare for costeffectiveness evaluations to the Central Social Insurance Medical Council.
Standard reporting format included Not included
Target audience of funding/ author's interests
Perspective Public healthcare payer’s perspective is considered standard. Other perspectives can be applied, as necessary.
Target population Patient populations that meet the indications when the target technology is selected should be considered as the target population of the cost-effectiveness evaluation.
Subgroup analysis Should be performed if needed
Choice of comparator Technology, reimbursed by public health insurance, widely used in clinical practice and expected to be to a large extent
Time horizon Long enough to evaluate the value of health care technologies
Assumptions required The assumption used to create the model should be described clearly.
Preferred analytical technique CEA (basically CUA should be used)
Costs to be included Only public healthcare costs should be included in the case of analysis from public healthcare payers’ perspective.
Source of costs Medical fee schedule and drug price list set by the MHLW
Modeling Yes
Systematic review of evidences The additional benefit in terms of effectiveness, safety, and/or other factors of the technology should be evaluated on the basis of a systematic review.
Preference for effectiveness over efficacy
Preferred outcome measure QALY should be used as a basic outcome.
Preferred method to derive utility If Japanese utilities are newly collected for a cost-effectiveness analysis, EQ-5D-5L is recommended as the first choice
Equity issues stated Not stated
Discounting costs 2%
Discounting outcomes 2%
Sensitivity analysis-parameters and range The range moving parameter in the sensitivity analysis can refer to the 95% confidence interval of the estimator.
Sensitivity analysis-methods Deterministic and probabilistic sensitivity analyses
Presenting results The results of the analysis should be reported in the style set (in Japanese) forth elsewhere.
Incremental analysis Incremental cost-effectiveness ratio
Total costs vs effectiveness (cost/effectiveness ratio)
Portability of results (Generalizability)
Financial impact analysis Not required
Mandatory or recommended or voluntary Mandatory


The ISPOR Japan Chapter contributed to the key feature form.
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