Country/Region: Japan
PE Guidelines

Guideline for preparing cost-effectiveness evaluation to the central social insurance medical council (2016)
PDF in English

PE Guidelines Source:
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.

Last Webpage Update: Tuesday, January 30, 2018

PE Guidelines Key Features:

Key Features:  
Title and year of the document
Guideline for preparing cost-effectiveness evaluation to the central social insurance medical council (2016)  
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  
Disclosure
 
Target audience of funding/ author's interests
 
Perspective
Public healthcare payer’s perspective is considered standard. Other perspectives can be applied, as necessary. 
Indication
 
Target population
Patients who meet the indication of the technology at the time of a nalysis  
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
All costs paid by public insurers,central and local governments, and patients; productivity loss,depending on choice of 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
QALYshould be used as a basic outcome.  
Preferred method to derive utility
Preference-based instruments with scoring algorithms developed in Japan  
Equity issues stated
 
Discounting costs
2%  
Discounting outcomes
2%  
Sensitivity analysis-parameters and range
 
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  

Acknowledgement: The ISPOR Japan Chapter contributed to the key feature form.

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