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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 documentGuideline for preparing cost-effectiveness evaluation to the central social insurance medical council (2016)  
Affiliation of authorsPrepared 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 documentThis guideline presents methods of analysis to prepare for costeffectiveness evaluations to the Central Social Insurance Medical Council.  
Standard reporting format includedNot included  
Target audience of funding/ author's interests 
PerspectivePublic healthcare payer’s perspective is considered standard. Other perspectives can be applied, as necessary. 
Target populationPatients who meet the indication of the technology at the time of a nalysis  
Subgroup analysisShould be performed if needed  
Choice of comparatorTechnology, reimbursed by public health insurance, widely used in clinical practice and expected to be to a large extent 
Time horizonLong enough to evaluate the value of health care technologies  
Assumptions requiredThe assumption used to create the model should be described clearly.  
Preferred analytical techniqueCEA (basically CUA should be used)  
Costs to be includedAll costs paid by public insurers,central and local governments, and patients; productivity loss,depending on choice of perspective 
Source of costsMedical fee schedule and drug price list set by the MHLW  
Systematic review of evidencesThe 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 measureQALYshould be used as a basic outcome.  
Preferred method to derive utilityPreference-based instruments with scoring algorithms developed in Japan  
Equity issues stated 
Discounting costs2%  
Discounting outcomes2%  
Sensitivity analysis-parameters and range 
Sensitivity analysis-methodsDeterministic and probabilistic sensitivity analyses  
Presenting resultsThe results of the analysis should be reported in the style set (in Japanese) forth elsewhere.  
Incremental analysisIncremental cost-effectiveness ratio  
Total costs vs effectiveness (cost/effectiveness ratio) 
Portability of results (Generalizability) 
Financial impact analysisNot required  
Mandatory or recommended or voluntaryMandatory  

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

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