title: Development of an Official Guideline for the Economic Evaluation of Drugs/Medical Devices in Japan.
abstract: In Japan, cost-effectiveness evaluation was implemented on a trial basis from fiscal year 2016. The results will be applied to the future repricing of drugs and medical devices. On the basis of a request from the Central Social Insurance Medical Council (Chuikyo), our research team drafted the official methodological guideline for trial implementation. Here, we report the process of developing and the contents of the official guideline for cost-effectiveness evaluation.
  
  
  
  The guideline reflects discussions at the Chuikyo subcommittee (e.g., the role of quality-adjusted life-year) and incorporates our academic perspective. Team members generated research questions for each section of the guideline and discussions on these questions were carried out. A draft guideline was prepared and submitted to the Ministry of Health, Labour and Welfare (MHLW), and then to the subcommittee. The draft guideline was revised on the basis of the discussions at the subcommitte, if appropriate.
  
  
  
  Although the "public health care payer's perspective" is standard in this guideline, other perspectives can be applied as necessary depending on the objective of analysis. On the basis of the discussions at the subcommittee, quality-adjusted life-year will be used as the basic outcome. A discount rate of 2% per annum for costs and outcomes is recommended. The final guideline was officially approved by the Chuikyo general assembly in February 2016.
  
  
  
  This is the first officially approved guideline for the economic evaluation of drugs and medical devices in Japan. The guideline is expected to improve the quality and comparability of submitted cost-effectiveness data for decision making.
authors.affiliation: Department of Health and Welfare Services, National Institute of Public Health, Wako, Saitama, Japan. Electronic address: t.shiroiwa@gmail.com.
authors.forename: Takeru
authors.initials: T
authors.lastname: Shiroiwa
authors.affiliation: Department of Health and Welfare Services, National Institute of Public Health, Wako, Saitama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Fukuda
authors.affiliation: Department of Pharmaceutical Sciences, School of Pharmacy, International University of Health and Welfare, Ohtawara, Tochigi, Japan.
authors.forename: Shunya
authors.initials: S
authors.lastname: Ikeda
authors.affiliation: Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Takura
authors.affiliation: Department of Medical Statistics, Kobe Pharmaceutical University, Kobe, Hyogo, Japan.
authors.forename: Kensuke
authors.initials: K
authors.lastname: Moriwaki
mesh_terms: D026683:Advisory Committees; D003362:Cost-Benefit Analysis / Q000379:methods*; D003695:Delivery of Health Care / Q000191:economics*; D004864:Equipment and Supplies / Q000191:economics; D017408:Guidelines as Topic; D006801:Humans; D007564:Japan; D055553:Prescription Drugs / Q000191:economics; D019057:Quality-Adjusted Life Years; D018582:Sick Leave / Q000191:economics
chemical_list: D055553:Prescription Drugs
keywords: QALY; cost-effectiveness analysis; discount; guideline; productivity loss