Mechanisms that affect reimbursement prices for medical devices in Japan, the world’s third largest medical device market: A scoping review

ABSTRACTBackground Over the past two decades, Japanese reimbursement prices for medical devices used for percutaneous coronary intervention (PCI) were greatly reduced. This scoping review aimed to identify the mechanisms that influence the reimbursement prices of medical devices in Japan, such as devices used in cardiovascular diseases.Methods PubMed and Google Scholar were searched from their inception through July 31, 2022, for possible mechanisms that affect reimbursement in Japan.Results Reimbursement prices for PCI-related medical devices have declined since the middle of the 1990s because of the increasing number of PCI procedures performed due to an ageing society, differences in domestic and international prices, and differences between reimbursement prices and prevailing prices. In addition, the reimbursement price of medical devices is affected by the Health Technology Assessment, which considers the cost-effectiveness of medical devices and the market expansion re-pricing system, which is imposed on medical devices whose market has expanded significantly beyond the projections at the time of insurance listing.Conclusion Reimbursement prices of medical devices in Japan were primarily affected by three mechanisms aimed at controlling the healthcare expenditure; however, recently, in addition to these, the reimbursement price is evaluated from an economic perspective, including cost-effectiveness and market projection.Abbreviations: DES, Drug-eluting stent; EVAR, endovascular aneurysm repair; HTA, Health Technology Assessment; JFTC, Japanese Fair-Trade Commission; JROAD, Japanese registry of all cardiac and vascular disease; MHLW: Ministry of Health, Labor, and Welfare; NHRS, national health reimbursement system; PCI, percutaneous coronary intervention; TAVI, transcatheter aortic valve implantation; TEVAR, thoracic endovascular aortic repairKEYWORDS: Reimbursementprice mechanismpercutaneous coronary interventionPCI-related medical deviceshealth technology assessment AcknowledgementsThe authors would like to thank Ms. Keiko Takahashi for her help in the preparation of the figures and tables, Ms. Rie Arai for her research assistance and Mr. Emmanuel Asika for the English language editing.Data availability statementAvailable upon the request.Disclosure statementNo potential conflict of interest was reported by the author(s).Contributors: Satoru Hashimoto made a concept, research, and design of the article. Dr. Yoshihiro Motozawa provided his clinical experience, interpret the data, and supported writing the article. Professor Toshiki Mano was responsible for final approval of the article to be submitted.Additional informationNotes on contributorsSatoru HashimotoSatoru Hashimoto BS, MBA after a consistent career in sales and marketing in the cardiovascular intervention field, founded TCROSS Co., Ltd, in 2005. He received his MBA from the Graduate School of Management, Globis University, in 2021. Hashimoto is currently studying medical innovation in a doctoral program at Chuo University.Yoshihiro MotozawaYoshihiro Motozawa MD, PhD after graduating from the University of Tokyo, School of Medicine, he began his clinical career as a cardiologist. He then went on to obtain his Ph.D. in Medicine from the University of Tokyo. He currently works at hospital as a clinician while working as a business consultant in TCROSS Co., Ltd.Toshiki ManoToshiki Mano MD, PhD After gaining clinical experience as a diabetes physician, Prof. Mano studied at Cornell University Medical School as a research fellow. He later earned an MBA from the University of Leicester Graduate School of Medicine in the UK while working in the management for a pharmaceutical company. Prof. Mano also holds a PhD in economics from Kyoto University. He is currently involved in the MBA education programs and serves as Chairman of the Hospital Committee of the Ministry of Health, Labor and Welfare, and the Japan Medical Association.