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

Background: 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 repair.