Analysis of factors associated with premiums for reimbursed medical devices in Japan.

Aims: The aim of this study is to examine factors that relate to receipt of a reimbursement premium in Japan, which is defined as an increase in the initially calculated reimbursement price based on certain criteria, or an increase in the operating profit ratio.

Materials And Methods: Reimbursement submissions and decisions for newly reimbursed medical devices in Japan from fiscal year (FY) 2015 to FY 2023 were reviewed to consider their characteristics. Moreover, the relationship between reimbursement submission characteristics, as well as other characteristics such as regulatory submission category, risk class, location of the manufacturer headquarters, etc. and the receipt of a Novelty, Usefulness, or Improvement premium (hereafter "utility premium"), or an increase in the operating profit ratio, was examined using univariate and multivariate regression.

Results: Among 131 unique medical devices newly reimbursed in Japan from FY 2015 to FY 2023, 57 devices (44%) received a reimbursement premium. Among those, 30 devices (53%) were devices to treat cardiovascular conditions. Based on univariate regression, therapy area, reimbursement category and method used, duration since the comparator device was listed, and estimated peak annual patients for the new device are factors that affect the receipt of a utility premium or an increase in the operating profit ratio. However, based on multivariate regression, only the therapy area, risk-related regulatory submission class, regulatory submission type (novelty), and orphan device designation are associated with the receipt of a utility premium or an increase in the operating profit ratio.

Conclusions: Receipt of a utility premium can be challenging. Moreover, medical devices to treat cardiovascular conditions have benefited more from premiums. This may be due to those devices having more data on efficacy at the time of approval and listing. More opportunities for devices to obtain premiums following initial listing may be needed to adequately capture their value.