Evaluation of the usage of more than 50 sheets of autologous cultured epidermis (JACE®) sheets in treating patients with severe burns beyond insurance coverage limits

Background: Autologous cultured epidermis, JACE®, Japan's first regenerative medical product, is used as the standard treatment for wound closure in patients with severe burns. Although this product is listed for national health insurance in Japan, medical institutions place orders for JACE® beyond the limit of 50 sheets calculated for insurance coverage (insurance coverage limit) for lifesaving purposes. Therefore, the manufacturer and distributor continue to provide an excess amount, free from humanitarian considerations. Methods: As a project supported by the Ministry of Economy, Trade, and Industry, the authors planned and conducted a non-interventional survey on the usage of JACE® from June 21, 2023, to February 29, 2024. In cases where more than 50 sheets of JACE® were used for patients with severe burns, information obtainable at the manufacturing stage and post-treatment feedback from physicians in charge were collected, and the requirement for JACE® were reviewed. Results: During the survey period, interviews were conducted with physicians in charge at 30 institutions that placed orders for JACE® for the treatment of patients with severe burns. Of 43 patients, 13 received51 or more JACE® sheets. All were used at the request of the physician in charge and were confirmed to contribute to epithelialization, which closes burn wounds and saves lives. The mean age of the 13 patients who received 51 or more JACE® sheets (group H) was 53.2 years, which was lower than the63.1 years in the 30 patients who received 50 or fewer sheets (group L). The mean injured area was 55.9 % in group H and was clearly larger than the 37.0 % in group L. All patients with an injured area of 70 % or more were in group H, and three patients who received 100 or more JACE® sheets, with the highest reaching 165 sheets. In group H, JACE® tended to be used in younger patients with a large injured area and in elderly patients with a small injured area. A total of 434 sheets were provided to medical institutions free of charge to the 13 patients in group H. Conclusions: Among the number of JACE® orders placed for the treatment of patients with severe burns, 30 % received more sheets than the insurance coverage limit; of the total number of sheets, 20.7 % were provided free of charge to medical institutions. Given this situation, the 50-sheet limit for insurance reimbursements need to be revisited.