While much of the Western world has initiated regulations and reimbursement for SaMD products, Japan is still grappling with this product category. The number of SaMD product approvals in Japan dwarfs the number of approvals in the West. As Japan gets more familiar with the benefits of SaMD products, determining reimbursement is crucial. In Japan, it is illegal to use non-reimbursed medical devices
On July 26, Chuikyo, Japan’s reimbursement agency met to discuss the fiscal year 2024 reimbursement policy. For SaMD products, the group emphasized the importance of clarifying how SaMD products would be reimbursed based on clinical usefulness. Also debated were what reimbursement category SaMD products should be based on. Options included reimbursement via existing medical fees, medical fee premiums, a cost-based method, etc. Also considered was a way to increase reimbursement after SaMD products show increased healthcare benefits. A member of the group emphasized studying reimbursement amounts allotted in foreign countries. Japanese device reimbursement is normally determined by functional category or foreign reference pricing.