Executive Summary

To receive reimbursement for a drug in Japan, companies first need to obtain marketing authorisation. Following this process, companies can then submit a new drug reimbursement application to the MHLW. Approved drugs are then included in the publicly available reimbursement drug list. The recently introduced HTA process for drugs and medical devices is only applicable upon selection by the Chuikyo. The HTA (incl. cost-effectiveness analysis) is currently used for price adjustments of drugs and medical devices, rather than for reimbursement and pricing decision making.