Assessing Japan's Three Early Access Programs Based On Recent Discussions: Scope And Financial Aid.

Access to medicines is usually given under the regulatory approvals and subsequent coverage decisions, after efficacy and safety have been proven by clinical trials. Recently, systems to enable exceptional early access* have been explored to meet significant, unmet, and urgent medical needs for frontier medicines. In Japan, the Advanced Medical Care B system (AMC-B) is already in operation. Two other systems, the Japanese version of Compassionate Use system (CU) and the Patient-Initiated Mixed-Care system (PIMC), are planned to start.** The objective of this study is to understand the design and institutional positioning of these three systems, identifying opportunities for further improvements.