Clinical Research Support Center, The University of Tokyo, Tokyo, Japan.
Department of Medical Innovation, Academic Clinical Research Center, Osaka University Hospital, Osaka, Japan.
Clin Transl Sci. 2020 Jul;13(4):700-706. doi: 10.1111/cts.12751. Epub 2020 Feb 27.
Japan's Advanced Medical Care Program (AMCP) seeks to facilitate patient access to promising healthcare technologies through National Health Insurance (NHI) coverage. This study aimed to examine AMCP's contribution to the accelerated introduction of new technologies through NHI coverage. AMCP-type B technologies registered May 2006-March 2019 were examined. To investigate the use of AMCP for NHI coverage, data from the AMCP website and from regulatory authority documents were used. Of 127 AMCP-type B technologies, 38 underwent final review. Fifteen technologies were successfully introduced into NHI coverage. Eight technologies introduced directly through the Advanced Medical Care Conference were related to medical devices. Other technologies, including drugs, required additional accelerated frameworks for market approval. A strategic approach with the careful selection of target therapeutic technologies and accelerated frameworks is key for the rapid introduction of medical technologies through AMCP.
日本的先进医疗照顾计划（AMCP）旨在通过国民健康保险（NHI）覆盖来促进患者获得有前途的医疗技术。本研究旨在通过 NHI 覆盖来检验 AMCP 对加速新技术引入的贡献。检查了 2006 年 5 月至 2019 年 3 月登记的 AMCP 型 B 技术。为了研究 AMCP 在 NHI 覆盖范围内的使用情况，使用了 AMCP 网站和监管机构文件的数据。在 127 项 AMCP 型 B 技术中，有 38 项进行了最终审查。有 15 项技术成功纳入 NHI 覆盖范围。直接通过先进医疗照顾会议引入的 8 项技术与医疗器械有关。其他技术，包括药物，需要额外的加速框架来获得市场批准。通过 AMCP 快速引入医疗技术的关键是采取战略性方法，精心选择目标治疗技术和加速框架。
