The price, efficacy, and safety of within-class targeted anticancer medicines between domestic and imported drugs in China: a comparative analysis

作者：Xingxian Luo, Xin Du, Lin Huang, Qixiang Guo, Ruijie Tan, Yue Zhou, Zhuangqi Li, Xuecai Xue, Taifeng Li, Kaidi Le, Qian Feng, Shein‐Chung Chow, Yang Yue · 发表于：The Lancet Regional Health - Western Pacific · 年份：2022 · DOI：10.1016/j.lanwpc.2022.100670 · 被引用次数：30 · 研究领域：Economic and Financial Impacts of Cancer、Pharmaceutical Economics and Policy、Health Systems, Economic Evaluations, Quality of Life

Background Affordability to novel anticancer drugs has become a major health issue in China. It is encouraging to note that China initiated its drug regulatory reform and national price negotiation policies since 2015. As a growing number of domestic within-class targeted anticancer drugs are approved in China, it is expected that this may reduce the price of novel anticancer drugs and improve the affordability of anticancer drugs. This study aimed to evaluate the price, efficacy, and safety of the within-class anticancer drugs between domestic and imported drugs approved in China from 2010 to 2022. Methods The domestic and imported within-class targeted drugs for solid cancers approved in China between 2010 and 2022 were extracted. We classified it as a class of anticancer drugs based on the same indication and similar biological mechanism. The published literature derived from pivotal clinical trials of these domestic and imported drugs was identified based on the review report and the latest labels issued by the China National Medical Products Administration. We evaluated the monthly treatment price at launch and the latest (2022), primary efficacy endpoint and safety between domestic and imported anticancer drugs. Meta-analyses were further employed to evaluate the efficacy and safety of the domestic and imported anticancer drugs, including pooled hazard ratios (HR) for progression-free survival (PFS), overall survival (OS), objective response rates (ORR) for solid cancer...