澳大利亚PBS药品上市后再审查制度介绍及对我国的启示  

Introduction of Australian post-market reviews of pharmaceutical benefits scheme subsidized medicinesand its implication to China

作　　者：李大双 颜建周[1] 邵蓉[1] LI Dashuang;YAN Jianzhou;SHAO Rong(Research Center of National Drug Policy&Ecosystem,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学国家药物政策与医药产业经济研究中心,南京211198

出　　处：《中国药房》2023年第15期1793-1797,共5页China Pharmacy

基　　金：国家自然科学基金面上项目(No.72274217)。

摘　　要：目的 为加强我国医保目录内药品的准入后管理提供参考。方法 介绍澳大利亚药品福利计划(PBS)上市后再审查(PMR)制度的基本情况、开展流程和实施成效,同时对我国医保目录类药品的准入后管理提出建议。结果与结论 PMR制度体现了澳大利亚对PBS目录内药品进行全生命周期管理的理念,作为管理PBS药品的准入和调整的一种机制,可实现对PBS目录内药品的持续评估。其流程主要包括PBS药品审查启动前流程和PBS药品审查流程2种,涉及药品遴选、审查范围确定、实施管理等步骤。通过PMR,澳大利亚共完成了PBS目录内糖尿病、儿童哮喘、阿尔茨海默病等9个治疗领域的多个药品的审查。笔者建议我国可在制度层面完善药品准入后审查(明确审查对象的遴选标准和方法、主要程序和责任主体、保证审查过程公开透明);明确国家医疗保障局或委托第三方机构,直至成立专门的技术机构负责这一工作;与此同时,进一步完善数据收集和监测系统的建设。OBJECTIVE To provide a reference for strengthening the post-admission management of drugs on the medicare formulary in China.METHODS The basic situation,implementation process and effect of post-market reviews(PMR)were introduced after marketing approval of the Australian pharmaceutical benefits scheme(PBS)subsidized medicines.The suggestions were put forward for post-admission management of medicare formulary drugs in China.RESULTS&CONCLUSIONS PMR system exemplified Australia’s concept of life-cycle management of medicines on the PBS catalogue;as a mechanism for managing the admission and adjustment of PBS medicines,it provided a continuous evaluation of medicines in the PBS catalogue;the process mainly included two types:the pre-initiation process of PBS drug review and the PBS drug review process,involving steps such as drug selection,determination of review scope,and implementation management.Through PMR,Australia had completed the review of multiple medicines in nine treatment areas including diabetes,childhood asthma and Alzheimer’s disease in the PBS catalogue.The author suggests that China can improve the post-admission review of medicines at the institutional level(clarifying the selection criteria and methods of the review object,main procedures and responsible parties,and ensuring the transparency of the review process);specify the National Healthcare Security Administration or the third-party organization until a special technical organization is established to take charge of this work;at the same time,further improve the construction of data collection and monitoring systems.

关 键 词：医保准入 上市后再审查 澳大利亚药品福利计划 

分 类 号：R95[医药卫生—药学]