【摘要】 目的 助力药品医保准入，提高药品可及性和可负担性。方法 通过文献研究等方法探究国际及我国药品管理准入协议（MEA）的应用现状，从协议药品范畴、协议类型以及协议内容等方面进行比较分析，总结我国药品MEA应用中存在的问题并提出建议。结果与结论 英国、澳大利亚和意大利应用药品MEA的经验较丰富且运作管理机制完善，协议药品范畴较为宽泛，协议类型相对多元化。我国协议药品的治疗领域主要涉及肿瘤和罕见病；协议类型主要为个体层面的基于财务的协议和基于绩效的协议中的效果保证/按疗效支付；我国证据收集平台不完善且缺乏MEA标准化流程。建议利益相关方增加协议药品的品种，将协议类型多元化，提高证据收集准确性和持续性，建立MEA标准化流程。更多还原

【Abstract】 OBJECTIVE To boost access to medical insurance for drugs and improve the accessibility and affordability of drugs. METHODS The current status of the application of international and domestic drug Managed Entry Agreement(MEA)were investigated through literature research method and other methods,and analyzed comparatively from the aspects of the scope of agreement drugs,the types of agreements and the content of the agreement,etc. The problems existing in the application of drug MEA in China were summarized to put forward the suggestions. RESULTS & CONCLUSIONS The UK,Australia and Italy had rich experience in the application of drug MEA,and the operation management mechanism were complete. The scope of drugs included in MEA in these countries were relatively broad and the types of agreements were relatively diversified. In China,drugs included in MEA were mainly oncology drugs and rare disease drugs. The types of agreements mainly included“finance-based agreements”and effect guarantee/effect-based payment in individual-level of“performance-based agreements”. China’s evidence collection platform was imperfect and lacked standardized process of MEA. It is suggested that stakeholders should consider increasing the types of drugs,diversified types of agreements,improving the accuracy and continuity of evidence collection,establishing a standardized process for MEA.更多还原