附条件批准上市药品纳入基本医疗保险药品目录的政策风险分析  

Analysis of Policy Risk of Drugs with Conditional Approval Incorporated into Medicine List for Basic Medical Insurance

作　　者：周菁菁 黄梦琴 孙志明 张学宁 谈在祥 ZHOU Jingjing(School of Management,Xuzhou Medical University,Xuzhou,Jiangsu,221004,China)

机构地区：[1]徐州医科大学管理学院,江苏徐州221004 [2]徐州医科大学卫生政策与健康管理研究中心,江苏徐州221004 [3]江苏卫生发展研究中心,江苏南京210000 [4]徐州医科大学附属医院,江苏徐州221006

出　　处：《医学与社会》2023年第1期99-104,共6页Medicine and Society

基　　金：国家社会科学基金资助项目,编号为19FJYB014;2021年江苏省研究生科研创新计划,编号为KYCX21_2635;四川医事卫生法治研究中心重点项目,编号为YF22-Z01;江苏省卫生健康发展研究中心开放课题,编号为JSHD2021035。

摘　　要：通过对我国药品附条件批准上市制度和新药纳入国家基本医疗保险药品目录机制的发展现状进行研究,分析我国附条件批准上市药品纳入医保药品目录后的潜在风险,包括安全性无法得到有效保障;附条件批准上市药品过快纳入医保引发信用危机;公平性不足,不利于后续政策统一。借鉴美国、日本和英国等国家的经验,应完善药品上市后再评价体系,防范患者用药风险;优化特殊药品的准入程序,提高医保药品目录调整的动态性;完善卫生技术评估流程,增强决策的公开透明。By studying the development status of the conditional approval system and the mechanism of bringing new drugs in-to medicine list for national basic medical insurance,this paper analyzes the potential risks after the drugs with conditional approvalare incorporated into medicine list for medical insurance,including the lack of effective security for safety.Drugs with conditionalapproval are incorporated into medical insurance too quickly,causing a credit crisis.The lack of fairness is not conducive to the u-nification of follow-up policies.Combined with the experience of the United States,Japan and the United Kingdom,it’s suggestedto improve the re-evaluation system of post-approval to prevent the drug risk of patients,optimize the access procedure of specialdrugs and increase the dynamics of adjustment of medicine list for medical insurance,and improve the health technology evaluationprocess and enhance the openness and transparency of decision-making.

关 键 词：基本医疗保险 药品目录 附条件批准 医保准入 政策风险 

分 类 号：R197.1[医药卫生—卫生事业管理]