药品可及性视角下415种过评仿制药与基药、医保、集采目录的联动情况分析  

Analysis on the linkage of 415 generic medicines passing consistency evaluation and essential medicine list,medical insurance list and centralized procurement list from the perspective of medicine accessibility

作　　者：张焕[1] 徐诺 徐敢 刘利萍 ZHANG Huan;XU Nuo;XU Gan;LIU Liping(Kangda College,Nanjing Medical University,Jiangsu Lianyungang 222000,China;Jiangsu Hansoh Pharmaceutical Group Co.,Ltd.,Jiangsu Lianyungang 222000,China;School of Management,Beijing University of Chinese Medicine,Beijing 100029,China;Dept.of Clinical Pharmacy,School of Pharmacy,Nanjing Medical University,Nanjing 211166,China)

机构地区：[1]南京医科大学康达学院,江苏连云港222000 [2]江苏豪森药业集团有限公司,江苏连云港222000 [3]北京中医药大学管理学院,北京100029 [4]南京医科大学药学院临床药学系,南京211166

出　　处：《中国药房》2022年第6期661-665,705,共6页China Pharmacy

基　　金：2021年度江苏省教育厅高校哲学社会科学研究一般项目(No.2021SJA2499);2020年江苏省高等教育学会江苏高校“大学素质教育与数字化课程建设”专项课题(No.2020JDKT116);南京医科大学康达学院“科研人才培养计划”(No.南医大康发[2021]96号)。

摘　　要：目的了解我国仿制药一致性评价政策实施现状、成效和存在的问题。方法搜集、整理国家药品监督管理局官网公布的通过一致性评价的药品(以下简称“过评仿制药”)信息,统计分析过评仿制药的基本情况及其在各版《国家基本药物目录》(以下简称“基药目录”)、《国家基本医疗保险、工伤保险和生育保险药品目录》(以下简称“医保目录”)以及各批国家组织药品集中带量采购中选结果(以下简称“集采目录”)中的分布与变化情况。结果2017-2021年,我国已有415种化学仿制药通过一致性评价,涉及309个品种、1822个产品、6类剂型、17种药理作用类别,相关药品生产企业共计492家(除12个产品未查到所属企业外),分布于我国30个省份;过评仿制药在基药目录中的占比由2012年版的0.96%增长到2018年版的25.40%,在医保目录中的占比由2017年版的2.13%增长到2021年版的11.68%,在前五批国家集采目录中共占81.65%,进入目录后价格最大降幅达97.52%。结论我国过评仿制药数量和三大目录所含过评仿制药数量在不断增加,实现了政策联动;价格大幅降低,使得相关药品的可获得性和可负担性得到提升。但我国仍存在过评仿制药总量偏少、品种重复率较高、在三大目录中的占比依然偏低、供应保障措施有待加强等问题。OBJECTIVE To investigate the situation,achievements and problems of consistency evaluation policy of generic medicines in China.METHODS The descriptive analysis was performed after collecting and sorting out the information of generic medicine passing consistency evaluation(GMPCE)published on the official website of the National Medical Products Administration.The basic information,the distribution and changes of GMPCE were analyzed statistically in National Essential Medicine List(hereinafter refer to as“essential medicine list”),Medicine List for National Basic Medical Insurance,Industrial Injury Insurance and Maternity Insurance(hereinafter refer to as“medical insurance list”)and the result of the successful selection of centralized medicine procurement organized by the state(hereinafter refer to as“centralized procurement list”).RESULTS From2017 to 2021,415 chemical generic drugs had passed consistency evaluation in China,including 309 varieties,1822 specifications,6 dosage forms,and 17 pharmacological mechanisms,basically belonging to 30 provinces,and 492 drug manufacturers(except 12products had not been found the manufacturers);the proportion of GMPCE in essential medicine list increased from 0.96%in 2012edition to 25.40%in 2018 edition;that of GMPCE in medical insurance list increased from 2.13%in 2017 edition to 11.68%in 2021 edition;in the first 5 batches of centralized procurement list,GMPCE accounted for 81.65%,and the maximum price drop after entering the list was 97.52%.CONCLUSIONS The policy linkage has been achieved with the continual increase of the number of GMPCE and their total amount in three lists in China.The accessibility and affordability of related medicines have been improved with the apparent decrease of the price of those medicines.However,total number of GMPCE is a little small,with the higher repetition rate of variety and the low proportion in the three lists;the guarantee measures of those medicine supply need to be strengthened.

关 键 词：仿制药 一致性评价 基药目录 医保目录 集采目录 药品可及性 政策联动 

分 类 号：R95[医药卫生—药学]