泰国卫生技术评估在基本药物遴选中的应用及对我国的启示  

Application of Health Technology Assessment for the Selection of Essential Medicine in Thailand and Its Enlightenment to China

作　　者：颜建周[1] 葛文霞 邵蓉[1] YAN Jianzhou;GE Wenxia;SHAO Rong(National Drug Policy and Medical Industry Economy Research Center,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》2020年第19期2305-2310,共6页China Pharmacy

基　　金：国家社会科学基金重大项目(No.15ZDB167)。

摘　　要：目的:分析泰国卫生技术评估(HTA)在基本药物遴选中的应用,为优化我国基本药物遴选体系提供参考。方法:检索相关文献及官方网站,对泰国基本药物遴选概况(遴选模式、遴选机构与HTA机构)、流程(基本药物遴选主要流程、HTA流程)与配套措施(HTA指南、HTA研究数据库和标准成本清单)进行分析,并据此提出对我国基本药物遴选体系的建议。结果与结论:现行泰国基本药物遴选模式是基于利益相关者(制药公司、医疗保健提供者、患者或患者组织等)申请,通过专家遴选与HTA相结合的方式进行的。遴选是由基本药物目录小组委员会负责,其下设的卫生经济工作组中的卫生干预和技术评估项目中心是负责基本药物HTA具体工作的机构。其主要流程包括制药公司等递交申请、基本药物目录小组委员会筛选、专家遴选、基本药物目录协调工作组形成拟议目录,再依次由小组委员会、卫生部部长、国家药物体系发展委员会审批,最终发布目录。而其中价格高昂但必需的药品则在小组委员会遴选后由卫生经济工作组评估优先级,根据级别由非营利组织或其他感兴趣的组织进行HTA,再由卫生经济工作组与外审专家评估研究质量,由卫生经济工作组形成政策建议,由基本药物目录委员会进行目录准入或价格谈判,再交由小组委员会审议。泰国HTA的配套措施中,HTA指南包括HTA方法学指南(确保高质量的经济评估和推进研究框架标准化)和HTA流程指南(从透明度、问责制、包容性、及时性、质量、一致性、可竞争性对HTA的每个步骤进行了严格规定);HTA数据库内容包括了4种经济评估研究(最小成本分析、成本-效益分析、成本-效果分析和成本-效用分析)、结果评估、定量生活质量研究等供研究人员参考,标准成本清单则使经济性评估过程更加准确和便捷。我国基本药物遴选工作可参考泰OBJECTIVE:To analyze the application of health technology assessment(HTA)for the selection of essential medicine in Thailand,and to provide reference for optimizing the selection system of essential medicine in China.METHODS:By retrieving related literatures and official websites,the situation(selection mode,institution and HTA institution),process(main selection process of selection for essential medcine,HTA process)and supporting measures(HTA guideline,HTA research database,standard cost list)in the selection of essential medicine in Thailand were analyzed comprehensively.Suggestions to essential medicine selection in China were put forward.RESULTS&CONCLUSIONS:The current selection model of essential medicines in Thailand is based on the application of stakeholders(pharmaceutical manufacturers,healthcare providers,patients or patient organizations,etc.)through expert selection combined with HTA,which is charged by essential medicine list subcommittee.The Health Intervention and Technology Assessment Program Center of its health economics working group is responsible for the specific work of essential medicine HTA.Its main process include the submission of applications by pharmaceutical manufacturers,screening by essential medicine list committee,expert selection,and the coordination working group of essential medicine list to form the proposed list,which is then examined and approved by the subcommittee,minister of Health and National Drug System Development Committee;finally the list was released.The high-price but necessary drugs are selected by the subcommittee and then the priority is assessed by the health economics working group.Non-profit organization or other interested organizations conduct HTA;health economics working group and external audit experts evaluate the research quality,and the health economics working group forms policy recommendations;NLEM committee will carry out list access or price negotiation which then were considered by the subcommittee.In HTA supporting measures of Thailand,HTA guid

关 键 词：泰国 卫生技术评估 基本药物 遴选 启示 

分 类 号：R951[医药卫生—药学]