Page 7 - 2020年19期

·药事管理·

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 Δ

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颜建周 ，葛文霞，邵 蓉（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）
中图分类号 R951 文献标志码 A 文章编号 1001-0408（2020）19-2305-06
DOI 10.6039/j.issn.1001-0408.2020.19.01
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国相关经验，逐步建立卫生技
术评估体系、加强国际合作与人才培养，引入优先级概念、合理分配评估资源，制定HTA指南、完善配套措施，重视利益相关者的
参与、保证遴选过程规范透明，从体系建设、资源分配、配套措施、程序优化等方面不断完善我国相应遴选体系。
关键词 泰国；卫生技术评估；基本药物；遴选；启示

Application of Health Technology Assessment for the Selection of Essential Medicine in Thailand and Its
Enlightenment to China
YAN Jianzhou，GE Wenxia，SHAO Rong（National Drug Policy and Medical Industry Economy Research Center，
China Pharmaceutical University，Nanjing 211198，China）

ABSTRACT 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
Δ 基金项目：国家社会科学基金重大项目（No.15ZDB167）
committee will carry out list access or price negotiation which
＊讲师，博士。研究方向：医药政策与法规。电话：025-86185193。
E-mail：cpuqqyan@163.com then were considered by the subcommittee. In HTA supporting
# 通信作者：教授，博士生导师，博士。研究方向：医药政策与法 measures of Thailand， HTA guidelines include HTA
规。电话：025-86185193。E-mail：shaorong118@163.com methodology guidelines （ensuring high quality economic

中国药房 2020年第31卷第19期 China Pharmacy 2020 Vol. 31 No. 19 ·2305 ·