全球卫生技术评估发展的历史与经验

通过回顾卫生技术评估在各国发展的历史,总结其中的成功经验,可以为进一步探索符合我国国情的卫生技术评估发展模式和道路提供参考.将卫生技术评估在世界的发展分为起步和成长两个阶段,在成长阶段分别从非政府支持项目与评估项目团队、政府支持项目与政府支持评估机构、政府评估机构与政府支持的第三方评估机构和国际交流与合作几个方面.梳理了卫生技术评估发展中运作模式的变化.从各国经验可得,卫生技术的评估需要政府的推动,评估的开展需要公开透明以促进质量的提升,而第三方评估机构的建立则有利于评估向更加公平独立、规范化的方向发展.     

法国、德国、荷兰卫生技术评估发展历程及思考

在法国,由政府财政支持的独立性全国性卫生技术评估机构进行药品、服务、仪器设备等各项卫生技术的评估工作,其研究结果是重要的决策工具。在德国,卫生技术评估被卫生体系中各方广泛利用,针对各种不同类型技术,从不同角度出发,为政府、立法、保险等提供服务,是门诊服务中重要的决策工具。荷兰卫生技术评估曾经对政策有较强影响,但随着医保组织的退出,评估向学术研究发展,对政策的影响有所削弱。     

加拿大卫生技术评估机构研究:以加拿大药物和卫生技术局为例

加拿大卫生技术评估机构在世界范围内具有重要的影响力。加拿大药物和卫生技术局(CADTH)作为加拿大独立的、非营利性、国家级的卫生技术评估(HTA)研究机构,依靠联邦以及州政府的财政支持,在卫生技术评估的主题选取、评估质量提升、成果传播以及新技术评估等方面都有着较为成熟的经验。文章通过分析和研究CADTH的成功经验,从加大政府投入、提升评估质量以及建立新兴技术预警机制三方面,对我国卫生技术评估机构的发展和完善提出一些政策建议。     

日本卫生技术评估机制建设研究与启示

以日本药品和医疗器械机构(PMDA)为例,通过对日本卫生技术评估机制的研究,分析日本卫生技术评估机构的功能定位、运行机制以及日本卫生技术评估在药品、医疗器械评估中的应用,总结出日本卫生技术评估机制具有绩效评价完善、目标定位清晰以及专业化精准发展的特点以及存在的卫生技术评估决策被动转化的问题,为我国当前卫生技术评估的机构建设、机构运行、功能发挥以及决策转化机制的完善提供参考与启示。     

西班牙卫生技术评估的发展应用及启示

西班牙卫生技术评估的发展在全球是成功经验之一,经过多年发展,西班牙已经建立了较为成熟的卫生技术评估体系。通过文献复习,总结了西班牙卫生技术评估工作的基本特征、地位、决策过程、医院卫生技术评估发展的相关经验。提出了将HTA作为政府卫生政策的重要工具,加强卫生技术评估协作网建设,大力发展医院卫生技术评估,建立立体全面的卫生技术评估协作体系等政策建议。     

西班牙卫生技术评估机构发展研究及其经验与启示

卫生技术评估在西班牙的发展在全球是成功经验之一。通过总结西班牙卫生技术评估机构的发展历史、运作形式、新技术监测预警等领域的经验,为促进我国卫生技术评估的发展提供参考。     

我国卫生技术现存问题分析

利用卫生统计年鉴数据,通过比较分析我国卫生技术的现状,找出我国卫生技术评估存在的问题。建立权威性的卫生技术评估机构,发挥药物经济性评估在卫生技术中的意义,从而合理配置卫生技术资源,解决当前问题,有利于更好的开展卫生技术的改革与发展。     

泰国卫生技术评估机制建设现状及启示

文章介绍了泰国卫生技术评估的发展历程、具体应用、机构建设,以及运行机制和规范化评估工具。启示我国在国家级HTA机构发展良好的基础上,应鼓励各地区设立和发展HTA机构;建立完整规范的决策转化机制;逐步建设形成适合我国的卫生技术评估规范化工具;建设HTA数据共享平台,以不断提升我国卫生技术评估能力。     

英国和瑞典卫生技术评估的发展

英国和瑞典开展卫生技术评估较为成熟。对两国卫生技术评估的发展历程和主要机构进行回顾．希望从中汲取经验,进而对我国卫生技术评估的的发展起借鉴作用。     

国外卫生技术评估现状及筹资模式对我国的启示

通过对国际卫生技术评估组织(International Network of Agencies for Health Technology Assessment, INAHTA)中美国、英国、德国、新加坡、荷兰、韩国、马来西亚7个国家卫生技术评估机构筹资来源、筹资模式的比较分析,总结其筹资特点,得出卫生技术评估(HTA)机构的筹资模式与其机构属性、筹资来源、发展历程、医疗保障制度存在的相关启示。     

How do HTA agencies perceive conditional approval of medicines? Evidence from England,Scotland, France and Canada

There is a growing disconnect between regulatory agencies that are promoting expedited approval to medicines based on early phase clinical evidence and health technology assessment (HTA) agencies that require robust clinical evidence to inform coverage decisions. This paper provides an assessment of the evidence gap between regulatory and HTA agencies on medicines receiving conditional marketing authorisation (CMA) and examines how HTA agencies in France, England, Scotland, and Canada interpret and appraise evidence for these medicines. A mixed methods research design was used to identify the types and frequency of parameters raised in the context of HTA decision-making for all conditional approvals in Europe and Canada between 2010 and 2017. Significant heterogeneity was found across the HTA agencies in England, Scotland, France, and Canada in the assessment of medicines receiving CMA, with the highest likelihood of rejection present in Quebec (50%) and Scotland (25%). Rejected medicines were more likely to have unresolved uncertainties related to the magnitude of clinical benefit, study design, and issues in economic modelling. More systematic use of joint early dialogue and conditional reimbursement pathways would help clarify evidence requirements and avoid delays in patient access to innovative medicines.     

A short history of INAHTA. International Network of Agencies for Health Technology Assessment.

The need for better communication and collaboration between health technology assessment agencies led to the formation of an International Network of Agencies for Health Technology Assessment (INAHTA). The network now comprises 27 agencies and has been successful in improving exchange of information and in undertaking joint health technology assessment projects. Issues for the future include possible changes to criteria for membership and identification of resources for more extensive programs.     

澳大利亚卫生技术评估的应用

卫生技术评估在澳大利亚的发展在全球是成功经验之一。卫生技术评估在药品福利计划中的应用从开始走向成熟,并逐渐应用到其他领域,目前整个过程历经约20年。澳大利亚的成功既有与其他国家的共性之处,也有其独特之处,并且目前仍在摸索不断前进。这也提示了中国需要将国际成功经历本土化,从而达到将卫生技术评估不断发展和深化的作用。     

Overview of health technology assessment in France

Health technology assessment (HTA) in France covers a variety of activities performed for different customers (e.g., health professionals in the field and policy makers in government) for the benefit of patients. To promote the improvement of quality in health care, France has set up a series of distinct agencies that report to the Ministry of Health but are also accountable to their other customers. We place particular emphasis on ANAES (National Agency for Accreditation and Evaluation in Health) whose main remit is HTA. We show how the diversity of HTA activities and their decentralization suggests tight collaboration among all the different bodies which perform HTA or are closely involved with HTA, and we provide examples of such collaboration.     

Distributional Cost-Effectiveness Analysis of Health Technologies: Data Requirements and Challenges

Governments and health technology assessment agencies are putting greater focus on and efforts in understanding and addressing health inequities. Cost-effectiveness analyses are used to evaluate the costs and health gains of different interventions to inform the decision-making process on funding of new treatments. Distributional cost-effectiveness analysis (DCEA) is an extension of cost-effectiveness analysis that quantifies the equity impact of funding new treatments. Key challenges for the routine and consistent implementation of DCEA are the lack of clearly defined equity concerns from decision makers and endorsed measures to define equity subgroups and the availability of evidence that allows analysis of differences in data inputs associated with the equity characteristics of interest. In this article, we detail the data gaps and challenges to build robust DCEA analysis routinely in health technology assessment and suggest actions to overcome these hurdles.     

A Systematic Literature Review of Gaps and Challenges in Value Assessment of Biosimilars: An ISPOR Special Interest Group Report

ObjectivesThis study aims to provide an overview of the gaps and challenges in the value assessment of biosimilars and to identify potential approaches to address them.MethodsA multidisciplinary, international team of biosimilar experts identified gaps and challenges. A systematic review was conducted of the peer-reviewed literature in PubMed, EMBASE, Web of Science Core Collection, EBSCOhost Business Source Complete; and of the gray literature. Preliminary results were presented at ISPOR conferences and this article benefited from 2 review rounds among ISPOR Biosimilar Special Interest Group members.ResultsGiven that a biosimilar is highly similar to its reference biologic, health technology assessment agencies should accept the comparability exercise approved by regulatory authorities and, thus, conduct a price comparison when biosimilar reimbursement is requested for the same indication as the reference biologic. If the reference biologic is not reimbursed or is not the standard of care, a full economic evaluation of the biosimilar versus a relevant comparator needs to be conducted. To date, little consideration has been given to specific challenges, such as how biosimilar value assessment can account for the nocebo effect, potential differences between biologic-naive and biologic-experienced patients, the availability of intravenous and subcutaneous administration forms or different administration devices for the same active compound, value-added services, and the contribution of biosimilars for generating health gain at the population level.ConclusionsThere is a need to gather further insights in the methodology of value assessment for biosimilars, and health technology assessment agencies need to develop more elaborate guidance on biosimilar value assessment in specific circumstances.     

Inclusion of Environmental Spillovers in Applied Economic Evaluations of Healthcare Products

ObjectivesClimate change and environmental factors have an impact on human health and the ecosystem. The healthcare sector is responsible for substantial environmental pollution. Most healthcare systems rely on economic evaluation to select efficient alternatives. Nevertheless, environmental spillovers of healthcare treatments are rarely considered whether it is from a cost or a health perspective. The objective of this article is to identify economic evaluations of healthcare products and guidelines that have included any environmental dimensions.MethodsElectronic searches of 3 literature databases (PubMed, Scopus, and EMBASE) and official health agencies guidelines were conducted. Documents were considered eligible if they assessed the environmental spillovers within the economic evaluation of a healthcare product or provided any recommendations on the inclusion of environmental spillovers in the health technology assessment process.ResultsFrom the 3878 records identified, 62 documents were deemed eligible and 18 were published in 2021 and 2022. The environmental spillovers considered were carbon dioxide (CO₂) emissions, water or energy consumption, and waste disposal. The environmental spillovers were mainly assessed using the lifecycle assessment (LCA) approach while the economic analysis was mostly limited to costs. Only 9 documents, including the guidelines of 2 health agencies presented theoretical and practical ways to include environmental spillovers into the decision-making process.ConclusionsThere is a clear lack of methods on whether environmental spillovers should be included in health economic evaluation and how this should be done. If healthcare systems want to reduce their environment footprint, the development of methodology which integrates environmental dimensions in health technology assessment will be key.     

卫生应急人员对突发事件风险评估的认知分析

目的 :了解我国卫生应急人员对突发公共卫生事件风险评估的认知状况,从文化程度、职称情况、单位性质、单位级别等方面进行比较,为提高卫生应急人员风险评估的认识和能力提供依据。方法 :采用问卷调查的方法,对全国(大陆地区)31个省(自治区、直辖市)承担突发公共卫生事件应急处置的卫生应急工作人员进行调查。采用描述性分析和χ2检验对调查数据进行分析。结果 :我国卫生应急人员对风险评估概念熟悉程度较低,且不同学历、不同职称、不同工作年限、不同机构、不同层级之间的认知存在一定差异;对风险评估工作内容的认知也存在分歧。结论 :应加强风险评估培训,健全风险评估制度,以全面提高卫生应急人员对风险评估的认知水平。