国内外卫生技术评估应用进展及建议

卫生技术评估是对卫生技术影响进行系统评估的一种综合政策研究,国际上已广泛应用于医疗保险支付范围确定、卫生技术价格制定、新医药技术准入等方面.本文探讨了卫生技术评估在国内外的应用进展,归纳了国际卫生技术评估发展的模式和特点,分析了我国卫生技术评估的进展及存在问题,并提出了进一步发展的政策建议,为我国政府开展第三方医疗服务评价,特别是发展卫生技术评估事业提供决策依据.     

荷兰卫生技术评估体系分析及对我国的启示*

目的：介绍荷兰卫生技术评估体系和政策转化现状，为完善我国价值医疗体系、提高卫生改革决策水平提供借鉴。方法：通过查阅国内外相关文献，描述荷兰的卫生技术评估体系，分析其常规应用的转化特点，综合评价其在新冠肺炎疫情中急性护理服务的网络构建特点。结果：荷兰卫生体系被称为“欧洲最佳医疗体系”，卫生技术评估在荷兰卫生系统决策中发挥了重要作用，特别是在降低医疗成本层面。相比荷兰，我国卫生技术评估政策转化成果相对较少。结论：我国需要完善卫生技术评估机构体系，加强研究人员与政策制定者的沟通，提升决策科学性及加快卫生技术评估转化效率。同时，筑牢分级诊疗体系，提升卫生技术评估综合性评价标准，进而推动实践价值医疗，促进我国卫生健康事业发展。     

基本医疗保险循证决策体系构建：卫生技术评估的作用

卫生技术评估是一种基于当前最优证据支持卫生技术决策的评估方法,国际上已广泛应用于医疗保险政策制定过程,如医保支付范围和目录确定、支付价格形成等,并在优化卫生资源配置、控制医疗费用合理增长等方面发挥了重要作用。本文从价值追求、决策转化、证据提供等方面探讨卫生技术评估在促进我国基本医疗保险高质量发展中的作用,认为医保决策中建立卫生技术评估决策转化机制面临着医保改革深化的现实需求和医疗大数据快速发展等机遇,同时也面临着缺乏有效的HTA组织管理路径和决策转化机制,以及价值取舍等挑战。最后,从认知准备、决策转化和实施传播等方面提出卫生技术评估应用于我国基本医疗保险决策转化体系的构建策略。     

基于卫生技术评估构建医学人工智能技术临床应用评估路径的探讨

医学人工智能可以应用于疾病的预防、诊断和治疗等方面,以改善医疗服务的提供.卫生技术评估在国际上已广泛应用于新医药技术准入、医疗保险支付范围确定等方面.本文基于卫生技术评估,探讨构建我国医学人工智能临床应用评估路径,并提出了进一步发展的政策建议,为发展我国医学人工智能技术临床应用和卫生技术评估事业提供决策依据.     

价值重塑下的我国卫生技术评估发展与展望

基于价值的医疗服务供给是世界范围内的热点议题。通过系统梳理价值医疗内涵,分析价值重塑下我国卫生技术评估面临的挑战,提出建立科学的HTA运作机制,加强HTA筹资及服务购买机制建设,制定HTA方法指南、加强HTA相关数据库建设等建议,旨在为我国卫生事业高质量发展提供参考。     

基于多准则决策分析的中医医疗技术综合评价指标体系构建研究

目的：为科学推进中医适宜技术遴选等工作,基于卫生技术评估和多准则决策分析理论,构建符合中医药特点的中医医疗技术价值评估指标体系。方法：通过文献综述初步形成评价指标池,通过半结构式访谈和德尔菲法进一步完善评价指标。结果：形成了包括质量标准、安全性、有效性、经济性、传承创新、适宜性和可及性7个维度的中医医疗技术价值评价指标,内含17个二级指标和33个三级指标。问卷回收率为100%,17名专家的群体权威系数为0.87,一级指标的专家意见集中度和协调度较高。结论：本研究构建的指标池专家权威度高、专家意见集中度和协调度较好,对中医医疗技术价值评价具有重要意义。     

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。     

高值医用耗材价值评估框架研究

高值医用耗材价值评估能够为高性价比的医疗服务提供证据。文章在系统梳理英国、澳大利亚、韩国医用耗材价值评估框架基础上,采用专家咨询法建立高值医用耗材价值评估框架,包括需求评估、技术特性评估、临床获益评估、学习曲线评估、经济性评估和社会影响评估等6个维度,以期为高值医用耗材的评估和准入提供参考。     

我国新医疗技术的定价及支付优化策略探讨

平衡新医疗技术发展及医疗费用不合理增长是医改需要解决的重要课题。科学适宜的定价及支付机制是重要的影响因素。通过梳理我国新医疗技术的定价及支付机制，分析现行机制存在的问题，基于价值分层和卫生技术评估视角，从定价及支付定义、资源及分层规则、卫生技术评估支撑机制、定价及支付实施、新医疗技术应用和监测、创新生态治理系统等方面提出优化策略。     

我国高值医用耗材准入管理中价值评估框架探索

目的：构建高值医用耗材的价值评估框架,为我国高值医用耗材的医保和医院准入管理和评价提供参考。方法：以文献研究为基础,综合应用定性访谈和定量调研。定性访谈12位资深专家,定量调研100位卫生技术评估、医保、医院管理和临床4个领域的专家,确定价值评估框架构成和各条目评分,通过卡方检验计算评分差异,对指标的推荐程度进行分级。结果：建立了以6大维度为核心,二级维度条目16个和三级维度条目50个的高值医用耗材价值评估框架。在医保和医院准入场景下,在同一场景下不同类型的专家中,条目评分表现出显著差异。将条目分级后,在医保准入场景下包含8个高推荐条目,在医院准入场景下包含24个高推荐条目。结论：价值评估应鼓励持续推动多维度的价值评估,鼓励多学科参与,不断完善医保和医院准入中高值医用耗材的管理。     

The HTA Core Model®—10 Years of Developing an International Framework to Share Multidimensional Value Assessment

Background and Objectives

The HTA Core Model^® as a science-based framework for assessing dimensions of value was developed as a part of the European network for Health Technology Assessment project in the period 2006 to 2008 to facilitate production and sharing of health technology assessment (HTA) information, such as evidence on efficacy and effectiveness and patient aspects, to inform decisions.

A rapid needs assessment of the provision of Health Technology Assessment in the south-west peninsula

BACKGROUND: Key to delivering UK policies on clinical governance, evidence-based practice and value for money is Health Technology Assessment (HTA). Despite the provision of HTAs through the National Institute for Health and Clinical Excellence (NICE), local health organizations still undertake HTA and make decisions based on them. In some regions, capacity is provided by centralized arrangements, but in others provision is ad hoc. This rapid needs assessment evaluates the provision of HTA in the south-west peninsula, and its scope, content and quality. METHODS: We used semi-structured interviews and documentary analysis to assess the need for HTA. RESULTS: HTAs are most commonly used by drug and therapeutics committees and joint formulary committees. The scope of technologies assessed was predominantly drugs. The quality of literature review in HTAs was variable and virtually none considered value for money. Informants felt there was insufficient provision of local HTAs. Local focus and clinical engagement were seen as key to the implementation of appraisal decisions, but this was threatened by weak links with commissioning and processes to prioritize decisions across primary care trusts. CONCLUSIONS: The quality of some HTAs poses a risk to clinical and corporate governance.     

A Conceptual Framework for Life-Cycle Health Technology Assessment

ObjectivesHealth technology assessment (HTA) uses evidence appraisal and synthesis with economic evaluation to inform adoption decisions. Standard HTA processes sometimes struggle to (1) support decisions that involve significant uncertainty and (2) encourage continued generation of and adaptation to new evidence. We propose the life-cycle (LC)-HTA framework, addressing these challenges by providing additional tools to decision makers and improving outcomes for all stakeholders.MethodsUnder the LC-HTA framework, HTA processes align to LC management. LC-HTA introduces changes in HTA methods to minimize analytic time while optimizing decision certainty. Where decision uncertainty exists, we recommend risk-based pricing and research-oriented managed access (ROMA). Contractual procurement agreements define the terms of reassessment and provide additional decision options to HTA agencies. LC-HTA extends value-of-information methods to inform ROMA agreements, leveraging routine, administrative data, and registries to reduce uncertainty.ResultsLC-HTA enables the adoption of high-value high-risk innovations while improving health system sustainability through risk-sharing and reducing uncertainty. Responsiveness to evolving evidence is improved through contractually embedded decision rules to simplify reassessment. ROMA allows conditional adoption to obtain additional information, with confidence that the net value of that adoption decision is positive.ConclusionsThe LC-HTA framework improves outcomes for patients, sponsors, and payers. Patients benefit through earlier access to new technologies. Payers increase the value of the technologies they invest in and gain mechanisms to review investments. Sponsors benefit through greater certainty in outcomes related to their investment, swifter access to markets, and greater opportunities to demonstrate value.     

Challenges of Health Technology Assessment in Pluralistic Healthcare Systems: An ISPOR Council Report

Health technology assessment (HTA) has been growing in use over the past 40 years, especially in its impact on decisions regarding the reimbursement, adoption, and use of new drugs, devices, and procedures. In countries or jurisdictions with “pluralistic” healthcare systems, there are multiple payers or sectors, each of which could potentially benefit from HTA. Nevertheless, a single HTA, conducted centrally, may not meet the needs of these different actors, who may have different budgets, current standards of care, populations to serve, or decision-making processes.This article reports on the research conducted by an ISPOR Health Technology Assessment Council Working Group established to examine the specific challenges of conducting and using HTA in countries with pluralistic healthcare systems. The Group used its own knowledge and expertise, supplemented by a narrative literature review and survey of US payers, to identify existing challenges and any initiatives taken to address them. We recommend that countries with pluralistic healthcare systems establish a national focus for HTA, develop a uniform set of HTA methods guidelines, ensure that HTAs are produced in a timely fashion, facilitate the use of HTA in the local setting, and develop a framework to encourage transparency in HTA. These efforts can be enhanced by the development of good practice guidance from ISPOR or similar groups and increased training to facilitate local use of HTA.     

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.     

A Review of Current Approaches to Defining and Valuing Innovation in Health Technology Assessment

ObjectivesThe growing focus on the value of new drugs for patients and society has led to a more differentiated notion of innovation in the context of pharmaceutical products. The goal of this article is to provide an overview of the current debate about the definition and assessment of innovation and how innovation is considered in reimbursement and pricing decisions.MethodsTo compile the relevant literature, we followed a 2-step approach. First, we searched for peer-reviewed literature that deals with the definition of pharmaceutical innovation. Second, we reviewed health technology assessment (HTA) guidelines of 11 selected countries (Australia, Belgium, Canada, England, France, Germany, Italy, Japan, Norway, Sweden, and The Netherlands) regarding aspects of innovation that are currently considered as relevant by the respective HTA bodies.ResultsAll countries in our sample use 1 of 2 types of reward mechanism for novel drugs that they consider provide some sort of benefit. Generally, the focus is on the therapeutic benefit of a drug, whereas, depending on the exact arrangement, other aspects can also be taken into account. A reduction in side effects and aspects of treatment convenience can be invoked in some of the countries. Mostly, however, they are not considered unless they are already captured in the clinical outcomes used to measure the therapeutic benefit.ConclusionOur review shows that although the health economic literature discusses a range of aspects on how innovation may generate value even without providing an immediate added therapeutic benefit (or on top of it), these are only selectively considered in the reviewed HTA guidelines. For most part, only the added therapeutic value is crucial when it comes to pricing and reimbursement decisions.     

Expanding the scientific basis of health technology assessment: a research agenda for the next decade

OBJECTIVES: The complexity of health technology assessment (HTA) has increased, in part because of its evolution through three distinct phases: the machine, the clinical outcomes, and the delivery models. However, the theoretical foundation for the field remains underdeveloped. METHODS: It is high time for HTA to bring together aspects of conceptual and theoretical works from other fields to strengthen the foundation of HTA. RESULTS: Many challenges await the further development of HTA. They can be captured around three research themes: adapting HTA to an evolving analysis object; translating HTA results into policy, management, and practice decisions; and evaluating organizational models of HTA. CONCLUSIONS: Consolidating the scientific basis of HTA is essential if we are to succeed in increasing the relevance of HTA in some of the most challenging health-related decisions that we will make as individuals and societies.     

Key principles for the improved conduct of health technology assessments for resource allocation decisions

Health technology assessment (HTA) is a dynamic, rapidly evolving process, embracing different types of assessments that inform real-world decisions about the value (i.e., benefits, risks, and costs) of new and existing technologies. Historically, most HTA agencies have focused on producing high quality assessment reports that can be used by a range of decision makers. However, increasingly organizations are undertaking or commissioning HTAs to inform a particular resource allocation decision, such as listing a drug on a national or local formulary, defining the range of coverage under insurance plans, or issuing mandatory guidance on the use of health technologies in a particular healthcare system. A set of fifteen principles that can be used in assessing existing or establishing new HTA activities is proposed, providing examples from existing HTA programs. The principal focus is on those HTA activities that are linked to, or include, a particular resource allocation decision. In these HTAs, the consideration of both costs and benefits, in an economic evaluation, is critical. It is also important to consider the link between the HTA and the decision that will follow. The principles are organized into four sections: (i) "Structure" of HTA programs; (ii) "Methods" of HTA; (iii) "Processes for Conduct" of HTA; and (iv) "Use of HTAs in Decision Making."