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.     

法国卫生技术评估的发展历程与经验总结

通过文献评阅的方法,以法国几个主要卫生技术评估机构的演变过程为线索,回顾并总结卫生技术评估在法国发展的历程和经验。通过法国卫生技术评估机构的构建和发展,卫生技术评估得到了更多的支持和更广泛的运用,其结果得到政府的关注和重视,是政府决策的重要依据。     

发展我国卫生技术评估的政策建议

为避免卫生技术应用和推广带来的负面影响,在卫生技术生命周期中的产生、发展、成熟、进一步推广应用、淘汰等多个阶段需要开展相应卫生技术评估研究,为决策提供科学依据。建议成立专司卫生技术评估的政府部门及协调专家委员会,构建与技术成长周期相适应的分工协作机制,明晰各部门职责;进一步完善卫生技术评估的选题机制;建立以技术评估为证据、专家评议为形式的评审制度和以公共经费支持为主的技术评估委托机制;逐步提高卫生技术评估研究的质量,促进卫生技术评估信息的传播利用、决策转化。     

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。     

我国开展医院卫生技术评估的路径与策略

随着我国卫生医疗领域改革的不断深入和新版《医疗技术临床应用管理办法》的实施,医院在卫生技术准入和管理中的作用逐渐加强,对以医院卫生技术评估为代表的循证支持决策的需求也在增加。本文基于对我国开展医院卫生技术评估试点医院评估项目问题和经验的总结,并结合国际上典型国家的理论基础和实践经验,探索提出我国医院卫生技术评估的发展路径:一是技术路径,包括评估的技术类型、评估流程和评估结果等,并从五个维度提出了我国开展医院卫生技术评估需要重点关注的十个因素;二是治理路径,即如何引入和引导利益相关方以独立的方式参与评估。我国开展医院卫生技术评估试点项目和理论研究的发展目标是尽快探索出符合我国国情的医院卫生技术评估方法、流程及相关制度,发展策略是加强国家指导和与全国医院绩效考核工作相结合以强化认知共识;与医疗联合体建设相结合推进决策转化应用;注重在医院内部通过成果实施、传播和升华培养评估文化;加强卫生技术评估决策转化监管与评估。     

2022年四川省职业卫生技术服务机构职业卫生检测能力比对结果分析

目的 了解四川省职业卫生技术服务机构实验室的检测能力和总体水平,评估四川省职业卫生检测实验室的检测能力和质量控制水平。方法 选取2022年四川省69家职业卫生技术服务机构有机化合物类、金属与类金属类、非金属化合物类、粉尘中游离二氧化硅含量测定职业卫生检测能力实验室间比对检测结果,采用指定值法评价比对结果。并采用统计分析进行综合评定,率的比较采用χ²检验,以P<0.05为差异有统计学意义。结果 69家职业卫生技术服务机构总体项目合格率和综合评定结果合格率分别为94.57%和84.06%。其中,28家疾病预防控制中心和41家第三方职业卫生技术服务机构的总体项目合格率分别为93.75%、95.12%,综合评定结果合格率分别为82.14%和85.37%。疾病预防控制中心与第三方职业卫生技术服务机构的检测能力比对综合评定结果合格率差异无统计学意义(χ²=0.001,P=0.981)。结论 2022年四川省职业卫生技术服务机构职业卫生检测能力比对结果显示,项目合格率高于或相当于近几年全国职业卫生技术服务机构实验室间比对参比项目合格率、综合评定结果合...     

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。     

金砖五国卫生技术评估应用比较研究

卫生技术评估(HTA)能够为医疗卫生服务提供可靠决策依据。结合文献及国内外卫生技术评估网站的相关资料,从HTA的机构设置、职责范围、资金来源、流程等方面,对金砖五国HTA情况进行梳理和比较分析发现,金砖五国HTA发展水平不一,各国处于HTA发展的不同阶段。其中,巴西和中国的HTA体系发展较为完善,南非发展较为缓慢。金砖五国的HTA发展面临着缺乏专业知识、医疗卫生体系不健全等挑战,需加快发展步伐;巴西、中国仍需进一步加大政府投入,完善HTA体系建设评估指南,提升HTA研究能力;印度应扩大HTA评估网络,提高评估流程的透明度和客观性;南非需加快建立HTA机构。     

卫生技术评估研究结果产出方式的偏好分析

目的 比较研究人员和决策人员对卫生技术评估研究结果产出方式的偏好程度的差异,为扩大卫生技术评估研究的决策使用提供依据.方法 采用问卷调查的方法,收集研究人员和决策人员对不同卫生技术评估研究结果产出方式的评价,运用统计描述的方法,对偏好差异进行描述分析.结果 研究人员和决策人员对卫生技术评估研究结果的产出方式偏好有所差异;在不同行政单位、不同行政级别以及不同教育程度的决策者之间,对产出方式的偏好也存在不同;而不同职称、不同教育程度的研究者,所偏好的成果产出方式则较为一致.结论 进一步强化研究方与决策方之间的沟通交流,根据不同决策人员的需求采取合适的产出方式,加强机构对卫生技术评估结果决策转化的支持,逐步完善激励机制,并强化卫生技术评估结果向广大社会公众的传播.     

广州市职业卫生技术服务现状分析

摘要:目的　分析广州市职业卫生技术服务市场的状况,为政府对市场的监管提供建议。方法　采用市场分析法,从需方、供方、第三方监管三个方面,分析广州市职业卫生服务市场的现状和存在问题。结果　广州市有毒有害企业近5万家,接触职业病危害劳动者80余万人;虽全市备案的职业卫生技术服务机构28家,但2013年作业场所职业病危害因素检测不足2 000家,评价不足200家。结论　企业职业病防治主体责任不强,缺乏对职业卫生技术服务机构的管理。     

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.     

Priority setting for health technology assessments: a systematic review of current practical approaches

OBJECTIVES: This study sought to identify and compare various practical and current approaches of health technology assessment (HTA) priority setting. METHODS: A literature search was performed across PubMed, MEDLINE, EMBASE, BIOSIS, and Cochrane. Given an earlier review conducted by European agencies (EUR-ASSESS project), the search was limited to literature indexed from 1996 onward. We also searched Web sites of HTA agencies as well as HTAi and ISTAHC conference abstracts. Agency representatives were contacted for information about their priority-setting processes. Reports on practical approaches selected through these sources were identified independently by two reviewers. RESULTS: A total of twelve current priority-setting frameworks from eleven agencies were identified. Ten countries were represented: Canada, Denmark, England, Hungary, Israel, Scotland, Spain, Sweden, The Netherlands, and United States. Fifty-nine unique HTA priority-setting criteria were divided into eleven categories (alternatives; budget impact; clinical impact; controversial nature of proposed technology; disease burden; economic impact; ethical, legal, or psychosocial implications; evidence; interest; timeliness of review; variation in rates of use). Differences across HTA agencies were found regarding procedures for categorizing, scoring, and weighing of policy criteria. CONCLUSIONS: Variability exists in the methods for priority setting of health technology assessment across HTA agencies. Quantitative rating methods and consideration of cost benefit for priority setting were seldom used. These study results will assist HTA agencies that are re-visiting or developing their prioritization methods.     

The European way to health technology assessment. Lessons from an evaluation of EUR-ASSESS

OBJECTIVES: The EUR-ASSESS project was undertaken by a large number of members of European health technology assessment (HTA) agencies and programs with the aim of improving coordination through developments in several areas of HTA. At the conclusion of the project, an independent survey was undertaken to reassess the importance of the original objectives of EUR-ASSESS and determine the impact of the project on the way HTA activities are organized and carried out in Europe. METHODS: A postal questionnaire survey and a series of more in-depth personal interviews. RESULTS: EUR-ASSESS was generally considered successful in achieving its aims, particularly in creating an informal network of people and organizations, improving the understanding of the work of others, improving the ability to focus the objectives of HTA, facilitating the sharing of experience and mutual learning opportunities, exchanging ideas on research agendas, and developing a common language. However, significant differences emerged in the expectations of different actors in European HTA, and in their perceptions of the impact of the project. These reflect the wide diversity of approaches existing in Europe. CONCLUSIONS: Health technology assessment in Europe is changing its nature from a set of national or local initiatives with relatively limited impact to a truly European movement with strong links and coordination between its individual components. Important lessons can be learned from the experience of EUR-ASSESS, particularly in the light of an increasing commitment of the European Commission to play a role in the development of technology assessment.     

Introduction: health technology assessment and the European Union

Health technology assessment (HTA) has become increasingly important in the European Union as an aid to decision making. As agencies and programs have been established, there is increasing attention to coordination of HTA at the European level, especially considering the growing role of the European Union in public health in Europe. This series of papers describes and analyzes the situation with regard to HTA in the 15 members of the European Union, plus Switzerland. The final paper draws some conclusions, especially concerning the future involvement of the European Commission in HTA.     

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。     

Economic evaluations conducted by Canadian health technology assessment agencies: where do we stand?

OBJECTIVES: To examine the production of Health Technology Assessments (HTAs) with economic evaluations (EEs) conducted by Canadian HTA agencies. METHODS: This research used a three-step approach: (i) the Web sites of five Canadian organizations promoting HTA were searched to identify HTA reports with EEs; (ii) HTA agencies were surveyed to verify that our information was complete with respect to HTA activities and to describe the factors that influence the HTA process in Canada (i.e., selection of HTA topics, execution, dissemination of results and future trends); (iii) HTAs with EEs were appraised in terms of study design, retrieval of clinical and economic evidence, resource utilization and costing, effectiveness measures, treatment of uncertainty as well as presence of a budget impact analysis (BIA), and policy recommendations. RESULTS: Two hundred forty-nine HTA reports were identified of which 19 percent included EEs (n = 48). Decision analytic techniques were used in approximately 75 percent of the forty-eight EEs and probabilistic sensitivity analyses were commonly used by all agencies to deal with parameter uncertainty. BIAs or policy recommendations were given in 50 percent of the evaluations. Differences between agencies were observed in terms of selection of topics, focus of assessment and production of HTA (e.g., in-house activities). Major barriers to the conduct of HTAs with EEs were capacity, a lack of interest by decision makers and a lack of robust clinical information. CONCLUSIONS: The results of this research point to the need for increased HTA training, collaboration, evidence synthesis, and use of pragmatic "real world" evaluations.     

Knowledge in health technology assessment: who, what, how?

Health systems are placing more and more emphasis on designing and delivering services that are focused on the patient, and there is a growing interest in patient aspects of health policy research and health technology assessment (HTA). Only a few HTA agencies use and invest in scientific methods to generate knowledge and evidence about the patient aspects of a given technology. This raises questions about how knowledge is produced in HTA reports and what kind of knowledge is considered relevant. This article uses a Danish HTA on patient education from 2009 as empirical material for a critical examination and discussion of knowledge and knowledge production about the patient aspects of HTA.     

Regulatory and HTA early dialogues in medical devices

Introduction: Specific guidance and examples for health technology assessment (HTA) of medical devices are scarce in medical device development. A more intense dialogue of competent authorities, HTA agencies, and manufactures may improve evidence base on clinical and cost-effectiveness. Especially as the new Medical Device Regulation requires more clinical evidence.Methods: We explore the perceptions of manufacturers, competent authorities, and HTA agencies towards such dialogues and investigate how they should be designed to accelerate the translational process from development to patient access using semi-structured interviews. We synthesized the evidence from manufacturers, competent authorities, and HTA agencies from 14 different jurisdictions across Europe.Results: Eleven HTA agencies, four competent authorities, and eight manufacturers of high-risk devices expressed perceptions on the current situation and the expected development of three types of early dialogues.Discussion: The MDR has to be taken into account when designing the early dialogue processes. Transferring insights from medicinal product regulation is limited as the regulatory pathways differ substantially.Conclusion: Early dialogues promise to accelerate the translational process and to provide faster access to innovative medical devices. However, health policy-makers should promote and fully establish regulatory and HTA early dialogues before introducing parallel early dialogues of regulatory, HTA agencies, and manufacturers. For initiating change, the legislator must create the legal basis and set the appropriate incentives for manufacturers.     

“It all depends”: Conceptualizing public involvement in the context of health technology assessment agencies

There have been calls in recent years for greater public involvement in health technology assessment (HTA). Yet the concept of public involvement is poorly articulated and little attention has been paid to the context of HTA agencies. This article investigates how public involvement is conceptualized in the HTA agency environment. Using qualitative concept analysis methods, we reviewed the HTA literature and the websites of HTA agencies and conducted semi-structured interviews with informants in Canada, Denmark, and the United Kingdom. Our analysis reveals that HTA agencies' role as bridges or boundary organizations situated at the frontier of research and policymaking causes the agencies to struggle with the idea of public involvement. The HTA community is concerned with conceptualizing public involvement in such a way as to meet scientific and methodological standards without neglecting its responsibilities to healthcare policymakers. We offer a conceptual tool for analyzing the nature of public involvement across agencies, characterizing different domains, levels of involvement, and types of publics.     

Health technology assessment. The pharmaceutical industry perspective

Increasingly, health technology assessment (HTA) is used to aid decisions on the reimbursement of pharmaceuticals or recommendations for their use. The pharmaceutical industry seeks to work in partnership with HTA agencies; however, this presents a number of challenges. Clinical trials will need to include appropriate measures that capture economic and patient benefits as well as relevant clinical endpoints, and the industry will want to seek international harmonization of the many guidelines for economic evaluation. The problem of demonstrating cost-effectiveness of a product before it is available for use must be addressed, possibly by conditional reimbursement to allow collection of real world evidence. It is also important that reimbursement decision makers minimize bias, play fair, and adhere to the written rules they issue. If the industry fairly demonstrates the value of a product using the best available evidence, HTA agencies should be transparent in the rationale for their recommendations.