Transcript 卫生技术评估
卫生技术评估 Health Technology Assessment 复旦大学医学技术评估研究中心 陈英耀 陈 洁 Overview 提纲 • • • • • 卫生技术和卫生技术评估概述 卫生技术评估的内容 卫生技术评估的步骤 各国卫生技术评估发展回顾 我国卫生技术评估的发展 国际华夏医药学会－陈英耀发言 一、卫生技术和卫生技术评估 概述 Technology Definitions 技术定义 Technology (gr - tekhné) 技术 • The application of science to the arts 科学应用的艺术 – Art - skill, especially human skill opposed to nature 艺 术-技能，尤其是不同于自然的人类技能 – Science - as systematic and formulated knowledge 科 学，系统化和程式化的知识 • The systematic application of scientific or other organized knowledge to practical tasks 将科学和其它有组织的系 统知识运用到实践 国际华夏医药学会－陈英耀发言 Components of HT 卫生技术的组成 Medical Device Procedure Drugs Equipment Support system 国际华夏医药学会－陈英耀发言 Knowledge Health Technology Definition 卫生技术的定义 • Health Technology is considered to include the drugs, devices, medical and surgical procedures used in healthcare delivery, the knowledge associated with this, as well as the organisational and support systems within which such care is provided • 卫生技术是指用于医疗保健的药物，仪 器设备，内、外科程序及相关的组织管 理系统和支持系统的特定的知识体系 国际华夏医药学会－陈英耀发言 Three ways to describe HT 从三个方面描述卫生技术 •Physical nature 物理性质 •Clinical purpose 临床目的 •Stage of diffusion 传播阶段 Technology: physical nature 技术：物理特性 •Drugs药物 –Aspirin阿斯匹林 –Antibiotics抗生素 –Vaccines疫苗 •Devices, equipment, supplies 仪器设备和物资供应 –Cardiac pacemaker心脏起搏器 –Computed Topography scanner CT –Surgical gloves外科手套 •Medical and surgical procedures内外科诊疗程序 –Acupuncture针灸 –Cancer chemotherapy癌症化疗 –Cesarean section剖腹产手术 •Support systems支持系统 –Drug formulary药物报销目录 –Clinical laboratory临床实验室 –Patient record system病案系统 •Organizational, delivery, and managerial systems组织管理和服务提供系统 –Vaccination program免疫计划 –Clinical pathway临床路径 –Health care payment systems健康保健支付系统 Technology: Clinical purpose 技术：临床目的 • 预防 Prevention • 筛检 Screening • 诊断 Diagnosis • 治疗 Treatment • 康复 Rehabilitation Technology: Stage of diffusion 技术：传播阶段 • Future 未来 • Experimental (Laboratory or animal testing) 试验 阶段（实验室或动物试验） • Investigational (Clinical studies) 观察阶段（临 床研究） • Established (Standard approach) 应用阶段（标 准方法） • Obsolete 淘汰 Technology Life Cycle 技术寿命周期 David & Judd, Medical Technology Management, 1993 Healthcare Technology Life Cycle 卫生技术的生命周期 Marketing 市场 Transfer 转让 Distribution 分配 Manufacture 生产 PROVISION Testing 实验 提供 Development 发展 Research 研究 Assessment of Needs 需要评估 Technology Assessment 技术评估 Evaluation 评价 ACQUISITION 获得 Planning 规划 Procurement 获得 Installation 安置 Commissioning 使用 国际华夏医药学会－陈英耀发言 De-commissioning 报废 Maintenance 维护 Training 培训 Operation 操作 UTILISATION 使用 Why HTA is necessary? 卫生技术评估的必要性 • Effective therapies were rare until recently – 60% of the remedies in 1927 textbook of medicine as harmful, dubious, or merely symptomatic, while 3% provided fully effective treatment or prevention – By 1975, effective regimens increased sevenfold and dubious ones decreased by two-thirds – It was not until Bradford Hill formulated the principles of the RCT, testing a vaccine for pertussis in the mid 1930 – The most important problem was lack of a control or comparison group to assure the observed effect was due to the intervention 国际华夏医药学会－陈英耀发言 Beeson in 1980 Why HTA is necessary? 卫生技术评估的必要性 • Visibility of new technologies 新技术的广泛 使用 • High expenditures for health care 医疗费用的 不断上涨 • Necessity to begin to rationalize health care technology 卫生技术资源优化的必要性 Why HTA is necessary? 卫生技术评估的必要性 • 技术是一把双刃剑（两重性） –利 •技术创新 •改善医疗质量 •提高人群健康 –弊 •技术带来的负面后果 •伦理争论 •医疗费用过度增长 What is HTA?什么是卫生技术评估？ 卫生技术评估是对卫生技术的性质，效果和其 他影响进行系统评价 卫生技术评估的主要目的是给卫生技术领域的 政策制订提供信息 卫生技术评估可以针对技术直接的、预期的后 果，也能处理间接的、非预期的后果 卫生技术评估由多学科团体来完成（不同专业 领域的专家一起工作） 卫生技术评估采用明确的分析框架和多种方法 国际华夏医药学会－陈英耀发言 二、卫生技术评估的内容 国际华夏医药学会－陈英耀发言 Properties And Impacts Assessed 技术评估的内容 • Technical properties 技术特性 • Safety安全性 • Efficacy and effectiveness功效和效果 • Cost and other economic attributes经济性 • Social, legal, ethical, or political impacts社 会、法律、伦理道德和政治影响 安全性 • Rezulin’s slow removal in the US – Dec 1997: Rezulin taken off in the UK – By Mar 1999: 400 patients suffered liver failure – Mar 2000: FDA withdraw the Rezulin in the US – Four safety labeling changed in almost 2 years • liver functions monitored by blood test every 2-3 months during the first half-year use • test monthly for the first half-year • test monthly in the first 8 month of use • test monthly for the entire first year 国际华夏医药学会－陈英耀发言 The stages of pharmaceutical R&D 药品研发的阶段 平均时间(月) 成功上市新药成本 (百万美元，1987 年价格) 直接成本 资本成本 42.6 基础研究 动物试验 65.5 155.6 15.5 调查新药申请 (IND) 9.3 17.8 24.3 I 期临床研究 12.9 21.4 II 期临床研究 长期与其他动 物研究 5.7 8.9 III 期临床研 究 20.2 27.1 113.6 230.8 36.0 119.4 30.3 新药申请 (NDA) 149.7 上市后研究 Efficacy and Effectiveness 功效与效果 •功效是指在理想情况下，使用某项技术对某一特定 的健康问题所带来的效益，如在随机对照试验中或在 著名医学中心 •效果：在一般情况下或常规情况下使用某项技术对 某一特定的健康问题所带来的效益, 如在社区医院中 •测量指标 –死亡率(死亡率、期望寿命等) –发病率 –生命质量 –失能调节生命年或失能调节期望寿命 •应用：FDA的药品审批 Clinical Epidemiology / EBHC Iterative Measurement Loop 1 BURDEN OF ILLNESS 6 REASSESSMENT *Needs Based Efficacy? 2 COMMUNITY EFFECTIVENESS *Action oriented *Systematic subsets *Populations and individuals *Different Methods 5 MONITORING OF PROGRAM 3 ECONOMIC EFFICIENCY 4 KNOWLEDGE TRANSLATION & IMPLEMENTATION 国际华夏医药学会－陈英耀发言 Effectiveness [not Efficacy] 效果而非功效 Effectiveness = DOES it work in reality? Efficacy x Health x Patient x Coverage Provider Subject Systems Concordance Compliance Can it Work in Ideal 国际华夏医药学会－陈英耀发言 Circumstances? 经济性 比较和选择 在给定的情况下选择何种临床治疗方案 肾衰病人是选择肾移植还是肾透析 干预的时间选择 高血压防治：人群筛检、健康促进项目 在什么地点提供服务 医院、社区、还是在病人家里 国际华夏医药学会－陈英耀发言 经济性 针对不同卫生问题的可选方案 流感免疫还是建立冠心病监护中心 同一方案的不同应用规模 某免疫方案是针对高危人群还是整个人群 提高健康水平的不同途径 控制污染、加强公路安全保障还是采用其他 的卫生技术 国际华夏医药学会－陈英耀发言 Model of economic evaluation 经济学评价的模型 国际华夏医药学会－陈英耀发言 经济学评价解决什么问题？ • Rising expenditure for health care – payment decision – insurance coverage • Economic analysis is a valuable tool in decision making, but it is only one factor 国际华夏医药学会－陈英耀发言 Social impact 社会影响 •社会、伦理、道德和法律等正负影响 –genetic testing –fertility treatment –computer-based record system –transplantation of scarce organs –brain death 三、卫生技术评估的步骤 国际华夏医药学会－陈英耀发言 A Process for HTA 卫生技术评估的过程 Identification Testing Synthesis Dissemination Banta, D. Health care technology and its assessment 国际华夏医药学会－陈英耀发言 Ten Steps of HTA 卫生技术评估的十大步骤 1. Identify assessment topics确定评估项目 2. Specify assessment problem确定所要评估的问题 3. Determine locus or responsibility of assessment 决定评估的焦点和任务 4. Retrieve (gather) evidence收集数据 5. Collect new primary data (as appropriate)收集新的原始数据 (只要合适) 6. Interpret evidence解释数据 7. Synthesize (combine or consolidate) evidence综合分析数据(联合或者加 强) 8. Formulate findings and recommendations形成结果和建议 9. Disseminate (Communicate) findings and recommendations传播（交流） 结果和建议 10. Monitor impact监督评估的影响 Two Main Groups of Studies (Methods) 两种主要研究方法 • Primary data collection原始资料收集 – Collect original new data, for example, using experiments收集原 始的新数据，例如，利用试验数据 • Secondary data analyses第二手资料分析 – Combine (Synthesize or integrate) data from existing sources采 用已有资料 (综合或者整合) 国际华夏医药学会－陈英耀发言 原始资料研究方法的证据强弱 • • • • 前瞻性研究比回顾性研究更有说服力 有对照研究比无对照研究更有说服力 随机研究比非随机研究更有说服力 大样本（有足够的病人供检测治疗的真实效果） 研究比小样本研究更有说服力 • 当前对照组研究比历史对照组研究更有说服力 • 双盲法研究（指病人和医生不知道所采用的是 何种技术）比非盲法研究更有说服力 国际华夏医药学会－陈英耀发言 The relation between levels of evidence and grades of recommendation原始资料研究方 法的证据强弱排序 (stronger) (说服力强) Large randomized controlled trials with clear-cut results大规模 随机对照试验 • Small randomized trials with uncertain results小规模随机对照 试验 • Nonrandomized, contemporaneous controls 非随机,同期对照 研究 (不同种类) • Nonrandomized, historical controls 非随机，历史对照 • No controls, case series only 连续多个案例研究 • No controls, single case study 单个案例研究 (weaker) (说服力弱) 国际华夏医药学会－陈英耀发言 A B C Secondary Data Analyses 第二手资料分析 Expert opinion专家意见 Group judgment (Consensus development) （得出一致意见） 团体判断 Literature review文献评阅 Meta-analysis文献综合分析 Decision analysis, other modeling决策分析及其他 模型 国际华夏医药学会－陈英耀发言 Timing of Assessment 评估的时间选择 对一项技术而言并不存在开展技术评估的单一的正确时间 在整个技术寿命过程中，执行技术评估的目的是为了满足不同的 政策制订者的需要 在选择评估时间的时候，我们需要权衡下列因素： 一方面，对一项技术评估得越早，我们就越有可能限制其使 用（如果这项技术是有害的或者无效的话） 另外一方面，早期技术评估的结果可能会引起误导，因为在 技术应用的早期我们并没有足够的数据和信息来进行评估 “目标变动”问题 教训：“人们总是觉得现在开展评估太早了，而当危害发生的时候 却又已经太晚了。” (M.BUXTON 1987) 国际华夏医药学会－陈英耀发言 Types of Experts For HTA 参与技术评估的专家 • Clinicians (physicians, other)临床医生 • Pharmacists药师 • Laboratory and radiology technicians实验室和放射技术人员 • Hospital managers医院管理者 • Bio-medical engineers生物医学工程师 • Patients and community representatives病人和社区代表 • Economists经济学家 • Epidemiologists流行病学家 • Bio-statisticians 生物统计学家 • Decision scientists 决策科学家 • Lawyers律师 • Ethicists 伦理学家 • Librarians or information specialists图书和信息专业人员 四、各国卫生技术评估发展回顾 国际华夏医药学会－陈英耀发言 Development of HTA 卫生技术评估的发展 • 1967 the term used in the US Congress • 1972 Office of Technology Assessment (OTA) was established – Technology assessment: A comprehensive form of policy research that examines the short- and long-term social consequences of the application or use of technology • CT scanner was OTA’s first target for HTA 国际华夏医药学会－陈英耀发言 卫生技术评估在各国的发展 • 几乎和美国同时，瑞典开始进行技术评估工作 • 1985年，国际卫生技术评估组织(ISTAHC)成立 • 1987年，瑞典建立了卫生部与HTA项目合作机制 • 90年代，几乎所有的欧盟成员国建立了国家和区 域的HTA机构和项目 • 1993年，国际卫生技术评估机构网络(INAHTA) 成立 • 1994年1月卫生部在上海医科大学成立了国内第 一家卫生技术评估研究中心 • 2003年， ISTAHC更名为HTAi Health technologies typically regulated for placement 加强规制的主要技术 • Imaging devices – CT – MRI – PET • Radiation therapy • Transplants – – – – – – • Surgery – Neurosurgery – Cardiac surgery (with cardiac catheterization, PTCA, etc.) • Intensive care – especially neonatal Kidney (and renal dialysis) intensive care Heart Heart-lung • Genetic screening and Liver counseling Pancreas 国际华夏医药学会－陈英耀发言 • In vitro fertilization Bone marrow Relations between payment and HTA 运用于支付或补偿 • Every system is characterized by incentives and disincentives 各种补偿机制优劣并存 • Rising expenditures related to incentives for technological intervention 技术造成费用上涨 • Rising expenditures addressed by prospective fixed budgets 前瞻性的固定预算来解决费用上涨问题 • Fixed budgets can control costs and technology， but not assure cost-effectiveness or efficiency 固定 预算可以控制成本和技术，但不能保证效率 国际华夏医药学会－陈英耀发言 Coverage and HTA 运用于保险 报销范围 • Traditionally the “package” is defined by medical doctors 报销范围传统上由医生来确定 • New technology not admitted to package until shown to be effective (and possibly cost-effectiveness) 新技术必 须证明是有效而且经济，才能纳入报销范围 • Old technology removed from the package when shown to be ineffective or very expensive for the benefit gained 若老技术显示无效或昂贵，它会被从报销范围中删除 国际华夏医药学会－陈英耀发言 Quality assurance 运用于质量保证 • Wide range of activities, including – Routine statistics (for example, health outcome) 常规统计 – Audits 评审 – Licensing 许可证 – Accreditation 认证 – Certification 证明 – Informational strategies 信息化策略 – Clinical practice guidelines 临床指南或诊疗常 规 国际华夏医药学会－陈英耀发言 Relationship of HTA, CC and EBM HTA to work mainly to influence health policy CC EBM to develop the evidence on which to base decision to seek primarily to affect medical (healthcare) practice CC: Cochrane Collaboration EBM: Evidencebased Medicine 国际华夏医药学会－陈英耀发言 Banta. The development of health technology assessment. 2003 HTA in the US • The US has not a national HTA framework – 1972-1997:OTA – 1978-1981: National Center for Health Care Technology • Public and private mix structure • Main goals: – cost containment – improving quality or innovation – micro management 国际华夏医药学会－陈英耀发言 HTA participants • Public – NIH:clinical trials – AHCPR (Agency for Health Care Policy and Research): clinical guideline – HCFA: insurance coverage – VA (Veterans Administration) – FDA • Private – – – – AHA and AMA Health insurance and managed care companies Industrial companies Hospitals 国际华夏医药学会－陈英耀发言 HTA in UK • UK, along with Sweden, has the best organized and best funded HTA activities in the world • HTA leadership: a national agency or council for HTA – embedded in the Department of Health’s Research and Development Program – a national HTA committee, a coordinating center and centers • To enhance the role of the consumer in decisionmaking 国际华夏医药学会－陈英耀发言 HTA in Sweden • Swedish Council for Technology Assessment in Health Care (SBU) • Extend HTA activities into mental health care and social services by the government • Swedish patients are increasingly aware of HTA 国际华夏医药学会－陈英耀发言 International Society of Technology Assessment in Health Care, ISTAHC 国际卫生技术评估协会 • 1985年5月成立 • 秘书处设在加拿大，会员来自45个国家 • 宗旨是加强卫生技术安全性、有效性、经 济性和社会影响的研究、教育、合作与信息 交流，促进制定技术合理使用的相关政策 • 出版《国际卫生技术评估杂志》及简报 • 每年举办一次年会 • http://www.istahc.org Health Technology Assessment International (HTAi) 卫生技术评估国际 • HTAi will focus uniquely on health technology assessment (HTA) and provide the key forum for all those from the worlds of health care, academia and business interested in the science, development and application of HTA. • HTAi’s mission is to support and promote the development, communication, understanding and use of HTA around the world as a means of promoting the introduction of effective innovations and effective use of resources in health care. • www.htai.org 国际华夏医药学会－陈英耀发言 International Network of Agencies for Health Technology Assessment, INAHTA 国际卫生技术评估机构网络 • Mission – to accelerate exchange and collaboration among agencies – to promote information sharing and comparison – to prevent unnecessary duplication of activities • To provide a forum for the identification and pursuit of interests common to health technology assessment agencies 国际华夏医药学会－陈英耀发言 International Network of Agencies for Health Technology Assessment, INAHTA 国际卫生技术评估机构网络 • Established in 1993 • INAHTA has now grown to 39 member agencies from 20 countries • The Network stretches from North and Latin America to Europe, Australia, and New Zealand • The Secretariat is located at SBU in Sweden • http:www.inahta.org 国际华夏医药学会－陈英耀发言 五、 Health Technology Assessment in China 我国卫生技术评估的发展 The early HTA dissemination in China 我国卫生技术评估的早期传播 HTA workshop in Shanghai Medical University 1992上海医科大学的HTA研讨班 Dr. Banta and Dr. Jonsson presented HTA theory 国际华夏医药学会－陈英耀发言 Three phases of HTA development in China 我国发展的三个阶段 • MOH is positively involved in HTA development 卫生部积极推动HTA发展 • 3 phases in last decades: 三个阶段 • to develop HTA units (1994-) 建立机构 • to promote HTA (1994-) 促进传播 • to merge HTA with policy making(1999-) 与政 策融合 国际华夏医药学会－陈英耀发言 1st phase: Develop HTA units 第一阶段：建立HTA机构 • The first HTA Research Center in China was established in the former Shanghai Medical University in January 1994 我国第一家卫生技术评估中心于1994年在上海医科大 学成立 • Other two HTA units were established in Zhejiang University and the former Beijing Medical University respectively • The evidence-based medicine center was established in the former West China University of Medical Sciences (Chengdu) in 1997 • Different HTA units have different focuses 不同的中心有 不同的研究重点 国际华夏医药学会－陈英耀发言 2nd phase: promote HTA (example) 第二阶段：促进HTA传播(举例) A HTA training program developed by HTA Research Center, Fudan University (former Shanghai Medical University) 上海医科大学HTA 培训项目 Funded by China Medical Board 获得CMB资助 5-year program 1997-2001 5年项目 Participants: faculty and researchers in universities, policy makers at different levels, physicians, pharmacists, etc 参加者:大学研究 人员、决策者、医生、药师等 国际华夏医药学会－陈英耀发言 The Milestone of HTA in China 我国HTA的里程碑 1st National HTA seminar while hosting the ISTAHC board meeting in Shanghai in 1999 1999年卫生部在上海举行全国第一 届医学技术评估研讨会 Dr. Yu Peng, Vice Minister of MOH, meeting with all board members of ISTAHC in 1999 卫生部副部长彭玉接见ISTAHC理事会理事 国际华夏医药学会－陈英耀发言 复旦大学医学技术评估研究中心研究人员和 国际华夏医药学会－陈英耀发言 ISTAHC理事会理事合影 Achievements in the seminar 研讨会的成绩 ISTAHC board member presented the HTA theory, methodology and its mechanism in policy making The academic professors in China presented their HTA research results The policy makers realized that HTA is part of policy making in order to improve the quality and efficiency of healthcare 卫生部意识到HTA是政 策决策的重要组成部分，有益于改善卫生服务 的质量和效率 国际华夏医药学会－陈英耀发言 3rd phase: incorporate HTA research with health policy 第三阶段：HTA和卫生政策的融合 MOH sets HTA as priority 卫生部重视HTA Established the division of Health Technology Management under the department of Science and Education, MOH 卫生部科教司建立卫生 技术管理处 More grants to support HTA research 资助HTA 研究 Transfer HTA results for policy making 促进 HTA研究向政策转化 国际华夏医药学会－陈英耀发言 How to integrate HTA with health policy?-Mechanism融合的机制 Technology admission mechanism by MOH 卫生部的技 术准入机制 emerging technology 新兴技术 new technology (1st adopter) 新技术 hi-tech 高技术 …… Technology admission based on HTA 技术准入建立于 HTA基础上 safety 安全性 efficacy and effectiveness 功效和效果 cost-effectiveness成本效果 social impact 社会影响 国际华夏医药学会－陈英耀发言 How to integrate HTA with health policy? Process融合的过程 Identification 确认 identify the problem and priority 定位主要问题和优先重点 Testing 研究 MOH assigns project to the HTA unit 确定HTA 项目 HTA data collection 数据收集 HTA data analysis 数据分析 Synthesis 合成 report 报告 interpret information and results 解释信息和结果 make recommendation and judgment 建议 Dissemination 传播 the policy maker, the relative user, and the public 向政策决策者、 用户和公众 国际华夏医药学会－陈英耀发言 Case: Experiences from HTA on IVF 辅助生殖技术评估的案例 National regulations on IVF and Sperm Banking issued by the Minister in 2001 2001年卫生部部长签署人类辅助 生殖技术和精子库管理办法 HTA研究：复旦大学医学技 术评估研究中心吕军副教授 带领的研究组 国际华夏医药学会－陈英耀发言 Case: Experiences from HTA on prenatal diagnosis 产前诊断技术评估的案例 HTA 卫生技术评估 investigation: current situation 现场调查：我国 技术发展和利用现状 technology assessment 技术评估(国内外) Convert TA to policy 技术评估向政策转化 focusing on how to manage the technology 重点 在如何管理技术 technology admission 技术准入 institution license(accreditation) 机构准入 professional certification 专业人员准入 国际华夏医药学会－陈英耀发言 产前诊断技术评估与政策制定 2002年卫生部张文康部长签署 《产前诊断技术管理办法》 产前诊断的HTA研究：复旦大学医学技术 评估研究中心陈英耀副教授带领的研究组 国际华夏医药学会－陈英耀发言 HTA and health policy 卫生技术评估和政策的关系 政策问题 问题构建 卫生技术评估的过程 研究 确定问题 收集信息 政策效果 政策选择 综合分析 结果传播 监控 建议 政策行动 国际华夏医药学会－陈英耀发言 HTA and Technology Management HTA和技术管理 Responsiveness to peoples’ expectations 人群期望的反应性 Improved Health Outcomes 健康状况的改善 Resource Inputs 投入的资源 Human resources 人力资源 Population 人群 Facilities Organization & 设施 Management Devices 组织和管理 设备 Policy and fair 国际华夏医药学会－陈英耀发言 financing 政策和公平筹资 Thank you. 陈英耀 Yingyao Chen 电话Tel: 86-21-64043905 传真Fax: 86-21-64169552 电子邮件Email: [email protected]