Ciani Oriana, Wilcher Britni, Blankart Carl Rudolf, Hatz Maximilian, Rupel Valentina Prevolnik, Erker Renata Slabe, Varabyova Yauheniya, Taylor Rod S
Evidence Synthesis & Modelling for Health Improvement,Institute of Health Research,University of Exeter Medical School;Centre for Research on Health and Social Care Management (CERGAS),Bocconi
Institute of Health Research,University of Exeter Medical School.
Int J Technol Assess Health Care. 2015 Jan;31(3):154-65. doi: 10.1017/S0266462315000185. Epub 2015 Jun 5.
The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies.
HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1-agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2-semi-structured telephone interviews with key informants of a sub-sample of agencies.
In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non-MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices.
The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.
本研究旨在回顾和比较非欧盟卫生技术评估（HTA）机构对医疗器械的当前HTA活动。
从组织结构、流程和方法三个角度评估医疗器械的HTA活动。主要根据现有HTA网络的成员资格选择机构。数据收集分两个阶段进行：第一阶段——使用标准化问卷对机构网站进行评估，随后由该机构的代表对收集到的数据进行审查和验证；第二阶段——对部分机构的关键信息提供者进行半结构化电话访谈。
总共纳入了来自20个非欧盟国家的36个评估医疗器械的HTA机构。在第一阶段，36个机构中有27个（75%）被判定采用了针对医疗器械的HTA特定方法（特定于医疗器械的机构），这些方法主要是组织性或程序性的。特定于医疗器械的机构和非特定于医疗器械的机构在组织、流程和方法上似乎没有太大差异。尽管这两类机构中的大多数（69%）都有关于证据提交的特定方法指南或政策，但只有一个特定于医疗器械的机构制定了针对医疗器械的方法学指南。在第二阶段，许多特定于医疗器械的机构提到资源不足（预算、熟练员工）、缺乏协调（监管机构和报销机构之间）以及无法将证据综合的结果进行推广是医疗器械HTA中的关键挑战。
在医疗器械HTA的科学方法上缺乏差异化证据，这就提出了一个问题，即HTA是否需要为医疗器械开发新方法，而不是采用现有的方法学方法。相比之下，对现有HTA机构框架进行组织和/或程序上的调整以适应医疗器械似乎较为常见。
