Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Italian Ministry of Health, General Directorate for Health Prevention, Rome, Italy.
Front Public Health. 2022 Aug 10;10:932093. doi: 10.3389/fpubh.2022.932093. eCollection 2022.
In recent years, the rapid proliferation of genomic tests for use in clinical practice has prompted healthcare systems to use a health technology assessment (HTA) approach to distinguish valuable from unwarranted applications. In this study, we narratively review the Italian HTA mechanisms for medical devices (MDs), both at the national and regional levels, and discuss the opportunity and benefits of extending them to genomic technologies, for which a dedicated assessment path was advocated by the National Plan for Public Health Genomics in 2017. We found that the National Health Technology Assessment Program for MDs, completed in 2019, had developed a structured pathway for the HTA of MDs; it established a hub-and-spoke structure, run by a governmental institution, and put in place transparent methodological procedures to cover all four HTA phases (i.e., proposal and prioritization, assessment, appraisal, and dissemination). However, several factors have hindered its adoption, and the regions are at different stages of its implementation. For these reasons, efforts should be made to ensure its effective deployment, both at national and regional levels. In addition, we argue that to harmonize the institutional roles and methodological procedures adopted, the time has come to concentrate resources on a single pathway for the assessment of all technologies that include both MDs and genomic applications.
近年来，用于临床实践的基因组检测呈快速增长态势，促使医疗保健系统采用健康技术评估（HTA）方法，区分有价值和不必要的应用。在这项研究中，我们叙述性地回顾了意大利在国家和地区层面上的医疗器械（MDs）HTA 机制，并讨论了将这些机制扩展到基因组技术的机会和益处，2017 年国家公共卫生基因组计划倡导为基因组技术开辟专门的评估途径。我们发现，2019 年完成的国家 MDs 健康技术评估计划已经为 MDs 的 HTA 制定了结构化途径；它建立了一个由政府机构运行的枢纽和辐条结构，并制定了透明的方法程序来覆盖 HTA 的所有四个阶段（即提案和优先排序、评估、评估和传播）。然而，有几个因素阻碍了它的采用，而且各地区的实施情况也各不相同。因此，应努力确保在国家和地区层面上有效部署。此外，我们认为，为了协调所采用的机构角色和方法程序，现在是时候集中资源建立一条单一途径，用于评估包括 MDs 和基因组应用在内的所有技术了。
