Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015 Paris, France; Paris-Saclay University, GRADES, Faculty of Pharmacy, 17 Av. des Sciences, 91400 Orsay, France.
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015 Paris, France.
Health Policy. 2024 Oct;148:105146. doi: 10.1016/j.healthpol.2024.105146. Epub 2024 Aug 11.
The medical technology sector is characterised by a constant influx of innovations with the potential to revolutionise patient care. In France, there are several pathways for medical devices to enter the market, from diagnosis-related group tariffs to reimbursement lists. However, traditional regulatory pathways can delay market access for innovative technologies. In response, France has established Early Access Programs to expedite patient access to medical devices. This paper looks at three of these Early Access Programs for medical devices. Innovation Funding, introduced in its final version in 2015, provides temporary coverage for innovative devices and facilitates data collection for informed funding decisions. Transitional Coverage (PECT), established in 2021, targets CE-marked devices for rare or serious conditions. Transitional coverage for digital health applications (PECAN), introduced in 2022, covers digital medical devices, either therapeutic or for patient monitoring. Innovation funding has been granted to 16 technologies out of 35 applications (46%) since 2015. 6 technologies out of 11 (64%) applications benefit from PECT. PECAN, in its first year, has granted a telemonitoring solution with a favourable opinion. The French experience could provide valuable lessons for the development of a harmonised European framework to ensure that innovative medical technologies benefit those who need them, while maintaining high safety standards.
医疗技术领域不断涌现创新，有潜力彻底改变患者的护理方式。在法国，医疗器械有几种进入市场的途径，包括按诊断相关分组收费和报销清单。然而，传统的监管途径可能会延迟创新技术的市场准入。为此，法国设立了早期准入计划，以加快患者获得医疗器械的机会。本文研究了法国的三种早期准入计划。创新资金于 2015 年最终版本中推出，为创新设备提供临时覆盖，并促进数据收集，以做出明智的资助决策。2021 年设立的过渡性覆盖（PECT）针对罕见或严重疾病的 CE 标志设备。2022 年推出的数字健康应用过渡性覆盖（PECAN）涵盖数字医疗设备，无论是治疗性的还是用于患者监测的。自 2015 年以来，已有 16 项技术获得了 35 项申请中的创新资金（46%）。64%的 11 项申请获得了 PECT。PECAN 在第一年就批准了一种有利的远程监测解决方案。法国的经验可能为制定协调一致的欧洲框架提供宝贵的经验教训，以确保创新的医疗技术使那些需要的人受益，同时保持高标准的安全性。
