Mantovani Andrea, Leopaldi Claudia, Nighswander Cassandra Maria, Di Bidino Rossella
Alira Health, Milan, Italy.
Alira Health, Basel, Switzerland.
Front Med Technol. 2023 Feb 20;5:1101476. doi: 10.3389/fmedt.2023.1101476. eCollection 2023.
Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular attention is paid to software-based diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed.
We investigated the current regulatory scenarios and reimbursement approaches adopted for DTx and IVDs. The initial assumption was that countries apply different regulations for the access to the market and adopt different reimbursement systems for both DTx and IVDs. The analysis was limited to the US, European countries (Germany, France, and UK), and Australia due to maturity in digital health product adoption and regulatory processes, and recent regulations related to IVDs. The final aim was to provide a general comparative overview and identify those aspects that should be better addressed to support the adoption and commercialization of DTx and IVDs.
Many countries regulate DTx as medical devices or software integrated with a medical device, and some have a more specific pathway than others. Australia has more specific regulations classifying software used in IVD. Some EU countries are adopting similar processes to the Digital Health Applications (DiGA) under Germany's Digitale-Versorgung Gesetz (DVG) law, which deems DTx eligible for reimbursement during the fast access pathway. France is working on a fast-track system to make DTx available to patients and reimbursable by the public system. The US retains some coverage through private insurance, federal and state programs like Medicaid and Veterans Affairs, and out-of-pocket spending. The updated Medical Devices Regulation (MDR) and Diagnostic Regulation (IVDR) in the EU includes a classification system specifying how software integrated with medical devices, and IVDs specifically must be regulated.
The outlook for DTx and IVDs is changing as they are becoming more technologically advanced, and some countries are adapting their device classifications depending on specific features. Our analysis showed the complexity of the issue demonstrating how fragmented are regulatory systems for DTx and IVDs. Differences emerged in terms of definitions, terminology, requested evidence, payment approaches and the overall reimbursement landscape. The complexity is expected to have a direct impact on the commercialization of and access to DTx and IVDs. In this scenario, willingness to pay of different stakeholders is a key theme.
数字疗法（DTx）是一种创新解决方案，利用有意义的数据为疾病的预防、治疗和管理提供循证决策。尤其关注基于软件的诊断（体外诊断医疗器械）。从这个角度来看，DTx与体外诊断医疗器械之间存在着紧密的联系。
我们调查了DTx和体外诊断医疗器械当前采用的监管情况和报销方式。最初的假设是，各国对产品上市采用不同的法规，并对DTx和体外诊断医疗器械采用不同的报销系统。由于数字健康产品采用和监管流程的成熟度，以及与体外诊断医疗器械相关的最新法规，分析仅限于美国、欧洲国家（德国、法国和英国）以及澳大利亚。最终目的是提供一个总体比较概述，并确定那些为支持DTx和体外诊断医疗器械的采用和商业化而应更好解决的方面。
许多国家将DTx作为医疗器械或与医疗器械集成的软件进行监管，有些国家的监管途径比其他国家更具体。澳大利亚对体外诊断医疗器械中使用的软件有更具体的法规分类。一些欧盟国家正在采用与德国《数字供应法》（DVG）下的数字健康应用程序（DiGA）类似的流程，该流程认为DTx在快速审批途径中有资格获得报销。法国正在建立一个快速通道系统，使患者能够使用DTx并由公共系统报销。美国通过私人保险、联邦和州项目（如医疗补助和退伍军人事务部）以及自付费用保留了一些覆盖范围。欧盟更新的《医疗器械法规》（MDR）和《诊断法规》（IVDR）包括一个分类系统，规定了与医疗器械集成的软件以及体外诊断医疗器械必须如何进行监管。
随着DTx和体外诊断医疗器械在技术上越来越先进，它们的前景正在发生变化，一些国家正在根据特定特征调整其器械分类。我们的分析表明了这个问题的复杂性，展示了DTx和体外诊断医疗器械的监管系统是多么分散。在定义、术语、所需证据、支付方式和总体报销情况方面出现了差异。这种复杂性预计将对DTx和体外诊断医疗器械的商业化和获取产生直接影响。在这种情况下，不同利益相关者的支付意愿是一个关键主题。
