Gregor-Haack Johanna, Busse Thorsten, Hagenmeyer Ernst-Günther
GKV-Spitzenverband, Berlin, Deutschland.
Abteilung Ambulante Versorgung, GKV-Spitzenverband, Reinhardtstraße 28, 10117, Berlin, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2021 Oct;64(10):1220-1227. doi: 10.1007/s00103-021-03401-1. Epub 2021 Aug 30.
Since fall of 2020, the first Digital Health Applications (DiGA) have been available as a service of the statutory health insurance. The National Association of Statutory Health Insurance Funds considers digital applications to have the potential to improve health care, e.g., for people with chronic diseases, and to consolidate the interconnectedness of the provided offers. DiGA can empower the insured persons to help shape their health care actively and to self-contribute to a successful treatment. At the same time, statutory health insurance identifies a number of basic and substantial critical issues regarding the legal requirements for the authorization of DiGA for reimbursement by insurance and the conceptional design of the fast-track process from the Federal Institute for Drugs and Medical Devices (BfArM).This article examines the DiGA, which have been listed in the BfArM directory up to this point, and takes stock after six months of the fast-track process being in place. According to this, the requirements and legal specifications for directory listings and reimbursement via the fast-track process are insufficient from the point of view of the statutory health insurance regarding proven medical effectiveness and economically efficient health care. At present, most of the authorized DiGA, which so far could not provide sufficient evidence about positive healthcare effects, are subsequently only listed provisionally. At the same time, the requirements for proof of medical benefit do not ensure the generation of valid results in studies or clinical trials with regards to routine everyday care. So far, there has been only a moderate qualitative reliability of results. Furthermore, in the context of free pricing by manufacturers, significant price increases can be observed in some cases compared to prices before the BfArM listing.This paper gives recommendations towards further development of the legal basis for the fast-track process, particularly in the subject areas of benefit and patient safety as well as cost effectiveness.
自2020年秋季起，首批数字健康应用程序（DiGA）作为法定医疗保险的一项服务可供使用。法定医疗保险基金全国协会认为，数字应用程序有潜力改善医疗保健，例如对慢性病患者而言，并巩固所提供服务的相互关联性。DiGA可使被保险人有能力积极参与塑造自身的医疗保健，并为成功治疗做出自我贡献。与此同时，法定医疗保险确定了一些关于DiGA获得保险报销授权的法律要求以及联邦药品和医疗器械研究所（BfArM）快速通道程序的概念设计方面的基本且重大的关键问题。本文审视了截至目前已列入BfArM目录的DiGA，并在快速通道程序实施六个月后进行总结。据此，从法定医疗保险在已证实的医疗有效性和经济高效的医疗保健方面的角度来看，目录列名和通过快速通道程序报销的要求及法律规范并不充分。目前，大多数已获授权的DiGA，由于到目前为止无法提供关于积极医疗保健效果的充分证据，随后仅被临时列名。与此同时，医疗效益证明要求并不能确保在针对日常常规护理的研究或临床试验中产生有效的结果。到目前为止，结果的定性可靠性仅处于中等水平。此外，在制造商自由定价的情况下，与BfArM列名前的价格相比，某些情况下可观察到大幅价格上涨。本文针对快速通道程序法律基础的进一步发展提出建议，特别是在效益、患者安全以及成本效益等主题领域。
