Health Innovation Hub of the German Federal Ministry of Health, Berlin, Germany.
Leibniz University Hannover, Hannover, Germany.
Int J Technol Assess Health Care. 2023 Nov 17;39(1):e72. doi: 10.1017/S0266462323002726.
Germany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for "prescribable" health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA.
We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis.
When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for HTAs.
Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.
德国 2019 年《数字医疗法案》（Digitale-Versorgung-Gesetz，简称 DVG）为医疗保健系统的数字化转型创造了诸多机会。其中的关键举措是为以患者为中心的数字健康应用（digitale Gesundheitsanwendungen，简称 DiGA）创建报销途径。在全球范围内，这是首个针对大规模“可处方”健康应用的结构化途径。截至 2023 年 10 月 10 日，德国联邦药品和医疗器械研究所（Bundesinstitut für Arzneimittel und Medizinprodukte，简称 BfArM）维护的官方目录中列出了 49 种 DiGA；这些应用可由医生和心理治疗师开具处方，并由德国法定健康保险系统为其 7300 万受益人报销。展望未来，DiGA 制造商面临的主要挑战将是生成持续价格谈判和报销所需的证据。当前的卫生技术评估（Health Technology Assessment，简称 HTA）方法将需要适应 DiGA。
我们描述了在这种情况下区分 HTA 的核心问题：（i）明确允许更灵活的研究设计，（ii）初始证据生成的性质，其可以在成为可报销的一年后（以最终形式）交付，以及（iii）产品开发和产品评估的动态性质。我们将德国 DiGA 计划中的数字健康应用作为案例研究，并强调 RWE 在持续评估 DiGA 方面的作用。
当 DiGA 可能会定期更新和评估时，全面的 RCT 是不可行的；因此，我们提出了使用真实世界数据和真实世界证据（Real-World Data and Evidence，简称 RWD 和 RWE）进行 HTA 的观点。
使用 RWD 进行持续评估是一种监管创新，可以帮助提高市场上 DiGA 的质量。
