背景:这项研究旨在分析德国快速发展的数字健康应用生态系统(DigitaleGesundheitsanwendung;DiGA),受到2019年数字医疗法案的推动。现在,德国有超过7300万人可以使用DiGA,这些可规定的数字健康应用程序和基于Web的应用程序代表了医疗保健现代化的实质性进步,为患者和医疗保健提供者提供疾病管理和护理改善的数字解决方案。
目标:通过数据驱动的方法,这项研究旨在解开DiGA市场动态的复杂性,经济因素,和临床证据,提供他们在过去几年的影响的见解。
方法:分析来自一系列公共数据来源,包括DiGA目录,法定健康保险报告,应用商店反馈,和临床研究结果。
结果:截至2024年7月1日,联邦药品和医疗器械研究所(BundesinstittfürArzneimittelundMedizinprodukte)列出了56个DiGA,分为35个永久申请和21个初步列出的申请。我们的研究结果表明,大多数DiGA的期限超过了预期的1年期限,以实现永久上市,反映了证明临床疗效所需的广泛努力。经济分析揭示了一个动态的定价格局,初始价格约为200欧元至700欧元(1欧元=1.07美元),3个月DiGA处方的平均中位数为514欧元。在谈判或仲裁委员会决定后,价格通常会降低50%,中位数为221欧元。处方数据提供了对DiGA接受度的宝贵见解,总处方从第一期的约41,000张跃升至最近一期报告期内的209,000张。前15名DiGA的分析,占总处方的82%,显示这些性能最佳的应用程序每天收到最少8到最多77张处方,原生应用和早期市场进入者实现更高的费率。来自所有35个永久列出的DiGA的临床证据表明,对随机对照试验的一致偏好,以验证主要终点。没有值得注意的使用数字医疗法案和相关法规中鼓励的替代研究设计。此外,所有评估的DiGA都专注于医疗福利,以健康状况改善为关键终点,提示在证明医疗保健影响方面未充分利用患者相关的结构和程序改进。
结论:这项研究突出了DiGA行业的增长和挑战,建议未来研究的领域,例如探索新的研究设计以及与患者相关的结构和程序改进的潜在影响。对于DiGA制造商,强调提前进入市场的战略优势。总的来说,这篇论文强调了数字健康的发展态势,倡导对德国及其他地区的数字健康技术整合有细微差别的理解。
BACKGROUND: This study aimed to analyze the rapidly evolving ecosystem of digital health applications (Digitale Gesundheitsanwendung; DiGAs) in Germany, spurred by the 2019 Digital Healthcare Act. With over 73 million people in Germany now having access to DiGAs, these prescribable digital health apps and web-based applications represent a substantial stride in health care modernization, supporting both patients and health care providers with digital solutions for disease management and care improvement.
OBJECTIVE: Through a data-driven approach, this research aimed to unpack the complexities of DiGA market dynamics, economic factors, and clinical evidence, offering insights into their impact over the past years.
METHODS: The analysis draws from a range of public data sources, including the DiGA directory, statutory health insurance reports, app store feedback, and clinical study results.
RESULTS: As of July 1, 2024, there are 56 DiGAs listed by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), divided into 35 permanently and 21 preliminarily listed applications. Our findings reveal that a majority of DiGAs extend beyond the intended 1-year period to achieve permanent listing, reflecting the extensive effort required to demonstrate clinical efficacy. Economic analysis uncovered a dynamic pricing landscape, with initial prices ranging from approximately €200 to €700 (€1=US $1.07), averaging at a median of €514 for a 3-month DiGA prescription. Following negotiations or arbitration board decisions, prices typically see a 50% reduction, settling at a median of €221. Prescription data offer valuable insights into DiGA acceptance, with total prescriptions jumping from around 41,000 in the first period to 209,000 in the latest reporting period. The analysis of the top 15 DiGAs, representing 82% of the total prescriptions, shows that these best-performing apps receive from a minimum of 8 to a maximum of 77 daily prescriptions, with native apps and early market entrants achieving higher rates. Clinical evidence from all 35 permanently listed DiGAs indicates a uniform preference for randomized controlled trials to validate primary end points, with no noteworthy use of alternative study designs encouraged in the Digital Healthcare Act and related regulations. Moreover, all evaluated DiGAs focused on medical benefits, with health status improvement as a key end point, suggesting an underuse of patient-relevant structural and procedural improvement in demonstrating health care impact.
CONCLUSIONS: This study highlights the growth and challenges within the DiGA sector, suggesting areas for future research, such as the exploration of new study designs and the potential impact of patient-relevant structural and procedural improvements. For DiGA manufacturers, the strategic advantage of early market entry is emphasized. Overall, this paper underscores the evolving landscape of digital health, advocating for a nuanced understanding of digital health technology integration in Germany and beyond.