Department of Health Care Management, Technische Universität Berlin, Straße Des 17. Juni 135, 10623, Berlin, Germany.
Berlin Centre for Health Economics Research (BerlinHECOR), Technische Universität Berlin, Straße Des 17. Juni 135, 10623, Berlin, Germany.
Health Res Policy Syst. 2023 Oct 2;21(1):100. doi: 10.1186/s12961-023-01047-w.
The reimbursement of new technologies in inpatient care is not always linked to a requirement for evidence-based evaluation of patient benefit. In Germany, every new technology approved for market was until recently eligible for reimbursement in inpatient care unless explicitly excluded. The aim of this work was (1) to investigate the type of evidence that was available at the time of introduction of 25 innovative technologies and how this evidence evolved over time, and (2) to explore the relationship between clinical evidence and utilization for these technologies in German inpatient care.
This study combined different methods. A systematic search for evidence published between 2003 and 2017 was conducted in four bibliographic databases, clinical trial registries, resources for clinical guidelines, and health technology assessment-databases. Information was also collected on funding mechanisms and safety notices. Utilization was measured by hospital procedures captured in claims data. The body of evidence, funding and safety notices per technology were analyzed descriptively. The relationship between utilization and evidence was explored empirically using a multilevel regression analysis.
The number of included publications per technology ranges from two to 498. For all technologies, non-comparative studies form the bulk of the evidence. The number of randomized controlled clinical trials per technology ranges from zero to 19. Some technologies were utilized for several years without an adequate evidence base. A relationship between evidence and utilization could be shown for several but not all technologies.
This study reveals a mixed picture regarding the evidence available for new technologies, and the relationship between the development of evidence and the use of technologies over time. Although the influence of funding and safety notices requires further investigation, these results re-emphasize the need for strengthening market approval standards and HTA pathways as well as approaches such as coverage with evidence development.
住院患者的新技术报销并不总是与基于证据的患者获益评估要求相关联。在德国，直到最近，每一种获得市场批准的新技术都有资格在住院治疗中报销，除非明确排除在外。这项工作的目的是：（1）调查在引进 25 种创新技术时可用的证据类型，以及这些证据随时间的演变情况；（2）探索这些技术在德国住院治疗中的临床证据与利用之间的关系。
本研究结合了不同的方法。在四个书目数据库、临床试验登记处、临床指南资源和卫生技术评估数据库中，对 2003 年至 2017 年期间发表的证据进行了系统搜索。还收集了有关资助机制和安全通知的信息。利用通过索赔数据中捕获的医院程序来衡量。按技术对证据、资金和安全通知进行描述性分析。利用多层次回归分析实证探讨了利用与证据之间的关系。
每种技术的纳入文献数量从 2 篇到 498 篇不等。对于所有技术，非比较性研究构成了证据的主体。每种技术的随机对照临床试验数量从 0 到 19 不等。一些技术在没有充分的证据基础的情况下被利用了几年。可以看出，有几种技术的证据和利用之间存在一定的关系，但不是所有技术都存在这种关系。
这项研究揭示了新的技术可用证据的情况以及证据的发展与技术的利用之间的关系是复杂的。尽管资金和安全通知的影响需要进一步调查，但这些结果再次强调了需要加强市场审批标准和 HTA 途径以及覆盖证据开发等方法的必要性。
