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Building the Story of Scientific Evidence for Digital Therapeutics: Trials, Meta-Analysis, and Real-World Data
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Derek Richards, Angel Enrique, Jorge Palacios, Nora Eilert
As part of Germany's Digital Health Care Act 2019,5 the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte; BfArM) has been tasked with the assessment and approval of DTx products for statutory reimbursement in the health system. During the assessment BfArM carries out, DTx manufacturers' claims regarding their product are evaluated, including in such areas as data protection, usability and acceptability, patient-centered outcomes, and clinical effectiveness. Depending on the level of evidence a manufacturer has accumulated for their product at the time of assessment, direct, preliminary, or no access to the statutory health system is granted. Here, preliminary access represents an interesting approach to DTx regulation, in which the manufacturer is allowed to prove their product's effectiveness within the first year of operating in the health system via an independently conducted effectiveness trial.
The regulation of off-label uses in the EU, EU Member States, and UK
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
In Germany, the Federal Joint Committee (G-BA) decides on the reimbursement of medicines. In case of off-label prescription, the reimbursement decision is based on an evaluation of the current scientific knowledge of such off-label use, performed by expert commissions within the national medicines agency (Federal Institute for Drugs and Medical Devices, BfArM). These scientific evaluations are submitted as recommendations and do not bind the G-BA (Section 92, paragraph 1, no. 6 of the German Social Code Book V, SGB V). Either the G-BA or the Federal Ministry of Health may request such evaluations by the off-label expert committees. In any event, such evaluations need the consent of the respective MAH (Section 35c paragraph 1, SGB V). In 2005, the German Constitutional Court clarified that medicines prescribed off-label may be reimbursed even if there are only weak references for efficacy, if that the patient suffers from a life-threatening condition and alternatives are unavailable.94
The classical age in countries that are now leaders in herbal medicine
Published in C. P. Khare, Evidence-based Ayurveda, 2019
With the global interest in herbal medicine rapidly expanding, the German Commission E monographs established by the German government’s counterpart to the US Food and Drug Administration – the German Federal Institute for Drugs and Medical Devices – are being used as the foundation for other regulatory and monograph systems emerging in Europe and around the world.
Effectiveness and tolerability of the thyme/ivy herbal fluid extract BNO 1200 for the treatment of acute cough: an observational pharmacy-based study
Published in Current Medical Research and Opinion, 2021
Peter Kardos, Claudia B. Bittner, Jan Seibel, Dimitri Abramov-Sommariva, Surinder S. Birring
The study was reported to the German Federal Institute for Drugs and Medical Devices (BfArM) before commencement according to the national regulatory requirements for observational studies/non-interventional studies (NIS). This was a non-interventional study as patients had already purchased BNO 1200 for their cough and used it according to the package insert. Thus, the study was exempted from ethics committee review and informed consent. Participants returned the completed questionnaire anonymously and free of charge to the Clinical Research Organization involved using the provided return envelopes. The survey was conducted entirely anonymously and no patient identifying data (e.g. name, initials or date of birth) was collected, excluding the possibility for any follow-ups. Pharmacists involved in the study could not access any of the completed questionnaires.
Nasal residence time and rheological properties of a new bentonite-based thixotropic gel emulsion nasal spray – AM-301
Published in Drug Development and Industrial Pharmacy, 2023
Martin M. Sailer, Melanie Köllmer, Beatrice Masson, Fabio Fais, Ilja P. Hohenfeld, Michael E. Herbig, Assen K. Koitschev, Sven Becker
Examinations were performed at the Department of Otorhinolaryngology, Head and Neck Surgery of the University Medical Center of the Eberhard-Karls University Tübingen, Germany. Investigations were performed according to the Declaration of Helsinki on Biomedical Studies involving human subjects. The study design was approved by the local ethics committee (EC reference: 258/2021MPG1). The trial was registered in the German Clinical Trial Register (DRKS00025692) and with EUDAMED (CIV-21-03-036105). As this study involved a class I medical device, it was granted a formal approval waiver by the Federal Institute of Drugs and Medical Devices. All study subjects provided written informed consent, including consent for publication of the trial data in a scientific journal.
Qualitative Evidence for Concern: Digital Health Technologies and the COVID-19 Pandemic
Published in AJOB Neuroscience, 2022
Amelia Fiske, Stuart McLennan, Alena Buyx
Within the European landscape, Germany is an interesting place to think about the intersection of the COVID-19 pandemic and the implementation of digital health technologies, particularly regarding the issue of the digital divide. Germany is a wealthy nation where healthcare standards are high, yet it is largely outside of the enthusiastic and sometimes speculative portrayals of digital medicine in scholarly literature and media. Despite representing one of the largest health care markets in the world, Germany continues to have some of the lowest levels of digitization among other developed nations (Lovell 2019). In part in an effort to address this, in 2019 the Digital Healthcare Act (DVG) was passed, making Germany one of the first countries in the world to approve reimbursement for certain digital health applications with a doctor’s prescription (Gerke, Stern, and Minssen 2020). This includes, for example, some smartphone apps for mental health (Rövekamp 2021). The German Federal Institute for Drugs and Medical Devices (BfArM) is responsible for assessing whether or not each application meets substantial requirements, including safety, functionality, and positive effects on care, among others. When all requirements are met except for a demonstration of a positive benefit, the application receives a temporary inclusion in the BfArM registry to undergo more testing, after which the manufacturer must provide evidence of either a therapeutic benefit or a structural improvement to health care. The DVG also seeks to improve the uptake of telehealth, including in psychotherapy, making it easier for patients to make use of virtual consultations with their physicians and psychotherapists within the context of the COVID-19 pandemic (Gerke, Stern, and Minssen 2020).