PMD17 Comparison of Market Access Routes of Digital Health Applications in France, Germany and the UK

Vollmer, L; Foxon, G. E. H.; Danev, V.; Berard, I.; Benazet, F.; Walzer, Stefan

doi:10.1016/j.jval.2020.08.1050

Cited by 3 publications

(10 citation statements)

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“…To be eligible for reimbursement in France and funded through the standard P&R procedure regarding medical devices, DTx will need to provide: A CE marking as a medical device and privacy Compliance with EU General Data Protection Regulation A General Health Technology Assessment carried out by the Commission nationale d’evaluation des dispostifs médicaux et des technologies de (CNEDIMT) and HAS An actual medical benefit assessment A Clinical Evidence Evaluation A demonstration of clinical and socio-economic added value However, up to now, there are no current reimbursement pathways for DTx products, but it is possible to make individual funding decisions ( 28 ). Firstly, the CNEDIMTs gives an opinion on the actual medical benefit, a Service attendu (“SA”).…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…If the new digital healthcare product brings a minor improvement compared to the current strategy, the assessment is an ASA IV. In case of no improvements of the clinical value compared with other alternatives, the assessment is an ASA V ( 28 ).…”

Section: Resultsmentioning

confidence: 99%

“…• A demonstration of clinical and socio-economic added value • However, up to now, there are no current reimbursement pathways for DTx products, but it is possible to make individual funding decisions (28).…”

Section: • Compliance With Eu General Data Protection Regulation • a ...mentioning

confidence: 99%

“…To be eligible for reimbursement, the DTx must demonstrate a sufficient efficacy/safety ratio in a robust clinical study. The HAS published guidelines to explain how to develop a digital therapeutic which complies with the French HTA requirements and which elements are needed to be favorably assessed by the CNEDIMTs (28). If the SA is evaluated sufficient, the CNEDIMTs gives its opinion as well on the "Added Medical benefit assessment" [America Society of Anesthesiologist (ASA)].…”

Section: • Compliance With Eu General Data Protection Regulation • a ...mentioning

confidence: 99%

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Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges

Mantovani¹,

Leopaldi²,

Nighswander³

et al. 2023

Front. Med. Technol.

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ObjectivesDigital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular attention is paid to software-based in vitro diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed.MethodsWe investigated the current regulatory scenarios and reimbursement approaches adopted for DTx and IVDs. The initial assumption was that countries apply different regulations for the access to the market and adopt different reimbursement systems for both DTx and IVDs. The analysis was limited to the US, European countries (Germany, France, and UK), and Australia due to maturity in digital health product adoption and regulatory processes, and recent regulations related to IVDs. The final aim was to provide a general comparative overview and identify those aspects that should be better addressed to support the adoption and commercialization of DTx and IVDs.ResultsMany countries regulate DTx as medical devices or software integrated with a medical device, and some have a more specific pathway than others. Australia has more specific regulations classifying software used in IVD. Some EU countries are adopting similar processes to the Digital Health Applications (DiGA) under Germany's Digitale-Versorgung Gesetz (DVG) law, which deems DTx eligible for reimbursement during the fast access pathway. France is working on a fast-track system to make DTx available to patients and reimbursable by the public system. The US retains some coverage through private insurance, federal and state programs like Medicaid and Veterans Affairs, and out-of-pocket spending. The updated Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the EU includes a classification system specifying how software integrated with medical devices, and IVDs specifically must be regulated.ConclusionThe outlook for DTx and IVDs is changing as they are becoming more technologically advanced, and some countries are adapting their device classifications depending on specific features. Our analysis showed the complexity of the issue demonstrating how fragmented are regulatory systems for DTx and IVDs. Differences emerged in terms of definitions, terminology, requested evidence, payment approaches and the overall reimbursement landscape. The complexity is expected to have a direct impact on the commercialization of and access to DTx and IVDs. In this scenario, willingness to pay of different stakeholders is a key theme.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: • Compliance With Eu General Data Protection Regulation • a ...mentioning

confidence: 99%

Section: • Compliance With Eu General Data Protection Regulation • a ...mentioning

confidence: 99%

See 3 more Smart Citations

Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges

Mantovani¹,

Leopaldi²,

Nighswander³

et al. 2023

Front. Med. Technol.

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Rapid review on the incentives of digital health apps for physicians and psychotherapists: A German perspective

Kreuzenbeck,

Schneider,

Brenner

et al. 2024

DIGITAL HEALTH

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Objective The Digital Healthcare Act introduced the prescription of digital health applications under specific circumstances in 2019 in Germany. They are funded through the social security system. In market access of prescribed digital health applications, Germany is pioneering the market. There remains a gap in understanding the views of medical professionals on the incentives of using these applications. As prescription of digital health applications starts emerging in other European countries, we sought to generate an overview of incentives and barriers that affect the caregivers in their decision of promoting and prescribing them in Germany. Methods A Rapid Review of the Web of Science database for the years 2017–2023 was performed using sensitive search strings. Two reviewers conducted a three-phase selection via title, abstract and full-text independently from each other. The quality of studies was assessed systematically by both reviewers. Both quantitative and qualitative studies with primary data were included, and study quality was assessed using a standardised form. Results Out of 1643 initial results, 12 studies with information from 9302 physicians and psychotherapists were identified. Eight quantitative and four qualitative studies were included in the analysis. Key findings suggest that while between 40% and 60% of caregivers see relevant incentives mainly based on patients’ benefits, 20–40% see relevant barriers. For the physicians’ daily work, there were slightly more barriers than incentives identified in the quantitative synthesis. The qualitative studies revealed no relevant incentives that were not attributed to patients. Conclusion While digital health solutions offer promising avenues for enhancing patient care, their acceptance among healthcare professionals hinges on addressing prevailing concerns. Continuous research and dialogues with the medical community are pivotal to harness the full potential of digital health applications in healthcare.

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Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping

van Kessel,

Srivastava,

Kyriopoulos

et al. 2023

JMIR Mhealth Uhealth

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Background The adoption of digital health care within health systems is determined by various factors, including pricing and reimbursement. The reimbursement landscape for digital health in Europe remains underresearched. Although various emergency reimbursement decisions were made during the COVID-19 pandemic to enable health care delivery through videoconferencing and asynchronous care (eg, digital apps), research so far has primarily focused on the policy innovations that facilitated this outside of Europe. Objective This study examines the digital health reimbursement strategies in 8 European countries (Belgium, France, Germany, Italy, the Netherlands, Poland, Sweden, and the United Kingdom) and Israel. Methods We mapped available digital health reimbursement strategies using a scoping review and policy mapping framework. We reviewed the literature on the MEDLINE, Embase, Global Health, and Web of Science databases. Supplementary records were identified through Google Scholar and country experts. Results Our search strategy yielded a total of 1559 records, of which 40 (2.57%) were ultimately included in this study. As of August 2023, digital health solutions are reimbursable to some extent in all studied countries except Poland, although the mechanism of reimbursement differs significantly across countries. At the time of writing, the pricing of digital health solutions was mostly determined through discussions between national or regional committees and the manufacturers of digital health solutions in the absence of value-based assessment mechanisms. Financing digital health solutions outside traditional reimbursement schemes was possible in all studied countries except Poland and typically occurs via health innovation or digital health–specific funding schemes. European countries have value-based pricing frameworks that range from nonexistent to embryonic. Conclusions Studied countries show divergent approaches to the reimbursement of digital health solutions. These differences may complicate the ability of patients to seek cross-country health care in another country, even if a digital health app is available in both countries. Furthermore, the fragmented environment will present challenges for developers of such solutions, as they look to expand their impact across countries and health systems. An increased emphasis on developing a clear conceptualization of digital health, as well as value-based pricing and reimbursement mechanisms, is needed for the sustainable integration of digital health. This study can therein serve as a basis for further, more detailed research as the field of digital health reimbursement evolves.

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PMD17 Comparison of Market Access Routes of Digital Health Applications in France, Germany and the UK

Cited by 3 publications

References 0 publications

Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges

Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges

Rapid review on the incentives of digital health apps for physicians and psychotherapists: A German perspective

Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping

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