Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges
Digital 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 diagnostics (IVDs). With this point of view, a strong connection between DTx and...
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| Published in | Frontiers in medical technology Vol. 5; p. 1101476 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
Switzerland
Frontiers Media S.A
20.02.2023
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| Subjects | |
| Online Access | Get full text |
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| Summary: | Digital 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
diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed.
We 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.
Many 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
Diagnostic Regulation (IVDR) in the EU includes a classification system specifying how software integrated with medical devices, and IVDs specifically must be regulated.
The 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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| Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-Review-3 content type line 23 Abbreviations AI, artificial intelligence; ARTG, Australian register of therapeutic goods; BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte; ASA, American society of anesthesiologists; CAGR, compound annual growth rate; CDx, companion diagnostics; CE, Conformitè Europëenne; CLFS, clinical laboratory fee schedule; CMS, centers for medicare and medicaid services; CNEDIMT, Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé; CPT, current procedural terminology; CTTI, clinical trials transformation initiative; DHT, digital health technology; DiGA, digital health applications; DiGAV, Digitale-Gesundheitsanwendungen-Verordnung; DTAC, digital technology assessment criteria; DTC, direct-to-consumer; DTx, digital therapeutics; DVG, Digitale-Versorgung-Gesetz; EC, European commission; EDL, essential in vitro diagnostics; EFTA, European free trade association; EMA, European medicines agency; ESF, evidence standards framework; EU, European union; FDA, food and drug administration; FTC, federal trade commission; G-BA, Gemeinsame Bundesausschuss; GSP, genome sequencing procedure; HAS, Haute Autorité de Santé; HIPPA, health insurance portability and accountability act; HR-pQCT, high-resolution peripheral quantitative computed tomography; HTA, health technology assessment; ICER, incremental cost-effectiveness ratio; InEK, Institut für das Entgeltsystem im Krankenhaus; IT, information technology; IVD, in vitro diagnostics; IVDR, in vitro diagnostic regulation; MAC, medicare administrative contractor; MBS, medical benefits schedule; MDR, medical device regulation; MTEP, medical technologies evaluation program; MTG, medical technology guidance; NHS, national health service; NICE, national institute for health and care excellence; P&R, pricing and reimbursement; PAMA, protecting access to medicare act; PBAC, pharmaceutical benefits advisory committee; PLA, proprietary laboratory analyses; PMA, pre-market approval; SA, service attendu; SaMD, software as a medical device; SiMD, software in a medical device; SFS, structural fragility score; SHI, statutory health insurance; TGA, therapeutic goods administration; WP, work packages Edited by: Janet Sultana, Mater Dei Hospital, Malta Reviewed by: Andrea Aiello, Intexo Società Benefit, Italy Patricia Vella Bonanno, University of Malta, Malta John Borg, Malta Medicines Authority, Malta Specialty Section: This article was submitted to Regulatory Affairs, a section of the journal Frontiers in Medical Technology These authors have contributed equally to this work and share first authorship |
| ISSN: | 2673-3129 2673-3129 |
| DOI: | 10.3389/fmedt.2023.1101476 |