Cargando…

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

OBJECTIVES: 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 in vitro diagnostics (IVDs). With this point of view, a strong connec...

Descripción completa

Detalles Bibliográficos
Autores principales: Mantovani, Andrea, Leopaldi, Claudia, Nighswander, Cassandra Maria, Di Bidino, Rossella
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986593/
https://www.ncbi.nlm.nih.gov/pubmed/36891483
http://dx.doi.org/10.3389/fmedt.2023.1101476
_version_ 1784901200809820160
author Mantovani, Andrea
Leopaldi, Claudia
Nighswander, Cassandra Maria
Di Bidino, Rossella
author_facet Mantovani, Andrea
Leopaldi, Claudia
Nighswander, Cassandra Maria
Di Bidino, Rossella
author_sort Mantovani, Andrea
collection PubMed
description OBJECTIVES: 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 in vitro diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed. METHODS: 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. RESULTS: 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 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. CONCLUSION: 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.
format Online
Article
Text
id pubmed-9986593
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-99865932023-03-07 Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges Mantovani, Andrea Leopaldi, Claudia Nighswander, Cassandra Maria Di Bidino, Rossella Front Med Technol Medical Technology OBJECTIVES: 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 in vitro diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed. METHODS: 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. RESULTS: 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 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. CONCLUSION: 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. Frontiers Media S.A. 2023-02-20 /pmc/articles/PMC9986593/ /pubmed/36891483 http://dx.doi.org/10.3389/fmedt.2023.1101476 Text en © 2023 Mantovani, Leopaldi, Nighswander and Di Bidino. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) (https://creativecommons.org/licenses/by/4.0/) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medical Technology
Mantovani, Andrea
Leopaldi, Claudia
Nighswander, Cassandra Maria
Di Bidino, Rossella
Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges
title Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges
title_full Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges
title_fullStr Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges
title_full_unstemmed Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges
title_short Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges
title_sort access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: current scenario and challenges
topic Medical Technology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986593/
https://www.ncbi.nlm.nih.gov/pubmed/36891483
http://dx.doi.org/10.3389/fmedt.2023.1101476
work_keys_str_mv AT mantovaniandrea accessandreimbursementpathwaysfordigitalhealthsolutionsandinvitrodiagnosticdevicescurrentscenarioandchallenges
AT leopaldiclaudia accessandreimbursementpathwaysfordigitalhealthsolutionsandinvitrodiagnosticdevicescurrentscenarioandchallenges
AT nighswandercassandramaria accessandreimbursementpathwaysfordigitalhealthsolutionsandinvitrodiagnosticdevicescurrentscenarioandchallenges
AT dibidinorossella accessandreimbursementpathwaysfordigitalhealthsolutionsandinvitrodiagnosticdevicescurrentscenarioandchallenges