Comparison of health technology assessments for digital therapeutics in Germany, the United Kingdom and France
Objective Digital therapeutics (DTx) are promising technologies. However, current assessment and access frameworks, when they exist, are heterogeneous and fragmented. We analysed and compared health technology assessment (HTA) criteria for DTx across European countries that had assessed the same DTx...
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| Format: | Article |
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SAGE Publishing
2025-01-01
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| Series: | Digital Health |
| Online Access: | https://doi.org/10.1177/20552076241308704 |
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| _version_ | 1832591453242523648 |
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| author | Emanuele Arcà Dorothea Heldt Martina Smith |
| author_facet | Emanuele Arcà Dorothea Heldt Martina Smith |
| author_sort | Emanuele Arcà |
| collection | DOAJ |
| description | Objective Digital therapeutics (DTx) are promising technologies. However, current assessment and access frameworks, when they exist, are heterogeneous and fragmented. We analysed and compared health technology assessment (HTA) criteria for DTx across European countries that had assessed the same DTx products. This allowed us to conduct a direct comparison of these countries’ DTx assessment frameworks. Methods A scoping review identified HTA DTx documents from European HTA bodies with specific DTx frameworks in place. The HTAs of the same DTx products assessed across multiple countries were then extracted and analysed. Results Deprexis and Velibra were the only DTx products assessed by multiple countries: Deprexis, indicated for depression, was assessed by Germany, the United Kingdom (UK) and France; and Velibra, indicated for anxiety, was assessed by Germany and the UK. There are notable differences among those frameworks, but what they share is an emphasis on the context-specific positioning of products within the disease landscape, choice of comparators and usage and usability data. Safety data are not a major focus in DTx assessments in these countries, but a request is often made for the addition and evaluation of risk-flagging systems. Conclusion The majority of European countries do not have a specific framework in place for the assessment of DTx, and major differences exist among recently implemented frameworks. The current policy landscape at the European Union level offers an opportunity to establish a harmonized framework for the assessment of DTx and possibly faster access and integration of such promising technologies. |
| format | Article |
| id | doaj-art-8364bbc735704066997d77ae7e7c19c6 |
| institution | Kabale University |
| issn | 2055-2076 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Digital Health |
| spelling | doaj-art-8364bbc735704066997d77ae7e7c19c62025-01-22T11:03:38ZengSAGE PublishingDigital Health2055-20762025-01-011110.1177/20552076241308704Comparison of health technology assessments for digital therapeutics in Germany, the United Kingdom and FranceEmanuele Arcà0Dorothea Heldt1Martina Smith2 , Rotterdam, The Netherlands , Berlin, Germany , London, UKObjective Digital therapeutics (DTx) are promising technologies. However, current assessment and access frameworks, when they exist, are heterogeneous and fragmented. We analysed and compared health technology assessment (HTA) criteria for DTx across European countries that had assessed the same DTx products. This allowed us to conduct a direct comparison of these countries’ DTx assessment frameworks. Methods A scoping review identified HTA DTx documents from European HTA bodies with specific DTx frameworks in place. The HTAs of the same DTx products assessed across multiple countries were then extracted and analysed. Results Deprexis and Velibra were the only DTx products assessed by multiple countries: Deprexis, indicated for depression, was assessed by Germany, the United Kingdom (UK) and France; and Velibra, indicated for anxiety, was assessed by Germany and the UK. There are notable differences among those frameworks, but what they share is an emphasis on the context-specific positioning of products within the disease landscape, choice of comparators and usage and usability data. Safety data are not a major focus in DTx assessments in these countries, but a request is often made for the addition and evaluation of risk-flagging systems. Conclusion The majority of European countries do not have a specific framework in place for the assessment of DTx, and major differences exist among recently implemented frameworks. The current policy landscape at the European Union level offers an opportunity to establish a harmonized framework for the assessment of DTx and possibly faster access and integration of such promising technologies.https://doi.org/10.1177/20552076241308704 |
| spellingShingle | Emanuele Arcà Dorothea Heldt Martina Smith Comparison of health technology assessments for digital therapeutics in Germany, the United Kingdom and France Digital Health |
| title | Comparison of health technology assessments for digital therapeutics in Germany, the United Kingdom and France |
| title_full | Comparison of health technology assessments for digital therapeutics in Germany, the United Kingdom and France |
| title_fullStr | Comparison of health technology assessments for digital therapeutics in Germany, the United Kingdom and France |
| title_full_unstemmed | Comparison of health technology assessments for digital therapeutics in Germany, the United Kingdom and France |
| title_short | Comparison of health technology assessments for digital therapeutics in Germany, the United Kingdom and France |
| title_sort | comparison of health technology assessments for digital therapeutics in germany the united kingdom and france |
| url | https://doi.org/10.1177/20552076241308704 |
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