Managing the introduction of genomic applications into the National Health Service: A special challenge for health technology assessment in Italy
In recent years, the rapid proliferation of genomic tests for use in clinical practice has prompted healthcare systems to use a health technology assessment (HTA) approach to distinguish valuable from unwarranted applications. In this study, we narratively review the Italian HTA mechanisms for medic...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-08-01
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| Series: | Frontiers in Public Health |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpubh.2022.932093/full |
| _version_ | 1798037970049040384 |
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| author | Erica Pitini Giuseppe Migliara Valentina Baccolini Claudia Isonne Elena Mazzalai Federica Turatto Carla Salerno Federica Pagano Maria Teresa Menzano Corrado De Vito Carolina Marzuillo Paolo Villari |
| author_facet | Erica Pitini Giuseppe Migliara Valentina Baccolini Claudia Isonne Elena Mazzalai Federica Turatto Carla Salerno Federica Pagano Maria Teresa Menzano Corrado De Vito Carolina Marzuillo Paolo Villari |
| author_sort | Erica Pitini |
| collection | DOAJ |
| description | In recent years, the rapid proliferation of genomic tests for use in clinical practice has prompted healthcare systems to use a health technology assessment (HTA) approach to distinguish valuable from unwarranted applications. In this study, we narratively review the Italian HTA mechanisms for medical devices (MDs), both at the national and regional levels, and discuss the opportunity and benefits of extending them to genomic technologies, for which a dedicated assessment path was advocated by the National Plan for Public Health Genomics in 2017. We found that the National Health Technology Assessment Program for MDs, completed in 2019, had developed a structured pathway for the HTA of MDs; it established a hub-and-spoke structure, run by a governmental institution, and put in place transparent methodological procedures to cover all four HTA phases (i.e., proposal and prioritization, assessment, appraisal, and dissemination). However, several factors have hindered its adoption, and the regions are at different stages of its implementation. For these reasons, efforts should be made to ensure its effective deployment, both at national and regional levels. In addition, we argue that to harmonize the institutional roles and methodological procedures adopted, the time has come to concentrate resources on a single pathway for the assessment of all technologies that include both MDs and genomic applications. |
| first_indexed | 2024-04-11T21:33:49Z |
| format | Article |
| id | doaj.art-40985e337ec1426bb948390cfa31c4f4 |
| institution | Directory Open Access Journal |
| issn | 2296-2565 |
| language | English |
| last_indexed | 2024-04-11T21:33:49Z |
| publishDate | 2022-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Public Health |
| spelling | doaj.art-40985e337ec1426bb948390cfa31c4f42022-12-22T04:01:50ZengFrontiers Media S.A.Frontiers in Public Health2296-25652022-08-011010.3389/fpubh.2022.932093932093Managing the introduction of genomic applications into the National Health Service: A special challenge for health technology assessment in ItalyErica Pitini0Giuseppe Migliara1Valentina Baccolini2Claudia Isonne3Elena Mazzalai4Federica Turatto5Carla Salerno6Federica Pagano7Maria Teresa Menzano8Corrado De Vito9Carolina Marzuillo10Paolo Villari11Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyItalian Ministry of Health, General Directorate for Health Prevention, Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, ItalyIn recent years, the rapid proliferation of genomic tests for use in clinical practice has prompted healthcare systems to use a health technology assessment (HTA) approach to distinguish valuable from unwarranted applications. In this study, we narratively review the Italian HTA mechanisms for medical devices (MDs), both at the national and regional levels, and discuss the opportunity and benefits of extending them to genomic technologies, for which a dedicated assessment path was advocated by the National Plan for Public Health Genomics in 2017. We found that the National Health Technology Assessment Program for MDs, completed in 2019, had developed a structured pathway for the HTA of MDs; it established a hub-and-spoke structure, run by a governmental institution, and put in place transparent methodological procedures to cover all four HTA phases (i.e., proposal and prioritization, assessment, appraisal, and dissemination). However, several factors have hindered its adoption, and the regions are at different stages of its implementation. For these reasons, efforts should be made to ensure its effective deployment, both at national and regional levels. In addition, we argue that to harmonize the institutional roles and methodological procedures adopted, the time has come to concentrate resources on a single pathway for the assessment of all technologies that include both MDs and genomic applications.https://www.frontiersin.org/articles/10.3389/fpubh.2022.932093/fullhealth technology assessment (HTA)National Health Servicepublic health genomicspublic health governanceItalynarrative review |
| spellingShingle | Erica Pitini Giuseppe Migliara Valentina Baccolini Claudia Isonne Elena Mazzalai Federica Turatto Carla Salerno Federica Pagano Maria Teresa Menzano Corrado De Vito Carolina Marzuillo Paolo Villari Managing the introduction of genomic applications into the National Health Service: A special challenge for health technology assessment in Italy Frontiers in Public Health health technology assessment (HTA) National Health Service public health genomics public health governance Italy narrative review |
| title | Managing the introduction of genomic applications into the National Health Service: A special challenge for health technology assessment in Italy |
| title_full | Managing the introduction of genomic applications into the National Health Service: A special challenge for health technology assessment in Italy |
| title_fullStr | Managing the introduction of genomic applications into the National Health Service: A special challenge for health technology assessment in Italy |
| title_full_unstemmed | Managing the introduction of genomic applications into the National Health Service: A special challenge for health technology assessment in Italy |
| title_short | Managing the introduction of genomic applications into the National Health Service: A special challenge for health technology assessment in Italy |
| title_sort | managing the introduction of genomic applications into the national health service a special challenge for health technology assessment in italy |
| topic | health technology assessment (HTA) National Health Service public health genomics public health governance Italy narrative review |
| url | https://www.frontiersin.org/articles/10.3389/fpubh.2022.932093/full |
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