Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico
- Autores
- Rey Ares, Lucila; Garay, U; García Martí, S.; Gilardino, R.; Cabra, H. A.; Pichón-Riviere, Andrés; Augustovski, Federico Ariel
- Año de publicación
- 2015
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- Objectives: To assess, describe and compare the requirements and pathwaysof medical devices from licensing to coverage in four Latin American countries(LAC) health systems. Methods: We conducted a literature search (February 2015)on Pubmed, Lilacs and Value in Health Regional Issues journal. We also searchedspecific websites of Health Technology Assessment (HTA) and regulatory agencies,ministries of health and health agencies; and a performed generic Internet search.We included all publications describing aspects related to regulation, coverage,medical technology innovation, and HTA and Economic Evaluation (EE) guidelines.We additionally interviewed key informants from all countries to gather informationrelated to the aforementioned processes. We present here the literature searchresults. Results: We included 60 studies out of 2190. Five percent of the publicationsanalyzed the four countries jointly, 75% were from Brazil, 8.3% from Mexico, 5%from Colombia and 5.7% from LAC in general. Half of the studies described the roleof the HTA and EE in decision-making and aspects or policies related to innovation(25% and 23.3%). Regarding the description of the coverage process, it was addressedin 13.3% of the studies; 10% of the publications focused on technovigilance; and also10% on regulatory aspects. Remaining publications were methodological guidelinesand general descriptions of the health systems and the role of medical devices. Allcountries had HTA and EE guidelines, although there did not include device specificrecommendations. There is a spectrum of HTA formalization for technology incorporationafter licensing, higher in Brazil and lower in Argentina Conclusions:There is scarce information on the processes and requirements to achieve coveragefor medical devices in these countries. Processes differ, are in general not explicit,lack transparency, and usually replicate those of drugs not taking into account thespecificities of medical devices.
Fil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Garay, U. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: García Martí, S.. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Gilardino, R.. Johnson & Johnson Medical Argentina; Argentina
Fil: Cabra, H. A.. Johnson & Johnson Medical; México
Fil: Pichón-Riviere, Andrés. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Augustovski, Federico Ariel. Instituto de Efectividad Clínica y Sanitaria; Argentina - Materia
- Medical Devices
- Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
- Repositorio
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/53658
Ver los metadatos del registro completo
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Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And MexicoRey Ares, LucilaGaray, UGarcía Martí, S.Gilardino, R.Cabra, H. A.Pichón-Riviere, AndrésAugustovski, Federico ArielMedical Deviceshttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Objectives: To assess, describe and compare the requirements and pathwaysof medical devices from licensing to coverage in four Latin American countries(LAC) health systems. Methods: We conducted a literature search (February 2015)on Pubmed, Lilacs and Value in Health Regional Issues journal. We also searchedspecific websites of Health Technology Assessment (HTA) and regulatory agencies,ministries of health and health agencies; and a performed generic Internet search.We included all publications describing aspects related to regulation, coverage,medical technology innovation, and HTA and Economic Evaluation (EE) guidelines.We additionally interviewed key informants from all countries to gather informationrelated to the aforementioned processes. We present here the literature searchresults. Results: We included 60 studies out of 2190. Five percent of the publicationsanalyzed the four countries jointly, 75% were from Brazil, 8.3% from Mexico, 5%from Colombia and 5.7% from LAC in general. Half of the studies described the roleof the HTA and EE in decision-making and aspects or policies related to innovation(25% and 23.3%). Regarding the description of the coverage process, it was addressedin 13.3% of the studies; 10% of the publications focused on technovigilance; and also10% on regulatory aspects. Remaining publications were methodological guidelinesand general descriptions of the health systems and the role of medical devices. Allcountries had HTA and EE guidelines, although there did not include device specificrecommendations. There is a spectrum of HTA formalization for technology incorporationafter licensing, higher in Brazil and lower in Argentina Conclusions:There is scarce information on the processes and requirements to achieve coveragefor medical devices in these countries. Processes differ, are in general not explicit,lack transparency, and usually replicate those of drugs not taking into account thespecificities of medical devices.Fil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Garay, U. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: García Martí, S.. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Gilardino, R.. Johnson & Johnson Medical Argentina; ArgentinaFil: Cabra, H. A.. Johnson & Johnson Medical; MéxicoFil: Pichón-Riviere, Andrés. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Augustovski, Federico Ariel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaWiley Blackwell Publishing, Inc2015-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/53658Rey Ares, Lucila; Garay, U; García Martí, S.; Gilardino, R.; Cabra, H. A.; et al.; Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico; Wiley Blackwell Publishing, Inc; Value In Health; 18; 7; 11-20151098-3015CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.jval.2015.09.086info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S1098301515021622info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:29:00Zoai:ri.conicet.gov.ar:11336/53658instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:29:00.996CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse |
dc.title.none.fl_str_mv |
Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico |
title |
Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico |
spellingShingle |
Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico Rey Ares, Lucila Medical Devices |
title_short |
Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico |
title_full |
Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico |
title_fullStr |
Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico |
title_full_unstemmed |
Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico |
title_sort |
Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico |
dc.creator.none.fl_str_mv |
Rey Ares, Lucila Garay, U García Martí, S. Gilardino, R. Cabra, H. A. Pichón-Riviere, Andrés Augustovski, Federico Ariel |
author |
Rey Ares, Lucila |
author_facet |
Rey Ares, Lucila Garay, U García Martí, S. Gilardino, R. Cabra, H. A. Pichón-Riviere, Andrés Augustovski, Federico Ariel |
author_role |
author |
author2 |
Garay, U García Martí, S. Gilardino, R. Cabra, H. A. Pichón-Riviere, Andrés Augustovski, Federico Ariel |
author2_role |
author author author author author author |
dc.subject.none.fl_str_mv |
Medical Devices |
topic |
Medical Devices |
purl_subject.fl_str_mv |
https://purl.org/becyt/ford/3.3 https://purl.org/becyt/ford/3 |
dc.description.none.fl_txt_mv |
Objectives: To assess, describe and compare the requirements and pathwaysof medical devices from licensing to coverage in four Latin American countries(LAC) health systems. Methods: We conducted a literature search (February 2015)on Pubmed, Lilacs and Value in Health Regional Issues journal. We also searchedspecific websites of Health Technology Assessment (HTA) and regulatory agencies,ministries of health and health agencies; and a performed generic Internet search.We included all publications describing aspects related to regulation, coverage,medical technology innovation, and HTA and Economic Evaluation (EE) guidelines.We additionally interviewed key informants from all countries to gather informationrelated to the aforementioned processes. We present here the literature searchresults. Results: We included 60 studies out of 2190. Five percent of the publicationsanalyzed the four countries jointly, 75% were from Brazil, 8.3% from Mexico, 5%from Colombia and 5.7% from LAC in general. Half of the studies described the roleof the HTA and EE in decision-making and aspects or policies related to innovation(25% and 23.3%). Regarding the description of the coverage process, it was addressedin 13.3% of the studies; 10% of the publications focused on technovigilance; and also10% on regulatory aspects. Remaining publications were methodological guidelinesand general descriptions of the health systems and the role of medical devices. Allcountries had HTA and EE guidelines, although there did not include device specificrecommendations. There is a spectrum of HTA formalization for technology incorporationafter licensing, higher in Brazil and lower in Argentina Conclusions:There is scarce information on the processes and requirements to achieve coveragefor medical devices in these countries. Processes differ, are in general not explicit,lack transparency, and usually replicate those of drugs not taking into account thespecificities of medical devices. Fil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Garay, U. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: García Martí, S.. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Gilardino, R.. Johnson & Johnson Medical Argentina; Argentina Fil: Cabra, H. A.. Johnson & Johnson Medical; México Fil: Pichón-Riviere, Andrés. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Augustovski, Federico Ariel. Instituto de Efectividad Clínica y Sanitaria; Argentina |
description |
Objectives: To assess, describe and compare the requirements and pathwaysof medical devices from licensing to coverage in four Latin American countries(LAC) health systems. Methods: We conducted a literature search (February 2015)on Pubmed, Lilacs and Value in Health Regional Issues journal. We also searchedspecific websites of Health Technology Assessment (HTA) and regulatory agencies,ministries of health and health agencies; and a performed generic Internet search.We included all publications describing aspects related to regulation, coverage,medical technology innovation, and HTA and Economic Evaluation (EE) guidelines.We additionally interviewed key informants from all countries to gather informationrelated to the aforementioned processes. We present here the literature searchresults. Results: We included 60 studies out of 2190. Five percent of the publicationsanalyzed the four countries jointly, 75% were from Brazil, 8.3% from Mexico, 5%from Colombia and 5.7% from LAC in general. Half of the studies described the roleof the HTA and EE in decision-making and aspects or policies related to innovation(25% and 23.3%). Regarding the description of the coverage process, it was addressedin 13.3% of the studies; 10% of the publications focused on technovigilance; and also10% on regulatory aspects. Remaining publications were methodological guidelinesand general descriptions of the health systems and the role of medical devices. Allcountries had HTA and EE guidelines, although there did not include device specificrecommendations. There is a spectrum of HTA formalization for technology incorporationafter licensing, higher in Brazil and lower in Argentina Conclusions:There is scarce information on the processes and requirements to achieve coveragefor medical devices in these countries. Processes differ, are in general not explicit,lack transparency, and usually replicate those of drugs not taking into account thespecificities of medical devices. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-11 |
dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo |
format |
article |
status_str |
publishedVersion |
dc.identifier.none.fl_str_mv |
http://hdl.handle.net/11336/53658 Rey Ares, Lucila; Garay, U; García Martí, S.; Gilardino, R.; Cabra, H. A.; et al.; Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico; Wiley Blackwell Publishing, Inc; Value In Health; 18; 7; 11-2015 1098-3015 CONICET Digital CONICET |
url |
http://hdl.handle.net/11336/53658 |
identifier_str_mv |
Rey Ares, Lucila; Garay, U; García Martí, S.; Gilardino, R.; Cabra, H. A.; et al.; Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico; Wiley Blackwell Publishing, Inc; Value In Health; 18; 7; 11-2015 1098-3015 CONICET Digital CONICET |
dc.language.none.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.jval.2015.09.086 info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S1098301515021622 |
dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by-nc-sa/2.5/ar/ |
eu_rights_str_mv |
openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/ |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Wiley Blackwell Publishing, Inc |
publisher.none.fl_str_mv |
Wiley Blackwell Publishing, Inc |
dc.source.none.fl_str_mv |
reponame:CONICET Digital (CONICET) instname:Consejo Nacional de Investigaciones Científicas y Técnicas |
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CONICET Digital (CONICET) |
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CONICET Digital (CONICET) |
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Consejo Nacional de Investigaciones Científicas y Técnicas |
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CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas |
repository.mail.fl_str_mv |
dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar |
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