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
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/53658

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network_name_str CONICET Digital (CONICET)
spelling 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
reponame_str CONICET Digital (CONICET)
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repository.name.fl_str_mv 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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