La Commission europ\u00e9enne a adopt\u00e9 sa premi\u00e8re d\u00e9cision de s\u00e9lection de dispositifs m\u00e9dicaux pour une \u00e9valuation clinique conjointe dans le cadre du r\u00e8glement europ\u00e9en sur l\u2019\u00e9valuation des technologies de sant\u00e9 (HTA). Deux dispositifs visant la prise en charge des maladies cardiovasculaires ont \u00e9t\u00e9 retenus.<\/p>\n
Le premier dispositif est le syst\u00e8me de remplacement valvulaire mitral par voie transcath\u00e9ter SAPIEN M3, fabriqu\u00e9 par Edwards Lifesciences LLC. L\u2019\u00e9valuation clinique conjointe sera men\u00e9e par un \u00e9valuateur principal du Dutch National Health Care Institute (ZIN, Pays-Bas) et un co\u2011\u00e9valuateur de la Norwegian Medical Products Agency (DMP, Norv\u00e8ge).<\/p>\n
Le second dispositif est le syst\u00e8me de remplacement valvulaire mitral trans-septal Highlife, fabriqu\u00e9 par Highlife SAS. Pour ce dispositif, l\u2019\u00e9valuateur principal est la Haute Autorit\u00e9 de sant\u00e9 (HAS, France) et un co\u2011\u00e9valuateur est l\u2019Agency for Health Technology Assessment and Tariff System (AOTMiT, Pologne).<\/p>\n
Cette d\u00e9cision de la Commission fait suite \u00e0 une recommandation du groupe de coordination des \u00c9tats membres sur l\u2019\u00e9valuation des technologies de sant\u00e9, formul\u00e9e lors de sa r\u00e9union du 22 juin. Elle marque le d\u00e9marrage des travaux conjoints sur les dispositifs m\u00e9dicaux sous le r\u00e9gime du r\u00e8glement HTA, alors que 15 \u00e9valuations cliniques conjointes de m\u00e9dicaments sont d\u00e9j\u00e0 en cours, dont 4 rapports d\u2019\u00e9valuation d\u00e9j\u00e0 publi\u00e9s.<\/p>\n
Les \u00e9valuations cliniques conjointes permettent aux \u00c9tats membres de l\u2019UE de travailler ensemble pour comparer les b\u00e9n\u00e9fices cliniques de nouveaux m\u00e9dicaments et de certains dispositifs m\u00e9dicaux par rapport aux technologies de sant\u00e9 existantes. Les patients et des experts cliniques sont consult\u00e9s de mani\u00e8re syst\u00e9matique au cours du processus. Les r\u00e9sultats prennent la forme d\u2019un rapport d\u2019\u00e9valuation clinique conjoint et d\u2019un rapport r\u00e9sum\u00e9, destin\u00e9s \u00e0 \u00eatre utilis\u00e9s par les \u00c9tats membres dans leurs proc\u00e9dures nationales de d\u00e9cision. La s\u00e9lection de dispositifs m\u00e9dicaux pour les futures \u00e9valuations cliniques conjointes devrait intervenir sur une base trimestrielle. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA) \u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" La Commission europ\u00e9enne a adopt\u00e9 sa premi\u00e8re d\u00e9cision de s\u00e9lection de dispositifs m\u00e9dicaux pour une \u00e9valuation clinique conjointe dans le cadre du r\u00e8glement europ\u00e9en sur l\u2019\u00e9valuation des technologies de sant\u00e9 […]<\/p>\n","protected":false},"author":1,"featured_media":17753,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[212,7,31],"tags":[258,227,226],"class_list":["post-19983","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gestion-des-crises","category-medicaments-et-produits-de-sante","category-politiques-europeennes-sante-social-travail","tag-hera","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/19983","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=19983"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/19983\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17753"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=19983"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=19983"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=19983"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}