{"id":9454,"date":"2023-11-21T16:28:07","date_gmt":"2023-11-21T15:28:07","guid":{"rendered":"https:\/\/www.afaf.asso.fr\/?p=9454"},"modified":"2023-11-21T16:28:09","modified_gmt":"2023-11-21T15:28:09","slug":"skyclarys-rapport-positif-de-la-has","status":"publish","type":"post","link":"https:\/\/www.afaf.asso.fr\/2023\/11\/21\/skyclarys-rapport-positif-de-la-has\/","title":{"rendered":"SKYCLARYS : rapport positif de la HAS!"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Communiqu\u00e9 de la HAS du 20\/11\/ 2023<br><\/strong>\u00ab L\u2019autorisation d\u2019acc\u00e8s pr\u00e9coce pr\u00e9vue au III de l&#8217;article L. 5121-12 du code de la sant\u00e9 publique est octroy\u00e9e \u00e0 la sp\u00e9cialit\u00e9 : SKYCLARYS (omaveloxolone) 50 mg &#8211; Boite de 90 g\u00e9lules du laboratoire Reata Swiss International GmbH dans l\u2019indication \u00ab traitement de l\u2019ataxie de Friedreich (AF) chez les adultes et les adolescents \u00e2g\u00e9s de 16 ans et plus \u00bb.<br>Cette sp\u00e9cialit\u00e9 rel\u00e8ve de la cat\u00e9gorie des m\u00e9dicaments soumis \u00e0 prescription hospitali\u00e8re, r\u00e9serv\u00e9e aux sp\u00e9cialistes en neurologie ou en neurop\u00e9diatrie et n\u00e9cessitant une surveillance particuli\u00e8re pendant le traitement \u00bb.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>R\u00e9unions pr\u00e9vues dans les semaines \u00e0 venir, entre le laboratoire Biogen (qui vient de racheter Reata), les m\u00e9decins du r\u00e9seau de soins habilit\u00e9s \u00e0 prescrire dans ce cadre d\u2019acc\u00e8s pr\u00e9coce et l\u2019AFAF.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Aussi pourrons-nous vous apporter d\u00e8s que possible des r\u00e9ponses concr\u00e8tes \u00e0 vos questions.<br>C\u2019est un grand premier pas ! <strong>Nous avons apport\u00e9 notre contribution lors d\u2019une audition, continuons ensemble \u00e0 porter nos espoirs.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Retrouvez le dossier <strong>complet sur le site de la HAS<\/strong> :<br><a href=\"https:\/\/www.has-sante.fr\/jcms\/p_3474022\/fr\/skyclarys-omaveloxolone-traitement-de-l-ataxie-de-friedreich-af\">https:\/\/www.has-sante.fr\/jcms\/p_3474022\/fr\/skyclarys-omaveloxolone-traitement-de-l-ataxie-de-friedreich-af<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Acc\u00e8s pr\u00e9coce, rappel :<\/strong><br>https:\/\/ansm.sante.fr\/vos-demarches\/industriel\/demande-dautorisation-dacces-precoce revoir le lien le site de la HAS est en maintenance \u00e0 cette heure ..<br>\u00ab Le proc\u00e9d\u00e9 de prescription en acc\u00e8s pr\u00e9coce concerne des m\u00e9dicaments innovants et consiste \u00e0 les autoriser et \u00e0 les financer \u00e0 une phase pr\u00e9coce de leur d\u00e9veloppement (pr\u00e9-AMM) ou dans l&#8217;attente de leur inscription au remboursement (post-AMM), et ce jusqu&#8217;\u00e0 ce qu&#8217;ils int\u00e8grent le r\u00e9gime de droit commun d&#8217;autorisation et de remboursement des produits de sant\u00e9.<br>L&#8217;acc\u00e8s pr\u00e9coce est d\u00e9sormais autoris\u00e9 par la HAS, apr\u00e8s avis de l&#8217;ANSM, pour les m\u00e9dicaments sans AMM dans l&#8217;indication consid\u00e9r\u00e9e. \u00bb 2021<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Communiqu\u00e9 de la HAS du 20\/11\/ 2023\u00ab L\u2019autorisation d\u2019acc\u00e8s pr\u00e9coce pr\u00e9vue au III de l&#8217;article L. 5121-12 du code de la sant\u00e9 publique est octroy\u00e9e \u00e0 la sp\u00e9cialit\u00e9 : SKYCLARYS (omaveloxolone) 50 mg &#8211; Boite de 90 g\u00e9lules du laboratoire Reata Swiss International GmbH dans l\u2019indication \u00ab traitement de l\u2019ataxie de Friedreich (AF) chez les 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