Arrêté du 3 juin 2021 relatif à la prise en charge d'une spécialité pharmaceutique bénéficiant d'une recommandation temporaire d'utilisation et pris en application de l'article L. 162-17-2-1 du code de la sécurité sociale
Jurisdiction | France |
Record Number | JORFTEXT000043618524 |
Date de publication | 08 juin 2021 |
ELI | https://www.legifrance.gouv.fr/eli/arrete/2021/6/3/SSAS2117183A/jo/texte |
Publication au Gazette officiel | JORF n°0131 du 8 juin 2021 |
Court | Ministère des solidarités et de la santé |
Enactment Date | 03 juin 2021 |
Le ministre de l'économie, des finances et de la relance et le ministre des solidarités et de la santé,
Vu le code de la santé publique, notamment son article L. 5121-12-1 ;
Vu le code de la sécurité sociale, notamment son article L. 162-17-2-1 ;
Vu la recommandation temporaire d'utilisation (RTU) de l'Agence nationale du médicament et des produits de santé en date du 2 janvier 2021 relative à l'utilisation de la spécialité NAMUSCLA® ;
Vu la recommandation de la Haute Autorité de santé en date du 24 mars 2021,
Arrêtent :
En application de l'article L. 162-17-2-1 du code de la sécurité sociale et dans le cadre de la recommandation temporaire d'utilisation dont elle fait l'objet, la spécialité pharmaceutique mentionnée en annexe du présent arrêté est prise en charge, pour une durée de trois ans, dans l'indication mentionnée dans ladite annexe.
La spécialité pharmaceutique dans l'indication mentionnés en annexe du présent arrêté est soumise à prescription hospitalière et nécessitant une surveillance particulière pendant toute la durée du traitement.
L'entreprise exploitant la spécialité pharmaceutique figurant en annexe est tenue de mettre en place le suivi des patients selon les modalités prévues dans le protocole mentionné à l'article R. 5121-76-1 du code de la santé publique.
Le présent arrêté sera publié au Journal officiel de la...
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