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    Inicio > Historias > El Consejo Interterritorial y el NC1 del Hospital Puerta de Hierro 2019-10-15

    El Consejo Interterritorial y el NC1 del Hospital Puerta de Hierro

    De la reseña del Consejo Interterritorial del Sistema Nacional de Salud, celebrado el día 14 de diciembre de 2019 en el que parecía se iba a abordar las nuevas designaciones de hospitales para aplicar la terapia CAR-T, - y no parece haya sido así - ha sido el medicamento  NC1 del Hospital Puerta de Hierro de Madrid de la que ya hablábamos aquí el pasado 17 de abril de 2019, el protagonista.


    MEDICAMENTOS DE TERAPIA AVANZADA DE TITULARIDAD PÚBLICA

    Gobierno y CCAA han acordado además las condiciones generales de planificación, coordinación, contratación, adquisición y suministro de medicamentos de terapia avanzada de las estructuras y servicios de titularidad pública integrados en el Sistema Nacional de Salud (SNS).

    El pasado 1 de octubre se incluyó en la prestación farmacéutica del SNS el primer medicamento de terapia avanzada de fabricación no industrial. Por primera vez, la titularidad es de un hospital público. 

    “Este hito supone un nuevo paradigma tanto en el proceso productivo del medicamento en España como en su gestión”, ha destacado la ministra. “Se abre así una fuente de oportunidades al SNS, tanto en el fomento de la fabricación propia y pública de estos medicamentos como para la investigación clínica independiente”. Ambos son objetivos recogidos en el Plan para el Abordaje de las terapias avanzadas en el SNS: medicamentos CAR-T.

    Carcedo ha insistido en que todo el proceso cuenta con unas condiciones que satisfacen las garantías exigibles a todo medicamento referentes a la calidad, seguridad, eficacia, identificación e información.


    Según se lee en prensa profesional será la Comisión de Farmacia ¿Comisión Interministerial de Precios de los Medicamentos? quién fijará el precio de NC1. En prensa generalista se habla de un precio de 15.000€,

    Reproducimos de nuevo parte de la ficha técnica


    2. COMPOSICIÓN CUALITATIVA Y CUANTITATIVA

    La sustancia activa de este medicamento son las células mesenquimales troncales adultas autólogas de médula ósea expandidas, a una concentración de 100.000 células/μl.

    Excipientes: Plasma sanguíneo autólogo 

    ....

    4.1 Indicaciones terapéuticas

    NC1 está indicado en el tratamiento de pacientes adultos (≤65 años) con secuelas de lesión medular traumática crónica, que presenten lesiones medulares incompletas a nivel dorsal o lumbar.

    Las lesiones medulares dorsales o lumbares completas están excluidas, con la excepción de lesiones completas localizadas quísticas, con cavidad centro-medular que no se extienda más de 1-3 segmentos medulares.  

    .....

    5.1 Propiedades farmacodinámicas

    Grupo farmacoterapéutico: terapia celular somática

    Mecanismo de acción

    El mecanismo de acción no ha sido completamente elucidado. Un posible mecanismo de acción, basado en resultados de experimentos in vitro, sería la diferenciación neural de las células contenidas en el medicamento NC1 tras entrar en contacto con factores solubles aportados por células gliales, fenómeno que se denomina transdiferenciación biológica


    2019-10-15 05:42 | 11 Comentarios


    Referencias (TrackBacks)

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