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    Inicio > Historias > Acuerdo de la COMISIÓN INTERMINISTERIAL DE PRECIOS DE LOS MEDICAMENTOS sobre Alofisel 2019-10-21

    Acuerdo de la COMISIÓN INTERMINISTERIAL DE PRECIOS DE LOS MEDICAMENTOS sobre Alofisel

    Se han hecho públicos en la web del MSCBS los ACUERDOS DE LA REUNIÓN DE LA COMISIÓN INTERMINISTERIAL DE PRECIOS DE LOS MEDICAMENTOS.SESIÓN 193 DE 12 DE JULIO DE 2019. En sus páginas 6 y 7 se publicita lo referente a Alofisel



    LABORATORIO

    MEDICAMENTO

    FORMATO

    CN

    Precio €

    Criterios para la financiación

    Takeda Pharma A/S

    Alofisel 5 millones de células/ml

    suspensión inyectable 4 viales de 6 ml

    722305

    60.000

    c)


    o ALOFISEL

     Principio activo: Darvadstrocel, células madre expandidas alogénicas humanas adultas de origen mesenquimal extraídas de tejido adiposo.

    Indicación terapéutica: Alofisel está indicado para el tratamiento de las fístulas perianales complejas en pacientes adultos con enfermedad de Crohn luminal inactiva o leve, cuando las fístulas han presentado una respuesta inadecuada a, como mínimo, un tratamiento convencional o biológico. Alofisel se debe utilizar tras el acondicionamiento de la fístula.

    Condiciones de prescripción y dispensación: Con receta médica. Uso hospitalario

    Con respecto a este medicamento, la Comisión acuerda su financiación con las siguientes condiciones:

    • Fijar el precio del medicamento citado, que aparece relacionado en la tabla anterior

    • Financiar este medicamento mediante un acuerdo de pago por resultados.

    • Criterios clínicos que deben cumplir los pacientes para su utilización:

    a) Pacientes que presenten fístulas complejas con EC luminal inactiva o leve (CDAI ≤220) con supuración en las últimas 6 semanas: La fístula perianal compleja se define como aquélla que cumple uno o más de los siguientes criterios:

    ● Interesfintérica alta, transesfintérica, extraesfintérica o supraesfintérica

    ● Presencia ≥ 2 orificios externos.

    ● Abscesos

    b) Que hayan fracasado a tratamiento convencional y a tratamiento anti-TNF, o bien en aquellos pacientes en los que el tratamiento con anti-TNF no se considere adecuado.

    c) Que no presenten abscesos mayores de 2 cm, a menos que estos se resuelvan en la preparación.


    La Comisión acuerda, además:

     • Revisión anual de las ventas y de los precios ahora fijados, para asegurar que se encuentran en los parámetros establecidos legalmente, y en caso contrario, proceder a su adecuación mediante la rebaja correspondiente.

     • Además, el precio podrá ser revisado si las ventas superan en más de un 10 por cien la cifra de ventas declarada por el laboratorio y ello tuviese un impacto al alza en el gasto farmacéutico del Sistema Nacional de Salud.

     • El seguimiento y control del gasto causado se realizará mediante el proceso informático SEGUIMED y/o aquel otro del que se disponga. El laboratorio estará obligado a registrarse en dicha aplicación y a comunicar con periodicidad mensual la oportuna información respecto a las ventas realizadas del medicamento al SNS.

     • La Dirección General de Cartera Básica de Servicios del SNS y Farmacia elaborará un protocolo farmacoclínico de obligada cumplimentación en todo el SNS, a través de VALTERMED, que contenga los criterios de inicio, seguimiento y discontinuación del tratamiento.

     • La determinación del cumplimiento individual de las condiciones de pago se efectuará a través de un Comité de Seguimiento en cada CCAA que se constituirá entre las administraciones sanitarias y el laboratorio ofertante/suministrador. Dicha información se trasladará a la Dirección General de Cartera Básica de Servicios del SNS y Farmacia con objeto de determinar la necesidad de revisión de precios




    Un aspecto que no había entendido respecto al origen de las células madres, es que proceden de donantes sanos sometidos a liposucciones.

    2019-10-21 07:08 | 12 Comentarios


    Referencias (TrackBacks)

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