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    Inicio > Historias > The Centers for Medicare & Medicaid Services (CMS) establecen la cobertura sobre las CAR-T 2019-08-13

    The Centers for Medicare & Medicaid Services (CMS) establecen la cobertura sobre las CAR-T

    Veo en Fiercepharma una noticia sobre las normas para cubrir por el financiador público en USA el acceso a las CAR-T : Medicare's new CAR-T coverage rules could boost adoption of slow-growing meds


    Aquí la nota de The Centers for Medicare & Medicaid Services (CMS) Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N) sobre la regulación y a continuación el resumen de la misma:


    A. The Centers for Medicare & Medicaid Services (CMS) covers autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication as defined at Social Security Act section 1861(t)(2) i.e., is used for either an FDA-approved indication (according to the FDA-approved label for that product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia. 

    B. The use of non-FDA-approved autologous T-cells expressing at least one CAR is non-covered. Autologous treatment for cancer with T-cells expressing at least one CAR is non-covered when the requirements in Section A are not met. 

    C. This policy continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.


    Una detallada descripción del procedimiento de toma de la decisión constituye el documento con aportaciones específicas par mayores de 65, beneficiarios de Medicare.

    2019-08-13 22:28 | 29 Comentarios


    Referencias (TrackBacks)

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