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...
Blog de Medicamentos de terapias avanzadas (MTA): de medicamentos de terapias génicas y de medicamentos de terapias celulares somáticas autorizadas por la EMA y la FDA, principalmente.