Copiamos de la web de la FDA:
Proper Name: onasemnogene abeparvovec-xioi
Trade Name: ZOLGENSMA®
Manufacturer: AveXis, Inc
Indication: For the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Product Information Package Insert-ZOLGENSMA
Supporting Documents May 24, 2019 Approval Letter - ZOLGENSMA
The current 10-year cost of chronic therapy, which is given over the patient's lifetime, can often exceed USD 4 million in just the first 10 years of a young child's life. In addition, that therapy stops working if treatment is stopped. Zolgensma is expected to save costs in the healthcare system compared to chronic treatment for the treatment and care of SMA. The wholesale acquisition cost of Zolgensma of USD 2.125 million is:
y de acuerdos con pagadores:
AveXis has partnered with Accredo® to offer a pay-over-time option of up to 5 years to help ease possible short-term budget constraints, especially for states, small payers and self-insured employers. In addition, CuraScript SD® has been selected as the sole specialty distributor given its rare disease experience, including gene and cell therapies.
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