Qalsody™ (tofersen intrathecal injection) Medicare Advantage

Qalsody intrathecal injection is covered for adults (≥18) with ALS who have a documented SOD1 gene mutation; patients without an SOD1 mutation and pediatric patients are excluded. Coverage is granted for 12 months under accelerated approval (continued approval may depend on confirmatory trials) and requires documentation of age, ALS diagnosis, the SOD1 mutation, and use of the recommended dosing (three loading doses 14 days apart then maintenance every 28 days).

"Qalsody is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene."

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