Qalsody (tofersen)

Qalsody (tofersen) is FDA‑approved under accelerated approval for treating adults with ALS due to SOD1 mutations but EviCore does not recommend approval because of insufficient clinical efficacy data, effectively limiting coverage. Key requirements: indication restricted to adults with a confirmed SOD1 mutation and continued approval is contingent on confirmatory trials, while the policy provides no specific safety criteria, prior‑therapy rules, documentation, or frequency limits.

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

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