Spinal Muscular Atrophy - Zolgensma®

eviCore covers a one-time (lifetime) single IV dose of Zolgensma for patients <2 years with genetically confirmed bi-allelic SMN1 SMA and excludes repeat dosing, in utero use, prior gene‑therapy recipients, patients with complete limb paralysis or permanent ventilator dependence, and anyone not meeting the criteria. Approval requires documentation of SMN2 copy number (≤3 or 4 confirmed by a quantitative assay), baseline anti‑AAV9 titer ≤1:50, recent labs within specified limits (ALT/AST/total bilirubin/PT ≤2×ULN, creatinine <1.0 mg/dL, WBC ≤20,000, Hgb 8–18 g/dL), weight within 14 days, a steroid plan (prednisolone 1 mg/kg/day starting 1 day prior for 30 days), discontinuation of nusinersen/risdiplam if applicable, prescriber SMA/neuromuscular expertise, and Medical Director verification.

"Patients currently receiving or who have received Spinraza (nusinersen) must discontinue further therapy with Spinraza to be approved for Zolgensma."