Zolgensma® (Onasemnogene Abeparvovec-Xioi) – Commercial Medical Benefit Drug Policyopen_in_new

UnitedHealthcare covers one lifetime IV dose of Zolgensma for SMA patients <2 years — including symptomatic patients and pre‑symptomatic newborns with ≤4 SMN2 copies — and excludes patients >2 years, SMA without 5q SMN1 mutations/deletions, routine concomitant SMN‑modifying therapy, repeat dosing, invasive or prolonged non‑invasive ventilator dependence, and anti‑AAV9 titers >1:50. Authorization requires documented SMN1 genetic confirmation (or newborn screen with SMN2 ≤4), prescription and documentation by an SMA‑expert neurologist, age <2 years (premature infants must reach full‑term), documentation of respiratory status, anti‑AAV9 ≤1:50, planned peri‑infusion corticosteroids and IV administration per FDA labeling, and is limited to one dose approved for no more than 45 days (or until the patient turns 2).

"One treatment per lifetime for the treatment of spinal muscular atrophy (SMA) in patients who meet ALL of the following criteria:"