Onasemnogene abeparvovec-xioi (Zolgensma)

Zolgensma is covered only as a single intravenous lifetime dose (1.1×10^14 vg/kg) for pediatric patients <2 years with genetically confirmed SMA due to bi‑allelic SMN1 mutations; patients ≥2 years, those without bi‑allelic SMN1 mutations, with >3 SMN2 copies, anti‑AAV9 titers >1:50, or prior Zolgensma are excluded. Coverage requires documentation of SMN1 mutation and ≤3 SMN2 copies, baseline anti‑AAV9 ≤1:50, age/gestational criteria, baseline LFTs/platelets/troponin‑I, specialist prescription/consultation, systemic corticosteroids (prednisolone 1 mg/kg/day starting 1 day prior for 30 days), discontinuation of nusinersen if previously treated, and no repeat dosing.

"Prior therapy limitation: patient must not have received Zolgensma previously (prior Zolgensma is exclusionary)."

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