Onasemnogene Abeparvovec (Zolgensma and Itvisma) (CPB 0953, reviewed 2026-08-10)
Aetna's clinical policy bulletin covers onasemnogene abeparvovec (Zolgensma and Itvisma) for commercial medical plans and requires precertification of all Aetna participating providers and members in applicable plan designs. Aetna considers Zolgensma medically necessary as a single-dose intravenous infusion for spinal muscular atrophy (SMA) when the member is less than 2 years of age, has a genetically confirmed diagnosis with bi-allelic SMN1 variants and 3 or fewer copies of SMN2, and meets the other listed criteria, and considers Itvisma medically necessary as a single intrathecal dose for SMA when the member is 2 to less than 18 years of age, had onset of signs and symptoms at 6 months of age or older, and meets the other listed criteria. Aetna considers both products experimental, investigational, or unproven for all other indications, and considers repeat administration of onasemnogene abeparvovec experimental, investigational, or unproven.