Pdf Spinal Muscular Atrophy Gene Therapy Zolgensma Um Medical De Identified_Pdf
Defines prior-authorization, clinical eligibility, dosing, documentation, and exclusions for medical-benefit coverage of intravenous Zolgensma for patients with spinal muscular atrophy (SMA) with bi-allelic SMN1 mutations who are <2 years of age; approvals are one-time (per lifetime) single-dose with specific laboratory, genetic, and provider requirements.
Itvisma was added as a gene therapy that the patient should not have received previously; note allows physician confirmation if no claims history.
Approval duration changed from 30 days to 90 days.
Hemoglobin requirement changed from explicit range (8–18 g/dL) to hemoglobin within normal reference range.
Requirement for systemic corticosteroids (prednisolone 1 mg/kg/day starting 1 day prior and for 30 days) was removed.
Clarified that all approvals are provided for one-time (per lifetime) as a single dose and that dosing verification is required by Medical Director; verification in claims history required where available.
Note defining full-term gestational age as postmenstrual age (gestational + chronological) ≥ 39 weeks 0 days was added.
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