Zolgensma (onasemnogene abeparvovec) — Coverage Criteria (Spinal Muscular Atrophy)
Defines prior authorization, clinical, dosing, safety, and documentation requirements for coverage of Zolgensma for treatment of spinal muscular atrophy in patients under 2 years of age.
The condition 'Prior Receipt of Gene Therapy' was added to Conditions Not Recommended for Approval.
Removed the requirement that the prescribing physician attest the patient will receive systemic corticosteroids (prednisolone 1 mg/kg/day starting 1 day before infusion for 30 days).
Approvals are one-time (per lifetime) as a single dose and verification of appropriate weight-based dosing is required by a Medical Director; documentation and timing language adjusted (e.g., 'past' instead of 'last').
Added note that full-term gestational age of 39 weeks can be defined as postmenstrual age (gestational age plus chronological age) >= 39 weeks 0 days.
Updated Documentation requirements to include 'medical test results' and 'prescription receipts'; changed 'laboratory tests' to 'results'.
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