Coverage is subject to the specific terms of the member’s benefit plan.
The use of Onasemnogene abeparvovec (Zolgensma) may be considered medically necessary when ALL of the following criteria are met:
- The individual is less than 2 years of age; and
- The diagnosis is spinal muscular atrophy (SMA) with genetic testing confirming bi-allelic deletions or mutations in the SMN1 gene; and
- Medication is prescribed per the dosing guidelines in the package insert (recommended dose is 1.1 x 1014 vector genomes per kilogram); and
- Baseline Documentation has been submitted confirming anti-adeno-associated virus serotype 9 (anti-AAV9) antibody titer is ≤ 1:50 measured by Enzyme-linked Immunosorbent Assay (ELISA) binding immunoassay; and
- The individual must not have advanced SMA evidenced by one of the following:
- Complete paralysis of limbs; or
- Permanent ventilator dependence (defined as requiring invasive ventilation (tracheostomy) or respiratory assistance for 16 of more hours per day (including noninvasive ventilatory support) continuously for 14 or more days in the absence of an acute reversible illness, excluding perioperative ventilation.
Authorization: 1 month (Approval is limited to a single intravenous infusion per lifetime)
The use of onasemnogene abeparvovec (Zolgensma) for any other indication is considered experimental/investigational and therefore non-covered due to the lack of scientific evidence to support efficacy and safety.