Pharmacotherapy of Spinal Muscular Atrophy (Evrysdi, Spinraza, Zolgensma)
Defines medical necessity criteria, benefit assignment (pharmacy vs medical), dosing limits, investigational uses, authorization durations, reauthorization requirements, documentation and coding for Evrysdi (risdiplam), Spinraza (nusinersen), and Zolgensma (onasemnogene abeparvovec-xioi) for treatment of SMA.
2025 Update clarified that non-formulary exception review authorizations for all drugs may be approved up to 12 months and required prescriber attestation for Zolgensma outcome reporting.
2023 Update added coverage of individuals with 4 copies of SMN2 for Zolgensma.
2021 Update added Zolgensma black box warning safety information and expanded Evrysdi approval to include infants under 2 months.
Clarified that non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months (04/01/25).
Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information (04/01/25).
Updated Zolgensma coverage criteria to require prescriber attestation to provide clinical outcome information within the provider portal (08/01/25 history entry).
Added new HCPCS code C9309 effective April 1, 2026 (04/01/26).
Removed and added prior HCPCS codes at various historical dates (C9489 added 07/01/17 then terminated 01/01/18; J2326 added 01/01/18; J3590 added 07/01/19 then removed 02/01/21; J3399 added 02/01/21).
Updated Evrysdi (risdiplam) criteria removing requirement individual is 2 months of age or older (08/01/22).
Updated Spinraza (nusinersen) criteria to include that Spinraza is prescribed by a neurologist with expertise treating SMA (08/01/22).
Updated Zolgensma (onasemnogene abeparvovec-xioi) criteria to include coverage of individuals with 4 copies of the SMN2 gene (01/01/24).
Multiple annual reviews noted with no changes to policy statements (01/01/22, 10/01/23, 09/01/24).
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