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Prior Authorization Criteria for Onasemnogene Abeparvovec-xioi (Zolgensma) will be Updated for Texas Medicaid Effective May 1, 2021

Last updated on 3/26/2021

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to eligible clients. Administrative procedures such as prior authorization, pre-certification, referrals, and claims/encounter data filing may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the client's specific MCO for details.

Effective for dates of service on or after May 1, 2021, prior authorization criteria for onasemnogene abeparvovec-xioi (Zolgensma) will be updated for Texas Medicaid.

Prior authorization requests for an onasemnogene abeparvovec-xioi (Zolgensma) single-dose intravenous infusion must include documentation of all the following updated criteria:

  • The client is 24 months of age or younger.
  • The medical record supports any of the following mutation or deletion of genes in chromosome 5q:
    • Homozygous gene deletion of the SMN1 gene (e.g., absence of SMN1 gene)
    • Homozygous mutation of the SMN1 gene (e.g., biallelic mutation of exon 7)
    • Compound heterozygous mutation in the SMN1 gene (e.g., deletion of SMN1 exon 7 [allele 1] and mutation of SMN1 [allele 2])
  • The confirmed diagnosis of Type I SMA (diagnosis code G120) based on gene mutation analysis with biallelic SMN1 mutation (deletion or point mutation) and 3 or less copies of SMN2.
  • Evaluation of motor skill and function must be documented using a standardized test. However, it is not a prerequisite of therapy and should not delay treatment. Standardized testing tools that may be used to evaluate motor skill/function include, but are not limited to:
    • Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorder (CHOP-INTEND) score
    • Bayley scale of infant and toddler development screening test
    • WHO Multicenter Growth Reference Study (WHO MGRS)
  • Baseline documentation of AAV9 antibody titer of 1:50 or lower, as determined by enzyme-linked immunosorbent assay (ELISA) binding immunoassay.

If nusinersen (Spinraza) (procedure code J2326) or risdiplam (Evrysdi) has been previously prescribed, the prescriber must provide documentation of one of the following before switching to onasemnogene abeparvovec-xioi (Zolgensma) therapy:

  • Evidence of clinical deterioration (e.g., decreased physical function and motor skill/function test scores) while on nusinersen (Spinraza) or risdiplam (Evrysdi) therapy
  • Prescriber’s attestation that nusinersen (Spinraza) or risdiplam (Evrysdi) therapy has been discontinued

A physician attestation must verify that the client has not received prior onasemnogene abeparvovec-xioi (Zolgensma) therapy.

For more information, call the TMHP Contact Center at 800-925-9126.