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Prior Authorization Required for Onasemnogene Abeparvovec-brve (Itvisma) Effective September 1, 2026

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Effective for dates of service on or after September 1, 2026, prior authorization will be required for onasemnogene abeparvovec-brve (Itvisma) (procedure code J3405).

Onasemnogene abeparvovec-brve (Itvisma) is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric clients who are two years of age or older with confirmed mutation in the survivor motor neuron 1 (SMN1) gene.

Onasemnogene abeparvovec-brve (Itvisma) (procedure code 1-J3405) will be limited to one treatment per lifetime.

Important: Onasemnogene abeparvovec-brve (Itvisma) is not a benefit for clients who have a tracheostomy or use invasive ventilator support.

Prior Authorization Criteria

Providers must submit prior authorization requests for onasemnogene abeparvovec-brve (Itvisma) on the Special Medical Prior Authorization (SMPA) Request Form.

A prior authorization request for onasemnogene abeparvovec-brve (Itvisma) single-dose intrathecal injection must include documentation of all the following:

  • The client is two years of age or older.
  • The client has a confirmed diagnosis of SMA (diagnosis code G120, G121, G1225, G128, or G129).
  • An SMA diagnostic test has confirmed SMN1 deletion, or the client has documentation of a previous test that confirmed SMN1 deletion.
  • The client’s medical record supports one of the following mutations or deletions of genes in chromosome 5q:
    • Homozygous gene deletion of the SMN1 gene (i.e., absence of the 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 client has a baseline documentation of AAV serotype 9 (AAV9) antibody titer of 1:50 or lower as determined by enzyme-linked immunosorbent assay (ELISA) binding immunoassay.
  • The client’s overall baseline health status is stable, as evidenced by the following:
    • The client’s complete blood count, liver function, and creatinine are within normal limits.
    • The client has no signs or symptoms of active infection.
  • Female clients of childbearing age were counseled about the use of an effective method of contraception to prevent pregnancy during treatment and to refrain from egg donation for up to six months after the administration of onasemnogene abeparvovec-brve (Itvisma) therapy.
  • Important: Male clients should refrain from fathering a child or donating sperm for three months following therapy.
  • The client has not previously received onasemnogene abeparvovec-brve (Itvisma), onasemnogene abeparvovec-xioi (Zolgensma), or any other gene therapy for SMA.

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

  • The client’s clinical deterioration (e.g., decreased physical function and motor skill/function test scores) while receiving nusinersen (Spinraza) or risdiplam (Evrysdi) therapy
  • Discontinuation of nusinersen (Spinraza) or risdiplam (Evrysdi) therapy

Requirements for Safe Drug Administration

Onasemnogene abeparvovec-brve (Itvisma) administration may cause acute serious liver injury or failure. To administer the drug, providers must:

  • Examine the client’s liver function using clinical examination and laboratory testing such as hepatic aminotransferases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]), total bilirubin, and prothrombin time before onasemnogene abeparvovec-brve (Itvisma) infusion.
  • Administer a systemic corticosteroid before and after the infusion.
  • Continue to monitor the client’s liver function for at least three months after the infusion.

Required Monitoring Parameters

After administering an onasemnogene abeparvovec-brve (Itvisma) intrathecal injection, the prescriber must monitor the client for signs of the following:

  • Hepatotoxicity
  • Thrombocytopenia
  • Peripheral sensory neuropathy
  • Thrombotic microangiopathy
  • Elevated cardiac troponin I levels

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

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to Medicaid members who are enrolled in their MCO. Administrative procedures, such as prior authorization, precertification, referrals, and claims and encounter data filing, may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the member’s specific MCO for details.