Prior Authorization Required for Itvisma

Attention: All Providers 

Effective date: September 1, 2026

Call to action: Texas Children's Health Plan (TCHP) would like to inform providers that 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 patients 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 patients 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 patient is two years of age or older.
• The patient has a confirmed diagnosis of SMA (diagnosis code G120, G121, G1225, G128, or G129).
• An SMA diagnostic test has confirmed SMN1 deletion, or the patient has documentation of a previous test that confirmed SMN1 deletion.
• The patient’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 patient 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 patient’s overall baseline health status is stable, as evidenced by the following:
  • The patient’s complete blood count, liver function, and creatinine are within normal limits.
  • The patient has no signs or symptoms of active infection.
• Female patients 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 patients should refrain from fathering a child or donating sperm for three months following therapy.
• The patient 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 patient’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 patient’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 patient’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 patient for signs of the following:

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

Next step for providers: Providers should share this information with their staff.

If you have any questions, please email Provider Relations atproviderrelations@texaschildrens.org. 

For access to all provider alerts: www.texaschildrenshealthplan.org/provideralerts.