Starting September 01, 2026, prior authorization will be required for onasemnogene abeparvovec-brve (Itvisma), billed under procedure code J3405, for Texas Medicaid clients.

Onasemnogene abeparvovec-brve (Itvisma) is an adeno-associated virus (AAV) vector-based gene therapy used to treat spinal muscular atrophy (SMA) in adult and pediatric clients who are two years of age or older and have a confirmed mutation in the survivor motor neuron 1 (SMN1) gene. This treatment is limited to one administration per lifetime. It is not a covered benefit for clients who have a tracheostomy or use invasive ventilator support.

Prior Authorization Criteria

Providers must submit prior authorization requests using the Special Medical Prior Authorization (SMPA) Request Form. The request must include documentation confirming all of the following:

The client is two years of age or older. The client has a confirmed SMA diagnosis under diagnosis code G120, G121, G1225, G128, or G129. An SMA diagnostic test has confirmed SMN1 deletion, or prior documentation of a confirmed SMN1 deletion exists. The client's medical record supports one of the following: homozygous gene deletion of the SMN1 gene, homozygous mutation of the SMN1 gene such as biallelic mutation of exon 7, or compound heterozygous mutation in the SMN1 gene such as deletion of SMN1 exon 7 on one allele and a mutation on the other.

The client must have a baseline AAV serotype 9 (AAV9) antibody titer of 1:50 or lower as confirmed by enzyme-linked immunosorbent assay (ELISA) binding immunoassay. The client's overall health must be stable, meaning complete blood count, liver function, and creatinine are within normal limits, and the client shows no signs or symptoms of active infection.

Female clients of childbearing age must have been counseled about using effective contraception during treatment and to avoid egg donation for up to six months after receiving the therapy. Male clients should avoid fathering a child or donating sperm for three months following therapy.

The client must not have previously received onasemnogene abeparvovec-brve (Itvisma), onasemnogene abeparvovec-xioi (Zolgensma), or any other gene therapy for SMA. If nusinersen (Spinraza) or risdiplam (Evrysdi) was previously prescribed, the provider must document either clinical deterioration while on that therapy or that the therapy was discontinued before switching to Itvisma.

Requirements for Safe Drug Administration

Because this therapy can cause acute serious liver injury or failure, providers must check liver function through clinical examination and laboratory testing including aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and prothrombin time before the infusion. A systemic corticosteroid must be administered before and after the infusion, and liver function must continue to be monitored for at least three months following treatment.

Required Monitoring Parameters

After administering the intrathecal injection, providers must monitor the client for signs of hepatotoxicity, thrombocytopenia, peripheral sensory neuropathy, thrombotic microangiopathy, and 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 enrolled members. Administrative procedures including prior authorization, precertification, referrals, and claims filing may differ from traditional Medicaid fee-for-service and from one MCO to another. Providers should contact the member's specific MCO for details.