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Additional Criteria for Prior Authorization of Onasemnogene Abeparvovec-xioi (Zolgensma)

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Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to eligible clients. Administrative procedures such as prior authorization, precertification, 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 November 1, 2022, additional criteria will be added for prior authorization of an onasemnogene abeparvovec-xioi (Zolgensma) single-dose intravenous infusion.

Because the administration of onasemnogene abeparvovec-xioi (Zolgensma) may cause serious liver injury or failure, providers must also complete the following to administer the drug:

  • Examine the client’s liver function by clinical examination and laboratory testing (e.g., hepatic aminotransferases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], total bilirubin, and prothrombin time) before infusion of onasemnogene abeparvovec-xioi (Zolgensma).
  • Administer a systemic corticosteroid before and after the administration of the drug.
  • Continue to monitor the client’s liver function at least 3 months after the infusion of the drug.

Refer to the current Texas Medicaid Provider Procedures Manual, Outpatient Drug Services Handbook subsection 6.71.2, “Documentation Requirements,” for additional prior authorization requirements.

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