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Betibeglogene Autotemcel (Zynteglo) a Benefit of Texas Medicaid Effective July 1, 2023

Last updated on 7/21/2023

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.

Effective for dates of service on or after July 1, 2023, betibeglogene autotemcel (Zynteglo) is a benefit of Texas Medicaid when submitted with procedure code J3590 for clients who are four years of age or older.

Betibeglogene autotemcel (Zynteglo) is an autologous hematopoietic stem cell-based gene therapy indicated for treating adult and pediatric clients with β-thalassemia who require regular red blood cell (RBC) transfusions.

Betibeglogene autotemcel (Zynteglo) is limited to one transfusion treatment per lifetime and may be infused as a single infusion in one or more infusion bags.

Prior Authorization Criteria

Beginning September 1, 2023, prior authorization will be required for betibeglogene autotemcel (Zynteglo) therapy. It is a one-time infusion therapy for clients who meet the following requirements:

  • The client is four years of age or older.
  • The client has a documented diagnosis of β-thalassemia (diagnosis code D561) and other forms of thalassemia have been ruled out.
  • The client is RBC transfusion dependent and has a documented history of receiving RBC transfusions of at least 100 ml per kilogram per year (pRBC/kg/yr) or at least eight or more transfusions of regular RBCs per year for two years.
  • The client has not had a prior hematopoietic stem cell transplant (HSCT) and is unable to find a matched related donor.
  • The client is stable and eligible for HSCT, according to the following criteria:
    • No advanced liver disease
    • No human immunodeficiency virus positive diagnosis
    • No hepatitis B virus and hepatitis C virus
    • No prior or current malignancies
    • No bleeding disorders
    • Normal iron levels in the heart
    • Normal levels of white blood cells
    • Normal platelet counts

Prescriber attestations will be required for the following:

  • To avoid the use of anti-retroviral medications or hydroxyurea for one month prior to mobilization and until all cycles of apheresis are completed
  • To discontinue iron chelators at least seven days prior to initiation of myeloablative conditioning and the use of myelosuppressive iron chelators should be avoided for six months after betibeglogene autotemcel (Zynteglo) infusion

Additional Requirements

Prescribers of betibeglogene autotemcel (Zynteglo) infusion therapy must monitor the following:

  • The client’s platelet count for thrombocytopenia and bleeding during the treatment period with betibeglogene autotemcel (Zynteglo)
  • The client for at least 15 years post betibeglogene autotemcel (Zynteglo) infusion for possible hematologic malignancies

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