Zynteglo® now a Medicaid and CHIP Benefit - Prior Authorization Effective September 1, 2023

Date: July 18, 2023

Attention: All Providers

Effective Date: September 1, 2023

Call to action: Texas Children’s Health Plan (TCHP) would like to let providers know that effective September 1, 2023, the Texas Health and Human Services (HHSC) will be implementing required prior authorization criteria for Zynteglo® (procedure code J3590) for Medicaid and CHIP. Zynteglo® became a benefit of Medicaid and CHIP on July 1, 2023. Zynteglo® (betibeglogene autotemcel) is an autologous stem cell-based gene-therapy indicated for treating adult and pediatric patients with β-thalassemia who require regular blood cell (RBC) transfusion.

Authorization Requirements:

Prior authorization is required for Zynteglo® (betibeglogene autotemcel). The request for this single-dose therapy must include all the following documentation to support that the patient meets all approval criteria:

1. Patient is age 4 years and older.
2. Patient has a documented diagnosis of β-thalassemia (ICD 10 – D56.1) and other forms of thalassemia have been ruled out.
3. Patient is RBC transfusions dependent and has documented history of receiving red blood cell transfusion of at least 100ml per kilogram per year (pRBC/kg/yr) or at least 8 or more transfusion of regular red blood cell per year or 2 years.
4. Patient has not had prior hematopoietic stem cell transplant (HSCT) and is unable to find a matched related donor.
5. Patient is stable and is eligible for HSCT.
   
   • No advanced liver disease
   • No human immunodeficiency virus (HIV) positive diagnosis
   • No hepatitis B virus (HBV) or hepatitis C virus (HCV)
   • No prior or current malignancies
   • No bleeding disorders
   • Normal iron levels in the heart
   • Normal levels of white blood cells
   • Normal platelet counts
     
6. Prescriber must monitor the patient’s platelet count for thrombocytopenia and bleeding during the treatment period with Zynteglo®.  
7. Prescriber must monitor patient for at least 15 years post Zynteglo® infusion for possible hematologic malignancies.
8. Prescriber attestation to avoid the use of anti-retroviral medications or hydroxyurea for one month prior to mobilization and until all cycles of apheresis are completed.
9. Prescriber attestation to discontinue iron chelators at least 7 days prior to initiation of myeloablative conditioning and the use of myelosuppressive iron chelators should be avoided for 6 months after Zynteglo® infusion.
10. Zynteglo® (betibeglogene autotemcel), J3590 is limited to one transfusion treatment per lifetime. Zynteglo® may be infused as a single infusion in one or more infusion bag.

Refer to the Outpatient Drug Services Handbook Chapter of the Texas Medicaid Provider Procedure Manual for more details on the clinical policy and prior authorization requirements.

Why is this important?

TCHP recognizes we may serve potentially impacted patients in our membership. We want to ensure that the member meets clinical evidence for treatment.

Next steps for providers: Prescribers should share this communication with their staff. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting member has met all approval criteria in support for Zynteglo® approval.

Note: If request is for a non-FDA approved dose or indication, medical rational must be submitted in support of therapy (such as high-quality peer reviewed literature, acceptable compendia or evidence based practice guidelines) and exceptions will be considered on a case-by-case basis.

If you have any questions, please email TCHP Pharmacy at: tchppharmacy@texaschildrens.org.

For access to all provider alerts,log into:
www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.