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Updated Prior Authorization Criteria for Teplizumab-mzwv (Tzield)

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Effective for dates of service on or after October 1, 2026, Texas Medicaid will update the prior authorization criteria for teplizumab-mzwv (Tzield).

The U.S. Food & Drug Administration (FDA) has approved teplizumab-mzwv (Tzield) as a treatment to delay the decline in endogenous insulin production in pediatric clients who are 8 to 17 years of age who have recently been diagnosed with stage 3 type 1 diabetes (T1D).

Updated Prior Authorization Requirements

Teplizumab-mzwv (Tzield) is a cluster of differentiation 3 (CD3)-directed antibody. Teplizumab-mzwv (Tzield) therapy may be approved for treatment duration of up to 14 days when the therapy meets the following criteria:

  • It is being used to delay the onset of stage 3 T1D in adult and pediatric clients who are 1 year of age or older with stage 2 T1D.
  • It is being used to delay the decline in endogenous insulin production in pediatric clients who are 8 years to 17 years of age and have recently been diagnosed with stage 3 type 1 diabetes (T1D). These clients must meet the following criteria:
    • The client has a diagnosis of stage 3 T1D confirmed by the documentation of at least one positive pancreatic islet cell antibody:
      • Islet cell autoantibody (ICA)
      • Insulinoma-associated antigen 2 autoantibody (IA-2A)
      • Insulin autoantibody (IAA)
      • Zinc transporter 8 autoantibody (ZnT8A)
      • Glutamic acid decarboxylase 65 (GAD) autoantibodies
    • The client has residual beta cell function, as indicated by peak stimulated C-peptide > 0.2 pmol/mL on a mixed-meal tolerance test (MMTT) or by an alternative method if appropriate and MMTT is not available.

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 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.