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Prior Authorization Criteria for Teplizumab-mzwv (Tzield) Effective August 1, 2023

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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 August 1, 2023, prior authorization criteria will be added for teplizumab-mzwv (Tzield) procedure code J9381.

Prior Authorization

Prior authorization for teplizumab-mzwv (Tzield) therapy may be approved for the 14-day course if all the following criteria are met:

  • The client is 8 years of age or older.
  • The client does not have a clinical history of type 2 diabetes (T2D).
  • The client is given teplizumab-mzwv (Tzield) to delay the onset of stage 3 type 1 diabetes (T1D).

Note: The use of teplizumab-mzwv (Tzield) is not approved for clients with T2D or any other stages of T1D other than stage 2 T1D.

  • The client has a diagnosis of stage 2 T1D confirmed by the following:
    • Documentation of at least two positive pancreatic islet autoantibodies from the following:
      • Islet cell autoantibody (ICA)
      • Insulinoma-associated antigen-2 autoantibody (IA-2A)
      • Insulin autoantibody (IAA)
      • Zinc transporter 8 autoantibody (ZnT8a)
      • Glutamic acid decarboxylase 65 (GAD65) autoantibody
    • Documentation of dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT). Another appropriate test for dysglycemia may be used if an OGTT is not available.
  • The prescribing provider must obtain a complete blood count and liver enzyme tests prior to the start of treatment. Teplizumab-mzwv (Tzield) is not recommended for clients with certain lab abnormalities.
  • The prescribing provider must assess the client’s history of chronic infection and monitor for any signs of serious infections while on teplizumab-mzwv (Tzield). If a serious infection develops, teplizumab-mzwv (Tzield) therapy should be discontinued.

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