Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Teplizumab-mzwv (Tzield) may be considered medically necessary when ALL the following criteria are met:
- Individual is eight (8) to 49 years of age; and
- Confirmation of Stage 2 type 1 diabetes (T1D) by BOTH of the following
- Presence of at least two (2) of the following diabetes autoantibodies:
- Glutamic acid decarboxylase 65 (GAD) autoantibodies; or
- Insulin autoantibody (IAA); or
- Insulinoma-associated antigen 2 autoantibody (IA-2A); or
- Zinc transporter 8 autoantibody (ZnT8A); or
- Islet cell autoantibody (ICA); and
- Dysglycemia without overt hyperglycemia based on any of the following:
- Two (2)-hour plasma glucose (PG) level of 140-199 mg/dL during OGTT; or
- A fasting plasma glucose (FPG) level of 100-125 mg/dL; or
- Hemoglobin A1C of 5.7-6.4% or greater than or equal to 10% in A1C; and
- Individual's clinical history does not suggest type 2 diabetes; and
- Prescribed by or in consultation with an endocrinologist; and
- Therapy is prescribed to delay onset of Stage 3 T1D; and
- Authorization will be limited to one (1) 14-day course per lifetime.
The use of Teplizumab-mzwv (Tzield) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Note: The safety and effectiveness of repeat administration of teplizumab-mzwv (Tzield) has not been evaluated. Therefore, coverage will be limited to a single 14-day course per lifetime.
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