Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of teplizumab-mzwv (Tzield) may be considered medically necessary when
ALL
of the following criteria are met:
-
The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
-
The requested medication must be prescribed by, or in consult with, an endocrinologist;
and
-
The individual has a family history of Type 1 Diabetes;
and
-
The individual has at least two (2) of the following pancreatic islet cell 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
-
The individual has no symptoms of Type 1 Diabetes (e.g., polyuria, polydipsia, weight loss, fatigue, DKA);
and
- The individual has abnormal blood sugar levels determined by an oral glucose tolerance test
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.
Procedure Code
