Tzield® (teplizumab-mzwv)

Covered: one 14-day IV course of Tzield (BSA‑based daily dosing) to delay onset of Stage 3 type 1 diabetes in patients ≥8 years with Stage 2 T1D who have ≥1 biological relative with T1D, are positive for at least two specified T1D autoantibodies on two separate occasions, meet glycemic criteria within 2 months (2‑hr OGTT 140–199 mg/dL, fasting glucose 100–125 mg/dL, or HbA1c 5.7–6.4%), have normal baseline hematologic (lymphocytes ≥1,000/µL, Hgb ≥10 g/dL, platelets ≥150,000/µL, ANC ≥1,500/µL) and hepatic labs (ALT/AST ≤2×ULN, bilirubin ≤1.5×ULN), have no acute/active/chronic infection including EBV/CMV, have not previously received Tzield, and the prescription is from an endocrinologist. Excluded: patients <8 years, those with clinical (Stage 3) T1D or type 2 diabetes, lacking required family history or two qualifying autoantibody results, failing the glycemic or baseline lab criteria, with excluded infections or prior Tzield, or prescriptions from non‑endocrinologists.