Tzield® (teplizumab-mzwv)

Covered: one 14‑day IV course of Tzield (teplizumab‑mzwv) to delay progression from Stage 2 to Stage 3 type 1 diabetes in patients ≥8 years old; excluded for patients with clinical (Stage 3) type 1 diabetes, type 2 diabetes, prior Tzield treatment, active/acute or chronic serious infections (including EBV/CMV), or those lacking required family‑history/lab criteria. Key requirements: age ≥8, ≥2 specified islet autoantibodies positive on two occasions, qualifying glycemia within 2 months (OGTT 2‑hr 140–199 mg/dL or fasting 100–125 mg/dL or HbA1c 5.7–6.4%), 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), prescription by an endocrinologist, and administration as specified BSA‑based daily IV dosing for 14 consecutive days with documentation of all criteria.

"Not covered for individuals who have received Tzield in the past (no retreatment allowed)."