CurrentUnitedHealthcarePolicy IEX00117.07

Tzield (teplizumab-mzwv) one-time 14-day course to delay Stage 3 type 1 diabetes

Defines UnitedHealthcare medical benefit drug coverage criteria for Tzield (teplizumab-mzwv) to delay onset of Stage 3 type 1 diabetes in pediatric and adult patients, including eligibility, prescribing/diagnostic requirements, dosing conformity to FDA labeling, lifetime limit, and related billing/applicability notes.

Policy Summary

PayerUnitedHealthcare

PolicyTzield (teplizumab-mzwv) one-time 14-day course to delay Stage 3 type 1 diabetes

Policy CodePolicy IEX00117.07

Change TypeSupporting Information (Clinical Evidence and References updated)

Effective DateMay 1, 2025

Next Review Date

Key ActionEnsure prior authorization is obtained and document age, required autoantibodies (≥2), dysglycemia values, absence of Stage 3 symptoms, ruling out type 2 diabetes, prescriber specialty, and that the patient is treatment-naïve; authorization limited to one 14-day course per lifetime.

POLICY UPDATE CHANGES

Updated Clinical Evidence and References sections to reflect the most current information.

1Lifetime treatment courses allowed

>=8Minimum age for coverage

>=2Required islet autoantibodies

14Days per treatment course

Coverage stance: covered_with_criteria — Tzield (teplizumab-mzwv) is covered when used to delay onset of Stage 3 type 1 diabetes in patients meeting the policy's eligibility criteria. Scope: Defines UnitedHealthcare medical benefit drug coverage criteria for Tzield to delay onset of Stage 3 type 1 diabetes in pediatric and adult patients, including eligibility (minimum age and diagnostic requirements), prescribing/diagnostic requirements, dosing conformity to FDA labeling, a single-lifetime course limit, and related billing and applicability notes.

Key thresholds and statistics

Minimum age for coverage>= 8 years

Required islet autoantibodies>= 2 (GAD, IAA, IA-2A, ZnT8A, ICA)

Dysglycemia thresholds (any one)Fasting plasma glucose >= 100 mg/dL and < 126 mg/dL; OR 2-hour postprandial >= 140 mg/dL and < 200 mg/dL; OR A1C >= 5.7% and < 6.5% or >= 10% increase

Days per treatment course14 (one-time IV infusion course)

Lifetime treatment courses allowed1 course (authorization for no more than one 14-dose course per lifetime)

OpenPayer

Tzield (teplizumab-mzwv) one-time 14-day course to delay Stage 3 type 1 diabetes

Coverage Summary