CurrentUnitedHealthcarePolicy CSPA2026D00117E

Tzield (teplizumab-mzwv) — Coverage for delaying Stage 3 Type 1 Diabetes in Pennsylvania

Policy governs medical benefit coverage of Tzield (teplizumab-mzwv) as a one-time 14-day IV course to delay onset of Stage 3 type 1 diabetes in eligible Pennsylvania members, and applies to providers prescribing or consulting on therapy.

Policy Summary

PayerUnitedHealthcare

PolicyTzield (teplizumab-mzwv) — Coverage for delaying Stage 3 Type 1 Diabetes

Policy CodePolicy CSPA2026D00117E

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for a single 14-dose course and include documentation confirming Stage 2 T1D with ≥2 islet autoantibodies and dysglycemia per specified thresholds.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

onetreatment course authorized per lifetime

14 daysduration of the treatment course

≥8minimum patient age for eligibility

≥2required number of islet autoantibodies

J9381listed drug HCPCS code

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Coverage Criteria for Tzield (teplizumab-mzwv)

Initial Therapy Criteria

Covered when ALL of the following are met:

Initial therapy criteria

Autoantibodies: Presence of at least two pancreatic islet autoantibodies (GAD65, IAA, IA-2A, ZnT8A, ICA).
Dysglycemia (one of)
- Fasting plasma glucose ≥100 mg/dL and <126 mg/dL.
- 2-hour postprandial plasma glucose ≥140 mg/dL and <200 mg/dL.
- A1C ≥5.7% and <6.5% or a ≥10% increase in A1C.
Patient does not have symptoms associated with Stage 3 type 1 diabetes (e.g., increased urination, excessive thirst, weight loss).
Diagnosis of type 2 diabetes has been ruled out.
Prescribed by or in consultation with an endocrinologist.
Dosing is in accordance with the United States Food and Drug Administration approved labeling (one-time 14-day course).
Patient has not been previously treated with Tzield.
Authorization will be issued for no more than one treatment course (14 doses) per lifetime.

Prior treatment with Tzield is an exclusion for additional authorization. Authorization will be issued for no more than one treatment course (14 doses) per lifetime, and members previously treated with Tzield are not eligible for another course.

Use of Tzield to treat Stage 3 (overt symptomatic) type 1 diabetes is not an indicated coverage scenario. Coverage is limited to use to delay progression from Stage 2 to Stage 3 when all coverage criteria are met (including age ≥8 years, ≥2 islet autoantibodies, dysglycemia within specified thresholds, absence of Stage 3 symptoms, and other listed requirements).

Coding and Diagnostic Information

Procedure / Drug HCPCSHCPCS

J9381

Injection, teplizumab-mzwv, 5 mcg.

Diagnosis Codes (examples)ICD-10

E10.8	Type 1 diabetes mellitus with unspecified complications.
E10.9	Type 1 diabetes mellitus without complications

Glycemic thresholds for Stage 2 dysglycemia

Fasting plasma glucose≥100 mg/dL and <126 mg/dL

2-hour postprandial (OGTT) plasma glucose≥140 mg/dL and <200 mg/dL

Hemoglobin A1C (A1C)≥5.7% and <6.5% OR ≥10% increase in A1C

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization required. Authorization is required and will be issued for no more than one 14-dose treatment course (single 14-day course) per lifetime when all clinical criteria are met.

Effect: Prior authorization must be obtained before dispensing/administering Tzield (teplizumab-mzwv, J9381).
Limit: Authorization covers a single 14-dose treatment course per lifetime.

Step Therapy

Step therapy / Treatment limit

No step therapy is required. Treatment is limited to a single 14-day (14-dose) course per lifetime.

Step therapy: None required.
Treatment limit: One 14-dose course per lifetime.

Background

Type 1 diabetes is an autoimmune process that progressively destroys pancreatic beta cells and evolves through presymptomatic stages before symptomatic disease. Stage 1 is characterized by the presence of pancreatic islet autoantibodies; Stage 2 includes the presence of multiple islet autoantibodies plus dysglycemia (see glycemic thresholds) without overt hyperglycemia; and Stage 3 represents overt symptomatic hyperglycemia (for example, polyuria, polydipsia, and weight loss).

Definitions

Stage 2 Type 1 Diabetes (definition)

Core definitionStage 2 type 1 diabetes: presence of multiple islet autoantibodies and dysglycemia without overt hyperglycemia

Islet autoantibodies requiredPresence of at least two autoantibodies (GAD65, IAA, IA-2A, ZnT8A, ICA)

Dysglycemia criteria examplesFasting plasma glucose 100–125 mg/dL; 2‑hour postprandial 140–199 mg/dL; or A1C 5.7–6.4% or ≥10% increase in A1C

Tzield (teplizumab-mzwv)

Drug class and mechanismCD3-directed monoclonal antibody that binds CD3 on T lymphocytes and modulates immune response

Brand and generic nameTzield (teplizumab-mzwv)

Documentation Required

Required Documentation to Support Authorization

Documentation must be provided to support the prior authorization request. Required documentation includes patient age, confirmation of Stage 2 type 1 diabetes with ≥2 islet autoantibodies, evidence of dysglycemia in the specified ranges, absence of stage 3 symptoms, rule-out of type 2 diabetes, prescriber specialty, dosing per FDA labeling, and confirmation that the patient has not previously received Tzield.

Age: Patient ≥ 8 years.
Islet autoantibodies: Documentation of ≥2 positive pancreatic islet autoantibodies (e.g., GAD65, IAA, IA-2A, ZnT8A, ICA).
Dysglycemia: One of the following documented: fasting plasma glucose ≥100 and <126 mg/dL; 2‑hour postprandial plasma glucose ≥140 and <200 mg/dL; A1C ≥5.7% and <6.5% or ≥10% increase in A1C.
Symptoms: Documentation that patient does not have symptoms of stage 3 T1D (eg, polyuria, polydipsia, weight loss).
Diabetes type: Documentation that type 2 diabetes has been ruled out.
Prescriber: Prescribed by or in consultation with an endocrinologist.
Dosing: Planned dosing consistent with FDA‑approved labeling (one 14‑day course).
Prior treatment: Evidence patient has not been previously treated with Tzield.

Denial Risk

Coverage Criteria Nonconformance

Requests that do not meet all coverage criteria will be denied or not authorized. Nonconformance grounds include insufficient or missing documentation, patient not meeting age requirement, lack of Stage 2 T1D confirmation with ≥2 autoantibodies, dysglycemia outside the specified ranges, presence of stage 3 symptoms, diagnosis of type 2 diabetes, dosing not consistent with FDA‑approved labeling, or prior receipt of Tzield.

Denial risks: Missing or incomplete documentation for any required element.
Clinical exclusions: Age <8 years; fewer than 2 positive islet autoantibodies; dysglycemia values outside specified ranges; presence of stage 3 symptoms; diagnosis consistent with type 2 diabetes.
Prior treatment exclusion: Prior treatment with Tzield will preclude authorization for another course.