CurrentUnitedHealthcarePolicy 2025D0117G

Tzield (Teplizumab-Mzwv) Medical Benefit Drug Policy

Policy Summary

PayerUnitedHealthcare

PolicyTzield (Teplizumab-Mzwv) Medical Benefit Drug Policy

Policy CodePolicy 2025D0117G

Change TypeTemplate update; administrative/reference revisions

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization limited to one 14-dose treatment course and document age ≥8, presence of ≥2 pancreatic islet autoantibodies, dysglycemia per defined thresholds, absence of Stage 3 symptoms, rule-out of type 2 diabetes, and that the patient is treatment-naive.

POLICY UPDATE CHANGES

Updated Benefit Considerations section (07/01/2025 Template Update).

Removed reference link to 'Provider Administered Drugs - Site of Care' policy (05/01/2025).

1Authorized treatment courses per lifetime

14Maximum doses per course

>=8 yearsMinimum covered age

Covered w/ criteriaCoverage stance

Coverage Summary

Defines UnitedHealthcare's medical benefit coverage criteria, dosing limits, provider requirements, and applicable billing codes for Tzield (teplizumab-mzwv) to delay onset of Stage 3 Type 1 diabetes in patients meeting Stage 2 criteria. Tzield (teplizumab-mzwv) is covered with criteria for patients meeting the Stage 2 diagnostic requirements (age ≥ 8 years, ≥ two pancreatic islet autoantibodies, dysglycemia per specified thresholds, absence of Stage 3 symptoms, and rule-out of type 2 diabetes). Authorization follows FDA labeling and is limited to a single one-time 14-dose course per lifetime. Effective date: 05/01/2025; Last review: 07/01/2025.

Quick facts / Thresholds

Authorized treatment courses per lifetime1

Maximum doses per authorized course14

Minimum covered age / Age threshold>= 8 years

Fasting plasma glucose threshold>= 100 mg/dL and < 126 mg/dL

2-hour post-prandial plasma glucose threshold>= 140 mg/dL and < 200 mg/dL

A1C threshold>= 5.7% and < 6.5% or >= 10% increase in A1C

Initial Therapy Criteria (Medically necessary)

Medically necessary (Initial therapy)

Tzield is medically necessary when ALL of the following criteria are met:

ALL of the following

Patient is 8 years of age or older>= 8 years
Diagnosis of stage 2 type 1 diabetes confirmed by ALL of the following
- At least two of
  - Glutamic acid decarboxylase 65 (GAD) autoantibodies
  - Insulin autoantibody (IAA)

Continuation Therapy Criteria

Authorization is limited to a single one-time 14-dose course (no more than 14 doses) per lifetime as specified in the policy; therefore there are no separate continuation or maintenance authorization criteria to render.

Exclusions / Limitations

Exclusions / Denial conditions

Denial / Exclusion conditions

Patient does not meet Stage 2 Type 1 diabetes criteria, including absence of at least two pancreatic islet autoantibodies or lack of dysglycemia per defined thresholds
Patient has symptoms of Stage 3 Type 1 diabetes (overt hyperglycemia) or diagnosis consistent with Stage 3
Diagnosis of type 2 diabetes has not been ruled out
Patient has been previously treated with Tzield
Request exceeds dosing or lifetime limits (more than one 14-dose course or more than 14 doses)

Applicable Codes

Drug HCPCSHCPCS

J9381

Injection, teplizumab-mzwv, 5 mcg

Diagnosis codes referencedICD-10

E10.9

Type 1 diabetes mellitus without complications

Provider Actions / Prior Authorization & Documentation

Prior Authorization

Prior authorization required and dosage/lifetime limit

Authorization is required for a one-time 14-dose treatment course per lifetime, and dosing must follow the FDA-approved labeling.

HCPCS: J9381
Limit: Authorization for no more than one treatment course (14 doses) per lifetime; no more than 14 doses

Documentation Required

Documentation of diagnostic criteria

Document that the patient is ≥ 8 years old; presence of at least two pancreatic islet autoantibodies (Glutamic acid decarboxylase 65 [GAD], Insulin autoantibody [IAA], Insulinoma-associated antigen 2 [IA-2A], Zinc transporter 8 [ZnT8A], Islet cell autoantibody [ICA]); dysglycemia per defined thresholds (fasting plasma glucose ≥ 100 mg/dL and < 126 mg/dL, 2-hour post-prandial ≥ 140 mg/dL and < 200 mg/dL, or A1C ≥ 5.7% and < 6.5% or ≥ 10% increase); absence of stage 3 symptoms; type 2 diabetes ruled out; and patient is treatment-naive to Tzield.

Clinical Evidence

Median time to Stage 3: 50 vs 25 monthsPrimary trial result

HR 0.41 (95% CI 0.22-0.78), p=0.0066Hazard ratio

Common adverse reactions: lymphopenia, rash, leukopenia, headacheSafety (common >10%)

Teplizumab-mzwv is a CD3-directed monoclonal antibody that binds CD3 on T lymphocytes and may deactivate T lymphocytes that attack pancreatic beta cells while increasing regulatory T lymphocytes. It is indicated to delay the onset of Stage 3 type 1 diabetes by modulating T lymphocytes. Efficacy was demonstrated in a randomized, double-blind, placebo-controlled trial in patients with Stage 2 T1D showing a statistically significant delay in progression to Stage 3 (median time to Stage 3: 50 months with teplizumab vs 25 months with placebo; HR 0.41, 95% CI 0.22–0.78; p=0.0066).

Background & Definitions

Teplizumab-mzwv is a CD3-directed monoclonal antibody that binds CD3 on the surface of T lymphocytes; it may deactivate T lymphocytes that attack pancreatic insulin-producing beta cells and increase regulatory T lymphocytes. It is indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients ≥ 8 years of age with Stage 2 disease. Stage 2 Type 1 Diabetes is defined as autoimmunity with dysglycemia (presymptomatic), requiring multiple islet autoantibodies (at least two) and dysglycemia per specified thresholds. Dysglycemia without overt hyperglycemia is defined by one of: fasting plasma glucose ≥ 100 mg/dL and < 126 mg/dL, 2-hour post-prandial plasma glucose ≥ 140 mg/dL and < 200 mg/dL, or A1C ≥ 5.7% and < 6.5% or ≥ 10% increase in A1C.

Revision History

2025-05-01policy_effective

Policy effective date; related policy reference removed, clinical evidence and references updated, and previous version archived. Page footer indicates effective 05/01/2025.

2025-07-01template_updateLatest

Template update noting an update to the Benefit Considerations section (07/01/2025).

Policy Summary

PayerUnitedHealthcare

PolicyTzield (Teplizumab-Mzwv) Medical Benefit Drug Policy

Policy CodePolicy 2025D0117G

Change TypeTemplate update; administrative/reference revisions

Effective DateMay 1, 2025

Next Review Date

On This Page

Insulinoma-associated antigen 2 autoantibody (IA-2A)

Zinc transporter 8 autoantibody (ZnT8A)

Islet cell autoantibody (ICA)

One of

Fasting plasma glucose >= 100 mg/dL and < 126 mg/dL>= 100 mg/dL and < 126 mg/dL
2-hour post-prandial plasma glucose level >= 140 mg/dL and < 200 mg/dL>= 140 mg/dL and < 200 mg/dL
A1C >= 5.7% and < 6.5% OR >= 10% increase in A1CA1C >= 5.7% and < 6.5% OR >= 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

ALL of the following

Dosing is in accordance with the United States Food and Drug Administration approved labeling
One-time 14-day course by IV per FDA label
Patient has not been previously treated with Tzield
Authorization will be issued for no more than one treatment course (i.e., 14 doses) per lifetimeMaximum 14 doses per lifetime
Authorization limited to 14 doses
Prescribed by or in consultation with an endocrinologist

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Maximum 1 course (14 doses) per lifetime

Autoantibodies: GAD, IAA, IA-2A, ZnT8A, ICA
Dysglycemia thresholds: fasting ≥ 100 and < 126 mg/dL; 2-hour post-prandial ≥ 140 and < 200 mg/dL; A1C ≥ 5.7% and < 6.5% or ≥ 10% increase

Denial Risk

Denial risk if criteria not met

Claims may be denied if the patient does not meet all Stage 2 T1D criteria (including required autoantibodies and dysglycemia thresholds), if the patient has been previously treated with Tzield, or if dosing beyond a single 14-dose course is requested.

Documentation Required

Specialist involvement

Therapy must be prescribed by or in consultation with an endocrinologist.