CurrentUnitedHealthcarePolicy 2025D0117G

Tzield (teplizumab-mzwv) — Coverage Criteria to Delay Progression from Stage 2 to Stage 3 Type 1 Diabetes

Defines UnitedHealthcare medical benefit coverage criteria for one 14-day course of Tzield to delay progression from Stage 2 to Stage 3 type 1 diabetes in patients aged ≥8 years, including required diagnostic and prescribing conditions.

Policy Summary

PayerUnitedHealthcare

PolicyTzield (teplizumab-mzwv) — Coverage Criteria to Delay Progression from Stage 2 to Stage 3 Type 1 Diabetes

Policy CodePolicy 2025D0117G

Change TypeMaterial revision and clarification

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document age ≥8 years, at least two specified islet autoantibodies, dysglycemia lab values, prescriber/endocrinology consult, and no prior Tzield exposure.

SourceLink

POLICY UPDATE CHANGES

Authorization will be issued for no more than one treatment course (i.e., 14 doses) per lifetime.

Detailed Stage 2 diagnostic criteria specified: at least two islet autoantibodies and defined dysglycemia thresholds (fasting, 2-hour OGTT, or A1C increases).

1treatment course allowed per lifetime

14 daysduration of dosing course

≥8 yrsminimum patient age for coverage

J9381HCPCS code

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Coverage Criteria for Tzield (teplizumab-mzwv)

Initial Therapy

Tzield is covered when ALL of the following are met:

Age: Patient is 8 years of age or older>=8 years

Stage 2 Type 1 Diabetes Diagnosis

Autoantibodies: Presence of at least two of the following pancreatic islet autoantibodies: GAD65 (glutamic acid decarboxylase 65), IAA (insulin autoantibody), IA-2A (insulinoma-associated antigen 2 autoantibody), ZnT8A (zinc transporter 8 autoantibody), or ICA (islet cell autoantibody)>=2 autoantibodies
Dysglycemia thresholds: Presence of dysglycemia without overt hyperglycemia defined by ONE of the following: fasting plasma glucose >= 100 mg/dL and < 126 mg/dL; 2-hour post-prandial (OGTT) plasma glucose >= 140 mg/dL and < 200 mg/dL; or A1C >= 5.7% and < 6.5% or a >= 10% increase in A1Cnumeric thresholds
Clinical presentation: No symptoms of Stage 3 type 1 diabetes (e.g., polyuria, polydipsia, weight loss) and clinical history not suggestive of type 2 diabetes (type 2 diabetes ruled out)

Prescriber and Dosing: Prescribed by or in consultation with an endocrinologist and dosing consistent with FDA-approved labeling14-day IV course per labeling

Authorization limited to no more than 14 doses per lifetime

Prior Tzield Exposure: Patient has not been previously treated with Tzieldno prior course

Authorization limited to one lifetime course

Tzield is not covered when any of the following exclusion criteria apply: the patient has symptoms consistent with Stage 3 type 1 diabetes (for example, increased urination, excessive thirst, or weight loss); the patient has been previously treated with Tzield; or the requested dosing would exceed the authorized limit of one 14‑dose treatment course per lifetime.

Use of Tzield is not medically necessary when the diagnostic criteria for Stage 2 type 1 diabetes are not fully met. Examples include having fewer than two positive islet autoantibodies, absence of dysglycemia as defined by the policy numeric thresholds, or clinical evidence of Stage 3 disease. Prior receipt of a Tzield course also renders further treatment not medically necessary.

Coding and Diagnostic Thresholds

Applicable HCPCS CodesHCPCS

J9381

Injection, teplizumab-mzwv, 5 mcg

Applicable ICD-10 Codes (examples)ICD-10

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

inv-06: Fasting plasma glucose threshold for dysglycemia

Fasting plasma glucose thresholdGreater than or equal to 100 mg/dL and less than 126 mg/dL

Role in Stage 2 diagnosisOne of the dysglycemia criteria used to confirm Stage 2 Type 1 Diabetes when ≥2 islet autoantibodies are present

Reference guidanceSpecified in UnitedHealthcare criteria and aligned with ADA numeric range for Stage 2 dysglycemia

inv-07: 2-hour post-prandial plasma glucose (OGTT) threshold for dysglycemia

2-hour post-prandial (OGTT) thresholdGreater than or equal to 140 mg/dL and less than 200 mg/dL

Use in diagnosis

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval is limited to one FDA-aligned 14‑dose treatment course for eligible patients. Prescriptions must be consistent with the FDA‑approved dosing schedule and issued by or in consultation with an endocrinologist.

Authorization limited to one 14‑dose course per lifetime
Prescribed by or in consultation with an endocrinologist
Dosing must follow FDA‑approved labeling

Documentation Required

Required Documentation

Providers must document patient age, evidence of stage 2 type 1 diabetes, specified islet autoantibodies, and dysglycemia laboratory values in the medical record to support medical necessity and prior authorization requests.

Patient age: ≥ 8 years
Presence of at least two pancreatic islet autoantibodies (choose from GAD65, IAA, IA‑2A, ZnT8A, ICA) — list which tests were positive and dates

Clinical Background

Type 1 diabetes is an autoimmune disorder characterized by immune‑mediated destruction of pancreatic beta cells. The disease typically progresses through defined stages: Stage 1 (presence of islet autoimmunity with normoglycemia), Stage 2 (autoimmunity with dysglycemia but no clinical symptoms), and Stage 3 (overt hyperglycemia with symptomatic disease). Teplizumab‑mzwv (Tzield) is administered as a one‑time 14‑day intravenous course and has been studied for delaying progression from Stage 2 to Stage 3 in appropriately selected patients.

Key Definitions

inv-14: Stage 2 Type 1 Diabetes — definition including islet autoantibodies plus dysglycemia thresholds.

Core definitionStage 2 Type 1 Diabetes: presence of islet autoantibodies (usually multiple) plus dysglycemia without overt hyperglycemia

Required autoantibodiesAt least two positive pancreatic islet autoantibodies (examples listed in policy: GAD65, IAA, IA-2A, ZnT8A, ICA)

Dysglycemia criteria (any one)Fasting plasma glucose ≥100 and <126 mg/dL; 2-hour OGTT ≥140 and <200 mg/dL; or A1C ≥5.7% and <6.5% or ≥10% increase in A1C

Clinical contextPatient is presymptomatic for Stage 3 (no polyuria, polydipsia, weight loss) and type 2 diabetes has been ruled out

Policy Summary

PayerUnitedHealthcare

PolicyTzield (teplizumab-mzwv) — Coverage Criteria to Delay Progression from Stage 2 to Stage 3 Type 1 Diabetes

Policy CodePolicy 2025D0117G

Change TypeMaterial revision and clarification

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document age ≥8 years, at least two specified islet autoantibodies, dysglycemia lab values, prescriber/endocrinology consult, and no prior Tzield exposure.

SourceLink

On This Page

Acceptable dysglycemia metric for confirming Stage 2 Type 1 Diabetes in the presence of ≥2 islet autoantibodies

AlignmentMatches ADA Stage 2 OGTT numeric range cited in policy

inv-08: A1C threshold for dysglycemia

A1C thresholdA1C ≥ 5.7% and < 6.5% OR a ≥ 10% increase in A1C

FunctionCounts as dysglycemia for Stage 2 diagnosis when combined with ≥2 positive islet autoantibodies

Documented requirementProviders must record A1C value or percentage increase as part of required dysglycemia laboratory values

Dysglycemia evidence (one of): fasting plasma glucose ≥100 mg/dL and <126 mg/dL; 2‑hour OGTT plasma glucose ≥140 mg/dL and <200 mg/dL; A1C ≥5.7% and <6.5% or ≥10% relative increase in A1C

Documentation that patient does not have symptoms of stage 3 T1D and that type 2 diabetes has been ruled out

Record of prior Tzield treatment status (must be treatment‑naïve for Tzield)

Denial Risk

Triggers for Denial

Providers should be aware of conditions that will result in denial of coverage for Tzield; applications missing required documentation or not meeting age, diagnostic, or prior‑treatment criteria will be denied.

Patient is younger than 8 years of age
Failure to document at least two positive pancreatic islet autoantibodies
Lack of documented dysglycemia meeting policy thresholds (fasting glucose, 2‑hour OGTT, or A1C criteria)
Clinical evidence of stage 3 type 1 diabetes (symptomatic hyperglycemia) at time of request
Diagnosis consistent with type 2 diabetes (not ruled out)
Patient has previously received Tzield
Request for dosing that exceeds one FDA‑aligned 14‑dose treatment course

Note

Provider Instructions and Plan Considerations

See the policy for additional administrative guidance and member‑specific benefit considerations. UnitedHealthcare reserves the right to require supporting records and to apply member benefit plan terms.

Benefit coverage governed by the member specific benefit plan document
UnitedHealthcare may request medical records to substantiate the authorization