ModifiedAmeriHealth Caritas VIP CarePolicy MA08.157b

Teplizumab-mzwv (Tzield)

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This policy governs medical-benefit coverage and medical necessity for intravenous teplizumab-mzwv (Tzield) to delay the onset of stage 3 type 1 diabetes in adults and pediatric members aged 8 years and older with stage 2 type 1 diabetes. Coverage requires specified clinical criteria, documentation, dosing, and one treatment course per lifetime, subject to the member's benefit contract.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyTeplizumab-mzwv (Tzield)

Policy CodePolicy MA08.157b

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionIf the member's dose, frequency, or regimen changes, submit the changes for a new approval as part of utilization management.

SourceLink

POLICY UPDATE CHANGES

Medical necessity criteria were removed for individuals with a first-degree or second-degree relative with type 1 diabetes.

The ICD-10 diagnosis code E10.A2 for presymptomatic stage 2 type 1 diabetes mellitus was added to the policy.

Age 8+Minimum age for covered stage 2 type 1 diabetes indication

2Minimum confirmed diabetes autoantibodies

14Treatment doses per lifetime

14 days

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ModifiedAmeriHealth Caritas VIP CarePolicy MA08.157b

Teplizumab-mzwv (Tzield)

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyTeplizumab-mzwv (Tzield)

Policy CodePolicy MA08.157b

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionIf the member's dose, frequency, or regimen changes, submit the changes for a new approval as part of utilization management.

SourceLink

POLICY UPDATE CHANGES

Medical necessity criteria were removed for individuals with a first-degree or second-degree relative with type 1 diabetes.

The ICD-10 diagnosis code E10.A2 for presymptomatic stage 2 type 1 diabetes mellitus was added to the policy.

Age 8+Minimum age for covered stage 2 type 1 diabetes indication

2Minimum confirmed diabetes autoantibodies

14Treatment doses per lifetime

14 days

Treatment course duration

J9381HCPCS code for teplizumab-mzwv

Coverage Criteria

Initial medically necessary therapy

Covered when all of the following criteria are met, including dosing and frequency.

Covered initial therapy criteria

Provider qualification: Prescribed by or in consultation with an endocrinologist.
Qualifying abnormal oral glucose tolerance result
- Fasting glucose is 100 to 125 mg/dL (5.6 to 6.9 mmol/L).100 to 125 mg/dL (5.6 to 6.9 mmol/L)
- Two-hour postprandial glucose is 140 to 199 mg/dL (7.8 to 11.1 mmol/L).140 to 199 mg/dL (7.8 to 11.1 mmol/L)
- A1c is 5.7 to 6.4 percent.5.7 to 6.4%
Autoantibody evidence: At least two confirmed diabetes autoantibodies are detected in two samples obtained within 6 months before treatment initiation.At least 2 confirmed autoantibodies; 2 samples; within 6 months before initiation
Examples include GAD autoantibodies, IAA, IA-2A, ZnT8A, and ICA.
No disqualifying condition: The individual does not have stage 3 type 1 diabetes or a clinical history consistent with type 2 diabetes.
Required regimen: Treatment is administered by intravenous infusion as one treatment course consisting of 14 doses per lifetime, using the specified dose-escalation schedule.Day 1: 65 mcg/m²; day 2: 125 mcg/m²; day 3: 250 mcg/m²; day 4: 500 mcg/m²; days 5–14: 1,030 mcg/m²

Experimental or investigational uses

All other uses are not covered unless supported as an accepted off-label use under the Company's off-label coverage policy.

Experimental or investigational uses: Uses of teplizumab-mzwv other than the covered indication to delay the onset of stage 3 type 1 diabetes in adults and pediatric individuals aged 8 years and older with stage 2 type 1 diabetes are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use under the Company's medical policy on off-label coverage for prescription drugs and biologics.

Stage 3 type 1 diabetes and a clinical history consistent with type 2 diabetes are excluded from the medically necessary coverage criteria for teplizumab-mzwv (Tzield).

Coding and Clinical Parameters

CPT Procedure Code Number(s)CPT

N/A

ICD - 10 Procedure Code Number(s)ICD-10

N/A

CPT Procedure Code Number(s)CPT

N/A

ICD - 10 Procedure Code Number(s)ICD-10

N/A

ICD - 10 Diagnosis Code Number(s)ICD-10

E10.A2	Type 1 diabetes mellitus, presymptomatic, Stage 2
R73.01	Impaired fasting glucose
R73.02	Impaired glucose tolerance (oral)
R73.03	Prediabetes
R73.09	Other abnormal glucose
R76.0	Raised antibody titer
Z83.3	Family history of diabetes mellitus

HCPCS Level II Code Number(s)HCPCSCovered

J9381

Injection, teplizumab-mzwv, 5 mcg

Revenue Code Number(s)Revenue

N/A

Age

Minimum age8 years of age

Eligible populationAdults and pediatric individuals

Covered indicationStage 2 type 1 diabetes to delay onset of stage 3 type 1 diabetes

Fasting glucose

Lower limit100 mg/dL

Upper limit125 mg/dL

Provider Actions and Documentation

Prior Authorization

New Approval Required for Regimen Changes

If the member’s dose, frequency, or regimen changes—including changes related to member weight or incomplete therapeutic response—the provider must submit the change to the Company for a new approval as part of utilization management.

Documentation Required

Medical Record Support Required

The medical record must reflect the medical necessity for the care provided. Acceptable supporting records may include documentation from the professional provider’s office, hospital, nursing home, home health agency, therapy records, and test reports. All documentation must be available to the Company upon request.

Documentation Required

Document Clinical Eligibility

Document the clinical evidence establishing stage 2 type 1 diabetes before treatment, including the qualifying glucose abnormality and at least two confirmed diabetes autoantibodies detected in two samples obtained within 6 months before treatment initiation.

Background

Type 1 diabetes results from autoimmune destruction of the insulin-producing beta cells and progresses through presymptomatic stages before symptomatic stage 3 disease. Stage 1 is characterized by two or more type 1 diabetes-associated islet autoantibodies with normal glucose levels. In stage 2, two or more islet autoantibodies are accompanied by glucose intolerance or dysglycemia due to loss of functional beta-cell mass. Stage 3 is clinical diabetes with symptoms such as polyuria, polydipsia, weight loss, fatigue, or diabetic ketoacidosis.

Type 1 Diabetes Stages

Stage 1 type 1 diabetes

AutoantibodiesTwo or more type 1 diabetes-associated islet autoantibodies

Glucose statusNormoglycemic

Disease stagePresymptomatic stage 1 type 1 diabetes

Stage 2 type 1 diabetes

AutoantibodiesTwo or more islet autoantibodies

Glycemic statusGlucose intolerance or dysglycemia

Underlying processLoss of functional beta-cell mass

Initial Teplizumab-mzwv Therapy

Initial teplizumab-mzwv course

Covered for one treatment course when all of the following clinical eligibility and regimen requirements are met.

Initial course eligibility

Qualifying dysglycemia
- Fasting glucose is 100 to 125 mg/dL (5.6 to 6.9 mmol/L).
- Two-hour postprandial glucose is 140 to 199 mg/dL (7.8 to 11.1 mmol/L).
- A1c is 5.7 to 6.4 percent.
Autoantibody evidence: At least two confirmed diabetes autoantibodies are detected in two samples obtained within 6 months before treatment initiation.

Quantity and Lifetime Limits

Teplizumab-mzwv (Tzield)

Lifetime limitOne treatment course per lifetime

Course quantity14 doses

RouteIntravenous infusion

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyTeplizumab-mzwv (Tzield)

Policy CodePolicy MA08.157b

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionIf the member's dose, frequency, or regimen changes, submit the changes for a new approval as part of utilization management.

SourceLink

On This Page

Equivalent range5.6 to 6.9 mmol/L

Two-hour postprandial glucose

Lower limit140 mg/dL

Upper limit199 mg/dL

Equivalent range7.8 to 11.1 mmol/L

A1c

Lower limit5.7 percent

Upper limit6.4 percent

Qualifying range5.7 to 6.4 percent

Diabetes autoantibodies

Minimum numberAt least two confirmed diabetes autoantibodies

Confirmation requirementAutoantibodies must be detected in two samples

Sample timingSamples must be obtained within 6 months before treatment initiation

Testing requirementTesting must demonstrate the presence of the confirmed autoantibodies

Qualifying glucose evidence: fasting glucose 100–125 mg/dL, two-hour postprandial glucose 140–199 mg/dL, or A1c 5.7%–6.4%.
Confirm at least two autoantibodies, such as GAD, IAA, IA-2A, ZnT8A, or ICA, in two samples obtained within the required 6-month period.

Unsupported block type: documentation

Denial Risk

Uncovered or Unsupported Indication

All uses other than delaying the onset of stage 3 type 1 diabetes in eligible individuals with stage 2 type 1 diabetes are considered experimental or investigational and are not covered unless the indication is supported as an accepted off-label use under the Company’s policy for off-label coverage of prescription drugs and biologics.

Denial Risk

Unsupported Regimen or Missing Records

Requests for an unsupported dose, frequency, or regimen require published peer-reviewed literature supporting the requested exception. In addition, failure to produce requested medical records or other documentation may result in denial, and the Company may conduct postpayment review and audits.

Submit supporting literature for dosing or frequency outside policy requirements.
Ensure requested records document medical necessity and are available upon Company request.

Denial Risk

Exclusionary Diabetes Stage or Type

Coverage is limited to individuals who do not have stage 3 type 1 diabetes or a clinical history consistent with type 2 diabetes. Claims may be denied when records show an exclusionary diabetes stage or type.

Stage 3 type 1 diabetes may present with excessive hunger or thirst, blurry vision, severe fatigue, frequent urination, or unexplained weight loss.
The therapy must be prescribed by or provided in consultation with an endocrinologist.

Stage 3 type 1 diabetes

Disease statusClinical diabetes

Associated symptomsPolyuria, polydipsia, weight loss, or fatigue

Acute presentationDiabetic ketoacidosis may occur

Exclusions: The member does not have stage 3 type 1 diabetes or a clinical history consistent with type 2 diabetes.

Intravenous dosing and lifetime frequency: The member receives one intravenous treatment course consisting of 14 doses per lifetime, with dose escalation from day 1 through day 4 and the maintenance dose on days 5 through 14.Day 1: 65 mcg/m²; day 2: 125 mcg/m²; day 3: 250 mcg/m²; day 4: 500 mcg/m²; days 5–14: 1,030 mcg/m²