CurrentMolina HealthcarePolicy C24729-A

Tzield (teplizumab-mzwv) Coverage Criteria

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This policy governs prior authorization and coverage of intravenous Tzield for eligible adults and pediatric members aged 8 years and older with Stage 2 type 1 diabetes when prescribed by or in consultation with a board-certified endocrinologist and clinical criteria are met.

Policy Summary

PayerMolina Healthcare

PolicyTzield (teplizumab-mzwv) Coverage Criteria

Policy CodePolicy C24729-A

Change TypeNo material clinical or coverage changes

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation showing eligibility, clinical criteria, prescriber qualifications, and the requested one-course, 14-day treatment plan.

SourceLink

POLICY UPDATE CHANGES

The revision history identifies updates to required medical information, place of administration, references, duration of approval, and contraindications/exclusions/discontinuation.

The revision history identifies prior updates to other special considerations, coding and billing information, available dosage forms, and references.

8+ yearsMinimum member age

2Required positive antibodies

60 daysGlucose test recency

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CurrentMolina HealthcarePolicy C24729-A

Tzield (teplizumab-mzwv) Coverage Criteria

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Sign up for Molina Healthcare Policy C24729-A alerts

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Policy Summary

PayerMolina Healthcare

PolicyTzield (teplizumab-mzwv) Coverage Criteria

Policy CodePolicy C24729-A

Change TypeNo material clinical or coverage changes

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation showing eligibility, clinical criteria, prescriber qualifications, and the requested one-course, 14-day treatment plan.

SourceLink

POLICY UPDATE CHANGES

The revision history identifies updates to required medical information, place of administration, references, duration of approval, and contraindications/exclusions/discontinuation.

The revision history identifies prior updates to other special considerations, coding and billing information, available dosage forms, and references.

8+ yearsMinimum member age

2Required positive antibodies

60 daysGlucose test recency

14 daysLifetime treatment course

25 monthsStage 3 delay in study

Coverage Criteria

Delay onset of Stage 3 type 1 diabetes

Covered when all of the following clinical requirements are met:

Stage 2 type 1 diabetes eligibility

Autoantibody confirmation: Stage 2 type 1 diabetes is confirmed by two positive pancreatic islet autoantibodies.Two positive antibodies
Examples listed include GAD65, IAA, IA-2A, ZnT8A, and ICA.
Dysglycemia without overt hyperglycemia is documented using an oral glucose tolerance test within the last 60 days, or an appropriate alternative method if an oral glucose tolerance test is unavailable.Within the last 60 days
Qualifying dysglycemia includes fasting glucose of 100 to 125 mg/dL, 2-hour postprandial plasma glucose of at least 140 mg/dL and less than 200 mg/dL, or an intervening postprandial glucose level greater than 200 mg/dL at 30, 60, or 90 minutes on two occasions.
Diabetes type assessment: The member's clinical history does not suggest type 2 diabetes.No clinical history suggesting type 2 diabetes

Avoid Tzield during pregnancy and for at least 30 days before a planned pregnancy.

Patients should complete all age-appropriate vaccinations before starting Tzield. Avoid concurrent use of live, inactivated, and mRNA vaccines during treatment.

Use of Tzield is not recommended when laboratory abnormalities include a lymphocyte count below 1,000 lymphocytes/mcL, hemoglobin below 10 g/dL, platelet count below 150,000 platelets/mcL, or absolute neutrophil count below 1,500 neutrophils/mcL. Use is also not recommended when ALT or AST is greater than 2 times the upper limit of normal or bilirubin is greater than 1.5 times the upper limit of normal.

Use of Tzield is not recommended with laboratory or clinical evidence of acute Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection. Avoid use in patients with an active serious infection or chronic active infection other than a localized skin infection.

Uses other than the labeled indication are considered experimental/investigational and follow Molina's Off-Label policy.

Coding and Clinical Thresholds

HCPCS CodeHCPCS

J9381

Injection, teplizumab-mzwv, 5 mcg

Fasting glucose

TestFasting glucose

Qualifying range100 to 125 mg/dL

Equivalent range5.6 to 6.9 mmol/L

2-hour postprandial plasma glucose

Test2-hour postprandial plasma glucose

Lower thresholdAt least 140 mg/dL

Qualifying rangeAt least 140 mg/dL (7.8 mmol/L) and less than 200 mg/dL (11.1 mmol/L)

Authorization and Documentation Requirements

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required for Tzield (teplizumab-mzwv) to delay onset of Stage 3 type 1 diabetes. Submit documentation establishing eligibility, clinical criteria, and qualified prescribing; initial authorization is limited to 3 months for one 14-day course per member lifetime, with no continuation authorization.

Member is 8 years of age or older.
Stage 2 type 1 diabetes is confirmed by two positive pancreatic islet autoantibodies.
Dysglycemia without overt hyperglycemia is documented, and the clinical history does not suggest type 2 diabetes.
The drug is prescribed by or in consultation with a board-certified endocrinologist.
Submit required member-specific dosing information, including weight or body surface area, when applicable.

Documentation Required

Policy Background

Tzield (teplizumab-mzwv) is an intravenous anti-CD3 antibody used to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients aged 8 years and older with Stage 2 type 1 diabetes. Treatment is administered as a single 14-day course.

Clinical Definitions

Dysglycemia without overt hyperglycemia

Fasting glucose100 to 125 mg/dL (5.6 to 6.9 mmol/L)

2-hour postprandial plasma glucoseAt least 140 mg/dL (7.8 mmol/L) and less than 200 mg/dL (11.1 mmol/L)

Intervening postprandial glucoseGreater than 200 mg/dL at 30, 60, or 90 minutes on two occasions

Pancreatic islet autoantibodies

Glutamic acid decarboxylase 65GAD autoantibodies

InsulinInsulin autoantibody (IAA)

Insulinoma-associated antigen 2

Initial Therapy

Initial therapy

Initial therapy is covered when all applicable requirements are met:

Initial Tzield eligibility

Age: The member is 8 years of age or older.8 years and older
Clinical criteria: Stage 2 type 1 diabetes is confirmed by two positive pancreatic islet autoantibodies, dysglycemia without overt hyperglycemia is documented using an oral glucose tolerance test within the last 60 days or an appropriate alternative method when an oral glucose tolerance test is unavailable, and the clinical history does not suggest type 2 diabetes.Two positive antibodies; qualifying dysglycemia test within 60 days; no clinical history suggesting type 2 diabetes

Dose, Duration, and Quantity Limits

Tzield quantity limit

Lifetime limitOne 14-day course per member lifetime

Initial authorization3 months

MedicationTzield (teplizumab-mzwv)

Tzield dose schedule

MedicationTzield (teplizumab-mzwv)

Treatment dayDay 1

Dose65 mcg/m2

Administration Site and Method

Billing Rule

Use a non-hospital infusion site

Administer the infused medication in a recommended non-hospital, facility-based location under the pharmacy or medical benefit.

Use a non-hospital facility-based place of service, such as an infusion center.

Billing Rule

Follow the required infusion administration

Administer Tzield by intravenous infusion over a minimum of 30 minutes. Treatment is given once daily for 14 days.

Do not administer two doses on the same day.

Policy Summary

PayerMolina Healthcare

PolicyTzield (teplizumab-mzwv) Coverage Criteria

Policy CodePolicy C24729-A

Change TypeNo material clinical or coverage changes

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation showing eligibility, clinical criteria, prescriber qualifications, and the requested one-course, 14-day treatment plan.

SourceLink

On This Page

Intervening postprandial glucose

Qualifying valueGreater than 200 mg/dL

TimingAt 30, 60, or 90 minutes postprandially

Occurrence requirementDocumented on two occasions

Submit Complete Supporting Documentation

Provide complete medical rationale and supporting documentation with the request. Molina may require additional records for coverage determination, quality improvement, and fraud, waste, and abuse prevention.

Patient medical records and relevant test results.
Credentials of the provider ordering or performing the drug or service.
Any additional case-specific information needed to complete the medical-necessity review.

Documentation Required

Document Clinical Eligibility

Document all clinical elements supporting eligibility for Tzield, including Stage 2 type 1 diabetes, qualifying autoantibodies, and dysglycemia without overt hyperglycemia.

Document two positive pancreatic islet autoantibodies; examples include GAD65, IAA, IA-2A, ZnT8A, and ICA.
Submit an oral glucose tolerance test performed within the last 60 days, or an appropriate alternative method if an oral glucose tolerance test is unavailable.
Document dysglycemia as fasting glucose 100–125 mg/dL, 2-hour postprandial glucose at least 140 mg/dL and less than 200 mg/dL, or an intervening 30-, 60-, or 90-minute postprandial glucose greater than 200 mg/dL on two occasions.
Document that the clinical history does not suggest type 2 diabetes.

Documentation Required

Submit Endocrinology Consultation Notes

When Tzield is prescribed in consultation with a board-certified endocrinologist, submit the endocrinology consultation notes with the initial request.

Denial Risk

Failure to Meet Clinical Criteria

Coverage may be denied when the submitted records do not establish every required clinical element for the labeled indication.

Stage 2 type 1 diabetes is not documented or is not confirmed by two positive pancreatic islet autoantibodies.
Qualifying dysglycemia without overt hyperglycemia is not documented within the required timeframe or by an acceptable alternative method.
The clinical history suggests type 2 diabetes.
Other age, prescriber, or clinical eligibility requirements are not met.

Denial Risk

Insufficient Supporting Documentation

Molina may deny reimbursement or take other appropriate action when documentation does not support medical necessity, non-investigational status, benefit eligibility, or appropriate billing and utilization.

Provide records supporting that the treatment is medically necessary and within the member's benefit scope.
Support that the requested use is not investigational or experimental.
Molina may request additional documentation and may act when records show inappropriate or excessive billing or other practice.

Denial Risk

Non-Covered or Investigational Use

Uses of Tzield outside the covered labeled indication are considered experimental/investigational and follow Molina's Off-Label policy.

Do not assume coverage for non-labeled uses.
Review and apply Molina's Off-Label policy when the requested use falls outside the covered labeled indication.

Denial Risk

Assess Pregnancy, Vaccination, Laboratory, and Infection Restrictions

Before treatment, assess and document pregnancy status, vaccination timing, laboratory values, and infection status. Tzield should not be used in the listed exclusion circumstances.

Avoid use during pregnancy and for at least 30 days before a planned pregnancy.
Administer all age-appropriate vaccinations before starting Tzield; avoid concurrent live, inactivated, and mRNA vaccines during treatment.
Use is not recommended with lymphocyte count <1,000/mcL, hemoglobin <10 g/dL, platelets <150,000/mcL, or absolute neutrophil count <1,500/mcL.
Use is not recommended with ALT or AST >2 times ULN or bilirubin >1.5 times ULN.
Use is not recommended with laboratory or clinical evidence of acute EBV or CMV infection, or with an active serious infection or chronic active infection other than a localized skin infection.

Zinc transporter 8ZnT8A autoantibody

Islet cellIslet cell autoantibody (ICA)

Stage 1 type 1 diabetes

StageStage 1 type 1 diabetes

Defining featureAppearance of type 1 diabetes-related autoantibodies

Disease phaseA stage before overt hyperglycemia requiring insulin treatment

Stage 2 type 1 diabetes

StageStage 2 type 1 diabetes

Defining featureDysglycemia after autoimmune disease has begun

Clinical phasePresymptomatic period before Stage 3 type 1 diabetes

Stage 3 type 1 diabetes

StageStage 3 type 1 diabetes

Underlying processAutoimmune destruction of beta cells has occurred

Clinical featuresElevated blood glucose, symptoms, and need for insulin treatment

The drug is prescribed by or in consultation with a board-certified endocrinologist.

Board-certified endocrinologist

If prescribed in consultation, consultation notes must be submitted with the initial request.

Tzield dose schedule

MedicationTzield (teplizumab-mzwv)

Treatment dayDay 2

Dose125 mcg/m2

Tzield dose schedule

MedicationTzield (teplizumab-mzwv)

Treatment dayDay 3

Dose250 mcg/m2

Tzield dose schedule

MedicationTzield (teplizumab-mzwv)

Treatment dayDay 4

Dose500 mcg/m2

Tzield dose schedule

MedicationTzield (teplizumab-mzwv)

Treatment daysDays 5 through 14

Dose1,030 mcg/m2

Tzield administration schedule

FrequencyOnce daily

Duration14 consecutive treatment days

Daily dose restrictionDo not administer two doses on the same day