ModifiedCentenePolicy CP.PHAR.492

Teplizumab‑mzwv (Tzield) coverage for delaying Stage 3 type 1 diabetes

Defines medical necessity and prior authorization requirements for Tzield to delay onset of Stage 3 type 1 diabetes in eligible members covered by Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyTeplizumab‑mzwv (Tzield) coverage for delaying Stage 3 type 1 diabetes

Policy CodePolicy CP.PHAR.492

Change TypeMaterial updates to age, dosing, autoantibody criteria, and coding

Effective DateNov 17, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation of Stage 2 T1D criteria, current BSA for dosing, and required autoantibody test results.

SourceLink

POLICY UPDATE CHANGES

Revised age requirement from ≥ 8 years to ≥ 1 year and added new boxed warning (viral reactivation) per updated prescribing information.

Added ZnT8A and IA-2A as accepted diabetes-related autoantibody options and removed requirement for familial history of T1D.

Updated maximum total dose to 11,240 mcg/m2 over a 14-day course and added requirement to document current body surface area (BSA) for dose calculation.

Added HCPCS code J9381; removed C9399 and later removed J3590 per coding updates.

114-day course

≥1 yrMin approved age

11,240 mcg/m2Max total dose

Required autoantibodies

boxed warningNew labeled warning

Coverage Criteria and Clinical Eligibility

Initial Therapy

Covered when ALL of the following are met:

Initial Approval: Delayed Onset of Stage 3 T1D

Diagnosis of Stage 2 T1D: Presence of 2 or more diabetes-related autoantibodies detected in 2 samples obtained within the last 6 months (options include mIAA, ICA, GAD65ab, ICA512ab, ZnT8A, IA-2A); abnormal glucose tolerance on OGTT confirmed within last 7 weeks (one of: fasting plasma glucose ≥110 and <126 mg/dL; 2-hour plasma glucose ≥140 and <200 mg/dL; or 30/60/90 minute OGTT value ≥200 mg/dL); and no symptoms of diabetes.
Prescriber and Age: Prescribed by or in consultation with an endocrinologist; age ≥ 1 year.
Exclusions and Dose: No diagnosis of Stage 3 T1D or type 2 diabetes; documentation of member's current body surface area (BSA) (m2); total dose does not exceed 11,240 mcg/m2 administered over a 14-day treatment course (day-specific dosing per protocol: 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).

Approval Duration: Approval duration: 3 months (one 14-day treatment course only)

Continuation Therapy

Covered when ALL of the following are met:

Continuation Therapy: No continued therapy will be authorized; Tzield is indicated to be administered as a one-time treatment course only.

Approval Duration: Approval duration: Not applicable

Initial Coverage Criteria (summary)

Covered when ALL of the following are met (summary of updated elements):

Age: Member is ≥ 1 year of age>= 1 year

Revised from ≥ 8 years per pediatric extension

Diabetes type and symptoms: Member does not have type 2 diabetes and is asymptomatic for diabetes at time of treatment (no polyuria, polydipsia, polyphagia).

Per updated labeling

Dosing documentation: Documentation of current body surface area (BSA) for dose calculation is requiredcurrent BSA documented

Added during FDA approval update

This policy does not authorize coverage for non‑FDA approved indications for teplizumab unless those uses are supported by the applicable off‑label use policies (e.g., CP.CPA.09, CP.PMN.53) or other evidence of coverage. Members with Stage 3 or 4 type 1 diabetes are excluded from coverage under this policy. In addition, members with type 2 diabetes are not eligible for coverage per the exclusions listed in the policy.

Members diagnosed with type 2 diabetes or those who have symptomatic diabetes at the time of consideration are specifically excluded from coverage. The updated FDA‑based criteria and policy language require absence of symptoms and exclusion of type 2 diabetes as conditions for authorization.

Requests for ongoing or maintenance therapy beyond the single authorized 14‑day treatment course are not authorized. Teplizumab (Tzield) is indicated and covered only as a one‑time 14‑day treatment course to delay progression to Stage 3 type 1 diabetes; therefore continued therapy or repeat courses are considered not medically necessary.

Use of teplizumab in members who have clinical symptoms of diabetes or in members with a diagnosis of type 2 diabetes is considered not medically necessary under this policy. The criteria were revised to align with FDA labeling, which specifies that treated individuals should be without symptoms of diabetes and should not have type 2 diabetes.

Billing and Dosing Codes

HCPCS CodesHCPCS

J9381

Injection, teplizumab-mzwv, 5 mcg

Covered HCPCS CodesHCPCSCovered

J9381

Teplizumab-mzwv injection (HCPCS code added)

Deleted/Removed HCPCSHCPCSNot Covered

C9399

Previously used unspecified HCPCS code (deleted)

Removed HCPCSHCPCSNot Covered

J3590

Miscellaneous drug code (removed 1Q 2024)

inv-12: Maximum total dose per treatment course

Maximum total dose per 14-day treatment course11,240 mcg/m2 (total over 14 days; day-specific dosing provided in policy)

Per‑day dosing schedule (policy)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

Dose documentation requirementMember's current body surface area (BSA) must be documented for dose calculation

inv-13: Minimum age

Minimum approved ageAge ≥ 1 year

Prescriber requirement

Provider Requirements, Authorization, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tzield (single-course therapy). A single 14-day course is authorized when all coverage criteria are met; submit prior authorization before treatment.

Approval duration: one 14-day treatment course (single-course only)
Dose limit: ≤ 11,240 mcg/m2 total over the 14-day course

Denial Risk

Denial Triggers

Requests will be denied if required clinical information is missing or if the member does not meet the policy clinical eligibility (including excluded diagnoses or symptomatic disease).

Triggers for denial include: missing current body surface area (BSA) for dose calculation, documentation of Stage 3 or 4 T1D, diagnosis of type 2 diabetes, presence of symptoms of diabetes (e.g., polyuria, polydipsia, polyphagia), or requests for durations/uses outside the single 14‑day course

Clinical Definitions and Accepted Biomarkers

inv-23: Stage 1 T1D

Stage 1 definitionSingle or transient diabetes-related autoantibodies, normoglycemia, presymptomatic

Clinical contextRepresents earliest presymptomatic autoimmunity stage prior to dysglycemia

Contrast with Stage 2/3Does not meet Stage 2 criteria of ≥2 autoantibodies with dysglycemia

inv-24: Stage 2 T1D

Stage 2 definitionPresence of ≥2 diabetes-related autoantibodies and dysglycemia (abnormal OGTT), presymptomatic

Diagnostic requirements (policy)2 or more autoantibodies detected in 2 samples within last 6 months plus abnormal OGTT confirmed within 7 weeks

Background and Clinical Context

The clinical rationale for limiting use to presymptomatic Stage 2 disease reflects teplizumab’s role in modifying autoimmune progression prior to onset of symptomatic hyperglycemia. Per the updated policy and labeling, treatment is intended as a single course to delay onset of Stage 3 T1D in appropriately selected patients; members with manifest (symptomatic) diabetes, Stage 3 or 4 disease, or type 2 diabetes are outside the intended scope and are excluded from coverage.

Policy Revision History

2026-04-29labeling_updateLatest

Revised minimum approved age from ≥ 8 years to ≥ 1 year per pediatric extension and added boxed warning for viral reactivation in prescribing information.

2024-11-19criteria_update

Added ZnT8A and IA-2A as accepted diabetes-related autoantibody test options and removed requirement for familial history of type 1 diabetes.

2022-11-17dosing_documentation_update

Policy Summary

PayerCentene

PolicyTeplizumab‑mzwv (Tzield) coverage for delaying Stage 3 type 1 diabetes

Policy CodePolicy CP.PHAR.492

Change TypeMaterial updates to age, dosing, autoantibody criteria, and coding

Effective DateNov 17, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation of Stage 2 T1D criteria, current BSA for dosing, and required autoantibody test results.

SourceLink

On This Page

Autoantibodies: Diabetes-related autoantibody testing should include accepted options; ZnT8A and IA-2A are added as acceptable testsautoantibody positive per criteria

Added per pivotal study design and specialist feedback

Prescribed by or in consultation with an endocrinologist

Age change noteRevised from ≥ 8 years to ≥ 1 year per pediatric extension in updated labeling

Non‑FDA indications without appropriate off‑label justification per off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) will be denied

Documentation Required

Required Documentation

Provider must submit documentation supporting that the member meets all approval criteria. Incomplete documentation may result in denial of the request.

Office chart notes documenting symptom status (must be presymptomatic)
Laboratory results showing ≥ 2 diabetes‑related autoantibodies (examples: mIAA, ICA, GAD65ab, IA‑2A, ZnT8A) from up to two samples within the last 6 months
Oral glucose tolerance test (OGTT) results demonstrating abnormal glucose tolerance confirmed within the last 7 weeks (fasting plasma glucose, 2‑hour plasma glucose, or specified 30/60/90 minute values); two confirmatory tests required for members ≥ 18 years
Documentation of current body surface area (BSA) for dose calculation
Provider specialty documentation: prescribed by or in consultation with an endocrinologist
Member age documentation (must be ≥ 1 year)

Step Therapy

No step therapy is specified in this policy for Tzield.

Step therapy: Not applicable

Clinical relevanceTarget population for teplizumab to delay progression to Stage 3 T1D

inv-25: Stage 3 T1D

Stage 3 definitionPresence of ≥1 diabetes-related autoantibody, hyperglycemia, and symptomatic diabetes

Coverage exclusionMembers with Stage 3 (symptomatic) T1D are excluded from coverage for teplizumab

Clinical implicationRepresents onset of clinical disease with hyperglycemia and diabetes symptoms

inv-26: Accepted diabetes-related autoantibodies

Accepted diabetes‑related autoantibodiesmIAA (anti‑insulin), ICA (islet cell antibodies), GAD65ab, ICA512ab, ZnT8A, IA‑2A

Testing timing requirementAutoantibodies must be detected in 2 samples obtained within the last 6 months (per Stage 2 criteria)

Policy update noteZnT8A and IA‑2A were added per pivotal study design and specialist feedback; familial history is not required

Type 1 diabetes progresses through recognized stages from presymptomatic autoimmunity to symptomatic hyperglycemia. Teplizumab is an anti‑CD3 monoclonal antibody approved to delay progression from Stage 2 (presymptomatic with dysglycemia and ≥2 diabetes‑related autoantibodies) to Stage 3 T1D. Policy updates following FDA approval clarified eligible stages, excluded type 2 and symptomatic diabetes, revised dosing limits, and added a requirement to document current body surface area (BSA) for dose calculation.

Updated maximum total dose to 11,240 mcg/m2 for the 14-day treatment course and added requirement to document current body surface area (BSA) for dose calculation.

2022-03-30coding_review

References reviewed and updated during annual review while drug was not yet FDA-approved.

2024-11-19coding_changes

Added HCPCS code J9381 and deleted HCPCS code C9399; later removal of miscellaneous code entries noted in coding history.