CurrentCignaPolicy IP0537

Tzield (teplizumab-mzwv) — Delay of Onset of Type 1 Diabetes

Defines Cigna coverage and medical necessity criteria for a one-time 14-day course of Tzield to delay progression from stage 2 to stage 3 type 1 diabetes for insured members; applies to prescribers and utilization reviewers administering benefits under Cigna policies.

Policy Summary

PayerCigna

PolicyTzield (teplizumab-mzwv) — Delay of Onset of Type 1 Diabetes

Policy CodePolicy IP0537

Change TypeCriteria revisioncoding additionremoval of relative requirement

Effective Date

Next Review Date

Key ActionSubmit prior authorization for HCPCS J9381 with documentation confirming age ≥8, ≥2 diabetes-related autoantibodies on two occasions, qualifying OGTT or A1C, safety labs, no prior Tzield, and endocrinologist prescription.

SourceLink

POLICY UPDATE CHANGES

Updated criterion definition of fasting plasma glucose value and added A1C screening criterion.

Removed requirement for one biological relative with type 1 diabetes diagnosis.

Added HCPCS code J9381 for teplizumab-mzwv.

14-dayauthorized one-time course duration

≥ 8 yearsminimum patient age for eligibility

≥ 2required autoantibodies

J9381HCPCS code added

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One-timeauthorization frequency

Coverage and Medical Necessity Criteria

Initial Therapy (one-time)

Covered when ALL of the following are met:

Primary eligibility: Patient is age >= 8 years

Autoantibody requirement: Documentation of at least TWO diabetes-related autoantibodies on two separate occasions (examples: anti‑GAD65, anti‑IA‑2, islet‑cell autoantibody, micro insulin, anti‑zinc transporter 8)

Glycemic evidence

OGTT or IVGTT options: OGTT: EITHER of the following dysglycemia findings — fasting plasma glucose >=100 and <=125 mg/dL; OR two‑hour postprandial plasma glucose >=140 and <200 mg/dL; OR intervening postprandial glucose at 30, 60, or 90 minutes >200 mg/dL; OR IVGTT with FPIR rise in serum insulin below the first percentile of normal during first 10 minutes after IV glucose challengeFPG 100–125 mg/dL; 2‑hr 140–199 mg/dL; 30/60/90‑min >200 mg/dL; IVGTT FPIR <1st percentile
A1C option: HbA1c 5.7% to <6.5% within the preceding 2 monthsA1c 5.7% to <6.5% within 2 months

No clinical diabetes: Does NOT have Stage 3 (clinical) type 1 diabetes (no clinical symptoms, not receiving treatment, not meeting diagnostic thresholds)

Safety labs and infection status: Prescriber attests to adequate hematologic and hepatic function and absence of acute Epstein‑Barr virus or cytomegalovirus infection and absence of active serious infectionRefer to prescribing information for specific laboratory thresholds (e.g., lymphopenia, anemia, thrombocytopenia, neutropenia, increased liver enzymes)

Prior exposure and prescriber: Has NOT previously received Tzield; medication is prescribed by an endocrinologist

Use of Tzield (teplizumab‑mzwv) for indications other than the one specified in this policy is considered experimental, investigational, or unproven. Examples of non‑covered uses include treatment of clinical (Stage 3) type 1 diabetes and treatment of type 2 diabetes. This list is not exhaustive; other unapproved or investigational indications are also not covered.

Tzield is not indicated for patients with Stage 3 (clinical) type 1 diabetes and is not indicated for patients with type 2 diabetes. Because these uses fall outside the approved indication, they are considered not medically necessary and will not be covered under this policy.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J9381

Injection, teplizumab-mzwv, 5 mcg

OGTT and Glycemic Thresholds

Fasting plasma glucose (OGTT)Greater than or equal to 100 and less than or equal to 125 mg/dL (policy uses FPG >=100 to <=125 mg/dL as dysglycemia criterion)

2-hour postprandial plasma glucose (OGTT)Greater than or equal to 140 and less than 200 mg/dL

Intervening postprandial (30/60/90 min) glucose (OGTT)Postprandial glucose at 30, 60, or 90 minutes greater than 200 mg/dL (alternative dysglycemia criterion)

Hemoglobin A1c (A1C)5.7% to less than 6.5% within the preceding 2 months (qualifying A1C range)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for HCPCS J9381 (Injection, teplizumab-mzwv, 5 mcg). Submit a prior authorization request before initiating therapy. Approval, if granted, is typically for a one-time 14-day course consistent with the dosing regimen in the policy.

J9381 — prior authorization required
One-time approval for a 14-day course (see dosing)

Documentation Required

Required Clinical Documentation for Prior Authorization

The following clinical documentation must be provided with the prior authorization request to demonstrate medical necessity for Tzield (teplizumab-mzwv): age; documentation of at least TWO type 1 diabetes-related autoantibodies on two separate occasions (e.g., anti-GAD65, anti-IA-2, islet-cell autoantibody, micro insulin, anti‑zinc transporter 8); evidence of qualifying dysglycemia via OGTT or IVGTT FPIR OR A1c 5.7 to <6.5% within the preceding 2 months; confirmation that the member does NOT have clinical (Stage 3) type 1 diabetes; prescriber attestation of adequate hematologic and hepatic function and absence of active serious infection or acute EBV/CMV infection; documentation that the member has NOT received prior Tzield; and that the medication is prescribed by an endocrinologist.

Key Definitions

Stage 2 Type 1 Diabetes — Definition and Criteria

Minimum agePatient is ≥ 8 years of age

Autoantibody requirementDocumentation of two or more diabetes-related autoantibodies confirmed on at least two occasions

Dysglycemia requirementEvidence of dysglycemia on OGTT (FPG 100–125 mg/dL; 2‑hour 140–199 mg/dL; or 30/60/90‑min ≥200 mg/dL) or qualifying A1C per policy

Disease stagePre-symptomatic (Stage 2) type 1 diabetes — multiple islet autoantibodies plus dysglycemia

Stage 3 Type 1 Diabetes — Diagnostic Thresholds

Clinical definitionStage 3 (clinical/overt) type 1 diabetes characterized by overt hyperglycemia and presence of symptoms

Background and Indication

Tzield (teplizumab‑mzwv) is an anti‑CD3 monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients aged ≥ 8 years who have Stage 2 disease characterized by multiple islet autoantibodies and dysglycemia. Treatment is administered as a body surface area–based intravenous infusion daily for 14 consecutive days; baseline hematologic and liver tests are required and active EBV/CMV or other serious infections are contraindications to therapy.

Policy Changes and Revision History

2024-04-01criteria_revision

Updated fasting plasma glucose criterion definition and added A1C screening criterion for eligibility determination.

2024-04-01criteria_revision

Removed requirement for one biological relative with type 1 diabetes diagnosis.

2024-09-10coding_updateLatest

Policy Summary

PayerCigna

PolicyTzield (teplizumab-mzwv) — Delay of Onset of Type 1 Diabetes

Policy CodePolicy IP0537

Change TypeCriteria revisioncoding additionremoval of relative requirement

Effective Date

Next Review Date

SourceLink

On This Page

Age (≥ 8 years)
At least TWO autoantibodies documented on two occasions (list examples)
Qualifying dysglycemia: OGTT results OR IVGTT FPIR OR A1c 5.7–<6.5% in past 2 months
Does NOT have Stage 3 (clinical) type 1 diabetes
Prescriber attestation: adequate hematologic and hepatic function; no acute EBV/CMV infection; no active serious infection
No prior receipt of Tzield
Prescribed by an endocrinologist

Denial Risk

Not Covered Uses and Prior Therapy Exclusion

Not covered uses and exclusions — denials will be issued when therapy is requested for conditions not supported by the policy. Tzield is considered experimental, investigational, or unproven for any indication other than the specific Stage 1/2 (preclinical) delay-of-onset indication described in this policy. Deny when the member has Stage 3 (clinical) type 1 diabetes, has a diagnosis of type 2 diabetes, or has previously received Tzield. Receipt of sample product does not satisfy criteria.

Stage 3 (clinical) type 1 diabetes — not covered
Type 2 diabetes — not covered
Prior receipt of Tzield — not covered
Any other unapproved/experimental use — not covered
Samples do not meet documentation requirements

Step Therapy

Step Therapy and Site-of-Care

Step therapy / site-of-care note: No formal step therapy is specified for this policy. When coverage is approved, the dosage, frequency, duration (one-time 14-day course), and site-of-care must be reasonable, clinically appropriate, supported by evidence-based literature, and documented in the record.

No step therapy required
Dosing/frequency/duration/site-of-care must be reasonable and documented
One-time, 14-day intravenous regimen per dosing table

Fasting plasma glucose thresholdFPG ≥ 126 mg/dL

2-hour OGTT threshold2‑hour postprandial plasma glucose ≥ 200 mg/dL during a 75 g OGTT

Hemoglobin A1c thresholdHbA1c ≥ 6.5%

Added HCPCS code J9381 (Injection, teplizumab-mzwv, 5 mcg) to facilitate billing and prior authorization.