ModifiedCignaPolicy IP0537

Tzield (teplizumab-mzwv) for delaying onset of type 1 diabetes

Coverage policy for prior authorization, medical necessity criteria, dosing, and coding for Tzield (teplizumab-mzwv) to delay onset of stage 3 type 1 diabetes in eligible patients; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTzield (teplizumab-mzwv) for delaying onset of type 1 diabetes

Policy CodePolicy IP0537

Change TypeMaterial revisions to baseline hematologic and hepatic thresholds and prescriber verification requirements

Effective Date5/1/2026

Next Review Date

Key ActionObtain prior authorization and documentation of baseline hematologic and hepatic labs; prescriber must verify the patient has not previously received Tzield.

SourceLink

POLICY UPDATE CHANGES

Baseline hepatic thresholds required prior to initiation of Tzield: ALT ≤ 2×ULN; AST ≤ 2×ULN; bilirubin ≤ 1.5×ULN (documentation required).

Baseline hematologic thresholds required prior to initiation of Tzield: lymphocyte count ≥1,000/mcL; hemoglobin ≥10 g/dL; platelets ≥150,000/mcL; ANC ≥1,500/mcL (documentation required).

Requirement that prescriber verification is required to confirm patient has not previously received Tzield (prescriber must verify and attest).

Chronic active infection (other than localized skin infection) added to list of conditions the prescriber must attest the patient does NOT have.

Baseline hematologic thresholds required prior to initiation of Tzield documented with an effective date for those revisions.

Intervening postprandial glucose level at 30, 60, or 90 minutes greater than 200 mg/dL removed from criteria.

Results of acute first phase insulin response (FPIR) during IVGTT demonstrating rise in serum insulin below the first percentile removed from criteria.

Requirement that patient has at least one biological relative with type 1 diabetes was added then later removed (revisions dated 4/16/2026 and 5/01/2026).

one-time, 14-dayapproved course duration

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Coverage Criteria for Tzield (teplizumab-mzwv)

FDA-Approved Indication

Approve for a one-time per lifetime 14-day course when ALL of the following are met:

Age: Patient is ≥ 8 years of age

No clinical type 1 diabetes: Patient does NOT have a clinical diagnosis of type 1 diabetes (Stage 3)

Clinical type 1 diabetes is also referred to as Stage 3

No type 2 diabetes: Patient does NOT have type 2 diabetes

Autoantibodies: Patient has tested positive for at least TWO specified type 1 diabetes–related autoantibodies on two separate occasions (documentation required)two antibodies per occasion

Antibodies include GAD65, IA-2, ICA, IAA, ZnT8

Evidence of dysglycemia: Patient meets ONE of: (i) 2-hour OGTT 140–199 mg/dL in the preceding 2 months; OR (ii) fasting plasma glucose 100–125 mg/dL in the preceding 2 months; OR (iii) HbA1c 5.7%–<6.5% in the preceding 2 months (documentation required)

Baseline hematologic safety: At baseline (prior to initiation), patient does NOT have hematologic compromise defined by ALL of: lymphocyte count ≥ 1,000/mcL; AND hemoglobin ≥ 10 g/dL; AND platelet count ≥ 150,000/mcL; AND absolute neutrophil count ≥ 1,500/mcL (documentation required)see hematologic thresholds

Baseline hepatic safety: At baseline (prior to initiation), patient does NOT have hepatic compromise defined by ALL of: ALT ≤ 2×ULN; AND AST ≤ 2×ULN; AND bilirubin ≤ 1.5×ULN (documentation required)see hepatic thresholds

Infection exclusion: Per prescriber, patient does NOT have laboratory or clinical evidence of acute EBV or CMV infection, active serious infection, or chronic active infection (other than localized skin infection)

No prior Tzield: Patient has NOT received Tzield in the past (verification required by prescriber and claims history)

Verify through claims history; if no claim, prescriber must attest

Prescriber specialty: Medication will be prescribed by an endocrinologist

Initial therapy eligibility

Covered when ALL of the following are met

Baseline hematologic requirements: At baseline (prior to initiation of Tzield), patient does NOT have evidence of hematologic compromise as defined by: lymphocyte count >= 1,000/mcL; AND hemoglobin >= 10 g/dL; AND platelet count >= 150,000/mcL; AND absolute neutrophil count >= 1,500/mcL (documentation required)see hematologic thresholds

Baseline hepatic requirements: At baseline (prior to initiation of Tzield), patient does NOT have evidence of hepatic compromise as defined by: ALT <= 2x ULN; AND AST <= 2x ULN; AND bilirubin <= 1.5x ULN (documentation required)see hepatic thresholds

Infection and prior therapy exclusions: Prescriber attests patient does NOT have chronic active infection (other than localized skin infection) AND verifies patient has NOT received Tzield previously (verification required)

Tzield is considered not medically necessary for any use other than the FDA‑approved indication to delay onset of Stage 3 (clinical) type 1 diabetes in eligible patients. This explicitly includes use to treat clinical (Stage 3) type 1 diabetes, which is not an indicated or covered use.

The prescriber must attest that the patient does NOT have chronic active infection (other than localized skin infection). Presence of chronic active infection is an exclusion and may preclude approval.

Use of Tzield to treat clinical (Stage 3) type 1 diabetes is explicitly not indicated and is considered not medically necessary under this policy.

Some previously listed criteria and language were removed in recent revisions (for example, specific IVGTT FPIR and certain postprandial glucose criteria and prescriber attest language). Where language has been removed, the policy no longer relies on those criteria for coverage determination.

Coding and Laboratory Thresholds

Covered HCPCS CodesHCPCSCovered

J9381

Injection, teplizumab-mzwv, 5 mcg

inv-08: Baseline hematologic thresholds — required minimums

Lymphocyte count≥ 1,000 lymphocytes/mcL

Hemoglobin≥ 10 g/dL

Platelet count≥ 150,000 platelets/mcL

Absolute neutrophil count (ANC)≥ 1,500 neutrophils/mcL

inv-09: Baseline hepatic thresholds — required maximums

Alanine aminotransferase (ALT)≤ 2 × ULN

Aspartate aminotransferase (AST)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Tzield. Approvals are granted for a one-time, 14-day course when all eligibility and baseline safety criteria in the policy are met. Tzield must be prescribed by or in consultation with a physician who specializes in the condition being treated (endocrinologist for the FDA‑approved indication). Requests for doses outside the established dosing regimen will be reviewed case‑by‑case by a clinician. All approvals and denials are forwarded to the Medical Director for evaluation.

One-time, 14-day course per lifetime when ALL criteria met
Prescriber: endocrinologist or specialist in condition
Dose exceptions reviewed by clinician (Medical Director/Pharmacist)

Denial Risk

Coding and Documentation Noncompliance May Result in Denial

Claims submitted without covered diagnosis or procedure codes per this policy will be denied. Services not submitted in accordance with the policy’s coding and documentation requirements (including use of the most appropriate codes as of the date of service) will be denied as not covered. Providers must include patient‑specific identifying information with documentation.

Background on Tzield and Indication

Tzield (teplizumab‑mzwv) is an anti‑CD3 monoclonal antibody indicated to delay the onset of Stage 3 (clinical) type 1 diabetes in patients aged ≥ 8 years. The approved regimen is a one‑time, per‑lifetime intravenous course administered once daily for 14 days with body‑surface–area dosing escalation and maintenance. Baseline laboratory assessment and prescriber attestations are required because of risks including hematologic and hepatic abnormalities and potential viral reactivation.

Definitions and Key Clinical Terms

inv-22: Stage 2 type 1 diabetes — definition

DefinitionStage 2 type 1 diabetes: presymptomatic autoimmunity with dysglycemia (FPG 100–125 mg/dL; 2‑hour OGTT 140–199 mg/dL; HbA1c 5.7%–6.4% or ≥10% increase in HbA1c)

PopulationPatients ≥ 8 years of age with multiple diabetes‑related autoantibodies but without clinical (Stage 3) diabetes

Clinical relevanceIndication for Tzield is to delay onset of Stage 3 type 1 diabetes in eligible Stage 2 patients

inv-23: Autoantibody positivity — confirmation requirements

Required number of autoantibodiesTwo or more diabetes‑related autoantibodies

Confirmation timingConfirmed on at least two separate occasions (documentation required)

Policy Revision History

2026-02-01material_addition

Baseline hematologic thresholds were added requiring lymphocyte count ≥1,000/mcL; hemoglobin ≥10 g/dL; platelets ≥150,000/mcL; and ANC ≥1,500/mcL (documentation required).

2026-04-16removal

Requirement that the patient have at least one biological relative with type 1 diabetes was removed (first removal entry).

2026-05-01removal_finalized

Removal of the biological-relative requirement was finalized.

Policy Summary

PayerCigna

PolicyTzield (teplizumab-mzwv) for delaying onset of type 1 diabetes

Policy CodePolicy IP0537

Change TypeMaterial revisions to baseline hematologic and hepatic thresholds and prescriber verification requirements

Effective Date5/1/2026

Next Review Date

Key ActionObtain prior authorization and documentation of baseline hematologic and hepatic labs; prescriber must verify the patient has not previously received Tzield.

SourceLink

On This Page

Documentation Required

Baseline Laboratory and Other Documentation Required

Documentation is required where noted in the criteria. Required baseline laboratory documentation must be provided prior to initiation of Tzield and may include chart notes and laboratory test results. Specifically, documentation required includes positive autoantibody testing (at least two diabetes‑related autoantibodies on two separate occasions), dysglycemia testing within the prior 2 months (OGTT, fasting plasma glucose, or HbA1c), and baseline hematologic and hepatic values as detailed in the criteria.

Autoantibodies: ≥2 diabetes‑related autoantibodies positive on two separate occasions (GAD65, IA‑2, ICA, IAA, ZnT8)
Dysglycemia (within prior 2 months): 2‑hour OGTT 140–199 mg/dL OR fasting plasma glucose 100–125 mg/dL OR HbA1c 5.7–<6.5%
Hematologic baseline (documentation required): lymphocytes ≥1,000/mcL; hemoglobin ≥10 g/dL; platelets ≥150,000/mcL; ANC ≥1,500/mcL
Hepatic baseline (documentation required): ALT ≤2×ULN; AST ≤2×ULN; bilirubin ≤1.5×ULN

Denial Risk

Prescriber Verification and Potential Denial Triggers

Prescriber verification is required for certain items: confirmation the patient has not previously received Tzield (verify via claims history; if no claim exists, prescriber must attest no prior receipt), and attestation that the patient does not have listed contraindications or excluded conditions (e.g., active or chronic active infections, laboratory/clinical evidence of acute EBV/CMV). Lack of required verifications or documentation (including baseline labs and prior‑receipt verification) may trigger denial.

Prescriber must verify patient has NOT previously received Tzield (claims check; prescriber attestation if no claim)
Prescriber must attest patient does not have listed contraindications/conditions (e.g., acute EBV/CMV, active serious infection, chronic active infection)
Lack of verification or missing baseline labs may result in denial