CurrentCareSourcePolicy N/A

Tzield (teplizumab-mzwv) — Prior Authorization and Medical Necessity for Delay of Stage 3 Type 1 Diabetes

This policy governs prior authorization and medical necessity criteria for Tzield (teplizumab-mzwv) IV infusion to delay onset of Stage 3 (clinical) type 1 diabetes in eligible patients and applies to CareSource members and their providers in North Carolina.

Policy Summary

PayerCareSource

PolicyTzield (teplizumab-mzwv) — Prior Authorization and Medical Necessity for Delay of Stage 3 Type 1 Diabetes

Policy CodePolicy N/A

Change TypeRevised glycemic criteria

Effective DateN/A

Next Review DateNov 13, 2024

Key ActionObtain documentation of at least two positive type 1 diabetes autoantibodies on two occasions and glycemic testing within 2 months prior to authorization.

SourceLink

POLICY UPDATE CHANGES

Glycemic criteria for Stage 2 type 1 diabetes were updated: fasting plasma glucose threshold modified to >= 100 to 126 mg/dL and HbA1c 5.7% to <6.5% was added as an option; an intervening 30/60/90-minute postprandial glucose criterion was removed.

one-time 14-dayduration

>= 8 yrsmin age

>=2 on 2 occasionsautoantibodies

ANC≥1500; Hb≥10hematologic thresholds

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ALT/AST <2x; bilirubin <1.5xhepatic thresholds

Recommended Authorization Criteria

Initial Therapy (FDA-Approved Indication: Delay onset of Stage 3 Type 1 Diabetes)

Covered when ALL of the following are met

Eligibility: Patient is >= 8 years of age; does NOT have clinical/Stage 3 type 1 diabetes; does NOT have type 2 diabetes; patient has at least one biological relative with a diagnosis of type 1 diabetes; medication will be prescribed by an endocrinologist

From policy prerequisites; documentation required

Autoantibody requirement: Patient has tested positive for at least TWO type 1 diabetes-related autoantibodies on two separate occasions (at least two positive autoantibodies per occasion). Autoantibodies include anti-GAD65, anti-IA-2, islet-cell autoantibody (ICA), insulin autoantibody (micro insulin/IAA), and anti-ZnT8.>=2 autoantibodies on two occasions

Documentation required (reports of antibody testing)

Glycemic evidence of dysglycemia (Stage 2) within prior 2 months: One of: 2-hour OGTT glucose 140 to 200 mg/dL; fasting plasma glucose 100 to 126 mg/dL; OR HbA1c 5.7% to 6.5% (all tests must be within the preceding 2 months).see values

Documentation required (lab reports)

Baseline hematologic and hepatic labs: At baseline prior to initiation, patient must meet hematologic thresholds (lymphocyte count >= 1,000/mcL; hemoglobin >= 10 g/dL; platelet count >= 150,000/mcL; absolute neutrophil count >= 1,500/mcL) AND hepatic thresholds (ALT < 2x ULN; AST < 2x ULN; bilirubin < 1.5x ULN).see thresholds

Documentation required (baseline lab results)

Infection and prior exposure: No laboratory or clinical evidence of acute Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection; no active serious infection; no chronic active infection (other than localized skin infection); and patient has not previously received Tzield.

Verification required by prescriber and claims review

Dosing and duration: Approve a one-time, per-lifetime course: teplizumab administered intravenously per body surface area across 14 consecutive days as specified in policy (daily mcg/m2 dosing per Days 1–14).14-day regimen

Specific per-day mcg/m2 dosing regimen required as listed in policy

Treatment with Tzield (teplizumab) for patients who have clinical/Stage 3 type 1 diabetes (established symptomatic type 1 diabetes) is not recommended for approval.

Use of Tzield in patients with type 2 diabetes is explicitly excluded from coverage.

Coverage for Tzield is not recommended for any circumstances that are not specifically listed in the Recommended Authorization Criteria; criteria will be updated as new published data become available.

Drug and Clinical Thresholds / Codes

DrugNDC

teplizumab-mzwv

Tzield (drug name as listed)

Hematologic and hepatic baseline inclusion thresholds — required prior to initiation

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

Lymphocyte count>= 1,000 lymphocytes/mcL

Hemoglobin (Hb)>= 10 g/dL

Platelet count>= 150,000 platelets/mcL

Alanine aminotransferase (ALT)< 2 x ULN

Aspartate aminotransferase (AST)< 2 x ULN

Total bilirubin< 1.5 x ULN

What Providers Must Do

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Tzield. Approvals are provided for the duration noted in the policy and require the medication to be prescribed by or in consultation with a physician who specializes in the condition treated (endocrinologist). Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Approvals are one-time per lifetime 14-day course when criteria met.
Prescription must be by or in consultation with an endocrinologist.
Dose-exception requests reviewed case-by-case by clinician.

Step Therapy

Step therapy and dosing exceptions

No step therapy requirements are specified in the policy. Requests for dosing outside the established 14-day body-surface-area dosing regimen will be considered on a case-by-case basis by a clinician.

Established regimen: specified mcg/m2 dosing over 14 consecutive days (policy lists daily BSA-based doses).

Clinical Background

Tzield (teplizumab) is an anti-CD3 monoclonal antibody administered by intravenous infusion as a one-time, 14-day course intended to delay progression to symptomatic (Stage 3) type 1 diabetes in eligible patients. Administration requires screening with islet autoantibody and glycemic testing and assessment of baseline hematologic and hepatic laboratories prior to initiation.

Key Definitions

Definitions — Stages of Type 1 Diabetes

Stage 1 (presymptomatic)Presence of multiple islet autoantibodies with normal glycemia (no dysglycemia)

Stage 2 (presymptomatic with dysglycemia)Presence of multiple islet autoantibodies plus dysglycemia below overt diabetes thresholds (FPG 100–125 mg/dL; 2‑hr OGTT 140–199 mg/dL; or HbA1c 5.7%–6.4%) — meets Stage 2 glycemic criteria for consideration of delay therapy

Stage 3 (clinical/type 1 diabetes)Overt hyperglycemia with symptoms meeting diagnostic thresholds (FPG >=126 mg/dL; 2‑hr OGTT >=200 mg/dL; or HbA1c >=6.5%, or classic symptoms with glucose >=200 mg/dL)

Islet autoantibodies — tested markers and interpretation

Insulin autoantibody (IAA)Autoantibody to insulin; common first autoantibody in young children; not informative in those treated with insulin

Glutamic acid decarboxylase autoantibody (GADA / anti‑GAD65)

Policy Summary

PayerCareSource

PolicyTzield (teplizumab-mzwv) — Prior Authorization and Medical Necessity for Delay of Stage 3 Type 1 Diabetes

Policy CodePolicy N/A

Change TypeRevised glycemic criteria

Effective DateN/A

Next Review DateNov 13, 2024

Key ActionObtain documentation of at least two positive type 1 diabetes autoantibodies on two occasions and glycemic testing within 2 months prior to authorization.

SourceLink

On This Page

Glycemic criteria for Stage 2 (choose one; testing must be within prior 2 months)

2-hour OGTT (oral glucose tolerance test)2-hour postprandial glucose 140 to 200 mg/dL within the preceding 2 months

Fasting plasma glucose (plasma)100 to 126 mg/dL within the preceding 2 months

Hemoglobin A1c (HbA1c)>= 5.7% to < 6.5% within the preceding 2 months

Any deviation from that dosing requires individual clinical review.

Documentation Required

Required documentation

Documentation is required where noted and may include chart notes, laboratory tests, claims records, and/or other information. Required documentation must demonstrate autoantibody and glycemic testing, baseline hematologic and hepatic labs meeting thresholds, verification of no prior Tzield exposure, and family history.

Evidence of at least TWO type 1 diabetes–related autoantibodies on two separate occasions (at least two positive autoantibodies per occasion) [documentation required].
Glycemic testing within the preceding 2 months meeting one of: 2-hour OGTT 140–200 mg/dL, fasting plasma glucose 100–126 mg/dL, or HbA1c 5.7% to <6.5% [documentation required].
Baseline hematologic labs: lymphocytes ≥1,000/mcL; hemoglobin ≥10 g/dL; platelets ≥150,000/mcL; ANC ≥1,500/mcL [documentation required].
Baseline hepatic labs: ALT and AST <2× ULN; bilirubin <1.5× ULN [documentation required].
Verification that the patient has not previously received Tzield (claims review or prescriber attestation).
Documentation of at least one biological relative with type 1 diabetes.

Denial Risk

Denial triggers

Requests that do not meet the Recommended Authorization Criteria or that fall into situations listed as not recommended (for example, patients with clinical/Stage 3 type 1 diabetes or type 2 diabetes) will be denied.

Treatment of patients with clinical (Stage 3) type 1 diabetes is not recommended for approval.
Use in patients with type 2 diabetes is excluded.
Any request lacking required documentation (autoantibodies, glycemic testing, baseline labs, verification of no prior Tzield) may be denied.

Autoantibody to GAD; common in childhood and adulthood; associated with slower progression

Insulinoma antigen‑2 autoantibody (IA‑2 / IA‑2A)Autoantibody to IA‑2; associated with more advanced islet autoimmunity and faster progression

Islet cell autoantibodies (ICA / ICA512)Detected by indirect immunofluorescence against islet cells; adds risk information (often used in research)

Zinc transporter 8 autoantibody (ZnT8 / anti‑ZnT8)Autoantibody to ZnT8; can improve risk stratification when present