CurrentViva HealthPolicy IC-0687

Tzield (teplizumab-mzwv) — Delay onset of Stage 3 Type 1 Diabetes (coverage criteria)

Covers prior authorization requirements, dosing, eligibility, and coverage criteria for Tzield (teplizumab-mzwv) when used to delay onset of Stage 3 type 1 diabetes (Stage 2 presymptomatic disease) for Viva Health members.

Policy Summary

PayerViva Health

PolicyTzield (teplizumab) — Delay onset of Stage 3 Type 1 Diabetes

Policy CodePolicy IC-0687

Change TypeNo material changes

Effective Date

Next Review DateMay 5, 2026

Key ActionObtain prior authorization for a single 14‑dose (5600-unit) course and document age ≥1 year, no prior teplizumab exposure, up-to-date vaccinations, absence of active infection, undetectable EBV/CMV PCR, and required safety labs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14 dosescourse length

5600total units

J9381HCPCS

E10.A2diagnosis code

≥1 yrmin age

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Initial Therapy (Delay onset of Stage 3 T1DM)

Covered when ALL of the following are met:

Eligibility and safety: Member is at least 1 year of age; member has not received prior therapy with teplizumab; provider confirms member is up to date with age-appropriate vaccinations prior to initiating therapy; no active infection (including clinically important localized infections); undetectable EBV and CMV viral load by PCR; member meets required laboratory safety thresholds: lymphocytes ≥1,000/mcL; hemoglobin ≥10 g/dL; platelets ≥150,000/mcL; absolute neutrophil count (ANC) ≥1,500/mcL; ALT and AST ≤2× ULN; bilirubin ≤1.5× ULN; provider confirms member will not receive live or live-attenuated vaccines within 8 weeks or inactivated/mRNA vaccines within 2 weeks prior to or during treatment; used as single-agent therapy.see node text

Safety labs required prior to initiation

Diagnosis — indication: Member will receive treatment to delay onset of Stage 3 type 1 diabetes AND has a confirmed diagnosis of Stage 2 type 1 diabetes defined by: presence of two or more pancreatic islet autoantibodies (GAD65, IAA, IA-2A, ZnT8A, or ICA) AND dysglycemia without overt hyperglycemia documented by OGTT or alternative criteria (fasting glucose 100-125 mg/dL; 2-hour postprandial 140-199 mg/dL; an intervening postprandial ≥200 mg/dL at 30, 60, or 90 minutes; A1C 5.7–6.4% or ≥10% increase in A1C).see node text

FDA-approved indication to delay Stage 3 T1DM

Renewal Criteria

Renewal / Continuation criteria:

Renewal: Authorization may NOT be renewed; duration of authorization must not be exceeded (initial prior authorization is valid for a single 14-dose course).14 doses

No repeat courses allowed per policy

Use of teplizumab (Tzield) is not supported for non‑autoimmune forms of diabetes. Specifically, coverage excludes use for Type 2 diabetes mellitus, genetic forms of diabetes such as MODY, latent autoimmune diabetes in adults (LADA) when not meeting autoimmune Stage 2 criteria, and diabetes secondary to medication‑ or surgery‑induced causes. The provider must confirm the member’s diagnosis is of autoimmune origin consistent with Stage 2 Type 1 diabetes before therapy is authorized.

Treatment with teplizumab is not supported for members who do not meet the defined Stage 2 autoimmune presymptomatic criteria or who fail required safety and laboratory screening. Prior authorization is only provided when all initial approval conditions are met (including age ≥1 year, no prior teplizumab exposure, up‑to‑date vaccinations, absence of active infection, undetectable EBV/CMV PCR, and required laboratory indices within specified thresholds); members who do not satisfy these requirements are not eligible for coverage.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J9381

Injection, teplizumab-mzwv, 5 mcg; 1 billable unit = 5 mcg

NDCNDC

73650-0316-xx

Tzield 2 mg/2 mL solution for injection single-dose vial

Covered Diagnosis CodesICD-10Covered

E10.A2

Type 1 diabetes mellitus, presymptomatic, Stage 2

inv-08: Total units per course

Total units per 14-day course5600 billable units over a 14-day course of therapy

HCPCS unit definitionBilling units reported as HCPCS units (policy threshold applies to total HCPCS units over the course)

Course lengthSingle course = 14 consecutive days (see dosing schedule)

inv-09: Infusion minimum duration

Minimum infusion duration (age ≥8 years)30 minutes

Minimum infusion duration (age 1 to <8 years)2 hours

Dosing schedule noteTzield is administered once daily for 14 consecutive days; calculate dose using BSA

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval is provided for a single 14‑day (14‑dose) course (5600 billable units). No renewals or repeat authorizations will be permitted.

Initial authorization: single 14‑day course (14 doses; 5600 billable units).
Renewal: Not permitted.

Documentation Required

Documentation and Pre‑treatment Screening

Document the following BEFORE initiating therapy: the member is ≥1 year of age; the member has not received prior therapy with teplizumab; the member is up to date with age‑appropriate vaccinations per current guidelines; absence of active infection (including clinically important localized infections); undetectable EBV and CMV viral load (e.g., PCR); required baseline laboratory values within acceptable ranges (lymphocytes ≥1,000/mcL; hemoglobin ≥10 g/dL; platelets ≥150,000/mcL; absolute neutrophil count ≥1,500/mcL; ALT/AST ≤2×ULN; bilirubin ≤1.5×ULN); confirmation that live or live‑attenuated vaccines will not be given within 8 weeks (and inactivated or mRNA vaccines within 2 weeks) prior to or during treatment; diagnosis consistent with autoimmune Stage 2 type 1 diabetes (per diagnostic autoantibodies and dysglycemia criteria); and intent to use as single‑agent therapy.

Age: ≥1 year.
No prior teplizumab exposure.
Up‑to‑date with age‑appropriate vaccinations per current guidelines.
No active infection; undetectable EBV and CMV PCR viral load.
Baseline labs within acceptable ranges: lymphocytes ≥1,000/mcL; hemoglobin ≥10 g/dL; platelets ≥150,000/mcL; ANC ≥1,500/mcL; ALT/AST ≤2×ULN; bilirubin ≤1.5×ULN.
Vaccine timing: no live/live‑attenuated vaccines within 8 weeks, and avoid inactivated/mRNA vaccines within 2 weeks, prior to or during treatment.
Diagnosis: autoimmune Stage 2 type 1 diabetes as documented by required autoantibodies and dysglycemia criteria.
Therapy: to be used as single‑agent therapy.

Denial Risk

Denial‑Risk Conditions

Denial or non‑authorization may result if any of the following are present: prior treatment with teplizumab; active infection or clinically significant localized infection; detectable EBV or CMV viral load; out‑of‑range baseline laboratory indices (see documentation callout); recent receipt of contraindicated vaccines within specified windows; diagnosis inconsistent with autoimmune Stage 2 type 1 diabetes; or use in combination with other immunomodulatory agents.

Prior teplizumab exposure (prior therapy) — denial risk.
Active infection or clinically important localized infections.
Detectable EBV or CMV PCR viral load.
Laboratory values outside required ranges (see documentation).
Receipt of live/live‑attenuated vaccine within 8 weeks or inactivated/mRNA vaccine within 2 weeks prior to or during treatment.
Diagnosis not consistent with autoimmune Stage 2 type 1 diabetes.
Use in combination with other agents (not single‑agent therapy).

Step Therapy

No step therapy requirements are specified for teplizumab; it is required to be used as single‑agent therapy when authorized.

No step therapy specified.
Teplizumab must be used as single‑agent therapy when approved.

Background

Teplizumab (Tzield) is indicated to delay the onset of Stage 3 Type 1 diabetes in individuals with Stage 2 presymptomatic disease characterized by two or more pancreatic islet autoantibodies (GAD65, IAA, IA‑2A, ZnT8A, ICA) plus evidence of dysglycemia without overt hyperglycemia by oral glucose tolerance testing or accepted alternatives (examples: fasting glucose 100–125 mg/dL; 2‑hour postprandial 140–199 mg/dL; an intervening postprandial ≥200 mg/dL; A1C 5.7–6.4% or ≥10% increase in A1C). Eligibility also requires meeting safety criteria (age ≥1 year, no active infection, undetectable EBV/CMV PCR, and prespecified laboratory thresholds) and use as single‑agent therapy.

Definitions and Diagnostic Criteria

inv-15: Stage 2 T1DM

DefinitionStage 2 type 1 diabetes (T1DM) — presymptomatic disease in which the member will receive treatment to delay onset of Stage 3 T1DM

Clinical characterizationCharacterized by multiple islet autoantibodies and dysglycemia without overt hyperglycemia

Relation to indicationStage 2 is the FDA‑approved indication for teplizumab to delay progression to Stage 3 T1DM

inv-16: Confirmed Stage 2 diagnosis criteria

Autoantibody requirementPresence of two or more pancreatic islet cell autoantibodies (GAD65, IAA, IA-2A, ZnT8A, ICA)

Dysglycemia requirementDysglycemia without overt hyperglycemia demonstrated by OGTT or alternative criteria (fasting 100–125 mg/dL; 2‑hour 140–199 mg/dL; intervening postprandial ≥200 mg/dL; A1C 5.7–6.4% or ≥10% increase in A1C)

Combined diagnostic standardBoth criteria (≥2 autoantibodies AND dysglycemia without overt hyperglycemia) are required to confirm Stage 2 diagnosis

OpenPayer

Tzield (teplizumab-mzwv) — Delay onset of Stage 3 Type 1 Diabetes (coverage criteria)

Coverage Criteria for Tzield (teplizumab)

Coding and Billing

Provider Requirements and Actions

Background

Definitions and Diagnostic Criteria