Currentmoda_health_plan_incPolicy IC-0687

Tzield (teplizumab-mzwv) (Intravenous) — Coverage Criteria for Stage 2 and Stage 3 Type 1 Diabetes

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Policy governing prior authorization, dosing, administration, and renewal criteria for Tzield (teplizumab-mzwv) for Stage 2 and Stage 3 type 1 diabetes patients under Moda Health Plan Inc.

Policy Summary

Payermoda_health_plan_inc

PolicyTzield (teplizumab-mzwv) (Intravenous) — Coverage Criteria for Stage 2 and Stage 3 Type 1 Diabetes

Policy CodePolicy IC-0687

Change TypeNo material change

Effective DateJan 3, 2023

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

Key ActionObtain prior authorization documenting covered ICD-10 diagnosis, stage, autoantibody and dysglycemia or C‑peptide evidence per criteria before initiating treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14 dosesInitial authorization length (Stage 2)

12 dosesInitial authorization length (Stage 3)

5600Max billable units (Stage 2)

4800

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Currentmoda_health_plan_incPolicy IC-0687

Tzield (teplizumab-mzwv) (Intravenous) — Coverage Criteria for Stage 2 and Stage 3 Type 1 Diabetes

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Policy governing prior authorization, dosing, administration, and renewal criteria for Tzield (teplizumab-mzwv) for Stage 2 and Stage 3 type 1 diabetes patients under Moda Health Plan Inc.

Policy Summary

Payermoda_health_plan_inc

PolicyTzield (teplizumab-mzwv) (Intravenous) — Coverage Criteria for Stage 2 and Stage 3 Type 1 Diabetes

Policy CodePolicy IC-0687

Change TypeNo material change

Effective DateJan 3, 2023

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

Key ActionObtain prior authorization documenting covered ICD-10 diagnosis, stage, autoantibody and dysglycemia or C‑peptide evidence per criteria before initiating treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14 dosesInitial authorization length (Stage 2)

12 dosesInitial authorization length (Stage 3)

5600Max billable units (Stage 2)

4800

Max billable units (Stage 3)

J9381HCPCS billing code

Coverage Criteria for Tzield (teplizumab-mzwv)

Initial Therapy Medical Necessity

Covered when ALL of the following are met:

Universal prerequisites: Member has not received prior therapy with teplizumab; provider will confirm member is up to date with age-appropriate vaccinations prior to initiating therapy; member does not have an active infection (including clinically important localized infections); member has undetectable EBV and CMV viral load (e.g., PCR); member does not have any FDA-labeled contraindications to teplizumab (e.g., immunocompromised or active viral infection); laboratory indices are within specified ranges (lymphocytes ≥1,000/mcL; hemoglobin ≥10 g/dL; platelet count ≥150,000/mcL; absolute neutrophil count ≥1,500/mcL; ALT/AST ≤2× ULN; bilirubin ≤1.5× ULN); provider will confirm timing restrictions for vaccines (no live or live-attenuated within 8 weeks, no inactivated or mRNA within 2 weeks prior to or during treatment); therapy will not be used as a disease-modifying therapy in nonautoimmune dysglycemic conditions; used as single-agent therapy.

Section III

Stage 2 – autoimmune T1D (age-specific antibody and dysglycemia requirements): Member has a confirmed diagnosis of Stage 2 type 1 diabetes of autoimmune origin (not due to insulin resistance, T2D, MODY, LADA, medication- or surgery-related causes) AND will receive treatment to delay onset of Stage 3; for ages ≥1 to <18 years: confirmation of two or more pancreatic islet autoantibodies (GAD65, IAA, IA-2A, ZnT8A, ICA) AND confirmation of dysglycemia without overt hyperglycemia by OGTT or acceptable alternative defined as one of: fasting glucose 100–125 mg/dL; 2-hour postprandial glucose 140–199 mg/dL; intervening postprandial glucose at 30/60/90 minutes ≥200 mg/dL; A1C 5.7–6.4% or ≥10% increase in A1C; for ages ≥18 to <45 years: similar dysglycemia confirmation criteria apply.

Autoantibody and glycemic thresholds listed in policy

Stage 3 – recent diagnosis (ages 8–17): Member has been recently (within the previous 8 weeks) diagnosed with Stage 3 type 1 diabetes; member is 8 to 17 years of age; will receive treatment to delay decline in endogenous insulin production; confirmation of at least one pancreatic islet autoantibody (GAD65, IA-2, ZnT8, ICA, or insulin autoantibodies if obtained within first 14 days of insulin treatment) AND peak C-peptide ≥0.2 pmol/mL on a mixed-meal tolerance test (or acceptable alternative).C-peptide ≥0.2 pmol/mL

Stage 3 specific

Renewal Therapy Medical Necessity

Renewal covered when ALL of the following are met:

Universal renewal prerequisites: Member continues to meet the universal and indication-specific criteria identified in initial approval (Section III); duration of authorization has not been exceeded; absence of unacceptable toxicity from the drug (examples include viral reactivation including EBV/CMV, cytokine release syndrome, serious bacterial or viral infections, lymphopenia, severe hypersensitivity reactions such as serum sickness, angioedema, urticaria, rash, vomiting, bronchospasm).

Section IV

Stage 3 second course timing: For Stage 3, member has not received more than one treatment course AND at least 6 months have elapsed since the initial treatment course; if the second course is delayed, it should be administered within 6 to 12 months after the first treatment course.6–12 months

Section IV

Covered when documented diagnosis and referenced dosing/guidance apply

Coverage is tied to documented Type 1 diabetes diagnoses and referenced dosing/guidance:

Supported coverage conditions: Member has a documented ICD-10 diagnosis within the E10 series (including presymptomatic codes E10.A0 or E10.A2) AND treatment is consistent with the referenced clinical dosing and guidance (e.g., recommended dosing schedule: Day 1: 106 mcg/m2; Day 2: 425 mcg/m2; Days 3–12: 850 mcg/m2; and other guidance cited in package insert and clinical references).

Appendix 1 and References

Coverage does not allow use of teplizumab as a disease‑modifying therapy for dysglycemic conditions that are not autoimmune in origin. Providers must confirm that the requested therapy will not be used for nonautoimmune dysglycemia (for example insulin resistance, type 2 diabetes, MODY, medication‑ or surgery‑related dysglycemia) as a condition of approval.

For Medicare members, applicable National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) take precedence where relevant. The preceding policy language is intended for non‑Medicare coverage determinations; providers should consult the CMS coverage database and any applicable NCD/LCD/LCA when requesting Medicare (Part B) coverage.

Therapy is inappropriate and may be denied when the member has any FDA‑labeled contraindication to teplizumab, an active infection (including clinically important localized infections), detectable EBV or CMV viral load, or laboratory values outside the policy thresholds. Relevant laboratory cutoffs include: lymphocytes <1,000/mcL; hemoglobin <10 g/dL; platelets <150,000/mcL; ANC <1,500/mcL; ALT/AST >2× ULN; and bilirubin >1.5× ULN. Vaccination timing restrictions must also be observed prior to and during treatment.

This section does not list any additional explicit conditions labeled as 'not medically necessary.' Refer to the clinical contraindications and laboratory thresholds above for situations in which treatment would be considered inappropriate.

Billing and Coding

HCPCS Covered CodesHCPCSCovered

J9381

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

NDCNDC

73650-0316-xx

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

Covered ICD-10 CodesICD-10Covered

E10	Type 1 diabetes mellitus
E10.1	Type 1 diabetes mellitus with ketoacidosis
E10.6	Type 1 diabetes mellitus with other specified complications
E10.65	Type 1 diabetes mellitus with hyperglycemia
E10.8	Type 1 diabetes mellitus with unspecified complications
E10.9	Type 1 diabetes mellitus without complications
E10.10	Type 1 diabetes mellitus with ketoacidosis without coma
E10.11	Type 1 diabetes mellitus with ketoacidosis with coma
E10.A0	Type 1 diabetes mellitus, presymptomatic, unspecified
E10.A2	Type 1 diabetes mellitus, presymptomatic, Stage 2

Maximum billable units per treatment course

Maximum billable units — Stage 2 (14-day course)5600 units per 14-day treatment course

Maximum billable units — Stage 3 (12-day course)4800 units per 12-day treatment course

HCPCS unit basisJ9381 (Injection, teplizumab-mzwv, 5 mcg per billable unit) — used to calculate total billable units

Dosing schedule — summary

Day 1106 mcg/m2

Day 2425 mcg/m2

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior authorization duration and renewal rules

Initial prior authorization approvals are limited to 14 doses for Stage 2 and 12 doses for Stage 3 per the policy. For Stage 3, a single renewal may be granted for one additional 12-dose treatment course provided the second course is given at least 6 months after the initial course (if delayed, it should be administered within 6–12 months).

Stage 2 initial authorization: 14 doses.
Stage 3 initial authorization: 12 doses.
Stage 3 renewal: may be renewed for one additional 12-dose course; at least 6 months after the initial course and, if delayed, administered within 6–12 months.
Renewal decisions require continued meeting of renewal criteria (absence of unacceptable toxicity and ongoing fulfillment of initial criteria).

Prior Authorization

Prior authorization requirement and required documentation

Prior authorization is required and decisions are informed by the NQTL factors; requests must include clinical documentation supporting the covered ICD-10 diagnosis from the E10 series. Providers must document indication-specific clinical criteria described in the policy to support PA approval.

Definitions and Clinical Thresholds

Dysglycemia without overt hyperglycemia — definition

Definition — dysglycemia without overt hyperglycemiaConfirmed by OGTT or acceptable alternative with one of: fasting glucose 100–125 mg/dL; 2-hour postprandial plasma glucose 140–199 mg/dL; an intervening postprandial glucose at 30, 60, or 90 minutes ≥200 mg/dL; A1C 5.7–6.4% or ≥10% increase in A1C.

Acceptable alternative when OGTT unavailableAlternative diagnostic methods per policy may be used to confirm dysglycemia without overt hyperglycemia (same numeric thresholds apply).

Age-specific noteCriteria apply for pediatric and adult staging as specified in the policy (see Stage-specific coverage criteria).

C‑peptide threshold for Stage 3 (ages 8–17)

C‑peptide threshold (Stage 3, ages 8–17)Peak C‑peptide ≥0.2 pmol/mL on a mixed‑meal tolerance test (MMTT)

Acceptable alternative

Background

Tzield (teplizumab‑mzwv) is an anti‑CD3 monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes or slow decline in beta‑cell function in selected Stage 2 and Stage 3 patients. Eligibility for coverage is tied to an autoimmune etiology (documented pancreatic islet autoantibodies), staging and dysglycemia/C‑peptide criteria, and adherence to safety precautions (vaccination timing, absence of active infection, and laboratory thresholds).

Revision History

2023-01-03policy_origin

Policy date of origin (document established).

2023-01periodic_review

Policy reviewed (Dates Reviewed list includes 01/2023).

2024-01periodic_review

Policy reviewed (Dates Reviewed list includes 1/2024).

Policy Summary

Payermoda_health_plan_inc

PolicyTzield (teplizumab-mzwv) (Intravenous) — Coverage Criteria for Stage 2 and Stage 3 Type 1 Diabetes

Policy CodePolicy IC-0687

Change TypeNo material change

Effective DateJan 3, 2023

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

Key ActionObtain prior authorization documenting covered ICD-10 diagnosis, stage, autoantibody and dysglycemia or C‑peptide evidence per criteria before initiating treatment.

SourceLink

On This Page

Include an appropriate covered ICD-10 code from the E10 series (see Appendix 1).
Provide clinical evidence that meets the policy's indication-specific criteria (stage, autoantibody status, dysglycemia or C‑peptide thresholds as applicable).

Note

Single‑agent disease‑modifying therapy requirement

Therapy must be used as a single-agent disease-modifying therapy and not combined with other disease‑modifying agents or used for nonautoimmune dysglycemic conditions.

Provider must confirm therapy will not be used as a disease‑modifying therapy in nonautoimmune dysglycemic conditions.
Policy specifies 'Used as single agent therapy' as a condition for approval.

Step Therapy

Step therapy — no required prior steps

There is no explicit step therapy sequence; the policy applies prior authorization considerations rather than mandating step edits, based on the NQTL assessment (indication, safety/efficacy, cost).

NQTL checklist indicates PA is used to manage indication, safety/efficacy, and cost rather than step requirements.

Documentation Required

Clinical documentation required to support PA

To support a PA request, include documentation of confirmed diagnosis and stage (Stage 2 or Stage 3 T1D), evidence the diagnosis is autoimmune in origin, autoantibody test results, dysglycemia confirmation (or C‑peptide for Stage 3), and information about vaccinations and prior teplizumab exposure.

Confirmed Stage 2 or Stage 3 diagnosis and statement that diagnosis is autoimmune (exclude T2D, MODY, LADA, medication- or surgery-related causes).
Autoantibody results: number and type per age-specific requirements (e.g., GAD65, IAA, IA‑2A, ZnT8A, ICA).
Dysglycemia confirmation via OGTT or acceptable alternative with specified glucose/A1C thresholds, or for Stage 3 (ages 8–17) peak C‑peptide ≥0.2 pmol/mL.
Record of vaccination status and confirmation member has not received prior teplizumab.

Documentation Required

Required documented diagnosis (covered ICD-10 codes)

The PA request must list a supporting ICD-10 diagnosis from the policy's covered codes (E10.*), including presymptomatic codes such as E10.A0 and E10.A2 where applicable.

Examples of acceptable diagnosis codes include E10, E10.9, E10.A0, and E10.A2 (see Appendix 1 for full list).
Ensure the submitted ICD-10 code aligns with the documented stage and clinical evidence.

Denial Risk

Denial risks: prior therapy, infections, contraindications, and lab thresholds

Requests may be denied if the member has prior teplizumab exposure, active infection, detectable EBV or CMV, FDA‑labeled contraindications, or laboratory values outside specified thresholds.

Prior therapy with teplizumab disqualifies the member for initial approval.
Active infection, including clinically important localized infections, or detectable EBV/CMV viral load (PCR) is a denial risk.
Laboratory thresholds that raise denial risk: lymphocytes <1,000/mcL; hemoglobin <10 g/dL; platelets <150,000/mcL; ANC <1,500/mcL; ALT or AST >2× ULN; bilirubin >1.5× ULN.
FDA‑labeled contraindications (e.g., immunocompromised or active viral infection) are exclusionary.

Billing Rule

NQTL factors that inform PA decisions

Prior authorization decisions are informed by the NQTL assessment: indication, safety and efficacy, and drug cost were identified as factors warranting PA consideration.

NQTL checklist conclusions: Consider for PA — Indication = Yes; Safety and efficacy = Yes; Cost of drug = Yes; Potential for misuse/abuse = No.

If MMTT is not available, an alternative method for measuring peak C‑peptide ≥0.2 pmol/mL may be appropriate per policy

Stage and timing requirementApplies to members recently (within previous 8 weeks) diagnosed with Stage 3 T1D aged 8–17

Dosing schedule (definitions)

Day 1 dosing106 mcg/m2

Day 2 dosing425 mcg/m2

Days 3–12 dosing850 mcg/m2 per day

2025-01periodic_review

Policy reviewed (Dates Reviewed list includes 1/2025).

2026-01periodic_review

Policy reviewed (Dates Reviewed list includes 01/2026).

2026-05periodic_review

Policy reviewed (Dates Reviewed list includes 05/2026).

2026-07-01last_reviewLatest

Most recent policy review and last review date recorded on the document header.