CurrentConnectiCarePolicy C24729-A

Tzield (teplizumab-mzwv) Coverage Criteria

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This policy governs prior authorization and coverage of intravenous Tzield (teplizumab-mzwv) to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients age 8 years and older with Stage 2 type 1 diabetes. It applies to providers requesting coverage under the member's applicable pharmacy or medical benefit.

Policy Summary

PayerConnectiCare

PolicyTzield (teplizumab-mzwv) Coverage Criteria

Policy CodePolicy C24729-A

Change TypeNo material clinical or coverage changes

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

Key ActionObtain prior authorization for the initial 14-day Tzield course; one course is allowed per member lifetime.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8+Minimum age for coverage

2Positive pancreatic islet autoantibodies required

60 daysMaximum age of oral glucose tolerance test

14 daysOne intravenous treatment course

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CurrentConnectiCarePolicy C24729-A

Tzield (teplizumab-mzwv) Coverage Criteria

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Policy Summary

PayerConnectiCare

PolicyTzield (teplizumab-mzwv) Coverage Criteria

Policy CodePolicy C24729-A

Change TypeNo material clinical or coverage changes

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

Key ActionObtain prior authorization for the initial 14-day Tzield course; one course is allowed per member lifetime.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8+Minimum age for coverage

2Positive pancreatic islet autoantibodies required

60 daysMaximum age of oral glucose tolerance test

14 daysOne intravenous treatment course

3 monthsInitial authorization duration

Stage 2 T1DCovered indication

Coverage Criteria

Initial therapy: delay onset of Stage 3 type 1 diabetes

Covered when all of the following are met:

Initial therapy requirements

Covered population and indication: The member is age 8 years or older and has Stage 2 type 1 diabetes; Tzield is indicated to delay onset of Stage 3 type 1 diabetes.Age 8 years or older
Stage 2 type 1 diabetes confirmation: Stage 2 type 1 diabetes is confirmed by two positive pancreatic islet autoantibodies.Two positive autoantibodies
Acceptable antibodies include GAD65, IAA, IA-2A, ZnT8A, and ICA.
Dysglycemia documentation: The member has dysglycemia without overt hyperglycemia documented by an oral glucose tolerance test within the last 60 days; an alternative diagnostic method may be appropriate if an oral glucose tolerance test is unavailable.Oral glucose tolerance test within the last 60 days
Dysglycemia must meet the policy glucose thresholds.
Diabetes type exclusion: The member's clinical history does not suggest type 2 diabetes.
Qualified prescriber: The drug is prescribed by or in consultation with a board-certified endocrinologist.Board-certified endocrinologist
Consultation notes are required when prescribed in consultation.

Stage 2 Type 1 Diabetes

Covered for the labeled indication:

Tzield labeled indication: The patient has Stage 2 type 1 diabetes and is an adult or pediatric patient aged 8 years or older.Age 8 years or older

Tzield is indicated to delay onset of Stage 3 type 1 diabetes.

No compendial approved off-label uses are identified for Tzield (teplizumab-mzwv).

Continuation therapy is not applicable. Prior authorization applies to the initial course, with one 14-day course per member lifetime and no continuation authorization specified.

Avoid Tzield during pregnancy and for at least 30 days before a planned pregnancy.

Tzield is not recommended when any specified laboratory abnormality is present: lymphocyte count less than 1,000 lymphocytes/mcL, hemoglobin less than 10 g/dL, platelet count less than 150,000/mcL, absolute neutrophil count less than 1,500/mcL, ALT or AST greater than 2 times the upper limit of normal, or bilirubin greater than 1.5 times the upper limit of normal.

Tzield is not recommended when there is laboratory or clinical evidence of acute Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection.

Tzield is not recommended in patients with an active serious infection or chronic active infection, other than a localized skin infection.

Uses of Tzield other than the covered labeled indication are considered experimental or investigational and follow the payer's off-label policy.

Coding and Dysglycemia Documentation

HCPCS CodeHCPCS

J9381

Injection, teplizumab-mzwv, 5 mcg

Fasting glucose

Threshold100 to 125 mg/dL

Equivalent range5.6 to 6.9 mmol/L

MeasurementFasting glucose

2-hour postprandial plasma glucose

Lower thresholdAt least 140 mg/dL

Upper thresholdLess than 200 mg/dL

Equivalent range7.8 mmol/L to less than 11.1 mmol/L

Provider Submission and Decision Considerations

Prior Authorization

Initial Authorization and Lifetime Course Limit

Obtain prior authorization before initiating Tzield. Approval is limited to an initial 3-month authorization and one 14-day course per member lifetime; continuation therapy is not applicable.

Lifetime limit: one 14-day treatment course per member.
Authorization period: 3 months.

Documentation Required

Medical Records and Supporting Documentation

Be prepared to submit additional documentation requested for coverage review, quality improvement, or fraud, waste, and abuse prevention. Records must support medical necessity, non-investigational use, and services within the member’s benefits.

Patient medical records and relevant test results.

Disease Progression Background

Type 1 diabetes progresses through three stages. Stage 1 is marked by diabetes-related pancreatic islet autoantibodies before dysglycemia or overt hyperglycemia. Stage 2 includes dysglycemia before overt hyperglycemia and symptomatic, insulin-requiring disease. Stage 3 is clinical type 1 diabetes, with elevated blood glucose, symptoms, and the need for insulin. Tzield is a CD3-directed antibody intended to delay progression from Stage 2 to Stage 3 and is administered by intravenous infusion once daily for 14 days.

Type 1 Diabetes Definitions

Stage 1 type 1 diabetes

Disease stageStage 1 type 1 diabetes

Defining findingAppearance of pancreatic islet autoantibodies

Disease statusOccurs before dysglycemia or overt hyperglycemia

Stage 2 type 1 diabetes

Disease stageStage 2 type 1 diabetes

Clinical statusPresymptomatic type 1 diabetes

Disease progressionDysglycemia occurs before overt hyperglycemia and symptomatic insulin-requiring disease

Initial Tzield Therapy

Initial Tzield Course

Initial therapy is covered when all policy criteria are met:

Initial Tzield therapy

Age and indication: The member is age 8 years or older and has Stage 2 type 1 diabetes; treatment is intended to delay onset of Stage 3 type 1 diabetes.Age 8 years or older
Autoantibody confirmation: Two positive pancreatic islet autoantibodies are documented.Two positive antibodies
Examples include GAD65, IAA, IA-2A, ZnT8A, and ICA.
Dysglycemia testing:

Dose and Course Limits

Tzield (teplizumab-mzwv)

MedicationTzield (teplizumab-mzwv)

Course limitOne course

Lifetime limitPer member lifetime

Tzield (teplizumab-mzwv)

MedicationTzield (teplizumab-mzwv)

Treatment dayDay 1

Dose65 mcg/m2

Administration Site and Method

Billing Rule

Use a non-hospital infusion location

For pharmacy or medical benefit coverage, administer the infused medication in a non-hospital facility-based location.

Billing Rule

Administer each dose by IV infusion

Administer Tzield by intravenous infusion over a minimum of 30 minutes once daily for 14 days.

Policy Summary

PayerConnectiCare

PolicyTzield (teplizumab-mzwv) Coverage Criteria

Policy CodePolicy C24729-A

Change TypeNo material clinical or coverage changes

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

Key ActionObtain prior authorization for the initial 14-day Tzield course; one course is allowed per member lifetime.

SourceLink

On This Page

Intervening postprandial glucose

Glucose valueGreater than 200 mg/dL

Measurement times30, 60, or 90 minutes postprandial

Required occasionsTwo occasions

Oral glucose tolerance test recency

Required testOral glucose tolerance test

RecencyWithin the last 60 days

AlternativeAn alternative method may be appropriate when an oral glucose tolerance test is unavailable

Credentials of the provider ordering or performing the drug or service.

Documentation Required

Stage 2 Type 1 Diabetes Evidence

Document Stage 2 type 1 diabetes with two positive pancreatic islet autoantibodies, dysglycemia without overt hyperglycemia, and a clinical history that does not suggest type 2 diabetes.

Accepted autoantibodies include GAD65, IAA, IA-2A, ZnT8A, and ICA.
Document the qualifying dysglycemia criteria and supporting clinical history.

Documentation Required

Recent Dysglycemia Testing

Provide an oral glucose tolerance test performed within the last 60 days to document dysglycemia without overt hyperglycemia. If an oral glucose tolerance test is unavailable, an appropriate alternative diagnostic method may be considered.

Dysglycemia may include fasting glucose 100–125 mg/dL, 2-hour postprandial glucose at least 140 and less than 200 mg/dL, or qualifying intervening postprandial glucose results on two occasions.

Documentation Required

Endocrinology Prescriber Documentation

Ensure Tzield is prescribed by, or in consultation with, a board-certified endocrinologist. When prescribed in consultation, submit the endocrinology consultation notes with the initial authorization request.

Include documentation of the endocrinologist’s board certification when requested.
Submit consultation notes with the initial request when the prescriber is not the endocrinologist.

Documentation Required

Member-Specific Dosing Data

Include the member-specific measurement required for medical-necessity review when dosing is based on weight, body surface area, or another individualized measurement.

Provide current weight, body surface area, or the other measurement used for dosing.

Denial Risk

Insufficient Supporting Documentation

Incomplete or insufficient documentation may result in denial or other action if it does not support medical necessity, non-investigational use, benefit eligibility, or appropriate billing practices.

Submit records and test results that substantiate the requested indication.
Ensure documentation supports use within the member’s covered benefits.

Denial Risk

Stage 2 Type 1 Diabetes Criteria Not Met

Coverage is at risk when the required Stage 2 type 1 diabetes evidence is not confirmed. The request must document two positive pancreatic islet autoantibodies and qualifying dysglycemia without overt hyperglycemia.

Confirm two positive pancreatic islet autoantibodies.
Provide qualifying dysglycemia testing, generally using an oral glucose tolerance test within the last 60 days or an appropriate alternative.

Denial Risk

Age or Indication Mismatch

Tzield is indicated for adults and pediatric patients aged 8 years and older with Stage 2 type 1 diabetes to delay the onset of Stage 3 type 1 diabetes. Requests outside the age or indication criteria may be denied.

Member must be at least 8 years old.
Document Stage 2 type 1 diabetes and the labeled prevention indication.

Denial Risk

Non-Labeled Use

All other uses of Tzield are considered experimental or investigational and are subject to the payer’s Off-Label policy.

Review the applicable Off-Label policy for non-labeled requests.

Denial Risk

Pregnancy, Laboratory, or Infection Exclusions

Assess pregnancy status, laboratory values, vaccination considerations, and infection status before treatment. Avoid use during pregnancy and for at least 30 days before a planned pregnancy.

Do not use with lymphocytes <1,000/mcL, hemoglobin <10 g/dL, platelets <150,000/mcL, or absolute neutrophils <1,500/mcL.
Do not use with ALT or AST >2 times ULN or bilirubin >1.5 times ULN.
Avoid treatment with acute EBV or CMV infection, active serious infection, or chronic active infection other than localized skin infection.
Complete age-appropriate vaccinations before treatment and avoid concurrent live, inactivated, and mRNA vaccines.

Billing Rule

Dosing Schedule Restrictions

Do not administer two Tzield doses on the same day. If an infusion is missed, resume treatment by administering all remaining doses on consecutive days to complete the 14-day course.

The treatment course must contain 14 doses administered according to the required schedule.
Missed infusions require consecutive-day completion of the remaining doses.

Stage 3 type 1 diabetes

Disease stageStage 3 type 1 diabetes

Clinical findingsElevated blood glucose and symptoms

Treatment requirementInsulin is required

Dysglycemia without overt hyperglycemia

Fasting glucose100 to 125 mg/dL (5.6 to 6.9 mmol/L)

2-hour postprandial plasma glucoseAt least 140 mg/dL (7.8 mmol/L) and less than 200 mg/dL (11.1 mmol/L)

Intervening postprandial glucoseGreater than 200 mg/dL at 30, 60, or 90 minutes on two occasions

Stage 3 T1D

Disease stageClinical-stage or Stage 3 type 1 diabetes

Disease statusOvert clinical type 1 diabetes

Treatment requirementInsulin therapy is required

Stage 2 T1D

Study definitionTN-10 study definition of Stage 2 type 1 diabetes

AutoantibodiesTwo or more type 1 diabetes-related autoantibodies

Glucose statusDysglycemia

Dysglycemia without overt hyperglycemia is documented by an oral glucose tolerance test obtained within the last 60 days, or by an appropriate alternative method when an oral glucose tolerance test is unavailable.

Within the last 60 days

Clinical history: The member's clinical history does not suggest type 2 diabetes.

Prescriber qualification: The drug is prescribed by or in consultation with a board-certified endocrinologist.Board-certified endocrinologist

Submit consultation notes when the prescription is issued in consultation with an endocrinologist.

Initial 14-Day Course

For the labeled indication, administer Tzield as a single treatment course:

Initial 14-day course: Administer Tzield by intravenous infusion over a minimum of 30 minutes once daily for 14 days.One dose daily for 14 days

Do not administer two doses on the same day. If an infusion is missed, administer the remaining doses on consecutive days to complete the 14-day course.

Tzield (teplizumab-mzwv)

MedicationTzield (teplizumab-mzwv)

Treatment dayDay 2

Dose125 mcg/m2

Tzield (teplizumab-mzwv)

MedicationTzield (teplizumab-mzwv)

Treatment dayDay 3

Dose250 mcg/m2

Tzield (teplizumab-mzwv)

MedicationTzield (teplizumab-mzwv)

Treatment dayDay 4

Dose500 mcg/m2

Tzield (teplizumab-mzwv)

MedicationTzield (teplizumab-mzwv)

Treatment daysDays 5 through 14

Dose1,030 mcg/m2

Tzield (teplizumab-mzwv)

MedicationTzield (teplizumab-mzwv)

RouteIntravenous infusion

ScheduleOne once-daily dose for 14 days