CurrentBaylor Scott & White Health PlanPolicy 303

Teplizumab-mzwv (Tzield) for Stage 2 Type 1 Diabetes

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This policy governs coverage and prior authorization for teplizumab-mzwv to delay progression from Stage 2 to Stage 3 type 1 diabetes. It applies to providers and members covered under Baylor Scott & White Health Plan, subject to the applicable benefit plan and program-specific requirements.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyTeplizumab-mzwv (Tzield) for Stage 2 Type 1 Diabetes

Policy CodePolicy 303

Change TypeRevised

Effective DateAug 1, 2026

Last ReviewJul 23, 2026

Next Review DateJul 23, 2027

Key ActionObtain prior authorization for teplizumab-mzwv (Tzield) before treatment.

SourceLink

POLICY UPDATE CHANGES

The minimum age criterion was revised from 8 years to 1 year to align with the FDA-labeled expanded indication.

The policy background was simplified and expanded-indication background was added.

Minor formatting changes were made during the 2026 policy update.

1 yearMinimum member age

14 daysAuthorized treatment course

1 lifetime courseMaximum medically necessary treatment

2 or more

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CurrentBaylor Scott & White Health PlanPolicy 303

Teplizumab-mzwv (Tzield) for Stage 2 Type 1 Diabetes

Customize your policy alerts

Sign up for baylor_scott_and_white_health_plan Policy 303 alerts

Get alerted when Policy 303 changes without checking for updates manually.

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyTeplizumab-mzwv (Tzield) for Stage 2 Type 1 Diabetes

Policy CodePolicy 303

Change TypeRevised

Effective DateAug 1, 2026

Last ReviewJul 23, 2026

Next Review DateJul 23, 2027

Key ActionObtain prior authorization for teplizumab-mzwv (Tzield) before treatment.

SourceLink

POLICY UPDATE CHANGES

The minimum age criterion was revised from 8 years to 1 year to align with the FDA-labeled expanded indication.

The policy background was simplified and expanded-indication background was added.

Minor formatting changes were made during the 2026 policy update.

1 yearMinimum member age

14 daysAuthorized treatment course

1 lifetime courseMaximum medically necessary treatment

2 or more

Required pancreatic islet autoantibodies

5Accepted dysglycemia test options

Stage 2 T1DCovered disease stage

Medical Necessity and Coverage Criteria

Initial treatment for Stage 2 type 1 diabetes

Teplizumab-mzwv may be considered medically necessary to delay the onset of Stage 3 type 1 diabetes when ALL of the following are met:

Initial treatment criteria

Basic eligibility: The member has Stage 2 type 1 diabetes; teplizumab-mzwv is prescribed by or provided in consultation with an endocrinologist; and the member is at least 1 year old.
Autoantibody and dysglycemia evidence
- At least 2 pancreatic islet autoantibodies: Documentation of at least two of the following pancreatic islet autoantibodies: glutamic acid decarboxylase 65 (GAD65), insulin autoantibody (IAA), insulinoma-associated antigen 2 autoantibody (IA-2A), zinc transporter 8 autoantibody (ZnT8A), or islet cell autoantibody (ICA).2 or more
- At least 1 qualifying dysglycemia result: Documentation of dysglycemia without overt hyperglycemia, conducted within 2 months of the request, demonstrated by at least one qualifying result: fasting blood glucose of 100 to 125 mg/dL (5.6 to 6.9 mmol/L); 2-hour post-prandial glucose of 140 to 199 mg/dL (7.8 to 11.0 mmol/L); or A1c of 5.7 to 6.4% (39 to 47 mmol/mol).Within 2 months of the request
No disqualifying condition: The member does not have any of the following: clinical diagnosis of type 1 diabetes (Stage 3 type 1 diabetes); type 2 diabetes; lymphocyte count less than 1,000 lymphocytes/mcL; hemoglobin less than 10 g/dL; platelet count less than 150,000 platelets/mcL; absolute neutrophil count less than 1,500 neutrophils/mcL; elevated ALT or AST greater than 2 times the upper limit of normal or bilirubin greater than 1.5 times the upper limit of normal; laboratory or clinical evidence of acute Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection; or active serious infection or chronic active infection other than localized skin infections.

Repeat administration

Repeat administration is not medically necessary.

Repeat treatment: Repeat administration of teplizumab-mzwv after one 14-day treatment course per lifetime is experimental and investigational and is not medically necessary because the effectiveness of repeat treatment has not been established.Maximum one 14-day course per lifetime

Other indications

Treatment for indications other than the covered indication is not medically necessary.

Other indications: Teplizumab-mzwv for indications other than delaying the onset of Stage 3 type 1 diabetes in members with Stage 2 type 1 diabetes is experimental and investigational and is not medically necessary because the effectiveness of this strategy has not been established.

Coverage is not available when the member has a clinical diagnosis of Stage 3 type 1 diabetes or type 2 diabetes; a lymphocyte count below 1,000 lymphocytes/mcL; hemoglobin below 10 g/dL; platelet count below 150,000 platelets/mcL; absolute neutrophil count below 1,500 neutrophils/mcL; ALT or AST greater than 2 times the upper limit of normal; bilirubin greater than 1.5 times the upper limit of normal; laboratory or clinical evidence of acute EBV or CMV infection; or an active serious or chronic active infection other than a localized skin infection.

Repeat administration of teplizumab after the one-time 14-day treatment course per lifetime is considered experimental and investigational and is not medically necessary because the effectiveness of repeat treatment has not been established.

Teplizumab for indications other than delaying the onset of Stage 3 type 1 diabetes in members with Stage 2 type 1 diabetes is considered experimental and investigational and is not medically necessary because effectiveness for those indications has not been established.

Coding and Eligibility Parameters

CPT CodesCPT

96365	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
93413	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug

HCPCS CodesHCPCS

J9381

Injection, teplizumab-mzwv, 5 mcg

ICD10 codesICD-10

E10.10-E10.9

Type 1 diabetes mellitus

Minimum age

Minimum ageAt least 1 year old

Eligibility requirementThe member must be at least 1 year old

Covered treatmentTeplizumab to delay onset of Stage 3 type 1 diabetes

Pancreatic islet autoantibodies

Required countAt least 2 pancreatic islet autoantibodies

Accepted antibodiesGAD65, IAA, IA-2A, ZnT8A, or ICA

Documentation

Provider Documentation and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for teplizumab-mzwv (Tzield®). Before submitting a request, review the member’s Evidence of Coverage (EOC) or Summary Plan Description (SPD). For Medicare plans, apply the appropriate Medicare NCD/LCD; if none applies, use the criteria below. For Medicaid plans, confirm coverage under the Texas Medicaid Provider Procedures Manual (TMPPM); Texas Mandate HB154 applies.

Documentation Required

Document Diagnosis and Specialist Involvement

Document that the member has Stage 2 type 1 diabetes (T1D) and that teplizumab is prescribed by or provided in consultation with an endocrinologist. The member must also be at least 1 year old.

Stage 2 T1D diagnosis is required.
Prescription by or consultation with an endocrinologist is required.
Member must be ≥ 1 year old.

Clinical Background

Type 1 diabetes is a progressive autoimmune disease in which pancreatic beta cells are destroyed. Stage 1 is marked by diabetes-related autoantibodies, indicating that the immune system has begun attacking pancreatic beta cells. Stage 2 is the asymptomatic stage, characterized by dysglycemia before overt hyperglycemia. Stage 3 involves significant autoimmune beta-cell destruction, elevated blood glucose, symptoms, and the need for insulin treatment. Teplizumab is an intravenous anti-CD3 monoclonal antibody intended to delay progression from Stage 2 to Stage 3 type 1 diabetes.

Type 1 Diabetes Disease Stages

Stage 1 type 1 diabetes

Defining featureAppearance of diabetes-related autoantibodies

Immune processThe immune system has started attacking beta cells in the pancreas

Disease stageStage 1 type 1 diabetes

Stage 2 type 1 diabetes

Defining featureAsymptomatic dysglycemia

Clinical statusThe stage occurs before overt hyperglycemia

Disease stageStage 2 type 1 diabetes

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyTeplizumab-mzwv (Tzield) for Stage 2 Type 1 Diabetes

Policy CodePolicy 303

Change TypeRevised

Effective DateAug 1, 2026

Last ReviewJul 23, 2026

Next Review DateJul 23, 2027

Key ActionObtain prior authorization for teplizumab-mzwv (Tzield) before treatment.

SourceLink

On This Page

The presence of the qualifying autoantibodies must be documented

Fasting blood glucose

Accepted range100 to 125 mg/dL

SI units5.6 to 6.9 mmol/L

TestFasting blood glucose

2-hour post-prandial glucose

Accepted range140 to 199 mg/dL

SI units7.8 to 11.0 mmol/L

Test2-hour post-prandial glucose

A1c

Accepted range5.7 - 6.4%

Equivalent units39 - 47 mmol/mol

TestA1c

Timing of dysglycemia testing

Required timeframeWithin 2 months of the request

Testing requirementDysglycemia testing must be conducted within the specified timeframe

Qualifying evidenceAt least one qualifying fasting glucose, 2-hour post-prandial glucose, or A1c result

Treatment duration

Treatment limitOne-time 14-day treatment course per lifetime

Course duration14 days

Repeat treatmentRepeat administration is not medically necessary

Lymphocyte count

Minimum countAt least 1,000 lymphocytes/mcL

Ineligible levelLess than 1,000 lymphocytes/mcL

Laboratory measureLymphocyte count

Hemoglobin

Minimum levelAt least 10 g/dL

Ineligible levelLess than 10 g/dL

Laboratory measureHemoglobin

Platelet count

Minimum countAt least 150,000 platelets/mcL

Ineligible levelLess than 150,000 platelets/mcL

Laboratory measurePlatelet count

Absolute neutrophil count

Minimum countAt least 1,500 neutrophils/mcL

Ineligible levelLess than 1,500 neutrophils/mcL

Laboratory measureAbsolute neutrophil count

Liver tests

ALT and ASTMust not be greater than 2 times the upper limit of normal (ULN)

BilirubinMust not be greater than 1.5 times ULN

Laboratory measuresALT, AST, and bilirubin

Documentation Required

Submit Autoantibody and Dysglycemia Testing

Submit documentation confirming both the required pancreatic islet autoantibodies and dysglycemia without overt hyperglycemia. Dysglycemia testing must have been conducted within 2 months of the request.

Document at least two pancreatic islet autoantibodies: GAD65, insulin autoantibody (IAA), IA-2A, ZnT8A, or islet cell autoantibody (ICA).
Document at least one dysglycemia result: fasting blood glucose 100–125 mg/dL (5.6–6.9 mmol/L); 2-hour post-prandial glucose 140–199 mg/dL (7.8–11.0 mmol/L); or A1c 5.7–6.4% (39–47 mmol/mol).

Documentation Required

Submit Safety Laboratory and Infection Assessment

Provide current safety laboratory results and infection assessment as part of the authorization documentation. Confirm that required blood counts, liver tests, and bilirubin meet the policy thresholds and that there is no disqualifying EBV, CMV, or other active infection.

Document lymphocyte count, hemoglobin, platelet count, absolute neutrophil count, ALT, AST, and bilirubin.
Assess for laboratory or clinical evidence of acute EBV or CMV infection.
Assess for active serious infection or chronic active infection, other than localized skin infections.

Denial Risk

Disqualifying Clinical Findings

Coverage is unavailable when any disqualifying clinical finding is present. Requests with any of the following findings are at risk for denial.

Clinical diagnosis of T1D (Stage 3 T1D).
Type 2 diabetes.
Lymphocyte count < 1,000 lymphocytes/mcL.
Hemoglobin < 10 g/dL.
Platelet count < 150,000 platelets/mcL.
Absolute neutrophil count < 1,500 neutrophils/mcL.
ALT or AST > 2 times the upper limit of normal (ULN), or bilirubin > 1.5 times ULN.
Laboratory or clinical evidence of acute EBV or CMV infection.
Active serious infection or chronic active infection, other than localized skin infections.

Denial Risk

Repeat Treatment Not Covered

Authorization is limited to a one-time 14-day teplizumab treatment course per lifetime. Repeat administration is considered experimental and investigational because the effectiveness of repeat treatment has not been established.

Only one treatment course per lifetime is medically necessary.
Repeat administration is not covered and is at risk for denial.

Denial Risk

Other Indications Not Covered

Teplizumab for indications other than delaying the onset of Stage 3 T1D in a member meeting the covered Stage 2 T1D criteria is considered experimental and investigational because effectiveness has not been established.

Use outside the covered indication is not medically necessary and is at risk for denial.

Stage 3 type 1 diabetes

Defining featureSignificant autoimmune destruction of pancreatic beta cells

Clinical findingsBlood glucose is elevated and patients are symptomatic

Treatment requirementInsulin treatment is required