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    v1.0.28
    OpenPayerPolicy UpdatesEndocrinologyUnitedHealthcare Tzield Prior Auth Update | OpenPa…
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    ModifiedUnitedHealthcarePolicy 2026D0117J

    Tzield (teplizumab-mzwv) Coverage

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    UnitedHealthcare Commercial and Individual Exchange benefit coverage for Tzield, including criteria to delay progression to Stage 3 type 1 diabetes or delay beta-cell-function decline.

    Policy Summary
    PayerUnitedHealthcare
    PolicyTzield (teplizumab-mzwv) Coverage
    Policy CodePolicy 2026D0117J
    Change TypeModified
    Effective DateOctober 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization confirming the patient meets the applicable age, disease-stage, laboratory, dosing, prior-treatment, and lifetime-course requirements.
    SourceLink
    POLICY UPDATE CHANGES

    The Stage 2 type 1 diabetes criteria were revised to exclude dysglycemia or insulin resistance related to obesity, type 2 diabetes, or other forms of diabetes, rather than only requiring that type 2 diabetes be excluded.

    Stage 2 authorization was revised to allow no more than one 14-dose treatment course per lifetime.

    Coverage criteria were added for delaying beta-cell-function decline in patients aged 8 through 17 years with recently diagnosed Stage 3 type 1 diabetes.

    Additional ICD-10 diagnosis codes for type 1 diabetes and its complications were added to the applicable-code section.

    ICD-10 codes E10.8 and E10.9 were removed from the applicable-code list.

    The policy was updated to state that Tzield is medically necessary to delay Stage 3 type 1 diabetes onset when all listed criteria are met.

    1+Minimum age for Stage 2 indication

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    1 courseStage 2 lifetime limit
    8-17Age range for recently diagnosed Stage 3 indication
    2 coursesStage 3 lifetime limit
    ≥0.2 pmol/mLRequired peak C-peptide

    Medical Necessity Criteria

    Delay Onset of Stage 3 T1D in Stage 2 T1D

    Tzield is covered and medically necessary to delay the onset of stage 3 T1D in pediatric and adult patients with stage 2 T1D when all applicable criteria below are met.

    ALL of the following

    • Patient is 1 year of age or older.>= 1 year

    • Stage 2 type 1 diabetes is confirmed by ALL of the following

      • At least two positive pancreatic islet autoantibodies

        • Glutamic acid decarboxylase 65 (GAD) autoantibodies.
        • Insulin autoantibody (IAA).
        • Insulinoma-associated antigen 2 autoantibody (IA-2A).
        • Zinc transporter 8 autoantibody (ZnT8A).
        • Islet cell autoantibody (ICA).

      • Dysglycemia without overt hyperglycemia demonstrated by ONE of the following

        • Fasting plasma glucose.>= 100 mg/dL and < 126 mg/dL
        • Two-hour post-prandial plasma glucose level.>= 140 mg/dL and < 200 mg/dL
        • A1C.>= 5.7% and < 6.5%, or >= 10% increase in A1C
      • Patient does not have symptoms associated with stage 3 T1D, such as increased urination, excessive thirst, or weight loss.
      • Clinical history does not suggest insulin resistance due to obesity, type 2 diabetes (T2D), or dysglycemia due to another form of diabetes, including genetic diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes in adults (LADA), or diabetes secondary to medications or surgery.
    • For medical necessity, prescribed by or in consultation with an endocrinologist.

      Applies to the medically necessary determination.

    • Dosing is in accordance with U.S. Food and Drug Administration (FDA)-approved labeling.
    • Patient has not been previously treated with Tzield.
    • Authorization is limited to no more than one 14-dose treatment course per lifetime.1 course / lifetime

    Delay Decline in Beta-Cell Function in Recently Diagnosed Stage 3 T1D

    Tzield is covered and medically necessary to delay the decline in beta-cell function in pediatric patients with recently diagnosed stage 3 T1D when all applicable criteria below are met.

    ALL of the following

    • Patient is aged 8 to 17 years.8–17 years
    • Stage 3 T1D was diagnosed recently, within the last 8 weeks.<= 8 weeks

    • Stage 3 T1D is confirmed by ALL of the following

      • At least one positive pancreatic islet cell autoantibody

        • Glutamic acid decarboxylase 65 (GAD) autoantibodies.

    Revised Criteria: Delay Onset of Stage 3 T1D in Stage 2 Disease

    Revised coverage criteria for delaying the onset of stage 3 T1D in adult and pediatric patients aged 1 year and older with stage 2 T1D are as follows.

    ALL requirements

    • Tzield is used to delay the onset of stage 3 T1D in a patient with confirmed stage 2 T1D who is at least 1 year of age.
    • The clinical history does not suggest insulin resistance due to obesity, T2D, or dysglycemia due to other forms of diabetes, including genetic diabetes, MODY, LADA, or diabetes secondary to medications or surgery.
    • Authorization is for no more than one 14-dose treatment course per lifetime.1 course / lifetime

    Added Indication: Delay Decline in Beta-Cell Function in Recently Diagnosed Stage 3 T1D

    Tzield is covered and medically necessary for the added indication of delaying beta-cell decline in pediatric patients aged 8 to 17 years with recently diagnosed stage 3 T1D when all requirements below are met.

    ALL of the following

    • Patient is aged 8 to 17 years.8–17 years
    • Stage 3 T1D was diagnosed within the last 8 weeks.<= 8 weeks

    • Diagnosis is confirmed by ALL of the following

      • At least one positive pancreatic islet autoantibody

        • Glutamic acid decarboxylase 65 (GAD) autoantibodies.

    Coverage does not apply when the patient's insulin resistance or dysglycemia is attributable to obesity, type 2 diabetes (T2D), or another form of diabetes, including genetic forms of diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes in adults (LADA), or diabetes secondary to medications or surgery.

    Tzield is not covered when the patient has been previously treated with Tzield.

    Tzield is not effective as a disease-modifying therapy in non-autoimmune dysglycemic conditions.

    Coverage for the recently diagnosed stage 3 T1D indication excludes dysglycemia or insulin resistance attributable to obesity, type 2 diabetes (T2D), or other forms of diabetes, including genetic diabetes, MODY, LADA, or diabetes secondary to medications or surgery.

    Applicable Codes and Clinical Thresholds

    Applicable Procedure CodeHCPCS
    J9381Injection, teplizumab-mzwv, 5 mcg
    Applicable Diagnosis CodesICD-10
    E10.10Type 1 diabetes mellitus with ketoacidosis without coma.
    E10.11Type 1 diabetes mellitus with ketoacidosis with coma.
    E10.21Type 1 diabetes mellitus with diabetic nephropathy.
    E10.22Type 1 diabetes mellitus with diabetic chronic kidney disease.
    E10.29Type 1 diabetes mellitus with other diabetic kidney complication.
    E10.311Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema.
    E10.319Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema.
    E10.3211Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right.
    E10.3212eye Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye.
    E10.3213Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral.
    1–10 of 88
    1/9
    Applicable ICD-10 Diagnosis CodesICD-10Covered
    E10.3549Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye.
    E10.3551Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, right eye.
    E10.3552Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, left eye.
    E10.3553Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral.
    E10.3559Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye.
    E10.3591Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye.
    E10.3592Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye.
    E10.3593Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral.
    E10.3599Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye.
    E10.36Type 1 diabetes mellitus with diabetic cataract.
    1–10 of 84
    1/9
    Removed ICD-10 Diagnosis CodesICD-10Not Covered
    E10.8Removed ICD-10 diagnosis code.
    E10.9Removed ICD-10 diagnosis code.
    Stage 2 dysglycemia threshold
    TestFasting plasma glucose
    Lower threshold≥ 100 mg/dL
    Upper threshold< 126 mg/dL
    Stage 2 dysglycemia threshold
    Test2-hour post-prandial plasma glucose
    Lower threshold≥ 140 mg/dL
    Upper threshold

    Authorization and Documentation Requirements

    Prior Authorization

    Stage 2 T1D Prior Authorization

    Prior authorization for Tzield to delay progression from Stage 2 to Stage 3 T1D requires documentation that the patient is at least 1 year old, has confirmed Stage 2 T1D, meets FDA-labeled dosing, has not previously received Tzield, and remains within the lifetime course limit.

    • Patient is 1 year of age or older.
    • Stage 2 T1D is confirmed by at least two positive pancreatic islet autoantibodies and qualifying dysglycemia without overt hyperglycemia.
    • Clinical history does not suggest insulin resistance from obesity, T2D, or another diabetes etiology, including genetic diabetes, MODY, LADA, medication-related, or postsurgical diabetes.
    • Treatment is prescribed by or in consultation with an endocrinologist and follows FDA-approved labeling.
    • No prior Tzield treatment; authorization is limited to one 14-dose treatment course per lifetime.
    Prior Authorization

    Recently Diagnosed Stage 3 T1D Prior Authorization

    For the recently diagnosed Stage 3 T1D indication, submit documentation that the patient is an eligible pediatric patient with a recent diagnosis, autoimmune disease, residual beta-cell function, appropriate dosing, no prior Tzield exposure, and no exceeded lifetime course limit.

    Policy and Therapy Context

    Tzield (teplizumab-mzwv) is addressed for two clinical uses: delaying the onset of Stage 3 type 1 diabetes in pediatric and adult patients with Stage 2 type 1 diabetes, and delaying decline in beta-cell function in pediatric patients with recently diagnosed Stage 3 type 1 diabetes. Eligibility is based on pancreatic islet autoantibodies, glycemic or C-peptide testing, age, disease stage, and exclusion of alternative causes of dysglycemia or insulin resistance.

    Diabetes Staging and Testing Definitions

    Stage 2 type 1 diabetes
    AutoimmunityAt least two positive pancreatic islet autoantibodies
    Glycemic statusDysglycemia without overt hyperglycemia
    Clinical statusNo symptoms associated with Stage 3 type 1 diabetes and no clinical history suggesting alternative diabetes or insulin resistance
    Dysglycemia without overt hyperglycemia
    Fasting plasma glucose≥ 100 mg/dL and < 126 mg/dL
    2-hour post-prandial plasma glucose≥ 140 mg/dL and < 200 mg/dL
    A1C
    Policy Summary
    PayerUnitedHealthcare
    PolicyTzield (teplizumab-mzwv) Coverage
    Policy CodePolicy 2026D0117J
    Change TypeModified
    Effective DateOctober 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization confirming the patient meets the applicable age, disease-stage, laboratory, dosing, prior-treatment, and lifetime-course requirements.
    SourceLink
    On This Page
    Medical Necessity CriteriaApplicable Codes and Clinical ThresholdsAuthorization and Documentation RequirementsPolicy and Therapy ContextDiabetes Staging and Testing Definitions
    Insulin autoantibody (IAA).
  1. Insulinoma-associated antigen 2 autoantibody (IA-2A).
  2. Zinc transporter 8 autoantibody (ZnT8A).
  3. Islet cell autoantibody (ICA).
  4. Peak C-peptide on a mixed-meal tolerance test (MMTT).>= 0.2 pmol/mL
  5. Clinical history does not suggest insulin resistance due to obesity, type 2 diabetes (T2D), or dysglycemia due to another form of diabetes, including genetic diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes in adults (LADA), or diabetes secondary to medications or surgery.
  6. For medical necessity, prescribed by or in consultation with an endocrinologist.

    Applies to the medically necessary determination.

  7. Dosing is in accordance with U.S. Food and Drug Administration (FDA)-approved labeling.
  8. Patient has not been previously treated with Tzield.
  9. Authorization is limited to no more than two 12-dose treatment courses per lifetime.2 courses / lifetime
  10. Insulin autoantibody (IAA).
  11. Insulinoma-associated antigen 2 autoantibody (IA-2A).
  12. Zinc transporter 8 autoantibody (ZnT8A).
  13. Islet cell autoantibody (ICA).
  14. Peak C-peptide on a mixed-meal tolerance test (MMTT).>= 0.2 pmol/mL
  15. Clinical history does not suggest insulin resistance due to obesity, T2D, or dysglycemia due to other forms of diabetes, including genetic diabetes, MODY, LADA, or diabetes secondary to medications or surgery.
  16. Prescribed by or in consultation with an endocrinologist.
  17. Dosing is in accordance with FDA-approved labeling.
  18. Patient has not been previously treated with Tzield.
  19. Authorization is limited to no more than two 12-dose treatment courses per lifetime.2 courses / lifetime
    20. < 200 mg/dL
    Stage 2 dysglycemia threshold
    TestA1C
    Range≥ 5.7% and < 6.5%
    Alternative qualification≥ 10% increase in A1C
    Recently diagnosed Stage 3 indication
    TestMixed-meal tolerance test (MMTT)
    MeasurePeak C-peptide
    Required threshold≥ 0.2 pmol/mL
    Recently diagnosed Stage 3 indication
    TestMixed-meal tolerance test
    MeasurePeak C-peptide
    Required threshold≥ 0.2 pmol/mL
    Recent diagnosis timing
    ConditionRecently diagnosed Stage 3 type 1 diabetes
    Permitted timingWithin the last 8 weeks
    Eligible age range8 through 17 years
    Stage 2 diagnostic threshold
    TestFasting plasma glucose
    Diagnostic range100-125 mg/dL
    Disease stageStage 2 type 1 diabetes
    Stage 2 diagnostic threshold
    Test2-hour postprandial plasma glucose
    Diagnostic range140-199 mg/dL
    Disease stageStage 2 type 1 diabetes
    Stage 2 diagnostic threshold
    TestA1C
    Diagnostic range5.7%-6.4%
    Alternative qualification≥10% increase in A1C
    • Patient is aged 8 through 17 years.
    • Stage 3 T1D was diagnosed within the last 8 weeks.
    • At least one pancreatic islet autoantibody is positive and peak C-peptide is at least 0.2 pmol/mL on a mixed-meal tolerance test (MMTT).
    • Clinical history does not suggest insulin resistance from obesity, T2D, or another diabetes etiology, including genetic diabetes, MODY, LADA, medication-related, or postsurgical diabetes.
    • Treatment is prescribed by or in consultation with an endocrinologist and follows FDA-approved labeling.
    • No prior Tzield treatment; authorization is limited to no more than two 12-dose treatment courses per lifetime.
    Billing Rule

    Lifetime Course Limits

    Authorization is subject to separate lifetime course limits for the two covered indications. Document the requested course and verify the patient’s complete prior Tzield treatment history before requesting authorization.

    • Stage 2 T1D: no more than one 14-dose treatment course per lifetime.
    • Recently diagnosed Stage 3 T1D: no more than two 12-dose treatment courses per lifetime.
    Prior Authorization

    FDA-Labeled Dosing and No Prior Tzield

    For the recently diagnosed Stage 3 T1D indication, the requested regimen must conform to FDA-approved labeling and the patient must have no previous Tzield treatment. Authorization cannot exceed the applicable lifetime course limit.

    • Use FDA-labeled dosing for the Stage 3 beta-cell-function indication.
    • Confirm that the patient has never previously been treated with Tzield.
    • Request no more than two 12-dose treatment courses over the patient’s lifetime.
    Documentation Required

    Diagnostic Laboratory Documentation

    Submit laboratory reports supporting the requested disease stage. Laboratory documentation must identify the qualifying pancreatic islet autoantibodies and the required glucose or C-peptide findings.

    • Stage 2 T1D: document at least two positive pancreatic islet autoantibodies from GAD65, IAA, IA-2A, ZnT8A, or ICA.
    • Stage 2 dysglycemia without overt hyperglycemia: fasting plasma glucose ≥100 and <126 mg/dL; or 2-hour post-prandial glucose ≥140 and <200 mg/dL; or A1C ≥5.7 and <6.5%, or a ≥10% increase in A1C.
    • Stage 3 T1D: document at least one positive pancreatic islet autoantibody from GAD65, IAA, IA-2A, ZnT8A, or ICA.
    • Stage 3 residual beta-cell function: document peak C-peptide ≥0.2 pmol/mL on an MMTT.

    Unsupported block type: documentation

    Unsupported block type: documentation

    Unsupported block type: documentation

    Denial Risk

    Stage 2 Denial Risks

    Stage 2 authorization may be denied when any eligibility or treatment condition is not documented or is inconsistent with the policy.

    • Patient is younger than 1 year.
    • Stage 2 T1D is not confirmed by at least two positive pancreatic islet autoantibodies and qualifying dysglycemia.
    • Dysglycemia represents overt hyperglycemia, or required glucose/A1C results are absent.
    • The patient has previously received Tzield, the regimen is not FDA-labeled, or the request exceeds one 14-dose lifetime course.
    • Clinical history suggests obesity-related insulin resistance, T2D, or another diabetes etiology.
    Denial Risk

    Recently Diagnosed Stage 3 T1D Denial Risks

    Requests for the recently diagnosed Stage 3 T1D indication may be denied when age, diagnosis timing, laboratory evidence, dosing, prior treatment, or lifetime course requirements are not met.

    • Patient is outside the 8–17-year age range or diagnosis occurred more than 8 weeks before the request.
    • No qualifying pancreatic islet autoantibody or required peak C-peptide result is documented.
    • Dosing does not follow FDA-approved labeling, the patient previously received Tzield, or the request exceeds two 12-dose lifetime courses.
    • Clinical history suggests obesity-related insulin resistance, T2D, or another diabetes etiology.
    Denial Risk

    Alternative Diabetes Etiology

    Coverage may be denied when the clinical history indicates obesity-related insulin resistance, T2D, or another non-covered diabetes etiology rather than autoimmune Stage 2 or Stage 3 T1D.

    • Obesity-related insulin resistance or T2D.
    • Genetic forms of diabetes, including MODY.
    • LADA when the requested criteria are not otherwise satisfied.
    • Diabetes secondary to medications or surgery.
    • Any other dysglycemia attributable to a non-autoimmune diabetes etiology.
    Denial Risk

    Stage 3 Indication Requirements Not Met

    The recently diagnosed Stage 3 beta-cell-function indication requires every specified criterion. Failure to establish the pediatric age range, recent diagnosis, autoimmune etiology, residual beta-cell function, appropriate dosing, and treatment history may result in denial.

    • Age 8–17 years and diagnosis within the last 8 weeks are required.
    • At least one listed pancreatic islet autoantibody and peak C-peptide ≥0.2 pmol/mL on an MMTT are required.
    • The patient must have no clinical history suggesting alternate diabetes etiology or insulin resistance.
    • FDA-labeled dosing, no prior Tzield, and no more than two 12-dose lifetime courses are required.
    Denial Risk

    Unsupported Clinical Population

    Tzield is not a disease-modifying treatment for non-autoimmune dysglycemic conditions, and FDA approval alone does not establish coverage. Use the policy criteria and supporting evidence to determine whether the requested population is covered.

    • Non-autoimmune dysglycemia or insulin resistance attributable to another diabetes etiology is not an eligible disease state.
    • There is limited evidence of safety and effectiveness in patients aged 45 years and older with Stage 2 T1D.
    • The recently diagnosed Stage 3 indication applies to pediatric patients aged 8–17 years and is approved under accelerated approval based on reduced C-peptide decline.
    • FDA approval alone is not a basis for coverage.
    ≥ 5.7% and < 6.5%, or ≥ 10% increase in A1C
    Recently diagnosed Stage 3 type 1 diabetes
    Diagnosis timingStage 3 type 1 diabetes diagnosed within the last 8 weeks
    AutoimmunityAt least one positive pancreatic islet autoantibody
    Residual beta-cell functionPeak C-peptide ≥ 0.2 pmol/mL on a mixed-meal tolerance test
    Stage 1 type 1 diabetes
    AutoimmunityMultiple islet autoantibodies
    Glycemic statusNormoglycemia; no dysglycemia
    SymptomsPresymptomatic
    Stage 2 type 1 diabetes
    Disease characteristicsAutoimmunity, dysglycemia, and presymptomatic disease
    Fasting plasma glucose100-125 mg/dL
    2-hour postprandial glucose140-199 mg/dL
    A1C5.7%-6.4% or ≥ 10% increase in A1C
    Stage 3 type 1 diabetes
    Disease characteristicsAutoimmunity, overt hyperglycemia, and symptomatic disease
    AutoantibodiesMay become absent
    Diagnostic standardDiabetes by standard criteria
    Mixed-meal tolerance test (MMTT)
    PurposeAssesses residual endogenous insulin production
    MeasurementPeak C-peptide during a mixed-meal tolerance test
    Required threshold≥ 0.2 pmol/mL for the recently diagnosed Stage 3 indication