Pharmacy Prior Authorization Criteria

Tzield (teplizumab - mzwv) - PA, NF

Indications for Prior Authorization

Tzield (teplizumab - mzwv)

• For diagnosis of Stage 2 Type 1 Diabetes
  Indicated to delay onset of stage 3 type 1 diabetes in adults and pediatric patients aged 1 years of age or older with stage 2 type 1 diabetes.

• For diagnosis of Stage 3 Type 1 Diabetes
  Indicated to delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced Cpeptide decline. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Criteria

Tzield

Prior Authorization

Length of Approval: One authorization per lifetime* [B, 1]
For diagnosis of Stage 2 type 1 Diabetes Mellitus

• Diagnosis of stage 2 type 1 diabetes mellitus [A, 3]
AND
• Diagnosis confirmed by BOTH of the following: [1, 2, 4]
• Two or more of the following 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)
AND
• Dysglycemia on oral glucose tolerance testing at baseline defined as one of the following:
• Fasting plasma glucose greater than or equal to 100mg/dL and less than 126mg/dL (5.6 - 6.9 mmol/L)
• 2-hour plasma glucose greater than or equal to 140mg/dL and less than or equal to 199mg/dL (7.8 -11.0 mmol/L)
• Hemoglobin A1C 5.7 to 6.4% (39-47mmol/mol) or greater than or equal to 10% increase in A1C
AND
• Patient is 1 years of age or older
AND
• Presence of type 2 diabetes mellitus or other forms of diabetes (e.g., genetic forms of diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes in adults (LADA), or diabetes secondary to medications or surgery) has been ruled out
AND
• Provider attests that patient does not have laboratory or clinical evidence of active Epstein-Barr virus (EBV) and cytomegalovirus (CMV) infection (e.g., undetectable viral load by PCR testing) prior to initiating treatment with Tzield
AND
• Patient has never received Tzield treatment in their lifetime [2]
AND
• Treatment will not exceed the recommended 14 doses [B, 1]
AND
• Prescribed by or in consultation with an endocrinologist

Tzield

Non Formulary

Length of Approval: One authorization per lifetime* [B, 1]
For diagnosis of Stage 2 type 1 Diabetes Mellitus

• Submission of medical records (e.g., chart notes) confirming diagnosis of stage 2 type 1 diabetes mellitus [A, 3]
AND
• Submission of medical records (e.g., chart notes) confirming diagnosis of BOTH of the following: [1, 2, 4]
• Two or more of the following 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)
AND
• Dysglycemia on oral glucose tolerance testing at baseline defined as one of the following:
• Fasting plasma glucose greater than or equal to 100mg/dL and less than 126mg/dL (5.6 - 6.9 mmol/L)
• Two - hour plasma glucose greater than or equal to 140mg/dL and less than 200mg/dL (7.8 -11.0 mmol/L)
• Hemoglobin A1C 5.7 to 6.4% (39-47mmol/mol) or greater than or equal to 10% increase in A1C
AND
• Patient is 1 years of age or older
AND
• Presence of type 2 diabetes mellitus or other forms of diabetes (e.g., genetic forms of diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes in adults (LADA), or diabetes secondary to medications or surgery) has been ruled out
AND
• Provider attests that patient does not have laboratory or clinical evidence of active Epstein-Barr virus (EBV) and cytomegalovirus (CMV) infection (e.g., undetectable viral load by PCR testing) prior to initiating treatment with Tzield
AND
• Submission of medical records (e.g., chart notes) AND absence of paid claims confirming patient has never received Tzield treatment in their lifetime [2]
AND
• Treatment will not exceed the recommended 14 doses [B, 1]
AND
• Prescribed by or in consultation with an endocrinologist

Tzield

Prior Authorization

Length of Approval: 12 months [C, 1]
For diagnosis of Stage 3 Type 1 Diabetes Mellitus

• Diagnosis of stage 3 type 1 diabetes mellitus
AND
• Patient is 8 years of age or less than or equal to 17 years of age
AND
• Diagnosis confirmed by BOTH of the following:
• One of the following: [4]
• Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (≥7.0 mmol/L)
• 2-Hour Plasma Glucose ≥ 200 mg/dL (≥11.1 mmol/L) during an oral glucose tolerance test
• Hemoglobin A1C ≥ 6.5% (≥ 48 mmol/mol)
• Random Plasma Glucose ≥ 200 mg/dL (≥11.1 mmol/L) in a patient with classic symptoms of hyperglycemia (e.g., polyuria, polydipsia, unexplained weight loss)
AND
• Presence of at least one positive pancreatic islet cell autoantibody (e.g., antibodies against glutamic acid decarboxylase, zinc transporter 8, insulin, islet cells, or islet antigen) [D, 1,4,7]
AND
• Evidence of residual beta-cell function as demonstrated by peak C-peptide ≥0.2 pmol/mL on a mixed-meal tolerance test (if a mixed meal tolerance test is not available, an alternative method for measuring peak C-peptide ≥0.2 pmol/mL may be appropriate) [1,7]
AND
• Provider attests that patient does not have laboratory or clinical evidence of active Epstein-Barr virus (EBV) and cytomegalovirus (CMV) infection (e.g., undetectable viral load by PCR testing) prior to initiating treatment with Tzield
AND
• Patient has never received Tzield treatment in their lifetime [1]
AND
• Provider attests to initiate Tzield treatment as soon as possible following stage 3 type 1 diabetes mellitus diagnosis but no later than 8 weeks from diagnosis [1]
AND
• Treatment will not exceed two,12-day, treatment courses [C, 1]
AND
• Prescribed by or in consultation with an endocrinologist

Tzield

Non Formulary

Length of Approval: 12 months [C, 1]
For diagnosis of Stage 3 Type 1 Diabetes Mellitus

• Submission of medical records (e.g., chart notes) confirming diagnosis of stage 3 type 1 diabetes mellitus
AND
• Patient is 8 years of age or less than or equal to 17 years of age
AND
• Submission of medical records (e.g., chart notes) confirming diagnosis by BOTH of the following:
• One of the following:[4]
• Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (≥7.0 mmol/L)
• 2-Hour Plasma Glucose ≥ 200 mg/dL (≥11.1 mmol/L) during an oral glucose tolerance test
• Hemoglobin A1C ≥ 6.5% (≥ 48 mmol/mol)
• Random Plasma Glucose ≥ 200 mg/dL (≥11.1 mmol/L) in a patient with classic symptoms of hyperglycemia (e.g., polyuria, polydipsia, unexplained weight loss)
AND
• Presence of at least one positive pancreatic islet cell autoantibody (e.g., antibodies against glutamic acid decarboxylase, zinc transporter 8, insulin, islet cells, or islet antigen) [D, 1,4,7]
AND
• Submission of medical records (e.g., chart notes) confirming evidence of residual beta-cell function as demonstrated by peak C-peptide ≥0.2 pmol/mL on a mixed-meal tolerance test (if a mixed meal tolerance test is not available, an alternative method for measuring peak C-peptide ≥0.2 pmol/mL may be appropriate) [1,7]
AND
• Provider attests that patient does not have laboratory or clinical evidence of active Epstein-Barr virus (EBV) and cytomegalovirus (CMV) infection (e.g., undetectable viral load by PCR testing) prior to initiating treatment with Tzield
AND
• Submission of medical records (e.g., chart notes) AND absence of paid claims confirming patient has never received Tzield treatment in their lifetime [1]
AND
• Provider attests to initiate Tzield treatment as soon as possible following stage 3 type 1 diabetes mellitus diagnosis but no later than 8 weeks from diagnosis [1]
AND
• Treatment will not exceed two,12-day treatment courses [C, 1]
AND
• Prescribed by or in consultation with an endocrinologist

P & T Revisions

2026-08-11, 2026-05-21, 2026-01-20, 2025-08-06, 2025-02-04, 2024-01-09, 2023-04-28, 2023-01-24

References

1. Tzield Prescribing Information. Provention Bio, Inc. Red Bank, NJ. June 2026.
2. ClinicalTrials.gov. Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk". Available at: https://clinicaltrials.gov/ct2/show/NCT01030861. Accessed January 19, 2026.
3. Insel, R., Dunne, J., et al. Staging Presymptomatic Type 1 Diabetes: A Scientific Statement of JDRF, the Endocrine Society, and the American Diabetes Association. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5321245/. Oct 2015. Accessed December 29, 2022.
4. American Diabetes Association. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes 2026 Available at: https://diabetesjournals.org/care/article/49/Supplement_1/S27/163926/2-Diagnosis-and-Classification-of-Diabetes. Accessed July 8, 2026.
5. Tzield for Healthcare Professionals. Available at: https://tzieldhcp.com/. Accessed May 7, 2026.
6. UptoDate. Type 1 diabetes mellitus: Prevention and disease-modifying therapy. Available at: https://www.uptodate.com/contents/type-1-diabetes-mellitus-prevention-and-disease-modifying-therapy?search=tzield&source=search_result&selectedTitle=2~4&usage_type=default&display_rank=1&searchCorrelationId=11ef995c-87af-4f51-91ea-6d28d8878323&searchCorrelationTerm=tzield. Accessed May 7, 2026.
7. ClinicalTrials.gov. Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab (PROTECT). Available at: https://clinicaltrials.gov/study/NCT03875729?cond=NCT03875729&viewType=Card&rank=1#participation-criteria. Accessed July 8, 2026.
8. Ramos, E., Dayan,C., Chatenoud, L., et al. Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes. Available at: https://www.nejm.org/doi/10.1056/NEJMoa2308743?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. Accessed July 8, 2026.

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End Notes

1. Stage 1 (Autoimmunity+/Normoglycemia/Presymptomatic Type 1 Diabetes Mellitus) represents individuals who have developed 2 or more type 1 diabetes-associated islet autoantibodies but are normoglycemic. Stage 2, (Autoimmunity+/Dysglycemia/Presymptomatic Type 1 Diabetes Mellitus), like stage 1, includes individuals with 2 or more islet autoantibodies but who disease has now progressed to the development of glucose intolerance or dysglycemia from loss of functional beta cell mass. Stage 3 (Autoimmunity+/Dysglycemia/Symptomatic Type 1 Diabetes Mellitus) represents manifestations of the typical clinical signs and symptoms of diabetes, which may include polyuria, polydipsia, weight loss, fatigue, diabetic ketoacidosis (DKA), and others. [3]
2. Administer Tzield by intravenous infusion (over a minimum of 30 minutes), using a body surface area-based dosing, once daily for 14 consecutive days [1]
3. Administer Tzield by intravenous infusion over a minimum of 30 minutes, once daily for 12 consecutive days for each treatment course, for a total of two treatment courses. Second treatment Course: Administer the second 12-day treatment course 6 months after the first treatment course. If the second course is delayed, administer the second treatment course within 6 to 12 months after the first treatment course. [1]
4. ADA 2026 Type 1 Diabetes - Individuals with screening results positive for one or more islet autoantibodies should be evaluated for stage 3 (overt) type 1 diabetes (using A1C, urinalysis, and/or plasma glucose), which would require prompt clinical management and education. [4]

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Revision History

• 2026-08-11: update guideline
• 2026-05-21: update guideline
• 2026-01-20: 2026 annual review. No criteria changes, updated authorization duration for clarity.
• 2025-08-06: NF criteria updated
• 2025-02-04: Annual review: Added submission of medical records verbiage to diagnosis criteria in NF section. Updated references
• 2024-01-09: 2024 UM Annual Review. No criteria changes. Background updates
• 2023-04-28: update guideline
• 2023-01-24: New Um Criteria

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