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 8 years of age or older with stage 2 type 1 diabetes.

Criteria

Tzield

*Per prescribing information, administer Tzield by intravenous infusion once daily for 14 consecutive days.

Prior Authorization

Length of Approval: 1 month* [B, 1]

• 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)
• 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 8 years of age or older
AND
• Presence of type 2 diabetes mellitus has been ruled out
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

*Per prescribing information, administer Tzield by intravenous infusion once daily for 14 consecutive days.

Non Formulary

Length of Approval: 1 month* [B, 1]

• 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 8 years of age or older
AND
• Presence of type 2 diabetes mellitus has been ruled out
AND
• Submission of medical records (e.g., chart notes) or 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

P & T Revisions

2025-02-04, 2024-01-09, 2023-04-28, 2023-01-24

References

1. Tzield Prescribing Information. Provention Bio, Inc. Red Bank, NJ. December 2023.
2. ClinicalTrials.gov. Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk". Available at: https://clinicaltrials.gov/ct2/show/NCT01030861. Accessed December 29, 2022.
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 Professional Practice Committee; 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S20–S42. https://doi.org/10.2337/dc24-S002
5. Tzield for Healthcare Professionals. Available at: https://tzieldhcp.com/. Accessed December 29, 2022.

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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]

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Revision History

• 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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