TZIELD (teplizumab-mzwv)

TZIELD (teplizumab-mzwv)

Office-Administration – intravenous

Indications for Prior Authorization:

• Stage 2 type 1 diabetes - Indicated to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients aged 8 years and older with stage 2 type 1 diabetes. 

Coverage Criteria:

For diagnosis of stage 2 type 1 diabetes:

• Dose does not exceed 1,030 mcg/m2 per day IV for the recommended 14 doses; AND

• Patient is 8 years of age or older; AND

• Prescribed by or in consultation with an endocrinologist; AND  

• Diagnosis of  stage 2 type 1 diabetes mellitus confirmed by BOTH of the following:

  • Two or more of the following pancreatic islet autoantibodies:

    • Glutamic acid decarboxylase 65 (GAD) autoantibodies)

    • Insulin autoantibody (IAA)

    • Insulinoma-associated antigen 2 autoantibodies (IA-2A)

    • Zinc transporter 8 autoantibody (ZnT8A)

    • Islet cell autoantibody (ICA)

  • Dysglycemia on oral glucose tolerance testing at baseline defined as one of the following:

    • Fasting plasma glucose greater than or equal to 100 mg/dL and less than 126 mg/dL (5.6 – 6.9 mmol/L)

    • Two-hour plasma glucose greater than or equal to 140 mg/dL and less than 200 mg/dL (7.8-11.0 mmol/L)

    • Hemoglobin A1C 5.7% to 6.4% (39-47 mmol/mol) or greater than or equal to 10% increase in A1C; AND

• Presence of type 2 diabetes mellitus has been ruled out; AND 

• Patient has never received Tzield treatment in their lifetime

Coverage Duration:

• 1-time approval (14 days)

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Warnings for Cytokine Release Syndrome (CRS), Lymphopenia, Serious Infections 

• All age-appropriate vaccinations should be administered prior to starting Tzield. 

Policy Updates:

• 06/01/2023 – New policy approved by P&T

References:

• Tzield Prescribing Information. Provention Bio, Inc. Red Bank, NJ. November 2022. 

• 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. 

• 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. 

• ElSayed, N., Aleppo, G., et al. Classification and Diagnosis of Diabetes: Standards of Care in Diabetes—2023. Available at: https://diabetesjournals.org/care/article/46/Supplement_1/S19/148056/2-Classification-and-Diagnosis-of-Diabetes. Dec 12, 2022. Accessed December 29, 2022. 

• Tzield for Healthcare Professionals. Available at: https://tzieldhcp.com/. Accessed December 29, 2022.