Background

Policy

The use of Tzield is MEDICALLY NECESSARY to delay the onset of Stage 3 Type 1 diabetes in pediatric and adult patients that meet the following criteria:

• Patient is 8 years of age or older; and
• Diagnosis of Stage 2 Type 1 diabetes confirmed by all of the following:
  • Presence of at least two 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)
  • Presence of dysglycemia without overt hyperglycemia defined by one of the following:
    • Fasting plasma glucose ≥ 100 mg/dL and < 126 mg/dL; or
    • 2-hour post-prandial plasma glucose level ≥ 140 mg/dL and < 200 mg/dL; or
    • A1C ≥ 5.7 and < 6.5% or ≥ 10% increase in A1C

AND

• • • Patient does not have symptoms associated with Stage 3 Type 1 diabetes (e.g., increased urination, excessive thirst, weight loss); and
    • Diagnosis of Type 2 diabetes has been ruled out; and
  • Prescribed by or in consultation with an endocrinologist; and
  • Dosing is in accordance with the United States Food and Drug Administration approved labeling; and
  • Patient has not been previously treated with Tzield; and
  • Authorization will be issued for no more than one treatment course (i.e., 14 doses) per lifetime

References

1. Herold KC, et al.(2019) An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes [published correction appears in N Engl J Med. 2020 Feb 6;382(6):586]. N Engl J Med. 2019;381(7):603–613. doi:10.1056/NEJMoa1902226
2. Sims EK, et al.(2021) Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals. Sci Transl Med. 2021;13(583):eabc8980. doi:10.1126/scitranslmed.abc8980
3. Tzield (teplizumab-mzwv) [package insert]. Red Bank, NJ. Provention Bio Inc.; November 2022.
4. Tzield (teplizumab-mzwv intravenous infusion – Provention). Drug Evaluation. Express Scripts. January 2023.
5. Tzield (teplizumab-mzwv). New Drug Review. IPD Analytics. Published December 2022. 

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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