Teplizumab-mzwv (Tzield™)

Restricted Product(s)

• teplizumab-mzwv (Tzield™) intravenous infusion for administration by a healthcare professional

FDA Approved Use

• To delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D

Criteria for Medical Necessity

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient is 8 years of age or older; AND 
2. The patient has a diagnosis of Stage 2 type 1 diabetes mellitus (T1DM); AND 
3. The diagnosis of Stage 2 disease is confirmed by BOTH the following:
   1. Presence of at least two positive pancreatic islet cell autoantibodies [e.g., 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)] [medical record documentation required]; AND 
   2. Evidence of dysglycemia without overt hyperglycemia during an oral glucose tolerance test (OGTT) or alternative method for diagnosing dysglycemia without overt hyperglycemia if appropriate and an OGTT is not available, as defined by ONE the following [medical record documentation required]:
      1. A fasting blood glucose level of 100-125 mg/dL; OR 
      2. A two-hour blood glucose level of at least 140 mg/dL; OR 
      3. An intervening postprandial glucose level greater than 200 mg/dL at 30, 60, or 90 minutes; AND 
4. The clinical history of the patient does NOT suggest presence of type 2 diabetes mellitus; AND 
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND 
6. The patient does NOT have any FDA labeled contraindications to the requested agent; AND 
7. The requested dose is within FDA labeled dosing for the requested indication; AND 
8. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).
   
   Duration of Approval: 60 days (one 14-day treatment course per lifetime)

References

All information referenced is from FDA package insert unless otherwise noted below.

1. Herold KC, Bundy BN, Long SA, et al. An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med. 2019 Aug 15;381(7):603-613. Epub 2019 Jun 9. Erratum In: N Engl J Med. 2020 Feb 6;382(6):586. 
2. American Diabetes Association Professional Practice Committee. 2. Diagnosis and classification of diabetes: Standards of Care in Diabetes—2024. Diabetes Care 2024;47(Suppl. 1):S20–S42.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

September 2024: Criteria change: Adjusted fasting blood glucose level requirement from 110-125 mg/dL to 100-125 mg/dL according to updated clinical guidelines.
July 2023: Coding change: Added HCPCS code J9381 to dosing reference table effective 7/1/2023; deleted C9149, J3490, and J3590 termed 6/30/2023.
April 2023: Coding update: Added HCPCS code C9149 to dosing reference table and updated maximum units per code definition effective 4/1/2023; deleted C9399 termed 3/31/2023.
February 2023: Original medical policy criteria issued.