Tzield®

Drug - Tzield® (teplizumab-mzwv injection) [Provention Bio, Inc.]

March 2025

Therapeutic Area - Disease Modifier, T1DM

Initial approval criteria

• Patient is at least 8 years of age; AND 
• Patient has a diagnosis of stage 2 type 1 diabetes, confirmed by:
  • Documenting at least 2 positive pancreatic islet cell autoantibodies (e.g., glutamic acid decarboxylase 65 [GAD65], insulin autoantibody [IAA], insulinoma-associated antigen 2 autoantibody [IA-2A], zinc transporter 8 autoantibody [ZnT8A], islet cell autoantibody [ICA]), AND 
  • Documenting dysglycemia without overt hyperglycemia using an oral glucose tolerance test (an alternative method for diagnosing dysglycemia without overt hyperglycemia may be used if an oral glucose tolerance test is not available); AND 
• Patient’s clinical history does not suggest type 2 diabetes; AND 
• Patient does not have hypersensitivity to any component of the product; AND 
• Prescriber has obtained a complete blood count and liver enzyme tests to confirm lymphocyte count ≥ 1,000 lymphocytes/mcL, hemoglobin ≥ 10 g/dL, platelet count ≥ 150,000 platelets/mcL, absolute neutrophil count ≥ 1,500 neutrophils/mcL, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal, and bilirubin ≤ 1.5 times the upper limit of normal; AND 
• Prescriber has confirmed the absence of acute Epstein-Barr virus (EBV) and cytomegalovirus (CMV) infection through laboratory or clinical evidence; AND
• Prescriber has confirmed the absence of an active serious infection or chronic active infection, excluding localized skin infection; AND
• Patient has received all age-appropriate vaccines, with live vaccines administered at least 8 weeks before treatment, and inactivated vaccines and mRNA vaccines administered at least 2 weeks before treatment; AND 
• Patient is not pregnant or planning to become pregnant during the 14-day treatment course; AND 
• Prescribed by or in consultation with an adult or pediatric endocrinologist.

Quantity limits

• One 14-day treatment course (14 doses of teplizumab-mzwv) and may not be renewed.
  • Day 1: 65 mcg/m2 
  • Day 2: 125 mcg/m2 
  • Day 3: 250 mcg/m2 
  • Day 4: 500 mcg/m2 
  • Days 5 through 14: 1,030 mcg/m2
• Patient’s body surface area must be submitted at time of request

Billing for Tzield

Tzield must be billed as a medical claim.

Questions

Provider Call Center (844) 575-7887