Clinical Criteria for Tzield® (procedure code J9381) effective August 1, 2023

Date: July 11, 2023

Attention: All Providers

Effective Date: August 1, 2023

Call to action: Texas Children’s Health Plan (TCHP) would like to let providers know that effective August 1, 2023, the Texas Health and Human Services (HHSC) will be implementing prior authorization criteria for Tzield® (procedure code J9381). The approval duration will be for the 14-day treatment. Tzield is the first-in-class therapy indicated to delay the onset of Stage 3 Type 1 diabetes (T1D) in adults and pediatric patients 8 years and older who currently have Stage 2 T1D. Tzield (teplizumab) is a humanized monoclonal antibody that binds to the CD3 makers molecules, deactivates immune cells, and thus prevents their destruction action on the pancreatic islet cells.

Authorization Requirements:

The approved duration will be for a one-time 14-day course of treatment

1. Age 8 years or older
2. Diagnosis for Stage 2 T1D mellitus
3. Documentation of at least TWO of the following positive pancreatic islet autoantibodies
   • Islet cell autoantibody (ICA)
   • Insulinoma-associated antigen 2 autoantibody (IA-2A)
   • Insulin autoantibody (IAA)
   • Zinc transporter 8 autoantibody (ZnT8A)
   • Glutamic acid decarboxylase 65 (GAD) autoantibodies
4. Does NOT have Type 2 diabetes mellitus or any other stages of T1D
5. Does NOT have Stage 3 T1D mellitus
6. Documentation of dysglycemia without overt hyperglycemia using oral glucose tolerance test (OGTT) or another appropriate test for dysglycemia may be used if OGTT is not available
7. Prescriber MUST obtain and assess a complete blood count and liver enzyme tests before initiating treatment with Tzield as using Tzield is not recommended in clients with specific lab abnormalities
8. Prescriber MUST assess the client’s history of chronic infection and monitor for any signs of serious active infection while on Tzield. If a serious infection develops, Tzield therapy should be discontinued

Refer to the Outpatient Drug Services Handbook Chapter[PKD1]  of the Texas Medicaid Provider Procedure Manual for more details on the clinical policy and prior authorization requirements.

Why is this important?

TCHP recognizes we may serve potentially impacted patients in our membership. We want to ensure that the member meets clinical evidence for treatment.

Next steps for providers: Prescribers should share this communication with their staff. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting member has met all approval criteria in support for Tzield approval.

Note: If request is for a non-FDA approved dose or indication, medical rational must be submitted in support of therapy (such as high-quality peer reviewed literature, acceptable compendia or evidence based practice guidelines) and exceptions will be considered on a case-by-case basis.  

If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org.

For access to all provider alerts,log into:
www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.

 [PKD1]Marketing: please make sure it links to this - https://www.tmhp.com/resources/provider-manuals/tmppm