Teplizumab-mzwv (Tzield™)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indication
Tzield is indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes.
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. Presence of two or more pancreatic islet cell autoantibodies within the past 6 months
B. Abnormal oral glucose tolerance test (OGTT) results within the past 2 months
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with an endocrinologist.
IV. CRITERIA FOR INITIAL APPROVAL
Delay of Stage 3 Type 1 Diabetes
Authorization of 1 month may be granted for members with Stage 2 type 1 diabetes to delay the onset of Stage 3 type 1 diabetes when all of the following criteria are met:
A. Member is 8 years of age and older
B. Member has two or more of the following pancreatic islet cell autoantibodies detected in two samples obtained within the past 6 months:
1. Glutamic acid decarboxylase 65 (GAD) autoantibodies
2. Insulin autoantibody (IAA)
3. Insulinoma-associated antigen 2 autoantibody (IA-2A)
4. Zinc transporter 8 autoantibody (ZnT8A)
5. Islet cell autoantibody (ICA)
C. Member has an abnormal oral glucose tolerance test (OGTT) confirming dysglycemia within the past 2 months when any of the following are met:
1. Fasting blood glucose level of 110 to 125 mg/dL (6.1 to 6.9 mmol/L)
2. 2-hour postprandial plasma glucose level of at least 140 mg/dL (7.8 mmol/L) and less than 200 mg/dL (11.1 mmol/L)
3. Intervening postprandial glucose level at 30, 60, or 90 minutes of greater than 200 mg per deciliter (11.1 mmol/L) on two occasions
D. Member does not have symptoms associated with type 1 diabetes (e.g., increased urination, excessive thirst, weight loss)
E. Member will not exceed a one-time 14-day treatment course consisting of the following dosing schedule:
1. Day 1: 65 mcg/m2
2. Day 2: 125 mcg/m2
3. Day 3: 250 mcg/m2
4. Day 4: 500 mcg/m2
5. Days 5 through 14: 1,030 mcg/m2
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Tzield [package insert]. Red Bank, NJ: Provention Bio, Inc.; November 2022.
2. 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; 381:603-613. https://www.nejm.org/doi/full/10.1056/nejmoa1902226.
ORIGINAL EFFECTIVE DATE: 3/2/2023
MOST RECENT REVIEW DATE: 5/14/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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