Tzield (teplizumab) prior authorization
Customize your policy alerts
Sign up for all Alaska Medicaid policy alerts
Know when Alaska Medicaid releases new policies or updates existing guidance.
Monitor payer policy activity
Criteria and authorization requirements for Alaska Medicaid coverage of Tzield (teplizumab) to delay onset of Stage 3 type 1 diabetes in patients meeting stage 2 criteria. Applies to providers requesting prior authorization for Alaska Medicaid members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Tzield (teplizumab-mzwv)
Initial Therapy
Covered when ALL of the following are met:
All listed conditions must be satisfied before approval.
Tzield is contraindicated during pregnancy and must not be administered within 30 days prior to planned pregnancy.
Therapy is not approved for members who currently have Stage 3 type 1 diabetes or who have a clinical history consistent with type 2 diabetes; such presentations meet the policy's denial criteria and will result in claim denial.
Key Definitions
Billing and Laboratory Criteria
Provider Actions, Authorization & Documentation Requirements
Prior authorization required; limits and billing
Prior authorization is required for Tzield. Initial approval is limited to 3 months; reauthorization is not approved because the treatment is a single course of 14 daily infusions. Bill using the listed HCPCS codes.
Submit complete prior authorization request before initiation
Submit a complete prior authorization request that includes the required documentation outlined in policy (diagnosis confirmation, labs, and BSA) before initiating therapy.
- Ensure CBC and liver enzyme panel are obtained prior to initiation
- Provide patient body surface area in m2
Required documentation to support PA
Provider must submit documentation confirming a diagnosis of stage 2 type 1 diabetes, including evidence of ≥2 pancreatic islet autoantibodies and dysglycemia, plus pre-initiation labs and patient BSA.
- Documentation showing presence of TWO or more islet cell autoantibodies (ICA, IA-2A, IAA, ZnT8A, GAD65)
- Evidence of dysglycemia on oral glucose tolerance test or alternative glycemic test
- Pre-initiation complete blood count and liver enzyme panel
- Patient body surface area (m2)
Denial triggers and exclusion conditions
Requests will be denied if approval criteria are not met or if exclusion conditions are present; specific laboratory and clinical conditions listed in policy will also trigger denial.
- Failure to meet approval criteria
- Patient currently has stage 3 type 1 diabetes
- Clinical history consistent with type 2 diabetes
- Active serious or chronic infection (e.g., EBV or CMV)
- Any of the following lab abnormalities: lymphocytes <1,000/mcL; hemoglobin <10 g/dL; platelets <150,000/mcL; ALT or AST >2×ULN; bilirubin >1.5×ULN
Background
Tzield (teplizumab-mzwv) is a CD3-directed (anti‑CD3) monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients aged 8 years and older who have Stage 2 disease. Treatment is given as a 14‑day daily intravenous infusion using body surface area–based dosing.
Revision History
Policy effective and last revised on 2022-01-21 establishing prior authorization criteria, duration of approval, coding, and clinical requirements for Tzield (teplizumab).
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.