CurrentAvMedPolicy Pub. 100-2

Prior authorization for Tzield (teplizumab) (medical infusion)

This form governs medical prior authorization and step-edit requests for a single 14-day course of Tzield (teplizumab) administered intravenously, and applies to AvMed members and their prescribing providers seeking coverage for this medication.

Policy Summary

PayerAvMed

PolicyPrior authorization for Tzield (teplizumab) (medical infusion)

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must sign and include member identifiers, weight/height/BSA, diagnosis and supporting documentation including labs and antibody test results when submitting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14-daytreatment course length covered

1 coursecourse renewal policy

≥8minimum member age

IVroute

requiredpre-treatment labs

Coverage Criteria for Tzield (teplizumab)

Initial Therapy

Covered when ALL of the following are met

Initial course approval: Member is >= 8 years of age; prescribed by or in consultation with an endocrinologist; confirmed diagnosis of Stage 2 Type 1 Diabetes documented by BOTH dysglycemia criteria and autoantibody criteria; at least TWO pancreatic islet autoantibodies positive (GAD65, IAA, IA-2A, ZnT8A, ICA); dysglycemia defined by fasting glucose 100-125 mg/dL OR 2-hour plasma glucose 140-199 mg/dL OR an intervening postprandial glucose >= 200 mg/dL at 30/60/90 minutes; member does NOT have Stage 1 or Stage 3 Type 1 Diabetes; member does NOT have Type 2 Diabetes; member has NOT received a prior course of teplizumab (Tzield) or donislecel (Lantidra); member is up to date with all vaccinations and will not receive live or live-attenuated vaccines within 8 weeks or inactivated/mRNA vaccines within 2 weeks before or during treatment; member does NOT have an active infection; member has acceptable baseline labs (lymphocytes >= 1,000/mcL; hemoglobin >= 10 g/dL; platelets >= 150,000/mcL; ANC >= 1,500/mcL; ALT/AST <= 2x ULN; bilirubin <= 1.5x ULN); requested medication will be used as single-agent therapysee node text

All supporting documentation including labs and antibody test results must be provided; approval limited to one 14-day course and may not be renewed.

Approval is excluded for members who meet any of the policy's stated disqualifying conditions. Specifically, members with Stage 1 or Stage 3 Type 1 Diabetes, Type 2 Diabetes, a history of prior receipt of teplizumab (Tzield) or donislecel (Lantidra), or an active infection are not eligible. In addition, members whose baseline laboratory values fall outside the required limits — for example, lymphocytes < 1,000/mcL, hemoglobin < 10 g/dL, platelets < 150,000/mcL, ANC < 1,500/mcL, ALT/AST > 2× ULN, or bilirubin > 1.5× ULN — are excluded from coverage.

Policy Summary

PayerAvMed

PolicyPrior authorization for Tzield (teplizumab) (medical infusion)

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must sign and include member identifiers, weight/height/BSA, diagnosis and supporting documentation including labs and antibody test results when submitting prior authorization.

SourceLink

On This Page

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All supporting documentation must be supplied with the request. To avoid delays or denial, provide laboratory results, antibody testing, diagnostics, and chart notes that directly support each criterion checked on the form. Members must also be up to date with vaccinations and must not receive live or live-attenuated vaccines within 8 weeks or inactivated/mRNA vaccines within 2 weeks before or during treatment.

Coverage is limited to a single treatment course: one 14-day course of teplizumab (Tzield). Requests for additional, repeat, or renewal courses beyond this single 14-day treatment course are not covered under this policy.

Billing and Coding

Medical billing HCPCS codes listed on formHCPCS

J3590	Unclassified drug (used for Tzield billing as indicated)
C9399	Unclassified drugs or biologics (used for Tzield billing as indicated)

Laboratory thresholds required prior to therapy (baseline labs)

Lymphocyte countMust be >= 1,000 lymphocytes/mcL (requests with lymphocyte count < 1,000/mcL are excluded)

Hemoglobin (Hgb)Must be >= 10 g/dL (requests with Hgb < 10 g/dL are excluded)

Platelet countMust be >= 150,000 platelets/mcL (requests with platelet count < 150,000/mcL are excluded)

Absolute neutrophil count (ANC)Must be >= 1,500 neutrophils/mcL (requests with ANC < 1,500/mcL are excluded)

Liver transaminases (ALT/AST)Must be <= 2 times the upper limit of normal (requests with ALT or AST > 2x ULN are excluded)

Total bilirubinMust be <= 1.5 times the upper limit of normal (requests with bilirubin > 1.5x ULN are excluded)

Provider Responsibilities and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tzield (teplizumab) billed under medical benefit codes (e.g., J3590/C9399). Authorization may be delayed or a request may be returned if the submission is incomplete, incorrect, or illegible. For urgent reviews, contact AvMed Pre-Authorization Department when a standard review would subject the member to adverse health consequences.

Prior authorization required for Tzield (teplizumab) — medical benefit codes J3590 / C9399
Fax completed form to 1-877-535-1391
For urgent reviews: call AvMed Pre-Authorization Department

Step Therapy

Step-Edit / Sample Policy

Use of free samples to initiate therapy does not meet step-edit/preauthorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes; if prior therapy information is not documented, the request may be denied or delayed.

Samples do not meet preauthorization criteria
Previous therapies verified via pharmacy paid claims or chart notes

Documentation Required

Prescriber Form Requirements

The prescribing physician must sign and clearly print their name on the authorization request form (preprinted stamps are not valid). All required member and clinical fields must be completed — missing or incorrect information can delay or result in denial of authorization.

Prescribing physician signature and printed name required (no preprinted stamps)
Member identifiers (AvMed #, DOB), weight, height, BSA, diagnosis and ICD code, dosing schedule, length of therapy must be provided
Authorization may be delayed if information is incomplete, incorrect, or illegible

Definitions

Definition of Stage 2 Type 1 Diabetes (policy-specific)

Core definitionStage 2 Type 1 Diabetes: dysglycemia without overt hyperglycemia plus evidence of autoimmunity, documented by BOTH dysglycemia criteria and at least two positive pancreatic islet autoantibodies.

Required autoantibodiesAt least TWO positive pancreatic islet autoantibodies (examples listed in policy: GAD65, IAA, IA-2A, ZnT8A, ICA)

Dysglycemia criteriaOne of: fasting glucose 100–125 mg/dL; 2-hour postprandial plasma glucose 140–199 mg/dL; or an intervening postprandial glucose ≥ 200 mg/dL at 30, 60, or 90 minutes.

Exclusions from this stageMember must NOT have Stage 1 or Stage 3 Type 1 Diabetes and must NOT have Type 2 Diabetes.

Background

Tzield (teplizumab) is administered as an intravenous infusion in a planned 14-day escalating dose course, with a quantity limit of one single-dose vial daily for the 14 days. The therapy is intended to delay progression to clinical (Stage 3) Type 1 Diabetes in eligible patients with Stage 2 disease; it must be prescribed by or in consultation with an endocrinologist and used as single-agent therapy. Premedication for infusion reactions is recommended during early dosing days, and the member must meet all clinical and laboratory entry criteria before initiation.