CurrentCignaPolicy IP0129

Tepezza (teprotumumab) coverage

Defines Cigna's prior authorization and medical necessity criteria for coverage of Tepezza (teprotumumab) for treatment of thyroid eye disease for covered members under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTepezza (teprotumumab) coverage

Policy CodePolicy IP0129

Change TypeRevised criteriaremoved smoking requirement

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization and document age, prescriber specialty, disease severity (at least moderate), and prior Tepezza doses (<8); approve up to 6 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

The criterion was changed to require that the patient has at least moderate severity level of disease based on signs and symptoms, removing the word 'active'.

The requirement that the individual not be a smoker and that smoking cessation be discussed was removed.

8maximum recommended number of Tepezza doses

20 mg/kgmaintenance dose per infusion

6 monthsinitial approval duration

J3241covered HCPCS code

Coverage Criteria for Tepezza (teprotumumab)

Policy Summary

PayerCigna

PolicyTepezza (teprotumumab) coverage

Policy CodePolicy IP0129

Change TypeRevised criteriaremoved smoking requirement

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization and document age, prescriber specialty, disease severity (at least moderate), and prior Tepezza doses (<8); approve up to 6 months when criteria are met.

SourceLink

On This Page

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Thyroid Eye Disease (FDA-approved indication)

Covered when ALL of the following are met:

FDA indication: Patient has thyroid eye disease (TED)

TED also recognized as Graves' ophthalmopathy, Graves' orbitopathy, thyroid-associated ophthalmopathy, or thyroid orbitopathy

Age: Patient is ≥ 18 years of age

Dose history: Patient has not received 8 doses (total) of Tepezza and is to receive up to a total of 8 doses<=7 prior doses

Maximum recommended treatment is 8 doses; for a patient who has started therapy but has not completed 8 doses, approve the number of doses required to complete 8 doses

Prescriber: Medication is prescribed by or in consultation with an ophthalmologist, endocrinologist, or a physician who specializes in thyroid eye disease

Tepezza (teprotumumab) for any indication other than thyroid eye disease (TED) is considered not medically necessary. This policy limits coverage to the FDA‑approved indication for TED and related criteria; uses outside that indication will not be approved.

Use of Tepezza for indications other than thyroid eye disease (also recognized as Graves' ophthalmopathy/orbitopathy, thyroid-associated ophthalmopathy, or thyroid orbitopathy) is considered not medically necessary and is excluded from coverage under this policy.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required — prior authorization is required; approve up to 6 months (to allow up to 8 doses) when medical necessity criteria are met.

Prior authorization is required for prescription benefit coverage of Tepezza.
Approvals provided for up to 6 months (to allow up to 8 doses) when medical necessity criteria are met.

Step Therapy

No Step Therapy Sequence

No explicit step therapy sequence is stated in this policy. Providers are not required to follow a stepwise medication trial sequence prior to requesting prior authorization under this policy.

Documentation Required

Documentation Requirements

Documentation must support the member’s age, disease severity (at least moderate), prior number of Tepezza doses received (<8), and prescriber specialty/credentials as required by the policy.

Evidence of patient age (≥ 18 years).
Clinical documentation demonstrating at least moderate severity of thyroid eye disease (examples: lid retraction ≥ 2 mm, moderate/severe soft tissue involvement, proptosis ≥ 3 mm above normal for race/sex, diplopia Gorman score 2–3).
Documentation of total prior Tepezza doses received (< 8) and intent to receive up to a total of 8 doses.
Prescription by or consultation with an ophthalmologist, endocrinologist, or physician who specializes in thyroid eye disease.

Denial Risk

Claims, Coding, and Denial Risk

Claims submitted without covered diagnosis/procedure codes or not meeting the Coverage Policy criteria will be denied; prior authorization and proper coding are required to avoid claim denials and billing risk.

Claims must include covered diagnosis and/or procedure codes that match the Coverage Policy.
Services billed for conditions or diagnoses not covered under this policy will be denied as not covered.
Use the most appropriate and active codes as of the date of service. Deleted or inactive codes at the time of service may be ineligible for reimbursement.
Covered HCPCS J-code: J3241 (Injection, teprotumumab-trbw, 10 mg) — ensure this and appropriate diagnosis code(s) are submitted when requesting coverage.

Definitions and Clinical Thresholds

Active thyroid eye disease

DefinitionActive thyroid eye disease is defined by the consensus as disease with a Clinical Activity Score (CAS) ≥ 3 or documented progression based on subjective or objective worsening of vision, soft tissue inflammation, motility, or proptosis.

CAS componentsCAS assesses seven items: spontaneous retrobulbar pain; pain on attempted up or lateral gaze; redness of the eyelids; redness of the conjunctiva; swelling of the eyelids; inflammation of the caruncle and/or plica; and conjunctival edema.

When to consider 'active'History or documentation of progression of thyroid eye disease based on subjective or objective worsening qualifies even if CAS not recorded.

Clinical relevance'Active' status identifies patients with ongoing inflammatory signs who may be candidates for pharmacologic treatments intended for disease inactivation (e.g., Tepezza).

Moderate severity (policy-level)

Policy-level definitionModerate severity is an assessment by the prescriber that the disease has at least moderate impact based on signs and symptoms.

Examples of signsLid retraction ≥ 2 mm; moderate or severe soft tissue involvement; proptosis ≥ 3 mm above normal for race and sex.

Functional signDiplopia consistent with Gorman score 2–3 (intermittent or inconstant diplopia impacting function).

Clinical implication'Moderate' indicates disease not sight‑threatening but with sufficient impact to justify medical or surgical intervention per prescriber judgment.

OpenPayer

Tepezza (teprotumumab) coverage

Coverage Criteria for Tepezza (teprotumumab)

Coding and Billing

Provider Actions, Authorization, and Documentation

Definitions and Clinical Thresholds

Background