CurrentCignaPolicy IP0129

Tepezza (teprotumumab) — Coverage Criteria

Defines medical necessity, prior authorization, dosing, and coding requirements for Tepezza (teprotumumab IV) for treatment of thyroid eye disease for Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyTepezza (teprotumumab) — Coverage Criteria

Policy CodePolicy IP0129

Change TypeRevised criteriaoperational edits

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit documentation that the patient meets medical necessity criteria, including age, disease severity, prior doses received, and prescriber specialty/consultation.

SourceLink

POLICY UPDATE CHANGES

The criterion requiring the patient to have 'active' disease was changed to require at least moderate severity level of disease based on signs and symptoms as assessed by the prescriber.

The criterion requiring discussion of smoking cessation for individuals who are smokers was removed.

8maximum recommended total doses

20 mg/kgmaintenance dose

≥18minimum patient age

J3241covered code

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Tepezza (teprotumumab)

FDA-Approved Indication (Thyroid Eye Disease)

Covered when ALL of the following are met

Age: Patient is ≥ 18 years of age>=18 years

Disease severity: Patient has at least moderate severity level of disease based on signs and symptoms, according to the prescriberat least moderate severity

Examples include lid retraction \u2265 2 mm; moderate or severe soft tissue involvement; proptosis \u2265 3 mm above normal for race and sex; diplopia (Gorman score 2 to 3)

Previous Tepezza exposure: Patient has not received 8 doses (total) of Tepezza; if therapy started but fewer than 8 doses received, approve doses required to reach a total of 8<8 prior doses

Maximum recommended total is 8 doses

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

Tepezza (teprotumumab) for any use other than the FDA‑approved indication of thyroid eye disease is considered not medically necessary. This policy limits coverage to the FDA‑approved indication and associated criteria; uses outside that indication are excluded from coverage.

Use of Tepezza for any indication other than thyroid eye disease is considered not medically necessary and is excluded from coverage under this policy.

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior authorization required; approvals provided for specified duration

Prior authorization is required for prescription benefit coverage of Tepezza; approvals are provided for the duration noted (approve for 6 months when the patient meets the FDA‑approved indication criteria).

Covered HCPCS code: J3241 (see coding section).
Approve up to 6 months when criteria A–D are met; for patients who have started therapy but not completed 8 doses, approve doses required to reach a total of 8.

Step Therapy

No step therapy required

No step therapy or prior medication trial requirements are specified in this policy for Tepezza.

Documentation Required

Required supporting documentation for medical necessity

Providers must submit documentation showing the patient meets medical necessity criteria, including patient age, disease severity assessment, prior Tepezza doses received, and prescriber specialty or consultation.

Document patient is ≥ 18 years of age (criterion A).
Document assessment of at least moderate disease severity and relevant signs/symptoms (criterion B) — e.g., lid retraction ≥ 2 mm, proptosis ≥ 3 mm, diplopia Gorman score 2–3.
Document number of prior Tepezza doses (criterion C) and that total will not exceed 8 doses or approval is for remaining doses to reach 8.
Document that medication is prescribed by or in consultation with an ophthalmologist, endocrinologist, or specialist in thyroid eye disease (criterion D).
Use the most appropriate diagnosis and procedure codes as of the date of service.

Denial Risk

Risk of denial for missing codes or documentation

Claims submitted without covered diagnosis/procedure codes or not accompanied by the required documentation will be denied as not covered or insufficient.

When billing, providers must use the most appropriate codes as of the effective date of submission; services billed without covered code(s) under this policy will be denied.
Lack of documentation demonstrating the criteria (age, severity, prior doses, prescriber involvement) may result in denial.

Background

Thyroid eye disease (TED), also referred to as Graves' ophthalmopathy or thyroid‑associated orbitopathy, is an autoimmune condition that causes inflammation and expansion of orbital tissues and can lead to proptosis, diplopia, soft tissue swelling, corneal exposure, and optic neuropathy. Teprotumumab (Tepezza) is an IGF‑1R antagonist indicated for the treatment of TED and is intended to reduce proptosis and improve motility and other disease manifestations.

Coverage of Tepezza under this policy follows the FDA‑approved indication: patients must be ≥ 18 years of age, have at least moderate severity disease based on the prescriber's assessment (examples include lid retraction ≥ 2 mm, moderate/severe soft‑tissue involvement, proptosis ≥ 3 mm above race/sex norms, or diplopia Gorman score 2–3), have received fewer than 8 total doses (approvals may be provided to reach a maximum of 8 doses), and the medication must be prescribed by or in consultation with an ophthalmologist, endocrinologist, or physician who specializes in thyroid eye disease.

Definitions and Scoring

Thyroid eye disease — definition and descriptors

DefinitionThyroid eye disease (also called thyroid-associated ophthalmopathy, Graves' ophthalmopathy, or Graves' orbitopathy): an autoimmune condition causing inflammation and expansion of orbital tissues leading to periorbital edema, lid retraction, proptosis, diplopia, corneal breakdown and, rarely, optic nerve compression.

Associated conditionsOften associated with Graves' disease and commonly occurs while patients are treated for hyperthyroidism.

Severity categoriesSeverity divided into mild, moderate (sufficient impact to justify treatment), and sight‑threatening (dysthyroid optic neuropathy, corneal breakdown, or globe subluxation).

Clinical Activity Score (CAS) — definition and scoring

Score constructionCAS is a 7‑item score; each item present scores 1 point (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; conjunctival edema).

Scoring rangeTotal possible points: 0–7.

Active disease thresholdCAS ≥ 3 is commonly used in consensus statements to define 'active' disease or documented progression.