CurrentCignaPolicy N/A

Tepezza (teprotumumab) — Coverage Criteria for Thyroid Eye Disease

This Cigna coverage policy governs prior authorization, medical necessity criteria, dosing, and coding for Tepezza (teprotumumab) for treatment of thyroid eye disease in covered members.

Policy Summary

PayerCigna

PolicyTepezza (teprotumumab) — Coverage Criteria for Thyroid Eye Disease

Policy CodePolicy N/A

Change TypeMaterial revisions and clarifications

Effective Date

Next Review DateMay 15, 2026

Key ActionSubmit prior authorization with prescriber specialty documentation and assessment that the patient has at least moderate severity of thyroid eye disease.

SourceLink

POLICY UPDATE CHANGES

Changed criterion from requiring 'active disease of at least moderate severity' to requiring 'at least moderate severity level of disease' (removes the word 'active').

Updated Note with examples of signs and symptoms of at least moderate severity (lid retraction ≥2 mm, moderate/severe soft tissue involvement, proptosis ≥3 mm above normal for race/sex, diplopia Gorman score 2-3).

Removed 'if the individual is a smoker, smoking cessation has been discussed' from criteria.

8maximum recommended total doses

20 mg/kgmaintenance dose per infusion

3 weeksminimum interval between infusions

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typical approval duration

J3241billable HCPCS code

Coverage Criteria for Tepezza (teprotumumab)

FDA-Approved Indication — Thyroid Eye Disease

Approve for thyroid eye disease for 6 months when ALL of the following are met:

FDA-Approved Indication Criteria: A) Patient is ≥ 18 years of age; AND B) According to the prescriber, patient has been assessed as having at least moderate severity level of disease based on signs and symptoms (examples include lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race and sex, or diplopia with Gorman score 2–3); AND C) Patient has not received 8 doses (total) of Tepezza (maximum recommended total = 8 doses); AND D) The medication is prescribed by or in consultation with an ophthalmologist, endocrinologist, or a physician who specializes in thyroid eye disease.none

Dosing: up to 20 mg/kg per dose IV no more frequently than every 3 weeks for up to 8 doses; approve for up to 6 months.

Tepezza (teprotumumab) for any use other than treatment of thyroid eye disease is considered not medically necessary. Criteria will be updated as new published data become available.

Use of Tepezza (teprotumumab) for indications other than thyroid eye disease (as specified in this policy) is considered not medically necessary. Criteria will be updated as new published data are available.

Coding and Dosing Information

Considered Medically Necessary when criteria metHCPCSCovered

J3241

Injection, teprotumumab-trbw, 10 mg

Maximum total doses

Maximum total doses8 doses (maximum recommended treatment)

Approval for patients who started therapyIf patient has started therapy but not completed 8 doses, approve remaining doses to reach a total of 8

Dosing interval contextDosing: up to 20 mg/kg per dose IV no more frequently than every 3 weeks for 8 doses

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required — Prior authorization is required

Prior authorization is required. Approvals are granted for 6 months when the patient meets all policy criteria, including age ≥18, assessed disease severity at least moderate, not having received a total of 8 doses, and prescriber specialty requirements. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician.

Approve for up to 6 months when ALL criteria are met
1 month = 30 days for duration calculations
Prior auth required when Tepezza is requested

Note

Provider actions — Requests for doses outside established dosing

Requests for doses outside the dosing specified in the policy (up to 20 mg/kg per dose IV no more frequently than every 3 weeks for a total of 8 doses) will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Maximum recommended treatment is 8 doses; approvals for partial courses may be issued to complete a total of 8 doses for patients already in therapy

Definitions and Clinical Thresholds

Active disease (ATA/ETA consensus)

Active disease (definition)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 signs (spontaneous retrobulbar pain; pain on attempted up or lateral gaze; eyelid redness; conjunctival redness; eyelid swelling; caruncle/plica inflammation; conjunctival edema); each scored 1 if present

Severity groups (context)Severity divided into mild, moderate, or sight‑threatening based on impact and signs

Moderate severity (policy)

Moderate severity (policy definition)Per prescriber assessment — patient has at least moderate severity level of disease based on signs and symptoms

Example: lid retraction

Background

Thyroid eye disease (also called Graves’ ophthalmopathy/orbitopathy) is an autoimmune disorder associated with Graves’ disease that can cause proptosis, diplopia, soft tissue swelling, corneal breakdown, and in rare cases optic nerve compression. It ranges from mild to sight‑threatening; moderate-to-severe and sight‑threatening disease occur in a minority of patients. Risk factors include older age, male sex, smoking, and thyroid dysfunction. Tepezza is an insulin‑like growth factor‑1 receptor (IGF‑1R) antagonist approved to treat thyroid eye disease to reduce proptosis, inactivate disease, and improve ocular motility. Prior authorization is required for benefit coverage; when criteria are met the policy allows approval for up to 6 months with dosing up to 20 mg/kg per infusion no more frequently than every 3 weeks for a maximum of 8 doses.

Policy Summary

PayerCigna

PolicyTepezza (teprotumumab) — Coverage Criteria for Thyroid Eye Disease

Policy CodePolicy N/A

Change TypeMaterial revisions and clarifications

Effective Date

Next Review DateMay 15, 2026

Key ActionSubmit prior authorization with prescriber specialty documentation and assessment that the patient has at least moderate severity of thyroid eye disease.

SourceLink

On This Page

Dose exceptions reviewed individually by a clinician

Documentation Required

Provider documentation — Prescriber specialty and severity assessment required

Prescriber specialty documentation is required: the medication must be prescribed by or in consultation with an ophthalmologist, endocrinologist, or a physician who specializes in thyroid eye disease. The prescriber must document assessment of disease severity (at least moderate) in the medical record.

Acceptable prescriber specialties: ophthalmologist, endocrinologist, or thyroid eye disease specialist
Prescriber assessment of at least moderate disease severity must be documented (examples: lid retraction ≥2 mm, moderate/severe soft tissue involvement, proptosis ≥3 mm above normal for race/sex, diplopia Gorman score 2–3)

Billing Rule

Billing and claim requirements — Claims without covered diagnosis/procedure codes will be denied

Claims submitted without covered diagnosis or procedure codes referenced in the applicable Coverage Policy will be denied as not covered. Prior authorization requirements must be met and documented on the request; claims lacking a corresponding approved prior authorization will be denied.

Claims without covered diagnosis/procedure codes will be denied
Prior authorization requirements apply — ensure prior auth is obtained and included with claim

Lid retraction ≥ 2 mm

Example: soft tissue involvementModerate or severe soft tissue involvement

Example: proptosisProptosis ≥ 3 mm above normal for race and sex

Example: diplopiaDiplopia with Gorman score 2–3