CurrentUnitedHealthcarePolicy CSLA2026D0089J

Tepezza (teprotumumab) for Thyroid Eye Disease

Medical benefit drug policy governing coverage and medical necessity criteria for Tepezza for treatment of thyroid eye disease (TED) for UnitedHealthcare Community Plan members in Louisiana.

Policy Summary

PayerUnitedHealthcare Community Plan

PolicyTepezza (teprotumumab) for Thyroid Eye Disease

Policy CodePolicy CSLA2026D0089J

Change TypeAdministrative revision

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit prior authorization with clinical documentation meeting the policy's medical necessity criteria and dosing consistent with FDA labeling (authorization limited to a maximum of 8 doses lifetime).

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information and archived previous policy version CSLA2025D0089I.

8maximum lifetime doses authorized

J3241procedure code listed for teprotumumab injection

LAstate of application

≥2 mmproptosis reduction responder definition

69% vs 20%

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Coverage and Medical Necessity Criteria

Initial Therapy Criteria

Tepezza is proven and medically necessary for treatment of thyroid eye disease when ALL of the following are met:

Overall: Member has a diagnosis of thyroid eye disease (TED); and Tepezza is prescribed by an endocrinologist or ophthalmologist; and Tepezza will not be used in combination with another biologic immunomodulator (e.g., rituximab, tocilizumab, sarilumab); and dosing is in accordance with FDA-approved labeling; and authorization is limited to a maximum of 8 doses per lifetime; and patient meets disease severity/activity and thyroid status criteria below.

based on policy requirements

Moderately to severe disease definitions

Symptomatic, active disease pathway (A): Presence of symptomatic, active disease; and at least one of the following: lid retraction ≥ 2 mm; moderate or severe soft tissue involvement; proptosis ≥ 3 mm above normal for race and sex; or diplopia.
Active disease defined elsewhere (e.g., CAS ≥ 3 or documented progression)
Stable, chronic (inactive) disease pathway (B): Presence of stable, chronic (inactive) disease; and at least one of the following: ≥ 3 mm increase in proptosis from before diagnosis of TED; or proptosis ≥ 3 mm above normal for race and sex; and one of: presence of significant proptosis or diplopia; OR if significant proptosis/diplopia are absent, a history of intolerance, failure, or contraindication to oral or IV glucocorticoids.
Nested OR within this branch (see text).

Use of Tepezza in combination with another biologic immunomodulator is not permitted. The policy explicitly lists examples of prohibited concomitant biologics including rituximab, tocilizumab, and sarilumab, and requires that Tepezza will not be used in combination with another biologic immunomodulator. Dosing must follow the FDA-approved labeling and the therapy must be prescribed by an endocrinologist or ophthalmologist as specified in the medical necessity criteria.

Providers should document that Tepezza is being administered as a single biologic therapy and that dosing adheres to the FDA regimen. The policy’s combination exclusion is a strict prohibition — requests indicating concurrent use with another biologic immunomodulator will not meet the coverage criteria.

The policy states that the clinical benefit of Tepezza has not been demonstrated beyond 8 infusions in clinical trials. Accordingly, continued use of Tepezza beyond 8 infusions in the patient’s lifetime is unproven and not medically necessary, and requests exceeding this lifetime limit will be denied.

Applicable Codes and Trial Definitions

Applicable HCPCS CodesHCPCS

J3241

Injection, teprotumumab-trbw, 10 mg

Applicable ICD-10 CodesICD-10

E05.00	Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm.
E05.01	Thyrotoxicosis with diffuse goiter with thyrotoxic crisis or storm.
H05.20	Unspecified exophthalmos.
H05.211	Displacement (lateral) of globe, right eye.
H05.212	Displacement (lateral) of globe, left eye.
H05.213	Displacement (lateral) of globe, bilateral.
H05.219	Displacement (lateral) of globe, unspecified eye.
H05.221	Edema of right orbit.
H05.222	Edema of left orbit.
H05.223	Edema of bilateral orbit.

1–10 of 27

1/3

Proptosis responder definition (trial)

Proptosis responder (trial definition)Reduction in proptosis of ≥ 2 mm from baseline in the study eye (without ≥ 2 mm worsening in the non‑study eye)

Proptosis severity threshold referenced in criteria

Proptosis severity thresholdProptosis ≥ 3 mm above normal values for race and sex (numerical examples: 19 and 21 mm for white female and male; 23 and 24 mm for black female and male)

Prior Authorization, Documentation, and Limits

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tepezza (teprotumumab-trbw). Dosing must follow the FDA-approved schedule and documentation supporting the request should be submitted with the prior authorization.

Tepezza must be prescribed by an endocrinologist or ophthalmologist.
Tepezza must not be used in combination with another biologic immunomodulator (e.g., rituximab, tocilizumab, sarilumab).
Dosing must be in accordance with the FDA-approved labeling.

Prior Authorization

Glucocorticoid Requirement for Certain Presentations

For patients with stable, chronic (inactive) TED without significant proptosis or diplopia, there must be documentation of intolerance to, failure of, or a contraindication to oral or intravenous glucocorticoids (for example, prednisone or methylprednisolone) prior to authorization of Tepezza.

Document prior treatment with oral or IV glucocorticoids and clinical response, or documentation of intolerance/contraindication.

Key Clinical Definitions

Active TED — definition

Active TED (CAS)Clinical Activity Score (CAS) ≥ 3

Active TED (progression)Documented progression of vision, soft tissue inflammation, motility, or proptosis

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

Definition of moderate-to-severe TED

Moderate-to-severe TED — primary featuresPresence of any one or more: lid retraction ≥ 2 mm; moderate or severe soft tissue involvement; proptosis ≥ 3 mm above normal for race and sex; or diplopia (Gorman score 2–3)

Clinical impact

Background and Clinical Context

Teprotumumab (Tepezza) is a monoclonal antibody that targets the insulin-like growth factor-1 receptor (IGF-1R) and is indicated for the treatment of thyroid eye disease (TED). TED is an autoimmune inflammatory disorder of the orbit that can cause eyelid retraction, soft tissue inflammation, restrictive strabismus, and proptosis, and in severe cases may threaten vision through compressive optic neuropathy or exposure keratopathy.

Clinical trials of teprotumumab evaluated an 8-infusion regimen (initial 10 mg/kg dose followed by 20 mg/kg every 3 weeks) and demonstrated meaningful reductions in proptosis and improvements in diplopia and quality of life. The policy requires patients be euthyroid or treated to achieve euthyroid status and that therapy be prescribed by an endocrinologist or ophthalmologist; it also defines thresholds used in eligibility determinations such as proptosis ≥ 3 mm above normal for race and sex and other features of moderate-to-severe disease.

Policy Revisions and Notes

2026-02-01Administrative updateLatest

Updated References section to reflect current information and archived previous policy version CSLA2025D0089I.