CurrentUnitedHealthcarePolicy CS2025D0089O

Tepezza (teprotumumab-trbw) for Thyroid Eye Disease — Medical Benefit Drug Policy

Covers medical benefit drug criteria for use of Tepezza in patients with thyroid eye disease for UnitedHealthcare standard benefit plans; affects providers prescribing or authorizing teprotumumab. State-specific exceptions are noted.

Policy Summary

PayerUnitedHealthcare

PolicyTepezza (teprotumumab-trbw) for Thyroid Eye Disease — Medical Benefit Drug Policy

Policy CodePolicy CS2025D0089O

Change TypeAdded state application clarification

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting diagnosis, disease severity (including proptosis or diplopia or glucocorticoid failure/intolerance), prescriber specialty, and follow FDA dosing; authorizations limited to a maximum of 8 lifetime doses.

SourceLink

POLICY UPDATE CHANGES

Added language to indicate this Medical Benefit Drug Policy does not apply to the state of Arizona; refer to the state's Medicaid clinical policy.

8maximum authorized lifetime doses

J3241HCPCS code

≥2 mmproptosis responder threshold

NCstate listed

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Root: Patient meets all listed conditions

Diagnosis of thyroid eye disease (TED)

Disease severity: Presence of moderately to severe disease with one of the following pathways

Severity pathways: Either active symptomatic disease with specified signs OR stable chronic (inactive) disease with specified proptosis criteria

Active disease pathway: Presence of symptomatic, active disease AND one of: lid retraction ≥ 2 mm; moderate or severe soft tissue involvement; proptosis ≥ 3 mm above normal for race and sex; or diplopia

Chronic disease pathway: Presence of stable, chronic (inactive) disease AND one of: ≥ 3 mm increase in proptosis from before diagnosis OR proptosis ≥ 3 mm above normal values for race and sex (examples: 19 mm female/21 mm male white; 23 mm female/24 mm male black)

Proptosis or diplopia requirement: One of the following: presence of either significant proptosis or diplopia; OR if neither is present, documentation of history of intolerance, failure, or contraindication to oral or IV glucocorticoids (e.g., prednisone, methylprednisolone)

Thyroid status: Patient is euthyroid (free T3 and T4 within normal limits) OR has mild hypo- or hyperthyroidism (free T3/T4 < 50% above or below normal) and is undergoing treatment to achieve/maintain a euthyroid state

Prescriber: Tepezza is prescribed by an endocrinologist or ophthalmologist

Concomitant therapy: Tepezza will not be used in combination with another biologic immunomodulator (e.g., rituximab, tocilizumab, sarilumab)

Dosing and authorization: Dosing must follow FDA-approved labeling; authorization is limited to a maximum of 8 doses per lifetime

Tepezza must not be used in combination with another biologic immunomodulator. Examples specified in the policy include rituximab (Rituxan®, Ruxience®, Truxima®, Riabni™), tocilizumab (Actemra®), and sarilumab (Kevzara®).

Requests for Tepezza that do not meet the policy’s diagnostic or disease-severity requirements are considered not medically necessary. Specifically, patients with mild TED without qualifying features (for example, lacking lid retraction ≥ 2 mm, moderate/severe soft tissue involvement, proptosis ≥ 3 mm above race/sex norms, or diplopia) or those who do not meet the glucocorticoid intolerance/failure criteria when required are not eligible under this policy.

Coding and Clinical Thresholds

Covered HCPCSHCPCSCovered

J3241

Injection, teprotumumab-trbw, 10 mg

Relevant 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

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Proptosis responder definition (trial) - inv-06

Clinical trial responder threshold≥ 2 mm reduction in proptosis from baseline (proptosis responder at week 24 in trials)

Responder definition detailDefined as ≥ 2 mm reduction in study eye proptosis from baseline without ≥ 2 mm increase in the non-study eye

Assessment timepointPrimary responder assessment at week 24 (trials reported earlier timepoints as well, e.g., week 6)

Proptosis policy threshold - inv-07

Policy proptosis thresholdProptosis ≥ 3 mm above normal values for race and sex

Examples of normal values providedWhite female/male: 19 mm and 21 mm; Black female/male: 23 mm and 24 mm

Use in pathwaysThreshold applies to both active and chronic disease pathways as a qualifying sign for treatment

Provider Requirements, Authorization, and Denial Triggers

Prior Authorization

Prior authorization required; 8-dose lifetime limit and FDA dosing

Prior authorization is required for teprotumumab (J3241). Authorization will be issued for a maximum of 8 doses per lifetime, and dosing must follow the U.S. Food and Drug Administration–approved labeling.

HCPCS code: J3241 (Injection, teprotumumab-trbw, 10 mg).

Step Therapy

Glucocorticoid step: document intolerance/failure/contraindication

If the patient does not have significant proptosis or diplopia, the request must include documentation of intolerance, failure, or contraindication to oral or intravenous glucocorticoids (for example, prednisone or methylprednisolone).

Required when absence of either significant proptosis or diplopia is documented.

Documentation Required

Required clinical documentation and objective measures

Clinical documentation must include a diagnosis of thyroid eye disease and objective evidence of moderate-to-severe or qualifying chronic disease (e.g., lid retraction ≥ 2 mm, proptosis measurements relative to race/sex norms, diplopia status), thyroid function status (euthyroid or treated mild hypo-/hyperthyroidism), prescriber specialty (endocrinologist or ophthalmologist), and prior treatment history including glucocorticoid intolerance/failure/contraindication when applicable.

Objective measures: lid retraction ≥ 2 mm; proptosis ≥ 3 mm above normal for race and sex or ≥3 mm proptosis from before diagnosis for chronic disease.
Thyroid status: euthyroid or mild hypo-/hyperthyroidism being treated to achieve euthyroid state.
Prescriber: endocrinologist or ophthalmologist.

Denial Risk

Denial triggers: missing diagnosis, severity, or required documentation

Requests that do not meet the policy’s diagnostic or disease-severity criteria will be denied—for example, absence of a TED diagnosis, disease that is only mild without qualifying features, or lack of required objective signs (lid retraction ≥ 2 mm, proptosis ≥ 3 mm above normal, diplopia) or missing documentation of glucocorticoid intolerance/failure when required.

Use of Tepezza for patients who do not meet the diagnostic or severity criteria is considered not medically necessary.
Requests lacking required objective measurements or prior-treatment documentation may be denied.

Background and Context

Thyroid eye disease (TED) is an orbital disorder associated with thyroid dysfunction that can present as either active inflammatory disease or stable chronic (inactive) disease. Clinical features include lid retraction, soft tissue inflammation, proptosis, and diplopia. Teprotumumab (Tepezza) is an insulin-like growth factor-1 receptor inhibitor approved for TED and has demonstrated efficacy in reducing proptosis, improving clinical activity and diplopia, and enhancing quality of life in randomized trials. The policy distinguishes an active disease pathway (symptomatic, active disease with signs such as lid retraction ≥ 2 mm, moderate/severe soft tissue involvement, proptosis ≥ 3 mm above normal for race/sex, or diplopia) from a chronic disease pathway (stable, inactive disease with prior or current proptosis ≥ 3 mm above normal or ≥ 3 mm increase from pre-disease values) to determine appropriate use.

Key Definitions Used in This Policy

Active disease (as per ATA/ETA) - inv-13

Active disease definition (ATA/ETA)Clinical Activity Score (CAS) ≥ 3 or documented progression based on subjective or objective worsening of vision, soft tissue inflammation, motility, or proptosis

CAS componentsSeven items: spontaneous retrobulbar pain, pain on attempted up or lateral gaze, eyelid redness, conjunctival redness, eyelid swelling, caruncle/plica inflammation, and conjunctival edema (1 point each)

Source guidanceATA/ETA 2022 consensus statement used to define 'active' disease in policy

Moderate-to-severe TED - inv-14

Moderate-to-severe TED definitionDisease that substantially impacts daily life and justifies medical or surgical intervention (not sight‑threatening)

Common qualifying featuresLid retraction ≥ 2 mm; moderate or severe soft tissue involvement; proptosis ≥ 3 mm above normal for race/sex; or diplopia (Gorman score 2–3)

Treatment implicationModerate-to-severe classification is used to select patients for pharmacologic therapies such as Tepezza when significant proptosis and/or diplopia are present

Euthyroid for policy - inv-15

Euthyroid requirement for policyFree T3 and T4 levels within normal limits

Permissible treated thyroid dysfunctionMild hypo- or hyperthyroidism (free T3/T4 <50% above or below normal) is acceptable if the patient is undergoing treatment to achieve/maintain a euthyroid state

Documentation expectedThyroid function tests (free T3 and free T4) should be documented to confirm euthyroid status or controlled mild dysfunction