CurrentUnitedHealthcarePolicy CSIND0089.10

Tepezza (teprotumumab-trbw) for thyroid eye disease

Medical benefit drug policy for use of Tepezza to treat thyroid eye disease (TED) in Indiana members; defines coverage criteria, dosing limits, and prescriber qualifications for UnitedHealthcare Community Plan members in Indiana.

Policy Summary

PayerUnitedHealthcare

PolicyTepezza (teprotumumab-trbw) for thyroid eye disease

Policy CodePolicy CSIND0089.10

Change TypeReferences updatedarchived prior version

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization demonstrating all coverage criteria are met and limit authorization to a maximum of eight doses per lifetime.

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information and archived previous policy version CSIND0089.09.

8maximum authorized doses per lifetime

J3241drug HCPCS code

INstate

≥3 mm / ≥2 mmproptosis/lid thresholds

CAS ≥ 3CAS threshold

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Coverage Criteria for Tepezza (teprotumumab-trbw)

Initial Therapy

Covered when ALL of the following are met:

Primary diagnosis: Diagnosis of thyroid eye disease (TED)

Moderately to severe disease: Presence of moderately to severe disease associated with at least one of the following pathways: (A) active disease with one or more of: lid retraction ≥ 2 mm; moderate or severe soft tissue involvement; proptosis ≥ 3 mm above normal for race and sex; or diplopia; OR (B) stable, chronic (inactive) disease with one or more of: proptosis increase ≥ 3 mm from before diagnosis; or proptosis ≥ 3 mm above normal values for race and sex (documented reference values as applicable).

Encodes the policy's active versus chronic/inactive sub-pathways.

Symptom or prior therapy requirement: Either presence of significant proptosis or diplopia; OR if neither is present, history of intolerance, failure, or contraindication to oral or intravenous glucocorticoids (e.g., prednisone, methylprednisolone).

Policy requires one of these options in addition to disease severity.

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

Prescriber and regimen: Tepezza prescribed by an endocrinologist or ophthalmologist; not to be used in combination with another biologic immunomodulator (e.g., rituximab products, tocilizumab, sarilumab); dosing per FDA labeling; authorization limited to a maximum of eight doses per lifetime.8 doses lifetime

Reauthorization/Continuation Therapy

Continuation: Continued use beyond eight infusions in the patient's lifetime is unproven and not medically necessary.

Use of Tepezza in combination with another biologic immunomodulator is excluded. Examples of biologic immunomodulators specifically cited in the policy include rituximab products (Rituxan®, Ruxience®, Truxima®, Riabni®), Actemra® (tocilizumab), and Kevzara® (sarilumab).

Requests for Tepezza beyond eight infusions in the patient's lifetime are considered unproven and not medically necessary. The policy states that clinical benefit has not been demonstrated beyond eight infusions in phase 3 clinical trials, and continued use past this limit will not be authorized.

Coding — HCPCS and Diagnosis Codes

Applicable HCPCSHCPCSCovered

J3241

Injection, teprotumumab-trbw, 10 mg.

Applicable Diagnosis 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.

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Proptosis — clinical threshold definitions

Policy thresholdProptosis defined as ≥ 3 mm above normal for race and sex, or an increase of ≥ 3 mm from pre‑diagnosis measurement.

Race/sex example valuesDocument cites example normal values: white female 19 mm, white male 21 mm; black female 23 mm, black male 24 mm.

Alternative chronic criterionFor stable chronic (inactive) disease, ≥ 3 mm increase in proptosis from before diagnosis qualifies as significant.

Lid retraction — clinical threshold

Policy thresholdLid retraction defined as ≥ 2 mm.

Role in severityLid retraction ≥ 2 mm is one of the objective findings that characterize moderate-to-severe TED.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tepezza (teprotumumab-trbw) for the treatment of thyroid eye disease (TED). Requests must demonstrate that all coverage criteria for TED are met, including disease severity/activity and prescriber qualifications. Authorization will be issued for a maximum of eight doses per lifetime; requests for more than eight infusions are not medically necessary and will be denied.

Affected drug code: J3241 (Injection, teprotumumab-trbw, 10 mg)
Maximum authorized quantity: Up to 8 infusions per lifetime

Documentation Required

Required Clinical Documentation

Provide required clinical documentation with the prior authorization request to support the diagnosis of TED and the clinical need for Tepezza. Include objective findings of disease activity/severity and prior interventions.

Documentation of diagnosis: Thyroid eye disease (TED) with relevant ICD-10 code(s) (e.g., H05.2x series)

Background

Teprotumumab (Tepezza) is a monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R) pathway and is indicated for treatment of thyroid eye disease (TED), an autoimmune inflammatory orbital disorder that can cause eyelid retraction, restrictive strabismus, proptosis, diplopia, and threaten vision. Clinical trials supporting approval demonstrated meaningful reductions in proptosis and improvements in clinical activity and symptoms following an 8‑infusion regimen.

Per the policy, Tepezza must be prescribed by an endocrinologist or ophthalmologist and dosing should follow FDA labeling. The drug is not to be used in combination with other biologic immunomodulators, and authorization is limited to a maximum of eight doses per lifetime. The evidence base does not support clinical benefit beyond eight infusions.

Definitions

Active TED — CAS threshold and definition

Definition (ATA/ETA consensus)Active thyroid eye disease is defined as clinical activity score (CAS) ≥ 3 or documented progression/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; conjunctival edema; each item scores one point.

Clinical implicationActive disease (CAS ≥ 3) identifies patients for whom medical therapy, including IV glucocorticoids or Tepezza, may be indicated depending on features like proptosis and diplopia.

Significant proptosis — policy definition

Policy definitionSignificant proptosis is defined as proptosis ≥ 3 mm above normal values for race and sex.

Alternative qualifying definition

Revision History

2026-02-01operational_revisionLatest

Updated References section and archived previous policy version CSIND0089.09; clinical criteria retained in this version.