CurrentColorado Rocky Mountain Health PlansPolicy 2026D0089L

Tepezza® (Teprotumumab-Trbw) – Commercial Medical Benefit Drug Policyopen_in_new

Defines medical necessity criteria, reauthorization limits, prescribing specialty, dosing alignment with FDA labeling, combination therapy exclusions, and applicable billing/diagnosis codes for teprotumumab (Tepezza) under UnitedHealthcare commercial medical benefit drug policy.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTepezza® (Teprotumumab-Trbw) – Commercial Medical Benefit Drug Policyopen_in_new

Policy CodePolicy 2026D0089L

Change TypeRevised (references)

Effective DateFeb 1, 2026

Next Review Date

Key ActionAuthorization must document diagnosis of TED, severity/activity criteria, thyroid status, prescribing specialty, lack of combination biologic therapy, and dosing per FDA labeling; authorization limited to maximum of 8 lifetime doses.

SourceLink

POLICY UPDATE CHANGES

Updated References section; no clinical policy statement changes noted.

8Maximum lifetime doses authorized

≥3 mmProptosis coverage threshold

J3241Primary billing code

2 mmClinical trial proptosis responder

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Coverage Summary

Teprotumumab (Tepezza) is a fully human IGF-1R monoclonal antibody indicated for the treatment of thyroid eye disease (TED). TED is an autoimmune inflammatory orbital condition characterized by eyelid retraction, restrictive strabismus, and proptosis that can threaten vision via compressive optic neuropathy or corneal exposure.

This policy defines medical necessity criteria for Tepezza under UnitedHealthcare commercial medical benefit plans and supports coverage with criteria. Coverage requires documentation of TED diagnosis, disease severity/activity, thyroid status, prescribing specialty, adherence to FDA dosing, and other criteria; authorization is limited to a maximum of 8 doses per lifetime.

Key thresholds and summary

Maximum lifetime doses authorized8

Primary billing codeJ3241 (Injection, teprotumumab-trbw, 10 mg)

Common proptosis coverage threshold≥ 3 mm above normal for race and sex

Lid retraction≥ 2 mm

Clinical trial proptosis responder threshold≥ 2 mm reduction in proptosis in the study eye from baseline without ≥ 2 mm increase in the non-study eye

Applicable Codes

Covered J-code for drugHCPCSCovered

J3241

Injection, teprotumumab-trbw, 10 mg

Relevant Diagnosis Codes (reference list)ICD-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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Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required with clinical criteria

Authorization must document the diagnosis of thyroid eye disease, the required severity/activity criteria (e.g., lid retraction ≥ 2 mm, moderate/severe soft tissue involvement, proptosis ≥ 3 mm above normal for race/sex, or diplopia), thyroid status (euthyroid or treated mild dysfunction), prescribing specialty (endocrinologist or ophthalmologist), that Tepezza will not be used in combination with another biologic immunomodulator, and that dosing follows FDA-approved labeling. Authorization is limited to a maximum of 8 lifetime doses.

Affected billing code: J3241
Maximum of 8 lifetime doses (infusions)

Documentation Required

Document thyroid status and prior steroid intolerance/failure if applicable

Record free T3 and free T4 laboratory values to demonstrate a euthyroid state or to show mild hypo- or hyperthyroidism that is being treated to maintain euthyroidism. When therapy is being justified because the patient lacks significant proptosis or diplopia, document a history of intolerance, failure, or contraindication to oral or intravenous glucocorticoids (e.g., prednisone, methylprednisolone).

Free T3 and free T4 lab values (to show euthyroid or treated mild dysfunction)
History of intolerance, failure, or contraindication to oral/IV glucocorticoids (when applicable)

Billing Rule

Dosing per FDA labeling

Dosing must follow the FDA-approved regimen to meet coverage criteria: an initial infusion of 10 mg/kg followed by 20 mg/kg every 3 weeks for a total of 8 infusions.

Initial dose: 10 mg/kg (first infusion)
Subsequent doses: 20 mg/kg every 3 weeks
Total infusions: 8 (over the treatment course)

Denial Risk

Denial if exceeding lifetime dose limit

Requests for treatment beyond 8 infusions in the patient's lifetime are considered unproven, not medically necessary, and may be denied.

Lifetime maximum: 8 infusions — requests beyond 8 may be denied

Clinical Evidence

2.41 mmPhase 4: mean proptosis reduction 2.41 mm vs 0.92 mm at Week 24 (p=0.0004)

Teprotumumab binds to and blocks activation of the insulin-like growth factor-1 receptor (IGF-1R), and is used to treat inflammatory orbital manifestations of TED such as proptosis, diplopia, eyelid retraction, and soft tissue swelling. Randomized trials demonstrated rapid and clinically meaningful reductions in proptosis and improvements in clinical activity and diplopia versus placebo, with phase 3 studies reporting substantially higher proptosis responder rates and a Phase 4 trial showing statistically significant proptosis reduction at Week 24.

Definitions & Thresholds

Euthyroid: free T3 and free T4 levels within the normal limits.

Mild hypo- or hyperthyroidism: free T3 and T4 levels less than 50% above or below the normal limits (patient must be undergoing treatment to restore/maintain euthyroid state).

Clinical Activity Score (CAS): CAS assesses seven items; active disease is often defined as CAS ≥ 3 per ATA/ETA guidance.

Coverage thresholds (from policy thresholds)

Proptosis threshold≥ 3 mm above normal for race and sex; examples: 19 mm (white female), 21 mm (white male), 23 mm (black female), 24 mm (black male)

Lid retraction≥ 2 mm

Proptosis responder definition (clinical trials)≥ 2 mm reduction in proptosis in the study eye from baseline without ≥ 2 mm increase in the non-study eye

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTepezza® (Teprotumumab-Trbw) – Commercial Medical Benefit Drug Policyopen_in_new

Policy CodePolicy 2026D0089L

Change TypeRevised (references)

Effective DateFeb 1, 2026

Next Review Date

SourceLink

On This Page

OpenPayer

Tepezza® (Teprotumumab-Trbw) – Commercial Medical Benefit Drug Policyopen_in_new

Coverage Summary

Initial Therapy Criteria (Thyroid Eye Disease)

Continuation / Reauthorization Criteria

Unproven / Not Medically Necessary

Applicable Codes

Provider Actions / Prior Authorization

Clinical Evidence

Definitions & Thresholds

Medicare Determinations

Revision History