CurrentColorado Rocky Mountain Health PlansPolicy 2026D0089L

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

Medical necessity and coverage criteria for teprotumumab (Tepezza) for treatment of thyroid eye disease (TED) under the UnitedHealthcare Commercial Medical Benefit Drug Policy as applied by Colorado Rocky Mountain Health Plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy 2026D0089L

Change TypeReferences updatedprevious version archived

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization with documentation of TED diagnosis, activity/severity criteria, prescribing provider specialty, FDA-aligned dosing, and adherence to the 8-dose lifetime maximum.

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information and archived previous policy version 2025D0089K.

8maximum authorized doses per lifetime

J3241HCPCS code listed

≥2 mmproptosis responder (study endpoint)

≥3 mmproptosis threshold (moderate-to-severe)

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Coverage Criteria for Teprotumumab (Tepezza)

Initial therapy criteria

Tepezza is medically necessary when ALL of the following are met:

Main eligibility: Member has a diagnosis of thyroid eye disease (TED)

Disease severity/activity

Active disease option
- Active disease required: Presence of symptomatic, active disease
  Defined by clinical assessment (e.g., Clinical Activity Score ≥3 or documented progression).
- Active disease signs (one of)
  - Lid and soft tissue: Lid retraction ≥ 2 mm≥ 2 mm
  - Soft tissue involvement: Moderate or severe soft tissue involvement
  - Proptosis ≥ 3 mm above normal for race and sex≥ 3 mm
    Examples in source: 19 and 21 mm for white female and male; 23 and 24 mm for black female and male.
  - Diplopia
Chronic (inactive) disease option
- Chronic disease required: Presence of stable, chronic (inactive) disease
- Chronic disease proptosis options
  - Increase from pre-diagnosis: ≥ 3 mm increase in proptosis from before diagnosis of TED≥ 3 mm
  - Proptosis absolute: Proptosis ≥ 3 mm above normal values for race and sex (examples provided)≥ 3 mm
    Examples in source: 19 and 21 mm for white female and male; 23 and 24 mm for black female and male.

Proptosis/diplopia or steroid failure

Significant proptosis or diplopia: Presence of either significant proptosis or diplopia
No proptosis/diplopia with steroid issue: Absence of either significant proptosis or diplopia AND history of intolerance, failure, or contraindication to oral or IV glucocorticoids (e.g., prednisone, methylprednisolone)
For Medicare reviews, refer to CMS section as applicable.

Thyroid status: Patient is euthyroid OR has mild hypo- or hyperthyroidism undergoing treatment to maintain euthyroid state

Euthyroid defined as free T3 and T4 within normal limits; mild hypo/hyperthyroidism defined as free T3 and T4 less than 50% above or below normal limits.

Prescribing provider: Tepezza is prescribed by an endocrinologist or ophthalmologist

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

Dosing and lifetime limit: Dosing is in accordance with FDA approved labeling AND authorization will be issued for a maximum of 8 doses per lifetime8 doses

Reauthorization/Continuation Therapy

Reauthorization/Continuation

Reauthorization: Continued use beyond 8 infusions in the patient's lifetime is considered unproven and not medically necessary.8 infusions

Authorization will be issued for a maximum of 8 doses per lifetime.

Tepezza (teprotumumab) must not be administered in combination with another biologic immunomodulator. Examples of biologic immunomodulators explicitly listed in the policy include rituximab, tocilizumab, and sarilumab. Documentation submitted for authorization should confirm that no concurrent biologic immunomodulator therapy is planned.

This Medical Benefit Drug Policy is provided for informational purposes and does not constitute medical advice. Coverage determinations are governed by the member-specific benefit plan document; when there is a conflict between this policy and the member-specific plan, the member-specific benefit plan document governs. Providers should check the member-specific plan document and any applicable federal or state mandates before relying on this policy for coverage decisions.

Continued use of Tepezza beyond a lifetime total of 8 infusions is considered unproven and is not medically necessary. Authorization will be issued for a maximum of 8 doses per lifetime, and requests for additional infusions beyond this limit are not supported by the phase 3 clinical trial evidence cited in the policy.

Coding and Clinical Thresholds

Applicable HCPCSHCPCS

J3241

Injection, teprotumumab-trbw, 10 mg

Applicable ICD-10 Codes (examples listed)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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inv-08: Proptosis responder / treatment threshold

Responder definitionProptosis responder = ≥ 2 mm reduction in proptosis in the study eye from baseline without deterioration (≥ 2 mm increase) in the non‑study eye (study endpoint at week 24)

Treatment threshold for moderate-to-severe diseaseProptosis ≥ 3 mm above normal for race and sex (qualifies as moderate-to-severe TED)

Context — trial dosingTeprotumumab regimen in pivotal trials: 10 mg/kg first infusion then 20 mg/kg for seven additional infusions (total 8 infusions)

Provider Responsibilities and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tepezza for the treatment of thyroid eye disease (TED). Submit documentation that supports the TED diagnosis, disease activity/severity, prior therapies, and planned dosing. Authorization, when approved, will be issued for a maximum of 8 infusions per lifetime.

Required: documentation of TED diagnosis and evidence of moderately to severe disease (e.g., CAS score, proptosis measurements, diplopia, lid retraction, soft tissue involvement).
Required: documentation of disease activity or stability (active vs chronic/inactive) and clinical findings supporting severity.
Required: documentation of prior therapies and responses — e.g., intolerance, failure, or contraindication to oral or IV glucocorticoids when applicable.
Dosing must follow FDA-approved labeling.
Authorization limit: maximum of 8 doses/infusions per lifetime; continued use beyond 8 infusions is not medically necessary.

Note

Verify Prior Authorization with Member Plan

Background on Teprotumumab and Thyroid Eye Disease

Teprotumumab (Tepezza) is a monoclonal antibody that targets the insulin-like growth factor 1 receptor (IGF-1R) and is indicated for treatment of thyroid eye disease (TED). Clinical development included randomized, double-masked, placebo-controlled trials that demonstrated significant reductions in proptosis and improvements in clinical activity score, diplopia, and patient-reported quality of life with an 8-infusion regimen. The policy references prescribing information and multiple randomized controlled trials and pooled analyses as supporting evidence of teprotumumab’s efficacy in active TED.

In clinical studies a proptosis responder was defined as a ≥ 2 mm reduction in proptosis from baseline, and the trials supporting benefit used an 8-infusion course. The policy therefore limits authorization to a maximum of 8 doses per lifetime because clinical benefit beyond that regimen has not been demonstrated in phase 3 trials.

Definitions and Study Endpoints

inv-18: Active TED definition

Active TED — Task Force definitionDisease with a Clinical Activity Score (CAS) ≥ 3 or history/documentation of progression based on subjective or objective worsening of vision, soft tissue inflammation, motility, or proptosis

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

Severity grouping noteActive disease classification informs management: moderate-to-severe versus sight‑threatening per ATA/ETA consensus

inv-19: Proptosis responder

Study endpoint (proptosis responder)Defined in trials as ≥ 2 mm reduction in proptosis in the study eye from baseline without ≥ 2 mm increase in the non‑study eye at week 24

Key trials