CurrentUnitedHealthcarePolicy CSPA2026D0089E

Tepezza (Teprotumumab-Trbw) (for Pennsylvania Only)

UnitedHealthcare Pennsylvania-specific medical benefit drug policy for Tepezza (teprotumumab-trbw) defining coverage criteria, reauthorization limits, prescribing clinician requirements, prohibited combinations, dosing conformity to FDA labeling, and applicable billing/diagnosis codes.

Policy Summary

PayerUnitedHealthcare

PolicyTepezza (Teprotumumab-Trbw) (for Pennsylvania Only)

Policy CodePolicy CSPA2026D0089E

Change TypeSupporting information / references updated

Effective DateMar 1, 2026

Next Review Date

Key ActionDocument diagnosis, disease activity/stability, objective findings (e.g., lid retraction, proptosis, diplopia), thyroid function or antithyroid treatment status, and request prior authorization limited to a maximum of 8 doses per lifetime.

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information.

8Maximum doses authorized per lifetime

J3241HCPCS drug code

≥3 mm / ≥2 mmClinical thresholds (proptosis / lid retraction)

Coverage Summary

Covered with criteria: Teprotumumab (Tepezza) is covered for Thyroid Eye Disease (TED) per this UnitedHealthcare Pennsylvania medical benefit drug policy (Policy Number CSPA2026D0089E, effective March 1, 2026). Coverage is conditional on meeting the policy criteria. Authorization is limited to a lifetime maximum of 8 doses, and use in combination with another biologic immunomodulator is excluded.

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Initial Therapy — Thyroid Eye Disease (TED)

Initial Therapy - Thyroid Eye Disease (TED)

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

ALL of the following

Diagnosis of thyroid eye disease (TED)
Presence of moderately to severe disease, associated with at least one of the following:
- Both of the following: Presence of symptomatic, active disease; and one of the following:
  - Presence of symptomatic, active disease
    Active disease per ATA/ETA: CAS ≥ 3 or documented progression
  - ONE of
    Lid retraction ≥ 2 mm≥ 2 mm
    Moderate or severe soft tissue involvement
    Proptosis ≥ 3 mm above normal for race and sex≥ 3 mm
    examples: 19 and 21 mm for white female and male; 23 and 24 mm for black female and male
    Diplopia
- Both of the following: Presence of stable, chronic (inactive) disease; and one of the following:
  - Presence of stable, chronic (inactive) disease
  - ONE of
    Greater than or equal to 3 mm in proptosis from before diagnosis of TED≥ 3 mm
    Proptosis ≥ 3 mm above normal values for race and sex≥ 3 mm
    examples: 19 and 21 mm for white female and male; 23 and 24 mm for black female and male
One of the following (history/intolerance requirement):
- ONE of
  - History of intolerance, failure, or contraindication to oral or intravenous glucocorticoids (e.g., prednisone, methylprednisolone)
  - Patient with history of significant proptosis, soft tissue involvement and/or diplopia
One of the following (thyroid function requirement):
- ONE of
  - Patient is euthyroid (defined as free triiodothyronine (T3) and thyroxine (T4) levels within the normal limits)free T3 and T4 within normal limits
  - Presence of mild hypo- or hyperthyroidism (defined as free T3 and T4 levels less than 50% above or below the normal limits) and patient is undergoing treatment to correct the mild hypo- or hyperthyroidism to maintain a euthyroid statefree T3 and T4 < 50% above or below normal limits
  - Patient has been initiated on antithyroid medication
Prescribing and combination therapy requirements
- Tepezza is prescribed by an endocrinologist or ophthalmologist
- Tepezza will not be used in combination with another biologic immunomodulator (e.g., rituximab, tocilizumab, sarilumab)
  Examples listed in policy
- Dosing is in accordance with the United States Food and Drug Administration approved labeling
  Initial infusion 10 mg/kg then 20 mg/kg for remaining 7 infusions every 3 weeks per FDA labeling
- Authorization will be issued for a maximum of 8 doses per lifetimemaximum 8 doses per lifetime

Provider Actions — Authorization, Documentation & Billing

Prior Authorization

Prior authorization required with qualifying criteria

Authorization limited to a maximum of 8 doses per lifetime; requests for more than 8 infusions will be reviewed on a case-by-case basis for medical necessity.

J3241

Documentation Required

Clinical documentation of disease severity and thyroid status

Provider must document diagnosis of thyroid eye disease (TED); disease activity or stability; specific objective findings such as lid retraction measurement, proptosis measurement, and presence of diplopia; history of intolerance, failure, or contraindication to oral or IV glucocorticoids if claimed; and thyroid function status (free T3 and T4 within normal limits, or initiation of antithyroid medication) or treatment to maintain euthyroid state.

Document lid retraction (e.g., ≥ 2 mm)
Document proptosis measurement (e.g., ≥ 3 mm above normal for race/sex or ≥ 3 mm change from pre-diagnosis)
Document diplopia and other objective findings
Document history of steroid intolerance/failure/contraindication when claimed
Provide free T3 and T4 results or evidence of antithyroid medication/initiation

Billing Rule

Dosing per FDA-approved labeling

Dosing must follow the FDA-approved labeling: initial infusion 10 mg/kg followed by seven infusions of 20 mg/kg every 3 weeks (total of 8 infusions) in order to meet the policy dosing requirement.

Follow FDA label dosing schedule (10 mg/kg then 20 mg/kg x7 every 3 weeks)
Adherence to labeled dosing is required for coverage under this policy

Denial Risk

Combination therapy exclusion

Claims will not meet criteria if Tepezza is used concurrently with another biologic immunomodulator at the time of therapy; such combination use is excluded.

Examples: rituximab (Rituxan, Ruxience, Truxima, Riabni)
Actemra (tocilizumab)
Kevzara (sarilumab)

Tepezza must be prescribed by an endocrinologist or ophthalmologist. This policy applies to UnitedHealthcare Pennsylvania members.

Background

Thyroid Eye Disease (TED) is an autoimmune inflammatory orbital condition that can cause upper eyelid retraction, restrictive strabismus, and proptosis, and can threaten vision via compressive optic neuropathy or corneal decompensation from exposure keratopathy. Teprotumumab is an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, a fully human IgG1 monoclonal antibody, indicated for the treatment of TED.

Definitions

Euthyroid (policy definition)Free triiodothyronine (T3) and thyroxine (T4) levels within the normal limits.

Active disease (per ATA/ETA consensus)Clinical activity score (CAS) ≥ 3 or documented progression of TED based on subjective or objective worsening of vision, soft tissue inflammation, motility, or proptosis.

Note on 'mild' thyroid dysfunction threshold‘Mild’ hypo- or hyperthyroidism defined as free T3 and T4 levels less than 50% above or below the normal limits (patient should be undergoing treatment to restore euthyroid state).

Policy Summary

PayerUnitedHealthcare

PolicyTepezza (Teprotumumab-Trbw) (for Pennsylvania Only)

Policy CodePolicy CSPA2026D0089E

Change TypeSupporting information / references updated

Effective DateMar 1, 2026

Next Review Date

SourceLink

On This Page

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

OpenPayer

Tepezza (Teprotumumab-Trbw) (for Pennsylvania Only)

Coverage Summary

Initial Therapy — Thyroid Eye Disease (TED)

Reauthorization / Continuation of Care

Provider Actions — Authorization, Documentation & Billing

Applicable Codes

Clinical Evidence

Background

Revision History