Pharmacy Prior Authorization Criteria

Tepezza (teprotumumab-trbw)

For diagnosis of Thyroid Eye Disease (TED)
Indicated for the treatment of thyroid eye disease regardless of Thyroid Eye Disease (TED) activity or duration.

Prior Authorization

Length of Approval: 6 Month(s)

Diagnosis of moderate-to-severe thyroid eye disease (TED), confirmed by both of the following:

Clinical Activity Score (CAS) ≥ 4
Orbital imaging (CT or MRI) confirming extraocular muscle or orbital fat involvement

AND

Trial and failure (minimum of 12 weeks), contraindication, or intolerance to at least 4.5 g IV glucocorticoid therapy (e.g., IV methylprednisolone)

AND

AND

Treatment with Tepezza has not exceeded a total of 8 infusions per treatment course [A, 1]

AND

2026-08-25, 2026-03-24, 2025-12-18, 2025-12-18, 2025-02-17, 2024-03-01, 2023-05-10, 2023-02-01, 2022-02-02, 2021-03-19, 2020-03-21, 2020-03-21

Tepezza prescribing information. Horizon Therapeutics USA, Inc. Deerfield, IL. November 2025.
Tepezza for Healthcare Professionals. Available at: https://www.tepezzahcp.com/about-thyroid-eye-disease/. Accessed May 2, 2023.
ClinicalTrials.gov. A Study Evaluating Tepezza Treatment in Patients with Chronic (Inactive) Thyroid Eye Disease. Available at: https://www.clinicaltrials.gov/ct2/show/NCT04583735?term=NCT04583735&draw=2&rank=1. Accessed May 2, 2023.
UptoDate.Treatment of Thyroid Eye Disease. Available at: https://www.uptodate.com/contents/treatment-of-thyroid-eye-disease?search=thyroid%20eye%20disease&source=search_result&selectedTitle=2%7E74&usage_type=default&display_rank=2. Accessed February 21, 2024.
Burch, H., Perros, P., Bednarczuk, T., et al. Management of Thyroid Eye Disease: A Consensus Statement by the American Thyroid Associati.n and the European Thyroid Association. Available at: https://www.liebertpub.com/doi/10.1089/thy.2022.0251. Accessed February 21, 2024.
L Bartalena, G J Kahaly, L Baldeschi, et. al. The 2021 European Group on Graves’ orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves’ orbitopathy, European Journal of Endocrinology, Volume 185, Issue 4, Oct 2021, Pages G43–G67.

In the pivotal trials, patients were given intravenous infusions (10 mg/kg for first infusion and 20 mg/kg for the remaining 7 infusions) every 3 weeks for a total of 8 infusions. [1]

2026-08-25: Clarify that treatment with Tepezza has not exceeded a total of 8 infusions per treatment course. Added requested drug will not be used in combination with Lumvoa.
2026-03-24: 2026 Annual Review. No clinical criteria changes. Updated reference.
2025-12-18: No criteria changes
2025-12-18: no criteria changes, added IL statute operational note
2025-02-17: 2025 Annual Review.
2024-03-01: 2024 Annual Review
2023-05-10: update guideline
2023-02-01: 2023 Annual Review
2022-02-02: 2022 Annual Review
2021-03-19: Annual Review - No changes.
2020-03-21: New program.
2020-03-21: New program.