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)

AND

Trial and failure (minimum 4 weeks), contraindication or intolerance to at least one oral or IV glucocorticosteroid (e.g., prednisone, methylprednisolone)

AND

AND

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. April 2023.
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.

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]