WHA

Tepezza (teprotumumab-trbw)

Indications for Prior Authorization

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.

Criteria

Tepezza

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Prior Authorization

Length of Approval: 6 Month(s)

  • Diagnosis of thyroid eye disease (TED)
    • AND
  • Trial and failure (minimum 4 weeks), contraindication or intolerance to at least one oral or IV glucocorticosteroid (e.g., prednisone, methylprednisolone)
    • AND
  • Prescribed by or in consultation with one of the following: [3]
    • Endocrinologist
    • Ophthalmologist
    AND
  • Treatment with Tepezza has not exceeded a total of 8 infusions [A, 1]

  • Guideline ID
    GL-486500

  • Formulary
    Premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Mar 18, 2020

P & T Revisions

1970-01-01, 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

  1. Tepezza prescribing information. Horizon Therapeutics USA, Inc. Deerfield, IL. April 2023.
  2. Tepezza for Healthcare Professionals. Available at: https://www.tepezzahcp.com/about-thyroid-eye-disease/. Accessed May 2, 2023.
  3. 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.
  4. 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.
  5. 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.
  1. 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]
  • 1970-01-01: 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.