Expert Clinical Network Insights: August 2025 - Prime Therapeutics
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Ophthalmology
August 13, 2025
Medication insights: teprotumumab-trbw (Tepezza)
The U.S. Food and Drug Administration (FDA) first approved teprotumumab-trbw (Tepezza) in January 2020 for the treatment of thyroid eye disease (TED). Since then, the original FDA approved indication has been updated. Tepezza is currently indicated for the treatment of TED regardless of disease activity or duration.¹ Prime Therapeutics (Prime) sought insight from key opinion leader(s) (KOLs) within our Expert Clinical Network (ECN) who specialize in ophthalmology and retinal disorders and treat patients with TED. This month’s newsletter summarizes KOL feedback on this FDA-approved insulin-like growth factor-1 receptor inhibitor for TED.
Place in therapy and clinical considerations
As the only FDA-approved therapy for the treatment of TED, Tepezza has established itself as a primary treatment option in moderate-to-severe, active TED. It can be prescribed after corticosteroids, instead of corticosteroids (in the setting of intolerance or contraindication) or as a first-line treatment in certain severe cases with significant proptosis or diplopia. The FDA-approved dosage of Tepezza is for an eight-infusion regimen (initial dose of 10 mg/kg, followed by 20 mg/kg every three weeks for seven additional infusions).¹
The 2022 American Thyroid Association (ATA) and European Thyroid Association (ETA) Consensus Statement as well as the 2021 European Group on Graves’ Orbitopathy (EUGOGO) Clinical Practice Guidelines are used to aid in therapy selection for patients with TED. Ultimately, patient-specific factors influence the choice of therapy.
The 2022 American Thyroid Association (ATA) and European Thyroid Association (ETA) Consensus Statement as well as the 2021 European Group on Graves’ Orbitopathy (EUGOGO) Clinical Practice Guidelines are used to aid in therapy selection for patients with TED. Ultimately, patient-specific factors influence the choice of therapy.
Management considerations: step therapy
Payers may be considering, or have implemented, a corticosteroid step within their Tepezza policy criteria. This strategy is appropriate in many cases of active disease, especially where inflammation is predominant. However, Prime KOLs have suggested that there are clinical settings in which the use of Tepezza may be clinically appropriate as a first-line treatment option.
While most retinal specialists support the trial of corticosteroids, others contend that a corticosteroid trial should not be required in all cases before Tepezza treatment. The argument for this is that although corticosteroids may provide symptom relief, they generally do not reverse proptosis or significantly impact long-term structural changes.
While most retinal specialists support the trial of corticosteroids, others contend that a corticosteroid trial should not be required in all cases before Tepezza treatment. The argument for this is that although corticosteroids may provide symptom relief, they generally do not reverse proptosis or significantly impact long-term structural changes.
Management considerations: Tepezza retreatment
Prime KOLs note that retreatment with Tepezza may be appropriate on a case-by-case basis for select patients who experience relapse after an initial response to Tepezza treatment. When considering retreatment, some Prime KOLs note that retreatment should not always be interpreted as an indication of initial treatment failure, but rather as a reflection of the relapsing nature of autoimmune disease, with evidence supporting benefit in select cases.
However, while some experts regard Tepezza retreatment as being clinically appropriate and verified in certain situations, others feel that there are not enough randomized clinical trials at this time to support additional treatment beyond the initial eight doses. While there is data that suggests some benefit of retreatment, there is a call for verification in trials with larger sample sizes.
However, while some experts regard Tepezza retreatment as being clinically appropriate and verified in certain situations, others feel that there are not enough randomized clinical trials at this time to support additional treatment beyond the initial eight doses. While there is data that suggests some benefit of retreatment, there is a call for verification in trials with larger sample sizes.
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References
The information contained in this report is intended for educational purposes only and is not intended to define a standard of care or exclusive course of treatment, nor be a substitute for treatment. All brand names are property of their respective owners.
- Tepezza. Prescribing information. Amgen Inc.; 2024
Our Expert Clinical Network is part of our value-based approach to medical and pharmacy benefit management where customers have access to over 175 national and world-renowned key opinion leaders in multiple disease categories. These experts assist clients with challenging prior authorization case reviews, peer-to-peer discussions, drug policy development and formulary guidance. Our ECN supports health plans and providers to make more informed decisions, leading to positive patient outcomes and avoidance of inappropriate care.
The information contained in this report is intended for educational purposes only and is not intended to define a standard of care or exclusive course of treatment, nor be a substitute for treatment. All brand names are property of their respective owners.
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