Effective March 1, 2026 UnitedHealthcare consolidated and clarified coverage criteria for teprotumumab (Tepezza) for Thyroid Eye Disease (TED). Coverage requires a TED diagnosis with specified severity thresholds: active symptomatic disease plus at least one objective sign (e.g., lid retraction ≥2 mm, moderate/severe soft tissue involvement, proptosis ≥3 mm above race/sex norms, or diplopia) or chronic inactive disease with ≥3 mm increased proptosis or proptosis ≥3 mm above norms. Patients must meet thyroid-status criteria (euthyroid or controlled/mild dysfunction), have prior intolerance/ failure/contraindication to glucocorticoids when applicable, and prescriptions must come from an endocrinologist or ophthalmologist; concurrent biologic immunomodulators are prohibited. Dosing must follow FDA labeling with a lifetime limit of 8 infusions; evidence from RCTs supports proptosis and symptom benefit with manageable safety considerations such as hyperglycemia.
March 2026 Revision: Consolidated Tepezza Coverage Criteria
This revision (Effective 2026-03-01) clarifies and consolidates coverage criteria for teprotumumab (Tepezza) in Thyroid Eye Disease (TED) under UnitedHealthcare Medical Benefit Drug Policy CSPA2026D0089E.
Key clarifications include explicit, enumerated clinical eligibility: requirement of a TED diagnosis, specification of disease severity thresholds (moderately to severe), and separate pathways for active versus chronic inactive disease with objective proptosis and soft-tissue criteria. The policy restates the maximum authorization limit of 8 lifetime doses and reaffirms that dosing must follow FDA labeling. It also emphasizes provider specialty requirements (endocrinologist or ophthalmologist) and a prohibition on concurrent use with other biologic immunomodulators.
Specific Clinical Eligibility and Severity Thresholds for TED
The policy defines precise clinical eligibility for Tepezza in TED. Covered patients must have a diagnosis of TED with "moderately to severe" disease demonstrated by either: (1) active symptomatic disease plus at least one objective sign (lid retraction ≥ 2 mm, moderate/severe soft tissue involvement, proptosis ≥ 3 mm above race/sex norms, or diplopia); or (2) stable, chronic inactive disease with ≥ 3 mm increase in proptosis from pre-diagnosis or proptosis ≥ 3 mm above race/sex norms (specific numeric norms are provided for white and black male/female patients).
Thyroid Status, Prior Therapy, and Concomitant Therapy Restrictions
The policy lists additional coverage conditions beyond disease phenotype. One of the following must be met: a history of intolerance/failure/contraindication to oral or IV glucocorticoids, or a patient history of significant proptosis, soft tissue involvement, and/or diplopia. Thyroid status requirements are explicit: the patient must be euthyroid (free T3 and T4 within normal limits), have only mild thyroid dysfunction (free T3/T4 < 50% above or below normal) while undergoing treatment to become euthyroid, or have been initiated on antithyroid medication. The policy also requires prescription by an endocrinologist or ophthalmologist and prohibits combining Tepezza with other biologic immunomodulators (examples listed include rituximab, tocilizumab, sarilumab).
Dosing Authorization Limits and Supporting Clinical Evidence
Authorization and dosing details are specified: dosing must align with the FDA-approved labeling (initial infusion 10 mg/kg then 20 mg/kg for remaining infusions every 3 weeks, total of 8 infusions per the clinical trials) and the policy limits authorization to a maximum of 8 doses per lifetime. The policy explicitly states Tepezza will not be authorized in combination with other biologic immunomodulators and requires the prescriber specialty to be an endocrinologist or ophthalmologist.
The policy background and clinical evidence sections summarize randomized controlled trial results supporting efficacy. Two pivotal trials and a Phase 4 trial demonstrated statistically significant reductions in proptosis, improved Clinical Activity Score, diplopia response, and quality-of-life measures versus placebo, with proptosis reductions around 2–2.8 mm at Week 24 and proptosis responder rates markedly higher in the teprotumumab arms. Commonly noted adverse events included hyperglycemia (manageable in diabetic patients) and infrequent serious events such as infusion reactions.
Alignment with ATA/ETA Guidance on Activity and Severity
The policy references ATA/ETA 2022 consensus statements to contextualize severity and activity definitions. It aligns coverage with the task force's framework that defines "active" disease by Clinical Activity Score (CAS) and categorizes severity into mild, moderate-to-severe, and sight-threatening. The guidance cited notes Tepezza as a preferred therapy for active moderate-to-severe TED with significant proptosis and/or diplopia, while IV glucocorticoids are preferred when activity predominates without marked proptosis or diplopia. The policy echoes the task force nuance that a numerical proptosis threshold may not capture all clinically significant cases, but the UnitedHealthcare policy provides explicit numeric thresholds for coverage pathways.
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