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This revision (Policy CSPA2026D0089E, effective 2026-03-01) formalizes UnitedHealthcare coverage criteria for teprotumumab (Tepezza) in thyroid eye disease (TED). The document specifies a lifetime authorization limit of a maximum of 8 doses per member. It also codifies prescriber restrictions (treatment must be prescribed by an endocrinologist or ophthalmologist) and explicit prohibition on concomitant use with other biologic immunomodulators (examples listed include rituximab, tocilizumab/Actemra, and sarilumab/Kevzara).

The policy aligns dosing expectations with U.S. Food and Drug Administration (FDA) labeling by requiring that dosing be in accordance with approved labeling (initial 10 mg/kg infusion then 20 mg/kg for remaining seven infusions every 3 weeks, as described in the clinical trial summaries). The revision therefore consolidates clinical trial dosing into the authorization conditions and clarifies administrative limits (prescriber type and maximum doses).

UnitedHealthcare defines medical necessity for Tepezza in TED by combining diagnostic, severity, and clinical-practice requirements. Covered patients must have a documented diagnosis of thyroid eye disease and either moderately to severely active disease with at least one sign (lid retraction ≥ 2 mm, moderate/severe soft tissue involvement, proptosis ≥ 3 mm above race/sex norms, or diplopia) or stable chronic (inactive) disease meeting specific proptosis thresholds (≥ 3 mm increase from pre-diagnosis or ≥ 3 mm above race/sex norms with numeric examples provided for white and black male and female patients).

The policy expressly requires either history of intolerance/failure/contraindication to oral or IV glucocorticoids or a clinical picture with significant proptosis, soft tissue involvement and/or diplopia. Thyroid status is addressed: patients must be euthyroid (normal free T3/T4) or have only mild hypo-/hyperthyroidism (free T3/T4 <50% above/below normal) while undergoing corrective treatment, or have been initiated on antithyroid medication.

Policy limits treatment to single-agent use: Tepezza may not be used concomitantly with other biologic immunomodulators — the policy lists rituximab (and its biosimilars), Actemra (tocilizumab), and Kevzara (sarilumab) as examples. Authorization is contingent on prescriber specialty (endocrinologist or ophthalmologist) and dosing that follows FDA labeling. The policy explicitly caps authorization at 8 doses per lifetime, consistent with the dosing regimen evaluated in clinical trials.

These administrative constraints reflect the clinical trial regimen described in the background and evidence sections (first infusion 10 mg/kg; subsequent seven infusions 20 mg/kg every 3 weeks) and emphasize single-agent therapy within the defined treatment course.

The policy summarizes the core clinical evidence supporting Tepezza efficacy: two randomized, double-masked, placebo-controlled trials (total n=171) demonstrated rapid and clinically meaningful reductions in proptosis and improvements in other TED outcomes. In the first trial, 69% (29/42) of teprotumumab patients achieved a ≥2 mm proptosis reduction at Week 24 versus 20% (9/45) for placebo (p < 0.001); early responses were observed by Week 6. In the second trial (n=83), results favored teprotumumab across primary and secondary endpoints: proptosis response 83% vs. 10% (p < 0.001), overall response 78% vs. 7%, diplopia response 68% vs. 29%, and mean proptosis change −2.82 mm vs. −0.54 mm.

A Phase 4 randomized trial in chronic, low-activity TED also showed statistically significant reductions in proptosis at Week 24 (mean change 2.41 mm vs. 0.92 mm; p = 0.0004). Safety findings across trials noted mostly mild-to-moderate adverse events, with hyperglycemia in patients with diabetes and rare serious events (including one infusion reaction leading to discontinuation).

UnitedHealthcare references professional guidance from the American Thyroid Association and European Thyroid Association (2022 consensus) to contextualize clinical definitions used in the coverage criteria. The policy echoes the Task Force’s activity and severity constructs — noting Clinical Activity Score (CAS) definitions and the classification of disease severity into mild, moderate-to-severe, and sight‑threatening categories. The policy operationalizes the Task Force’s concept of “significant proptosis” by providing numeric thresholds (≥ 3 mm above race/sex norms and explicit normative values for white and black males and females) while also allowing treatment for patients with lesser numeric proptosis if it sufficiently impacts daily life.

This alignment indicates the payer’s criteria attempt to balance guideline-based clinical definitions (CAS and severity) with specific measurable thresholds used in the trials and for utilization management.