Omalizumab (Xolair®)

Coverage is limited to FDA‑approved indications only: moderate‑to‑severe allergic asthma (age ≥6), chronic idiopathic urticaria (age ≥12), and nasal polyps (age ≥18); off‑label use is excluded. Approvals require indication‑specific documentation — e.g., baseline IgE ≥30 IU/mL and positive allergen test plus ≥3 months prior controller therapy and objective uncontrolled‑asthma criteria for asthma; failure of up‑titrated non‑sedating H1 antihistamines for urticaria; intranasal steroid use plus prior systemic steroid within 2 years or prior surgery/contraindication for nasal polyps — prescribed by/with the appropriate specialist (asthma: allergist/immunologist/pulmonologist; urticaria: allergist/immunologist/dermatologist; nasal polyps: allergist/immunologist/ENT), adherence to dosing/max frequency limits, and minimum treatment durations with documented clinical response for reauthorization (4 months for asthma/urticaria; 6 months for nasal polyps).

"Age restrictions by indication: asthma — 6 years of age and older; chronic idiopathic urticaria — 12 years of age and older; nasal polyps — 18 years of age and older."