Xolair® (omalizumab)

Xolair is covered for the FDA‑approved indications—moderate‑to‑severe allergic asthma (≥6 years), chronic spontaneous urticaria (≥12 years), chronic rhinosinusitis with nasal polyps (≥18 years), and IgE‑mediated food allergy (≥1 year)—and is not authorized for off‑label use or patients who do not meet the policy criteria. Coverage requires baseline testing and documentation (serum total IgE ≥30 IU/mL where specified; positive allergen testing for asthma), prior standard therapy trials (≥3 months ICS plus another controller for asthma; up‑titrated H1 antihistamines for urticaria; ≥4 weeks intranasal steroids for CRSwNP; allergen‑avoidant diet for food allergy), specialist prescribing/consultation, and documented clinical response with minimum treatment durations for reauthorization (generally ≥4 months, ≥6 months for CRSwNP).

"Asthma: Xolair is indicated for patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whos..."