Xolair® (omalizumab)

Xolair (omalizumab) is covered for its FDA‑approved indications—moderate‑to‑severe allergic asthma (≥6 years), chronic spontaneous urticaria (≥12 years), nasal polyps (≥18 years), and IgE‑mediated food allergy (≥1 year)—when all policy criteria are met and is not covered if those criteria/documentation are not satisfied. Key requirements include baseline total IgE testing (≥30 IU/mL where specified) and positive skin/in‑vitro IgE tests as applicable, prescriber specialty or consultation, documented trials of required prior therapies (e.g., ≥3 months inhaled corticosteroid plus controller for asthma; H1 antihistamines titrated to 4× dose for CSU; intranasal steroids ± prior systemic steroid or surgery for nasal polyps), objective evidence of uncontrolled disease at baseline, and documented clinical response for reauthorization (generally ≥4 months for asthma/CSU and ≥6 months for nasal polyps); food allergy also requires baseline testing, positive tests, an epinephrine auto‑injector prescription, and use with allergen‑avoidance.