Xolair (omalizumab)

Covered only for FDA‑approved uses — moderate‑to‑severe allergic asthma (≥6 years), chronic spontaneous urticaria (≥12 years), and nasal polyps (≥18 years); non‑FDA indications are excluded. Approval requires indication‑specific criteria including baseline serum total IgE ≥30 IU/mL for asthma and nasal polyps, positive allergen testing for asthma, documented prior therapy trials (≥3 months inhaled corticosteroid + additional controller for asthma; antihistamine up‑titration to 4× dose for CSU; ≥3 months intranasal corticosteroid for nasal polyps), specialist prescribing/consultation, dosing by IgE and weight, minimum initial treatment durations (4 months for asthma/CSU, 6 months for nasal polyps) and documented clinical response for reauthorization (renewals up to 12 months).

"Asthma: Xolair for patients >=6 years with moderate to severe persistent asthma with a baseline serum total IgE >= 30 IU/mL, a baseline positive skin test or in vitro test for allergen-specific IgE..."