Omalizumab (Xolair)

Xolair (omalizumab) is covered only for FDA‑approved uses — moderate-to-severe persistent allergic asthma (age ≥6 years) with positive perennial aeroallergen reactivity and inadequate control on prior therapy, and chronic idiopathic urticaria (age ≥12 years) refractory to H1 antihistamines — and is not covered for off‑label compendial uses, other allergic conditions, other forms of urticaria, acute bronchospasm, or status asthmaticus. Coverage requires documented diagnosis/age, baseline total IgE within specified ranges (30–700 U/mL for ≥12 years; 30–1300 U/mL for 6–<12 years), body weight ≤150 kg for asthma, failure of ≥3 months of specified prior asthma therapy (high‑dose inhaled corticosteroid plus a long‑acting beta‑agonist or leukotriene inhibitor), administration in a setting able to manage anaphylaxis with observation, and is authorized for up to 12 months.

"Treatment of moderate to severe persistent allergic asthma in individuals with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled ..."