Omalizumab (Xolair)

Xolair (omalizumab) is covered for FDA‑approved uses—moderate-to-severe persistent allergic asthma in patients ≥6 years and chronic idiopathic urticaria in patients ≥12 years—and for an off‑label compendial use (allergic rhinitis in patients ≥12); other indications are not covered. Coverage requires documentation of age criteria, baseline IgE ≥30 IU/mL and positive allergen skin/in‑vitro testing for asthma/allergic rhinitis, specified prior/concomitant therapy (≥3 months of defined asthma controllers or antihistamine failure/titration for urticaria; trial of drugs from two rhinitis drug classes and immunotherapy considerations), prescriber specialty (allergist/immunologist/pulmonologist; dermatologist allowed for urticaria), dosing per guidelines, initial approval for 4 months and reauthorization after ≥4 months with documented clinical response.

"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 who..."