Omalizumab (Xolair®)

Omalizumab (Xolair) is covered only for its FDA‑approved uses — moderate‑to‑severe allergic asthma (≥6 years), chronic spontaneous urticaria (≥12 years), and add‑on maintenance for nasal polyps (≥18 years) — and not for off‑label indications. Coverage requires baseline testing (total IgE ≥30 IU/mL for asthma and nasal polyps; positive allergen skin or in‑vitro test for asthma), documented prior therapy trials (≥3 months ICS+controller for asthma; nonsedating H1 antihistamine titrated to up to 4× dose for CSU; ≥3 months intranasal steroid for nasal polyps), specialist prescribing/consultation, objective measures of uncontrolled disease, and documented clinical response for reauthorization (≥4 months on therapy for asthma/CSU; ≥6 months for nasal polyps).

"Approval duration (initial): Nasal polyps 6 months, other indications 4 months. Approval duration (renewal): 12 months."