omalizumab — Blue Cross Blue Shield of Alabama

Initial criteria

• ONE of the following:
• - The patient has been treated with the requested agent within the past 90 days (not including samples) OR the prescriber states the patient has been treated within the past 90 days and is at risk if therapy changed;
• OR BOTH of the following care-level requirements for new starts:
• FOR moderate to severe persistent asthma:
• • Age ≥6 years and pretreatment IgE level and weight within specified range:
•   - Age 6–<12 years: IgE 30–1300 IU/mL and weight 20–150 kg
•   - Age ≥12 years: IgE 30–700 IU/mL and weight 30–150 kg
• • Allergic asthma confirmed by positive skin test or in vitro test (RAST) to perennial aeroallergen
• • Ongoing symptoms of moderate to severe persistent asthma as defined by:
•   - Moderate persistent: daily symptoms; nighttime awakenings >1x/week; daily SABA use; some activity limitation; FEV1 60–80%; exacerbations frequent/intense
•   - Severe persistent: symptoms throughout day; nightly awakenings; SABA several times per day; extremely limited activity; FEV1 <60%; frequent/intense exacerbations
• • Baseline disease severity assessed (use of corticosteroids, hospitalizations/ER visits, FEV1)
• • If asthma diagnosis, patient meets inhaled controller therapy rules: ≥3‑month treatment/adherence with inhaled corticosteroid (ICS) and one of LABA/LTRA/LAMA/theophylline OR intolerance/contraindication to those therapies; patient will continue control therapy with Xolair
• FOR chronic spontaneous urticaria (CSU/CIU):
• • Underlying cause not due to another allergic condition or other form of urticaria
• • ≥6 weeks hives and itching
• • If treated with drugs that cause or worsen urticaria, dose reduced/discontinued unless not appropriate
• • Baseline score from objective tool (UAS7, AAS, DLQI, AE-QoL, UCT, etc.) documented
• • Tried inadequate response ≥1 month to max dose of a second‑generation H1 antihistamine OR intolerance/contraindication
• • Tried inadequate response ≥1 month to at least one of: up‑titrated H1 (up to 4× max), LTRA, another H1, or H2 antagonist; OR intolerance/contraindications to all such therapies
• FOR chronic rhinosinusitis with nasal polyposis (CRSwNP):
• • Pretreatment IgE 30–1500 IU/mL and weight 30–150 kg
• • Bilateral symptomatic polyposis ≥12 weeks
• • ≥2 CRS symptoms (nasal discharge, obstruction, loss of smell, facial pain)
• • ≥3 indicators for biologic use (type 2 inflammation,≥2 systemic steroid courses/year or >3 months low‑dose, impaired QoL, loss of smell, comorbid asthma)
• • No antrochoanal polyps, major septal deviation, non‑type2 inflammation, cystic fibrosis, mucoceles
• • Other nasal obstruction causes ruled out
• • Baseline severity with objective tool assessed
• • Tried inadequate response ≥4‑week trial of one intranasal corticosteroid (e.g., fluticasone, mometasone, Sinuva) OR intolerance/contraindication
• FOR IgE‑mediated food allergy:
• • Pretreatment IgE 30–1850 IU/mL and weight 10–150 kg
• • Confirmed IgE‑mediated food allergy by diagnostic test (skin prick, serum IgE, or oral food challenge)
• • Not used for emergency treatment/anaphylaxis
• FOR other FDA‑approved/compendia indication:
• • Dose within FDA labeling
• • Age within or supported for that indication