omalizumab — Blue Cross Blue Shield of Illinois

Initial criteria

• Continuation of therapy: The prescriber states the patient has been treated with the requested agent within the past 90 days (starting on samples is not approvable) and is at risk if therapy is changed.
• For new starts: ONE of the following diagnoses criteria must be met:
• A. Moderate to severe persistent asthma AND ALL of the following:
• • For age 6–<12 years: pretreatment IgE 30–1300 IU/mL AND weight 20–150 kg.
• • For age ≥12 years: pretreatment IgE 30–700 IU/mL AND weight 30–150 kg.
• • Allergic asthma confirmed by positive skin or in vitro reactivity test to a perennial aeroallergen.
• • History of uncontrolled asthma despite control therapy demonstrated by ONE of: ≥2 systemic corticosteroid bursts in past 12 months, serious exacerbations requiring hospitalization/ER, deterioration with steroid taper, or baseline FEV1 < 80% predicted.
• • The patient is treated with or intolerant/hypersensitive/contraindicated to appropriate inhaled corticosteroid and additionally has been adherent to one of LABA, LAMA, LTRA, or theophylline or has intolerance/contraindication to them.
• • The patient will continue asthma control therapy in combination with requested agent.
• • The requested dose is based on pretreatment IgE and body weight and ≤375 mg every 2 weeks.
• B. Chronic spontaneous urticaria (CSU/CIU) AND ALL of the following:
• • ≥6 weeks of hives and itching.
• • If medications known to worsen urticaria are used, prescriber has reduced/discontinued them or reduction is not appropriate.
• • ONE of the following related to H1 antihistamines: inadequate response to FDA-labeled maximum dose for ≥2 weeks and to a dose up to 2× FDA max OR cannot tolerate titrated 2× max dose OR intolerance/hypersensitivity to one agent OR contraindication to all second-generation antihistamines.
• • Requested dose within FDA label and ≤300 mg every 4 weeks.
• C. Chronic rhinosinusitis with nasal polyps (CRSwNP) AND ALL of the following:
• • Pretreatment IgE 30–1500 IU/mL AND weight 30–150 kg.
• • ≥2 CRS symptoms (nasal discharge, obstruction/congestion, smell loss, facial pain/pressure).
• • Symptoms ≥12 weeks.
• • Diagnosis confirmed by rhinoscopy/endoscopy or sinus CT.
• • Inadequate response/intolerance/contraindication to ≥1 intranasal corticosteroid after ≥4 weeks (e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva).
• • Patient currently treated with and will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation and intranasal corticosteroid).
• • Requested dose based on serum IgE and weight and ≤600 mg every 2 weeks.
• D. IgE-mediated food allergy AND ALL of the following:
• • Pretreatment IgE 30–1850 IU/mL AND weight 10–150 kg.
• • Confirmed IgE-mediated food allergy by diagnostic testing (skin test, serum specific IgE, or food challenge).
• • Requested agent not used for emergency allergic reactions, including anaphylaxis.
• • Patient will avoid known food allergens during therapy.
• E. Another FDA labeled indication or compendia-supported indication for the requested agent with appropriate age use support.