Xolair — Blue Cross Blue Shield of New Mexico

Initial criteria

• Continuation of therapy allowed if patient has been treated with the requested agent (excluding samples) within past 90 days AND is at risk if therapy is changed
• OR new start requires ALL of the following:
• 1. Diagnosis and condition-specific criteria:
• A. Moderate to severe persistent asthma AND ALL:
• • Age 6–<12 years: pretreatment IgE 30–1300 IU/mL AND weight 20–150 kg OR Age ≥12 years: pretreatment IgE 30–700 IU/mL AND weight 30–150 kg
• • Allergic asthma confirmed by positive skin or in vitro test to perennial aeroallergen
• • Uncontrolled asthma while on control therapy shown by ≥2 systemic steroid bursts in past 12 months OR hospitalization/mechanical ventilation/ER or urgent care visit in past 12 months OR loss of control when corticosteroids tapered OR baseline FEV1 <80% predicted
• B. Chronic spontaneous urticaria AND ALL:
• • ≥6 weeks of hives and itching
• • If on medications that can worsen urticaria, prescriber has reduced/discontinued dose OR documents reduction not appropriate
• • Tried and had inadequate response to FDA labeled maximum dose of ONE second-generation H1 antihistamine (cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) for ≥2 weeks AND either inadequate response to ≥2× max dose for ≥2 weeks OR cannot tolerate titrated higher dose OR has intolerance/hypersensitivity or contraindication to all second-generation H1 antihistamines
• C. Chronic rhinosinusitis with nasal polyps (CRSwNP) AND ALL:
• • Pretreatment IgE 30–1500 IU/mL AND weight 30–150 kg
• • ≥2 CRS symptoms: nasal discharge, nasal obstruction/congestion, loss or decreased smell, facial pressure/pain
• • Symptoms for ≥12 consecutive weeks
• • Diagnosis confirmed by anterior rhinoscopy/endoscopy or CT of sinuses
• • Tried and had inadequate response to ≥1 intranasal corticosteroid (e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva) ≥4 weeks OR intolerance/hypersensitivity OR contraindication to all intranasal corticosteroids
• D. IgE-mediated food allergy AND ALL:
• • Pretreatment IgE 30–1850 IU/mL AND weight 10–150 kg
• • Confirmed IgE-mediated food allergy by diagnostic test (skin prick, serum specific IgE, or oral food challenge)
• • Will NOT be used for emergency treatment of allergic reactions including anaphylaxis
• 2. Age within FDA labeling for the indication or supported in compendia
• 3. For asthma, ALL:
• • If not on requested agent: on maximally tolerated inhaled corticosteroid ≥3 months AND adherent 90/120 days (chart notes)
• • If currently on requested agent: remains on inhaled corticosteroid ≥3 months AND adherent 90/120 days (chart notes) OR intolerance/hypersensitivity/contraindication to all ICS
• • Currently treated ≥3 months AND adherent 90/120 days (chart notes) with ONE: long-acting beta-2 agonist (LABA) OR long-acting muscarinic antagonist (LAMA) OR leukotriene receptor antagonist (LTRA) OR theophylline OR intolerance/hypersensitivity/contraindication to all LABA/LAMA
• • Will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with requested agent
• • Dose based on pretreatment IgE and weight per FDA label and ≤375 mg every 2 weeks
• 4. For CRSwNP: currently treated with and will continue standard nasal polyp therapy (e.g., nasal saline irrigation, intranasal corticosteroids), dose based on IgE and weight per FDA label and ≤600 mg every 2 weeks
• 5. For chronic spontaneous urticaria: dose within FDA labeled and ≤300 mg every 4 weeks
• 6. For food allergy: will avoid known food allergens while treated with requested agent