Xolair — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following: (A) The requested agent is eligible for continuation of therapy when the prescriber states the patient has been treated with the requested agent (not samples) within the past 90 days and is at risk if therapy is changed OR (B) ALL of the following indication-specific criteria are met.
• For moderate to severe persistent asthma: (1) Patient age 6 to <12 years with pretreatment IgE 30–1300 IU/mL and weight 20–150 kg OR age ≥12 years with pretreatment IgE 30–700 IU/mL and weight 30–150 kg; (2) Allergic asthma confirmed by positive skin test or in vitro reactivity to a perennial aeroallergen; (3) History of uncontrolled asthma on control therapy shown by ≥2 systemic corticosteroid bursts in past 12 months, or serious exacerbation requiring hospitalization, ventilation, or ED/urgent care, or worsened asthma when steroids tapered, or baseline FEV1 <80% predicted; and (4) Meets therapy prerequisites: currently or previously on maximally tolerated inhaled corticosteroid (ICS) therapy for ≥3 months with documented adherence ≥90 of past 120 days unless intolerance/hypersensitivity/contraindicated; and concurrently or previously on another controller (LABA, LAMA, LTRA, theophylline) with adherence unless intolerant/hypersensitive/contraindicated; and will continue asthma control therapy with Xolair; requested dose per IgE level and weight and ≤375 mg every 2 weeks.
• For chronic spontaneous urticaria: (1) ≥6 weeks of hives and itching; (2) If on medications that cause/worsen urticaria, dose reduced/discontinued or reduction not appropriate; (3) ONE of the following: inadequate response to FDA max dose of one second-generation H1 antihistamine for ≥2 weeks plus inadequate response to twice-max dose OR cannot use twice-max dose OR intolerance or hypersensitivity to one H1 antihistamine OR contraindication to all; dose within FDA labeling ≤300 mg every 4 weeks.
• For chronic rhinosinusitis with nasal polyps: (1) Pretreatment IgE 30–1500 IU/mL and weight 30–150 kg; (2) ≥2 CRS symptoms (nasal discharge, obstruction, smell loss, facial pressure/pain); (3) Symptoms ≥12 consecutive weeks; (4) Diagnosis by rhinoscopy/endoscopy or CT; (5) Tried and inadequate response to, or intolerance/contraindication to, ≥1 intranasal corticosteroid (fluticasone nasal spray, mometasone nasal spray, Sinuva) for ≥4 weeks; (6) Currently and will continue standard nasal polyp maintenance therapy (e.g., saline irrigation, intranasal steroids) with Xolair; requested dose per IgE and weight ≤600 mg every 2 weeks.
• For IgE-mediated food allergy: (1) Pretreatment IgE 30–1850 IU/mL and weight 10–150 kg; (2) Laboratory confirmed IgE-mediated food allergy (skin prick, serum specific IgE, or oral food challenge); (3) Will not use Xolair for emergency treatment of allergic reactions including anaphylaxis; (4) Will avoid known food allergens while on treatment.
• For all indications: patient age within or supported for FDA labeling or within compendia support.