Xolair — Blue Cross Blue Shield of Texas

Initial criteria

• The patient has been treated with the requested agent within the past 90 days and is at risk if therapy is changed OR meets new-start criteria.
• For moderate to severe persistent asthma: ALL of the following: (a) age and IgE criteria met (age 6–<12 years: pretreatment IgE 30–1300 IU/mL and weight 20–150 kg; age ≥12 years: pretreatment IgE 30–700 IU/mL and weight 30–150 kg); (b) allergic asthma confirmed by positive test to perennial aeroallergen; (c) history of uncontrolled asthma on asthma control therapy demonstrated by one of the following: ≥2 systemic corticosteroid bursts in past 12 months, hospitalization or ER/urgent care visit, worsened control when corticosteroids tapered, or baseline FEV1 <80% predicted; (d) patient is treated or intolerant/contraindicated to an inhaled corticosteroid (ICS) and treated or intolerant/contraindicated to a LABA, LAMA, LTRA, or theophylline; (e) patient will continue asthma controller therapy in combination with Xolair; and (f) dose based on pretreatment IgE and body weight not exceeding 375 mg every 2 weeks.
• For chronic spontaneous urticaria/chronic idiopathic urticaria: ALL of the following: (a) hives and itching >6 weeks; (b) if on medication known to cause/worsen urticaria, prescriber reduced, discontinued or justified not discontinuing; (c) one of the following: inadequate response to FDA-labeled max dose of a second-generation H1 antihistamine for ≥2 weeks and either inadequate response to ≥2x max dose or intolerance or contraindication to all second-generation H1 antihistamines; and (d) dose within FDA labeled dosing not exceeding 300 mg every 4 weeks.
• For chronic rhinosinusitis with nasal polyps: ALL of the following: (a) pretreatment IgE 30–1500 IU/mL and weight 30–150 kg; (b) ≥2 CRS symptoms (nasal discharge, nasal obstruction, decreased smell, facial pressure/pain); (c) symptoms ≥12 consecutive weeks; (d) diagnosis confirmed by anterior rhinoscopy, endoscopy, or CT; (e) inadequate response, intolerance, or contraindication to one intranasal corticosteroid for ≥4 weeks; (f) currently treated with and will continue nasal polyp maintenance therapy (nasal saline irrigation and intranasal corticosteroids) with Xolair; and (g) dose based on pretreatment IgE and body weight not exceeding 600 mg every 2 weeks.
• For IgE-mediated food allergy: ALL of the following: (a) pretreatment IgE 30–1850 IU/mL and weight 10–150 kg; (b) confirmed IgE-mediated food allergy by diagnostic test; (c) Xolair will not be used for emergency treatment of allergic reactions; (d) patient will avoid known food allergens while treated.
• For any other FDA labeled indication: patient’s age within FDA labeling or supported in compendia for requested indication.