Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Omalizumab (Xolair) vial may be approved when ALL of the following are met:
- ONE of the following:
- The individual’s age is within FDA labeling for the requested indication for omalizumab (Xolair); or
- The prescriber has provided information in support of using omalizumab (Xolair) for the individual’s age; and
- ONE of the following:
- The individual has a diagnosis of moderate to severe persistent asthma AND ALL of the following:
- ONE of the following:
- The individual is 6 to less than 12 years of age AND BOTH of the following:
- The pretreatment IgE level is 30 IU/mL to 1300 IU/mL; and
- The individual’s weight is 20 kg to 150 kg; or
- The individual is 12 years of age or over AND BOTH of the following:
- The pretreatment IgE level is 30 IU/mL to 700 IU/mL; and
- The individual’s weight is 30 kg to 150 kg; and
- Allergic asthma has been confirmed by a positive skin test or in vitro reactivity test (RAST) to a perennial aeroallergen; and
- The individual has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:
- Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months; or
- Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months; or
- Controlled asthma that worsens when the doses of inhaled and/or systemic corticosteroids are tapered; or
- The individual has baseline Forced Expiratory Volume (FEV1) that is less than 80% of predicted; and
- ONE of the following:
- The individual is NOT currently being treated with omalizumab (Xolair) AND is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months; or
- The individual is currently being treated with omalizumab (Xolair) AND ONE of the following:
- Is currently treated with an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms; or
- Is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months; or
- The individual has an intolerance or hypersensitivity to inhaled corticosteroid therapy; or
- The individual has an FDA labeled contraindication to ALL inhaled corticosteroids; and
- ONE of the following:
- The individual is currently being treated for at least 3 months with ONE of the following:
- A long-acting beta-2 agonist (LABA); or
- A Leukotriene receptor antagonist (LTRA); or
- Long-acting muscarinic antagonist (LAMA); or
- Theophylline; or
- The individual has an intolerance or hypersensitivity to therapy with long-acting beta-2 agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline; or
- The individual has an FDA labeled contraindication to ALL long-acting beta-2 agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), AND theophylline; and
- The individual will continue asthma control therapy (e.g., ICS, LABA, LTRA, LAMA, theophylline) in combination with omalizumab (Xolair); and
- The requested dose is based on pre-treatment serum IgE level and the individual’s body weight as defined in FDA approved labeling AND does NOT exceed 375 mg every 2 weeks; or
- The individual has a diagnosis of chronic idiopathic urticaria (CIU) AND ALL of the following:
- The individual has had over 6 weeks of hives and itching; and
- If the individual is currently being treated with medications known to cause or worsen urticaria, then ONE of the following:
- The prescriber has reduced the dose or discontinued any medications known to cause or worsen urticaria (e.g., NSAIDs); or
- The prescriber has provided information indicating that a reduced dose or discontinuation of any medications known to cause or worsen urticaria is not appropriate; and
- ONE of the following:
- The individual has tried and had an inadequate response to the FDA max dose of a second-generation H-1 antihistamine (e.g., cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) after at least a 2-week trial AND ONE of the following:
- The individual has tried and had an inadequate response to a dose above the FDA labeled maximum dose (e.g., up to 4 times the FDA labeled maximum dose); or
- The prescriber has provided information indicating the individual cannot be treated with a dose above the FDA labeled maximum dose; or
- The individual has an intolerance or hypersensitivity to second-generation H-1 antihistamine therapy; or
- The individual has an FDA labeled contraindication to ALL second-generation H-1 antihistamines; and
- The requested dose is within the FDA labeled dose AND does NOT exceed 300 mg every 4 weeks; or
- The individual has a diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) AND ALL of the following:
- There is information indicating the individual’s diagnosis was confirmed by ONE of the following:
- Anterior rhinoscopy or endoscopy; or
- Computed tomography (CT) of the sinuses; and
- ONE of the following:
- The individual has tried and had an inadequate response to intranasal corticosteroids (e.g., fluticasone, Sinuva) used for at least a 3-month trial; or
- The individual has an intolerance or hypersensitivity to therapy with intranasal corticosteroids (e.g., fluticasone, Sinuva); or
- The individual has an FDA labeled contraindication to ALL intranasal corticosteroids; and
- The individual will continue standard maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with omalizumab (Xolair); or
- The individual has another FDA labeled indication or an indication supported in DrugDex with 1 or 2a level of evidence for omalizumab (Xolair) AND the requested dose is within the FDA labeled dose for the requested indication; and
- ONE of the following:
- The individual has tried a self-administered Xolair product (i.e., Xolair prefilled syringe); or
- The individual has NOT yet received 3 doses of Xolair in the healthcare setting; or
- The prescriber has provided information that self-administration is not appropriate for the individual based on careful assessment of risk for anaphylaxis and mitigation strategies; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using omalizumab (Xolair) in combination with another biologic agent for the requested indication [e.g., injectable IL-5 inhibitor (Cinqair, Fasenra, Nucala), injectable IL-4 inhibitor (Dupixent)]; and
- The individual does NOT have any FDA labeled contraindications to omalizumab (Xolair)
Reauthorization Criteria
Omalizumab (Xolair) vial may be approved when ALL of the following are met:
- The individual has been previously approved for omalizumab (Xolair) through the Blue Cross Blue Shield of North Dakota precertification process; and
- ONE of the following:
- The individual has a diagnosis of moderate to severe persistent asthma AND ALL of the following
- The individual’s weight is within the FDA indicated range for their age (i.e., 20 kg to 150 kg for individuals age 6 to less than 12 years and 30 kg to 150 kg for individuals 12 years of age and above); and
- The individual has had clinical response or disease stabilization as defined by ONE of the following:
- Increase in percent predicted FEV1 from baseline; or
- Decrease in the dose of inhaled corticosteroid required to control the individual’s asthma; or
- Decrease in need for treatment with systemic corticosteroids due to exacerbations of asthma; or
- Decrease in the number of hospitalizations, need for mechanical ventilation, or visits to the emergency room or urgent care due to exacerbations of asthma; and
- The individual is currently treated and is compliant with standard therapy [i.e., inhaled corticosteroids, long acting beta-2 agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonist (LAMA), theophylline]; and
- The requested dose is based on pre-treatment serum IgE level and the individual’s body weight as defined in FDA approved labeling AND does not exceed 375 mg every 2 weeks; or
- The individual has a diagnosis of chronic idiopathic urticaria AND BOTH of the following:
- The individual has had clinical benefit with omalizumab (Xolair); and
- The requested dose is within the FDA labeled dose AND does NOT exceed 300 mg every 4 weeks; or
- The individual has a diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) AND BOTH of the following:
- The individual has had clinical benefit with omalizumab (Xolair); and
- The individual will continue standard maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with omalizumab (Xolair); or
- The individual has another FDA labeled indication or an indication supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for omalizumab (Xolair) AND BOTH of the following:
- The individual has had clinical benefit with omalizumab (Xolair); and
- The requested dose is within the FDA labeled dose for the requested indication; and
- ONE of the following:
- The individual has tried a self-administered Xolair product (i.e., Xolair prefilled syringe); or
- The individual has NOT yet received 3 doses of Xolair in the healthcare setting; or
- The prescriber has provided information that self-administration is not appropriate for the individual based on careful assessment of risk for anaphylaxis and mitigation strategies; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using omalizumab (Xolair) in combination with another biologic agent for the requested indication [e.g., injectable IL-5 inhibitor (Cinqair, Fasenra, Nucala), injectable IL-4 inhibitor (Dupixent)]; and
- The individual does NOT have any FDA labeled contraindications to omalizumab (Xolair).
The use of omalizumab (Xolair) vial for any indication not listed on this policy is considered experimental/investigational, and therefore, not covered. Scientific evidence does not support the use of omalizumab (Xolair) vial for any other indications.
Procedure Codes
