Anthem Blue Cross California Xolair (omalizumab) Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of Xolair (omalizumab), an anti-IgE antibody approved by the Food and Drug Administration (FDA) to treat moderate to severe persistent asthma in individuals 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms inadequately controlled with inhaled corticosteroids. Xolair also has FDA approved indications as add-on maintenance treatment of nasal polyps in adults with inadequate response to nasal corticosteroids as well as treatment of chronic idiopathic urticaria in individuals age 12 and older who remain symptomatic despite H1 antihistamine treatment. Asthma FDA approval for Xolair for moderate to severe persistent asthma was based in part on the results of three randomized, double-blind, placebo-controlled, multi-center trials where the number of asthma exacerbations was the principal outcome. The trials enrolled subjects with moderate to severe persistent asthma, a positive skin test reaction to a perennial aeroallergen and a total IgE level greater than 30 IU/mL. The number of exacerbations was reduced in those receiving Xolair compared to the placebo group. However, individuals whose forced expiratory volume in 1 second (FEV1) was greater than 80% predicted at enrollment did not experience a reduction in exacerbations. The 2022 Global Initiative for Asthma (GINA) guidelines list Xolair as a treatment option in Step 5 of their asthma management algorithm. Add-on targeted biologic therapy should be considered for individuals with exacerbations or poor symptom control despite taking at least high-dose inhaled corticosteroid/long acting beta 2 –agonists and who have allergic or eosinophilic biomarkers or need maintenance oral corticosteroids. Comparative Doses for Inhaled Corticosteroids (Adults and Adolescents) (Wenzel 2021) Medium Daily Dose Low Daily Dose High Daily Dose Drug Beclomethasone 40 or 80 mcg/actuation Budesonide 90 or 180 mcg/actuation Ciclesonide 80 or 160 mcg/actuation Fluticasone propionate MDI: 44, 110 or 220 mcg/actuation DPI: 50, 100 or 250 mcg/dose Fluticasone furoate 50, 100 or 200 mcg/dose Mometasone MDI: 50, 100 or 200 mcg/actuation DPI: 110 or 220 mcg/actuation 80-160 mcg >160-320 mcg >320-640 mcg 180-360 mcg >360–720 mcg >720-1440 mcg 160 mcg 320 mcg 640 mcg 176–220 mcg 100-250 mcg >220–440 mcg >250–500 mcg >440-1760 mcg >500-2000 mcg 50 mcg 200 mcg 220 mcg 100 mcg 200 mcg >200-400 mcg >220-440 mcg >400-800 mcg >440-880 mcg DPI = dry powder inhaler, MDI = metered dose inhaler Nasal Polyps FDA approval for Xolair for nasal polyps was based on the results of two randomized, double-blind, placebo-controlled, multi-center trials where nasal polyp score (NPS) and nasal congestion score (NCS) were the principal outcome. The trials enrolled subjects with nasal polyps with inadequate response to nasal corticosteroids and a total IgE level greater than 30 IU/mL. Participants received Xolair 1 or placebo in addition to background nasal mometasone therapy. The Xolair group had a statistically significant greater improvement at week 24 in NPS and NCS compared to the placebo group. In 2014, the Joint Task Force on Practice Parameters (JTFPP) representing the American Academy of Allergy, Asthma & Immunology (AAAAI), the American College of Allergy, Asthma & Immunology (ACAAI) and the Joint Council of Allergy, Asthma & Immunology published a practice parameter on the diagnosis and management of rhinosinusitis. In 2015, the American Academy of Otolaryngology- Head and Neck Surgery Foundation (AAO-HNS) published a clinical practice guideline on adult sinusitis. Both publications recommend confirming a clinical diagnosis of nasal polyps with imaging using anterior rhinoscopy, nasal endoscopy or computed tomography (CT). Intranasal corticosteroids are recommended for long-term treatment of nasal polyps. A short course of oral corticosteroids is included as a reasonable option to decrease polyp size and alleviate symptoms. Sinonasal surgery is another treatment option. The AAAAI/ACAAI guidance recommends consideration of Xolair for the treatment of nasal polyps when other medical and surgical options have failed. In 2022, the JTFPP published guidelines for the medical management of chronic rhinosinusitis with nasal polyposis (CRSwNP). The guidelines focus on select interventions for treatment of CRSwNP including intranasal corticosteroids, biologics and aspirin therapy after desensitization. The guidelines recommend intranasal corticosteroids over no intranasal corticosteroids in individuals with CRSwNP. The guidelines also recommend biologics over no biologics but note it is a conditional recommendation as other treatment options should be considered or used together with biologics (including inhaled corticosteroids and surgery. Chronic Idiopathic Urticaria Chronic idiopathic urticaria (CIU) is defined as itchy hives that last at least 6 weeks and have no apparent external trigger. The 2014 guidance from the Joint Task Force on Practice Parameters (JTFPP), representing the American Academy of Allergy, Asthma & Immunology (AAAAI), the American College of Allergy, Asthma & Immunology (ACAAI) and the Joint Council of Allergy, Asthma & Immunology, provides a step-based approach to the treatment of chronic urticaria. Xolair is included as an option in Step 4 of the algorithm when chronic urticaria has been refractory to treatment with potent antihistamines and leukotriene receptor antagonists. Xolair carries a black box warning for anaphylaxis. Anaphylaxis has been reported after the first dose of Xolair but also beyond one year after beginning treatment. Xolair should be initiated in a healthcare setting and individuals should be closely observed for an appropriate period of time. Health care providers should be prepared to manage anaphylaxis and individuals should be instructed on anaphylaxis signs and symptoms and to seek immediate medical care should they occur. Selection of individuals for self-administration of Xolair should be based on criteria to mitigate risk from anaphylaxis. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Xolair (omalizumab) Initial requests for Xolair (omalizumab) for moderate to severe persistent asthma may be if approved if the following criteria are met: I. II. III. IV. V. VI. Individual is 6 years of age or older; AND Individual has a diagnosis of moderate to severe persistent asthma; AND Documentation is provided that individual has had a 3 month trial and inadequate response or intolerance to combination controller therapy (high doses of inhaled corticosteroids plus long acting beta2 –agonists, leukotriene modifiers, long-acting muscarinic antagonists or oral corticosteroids) (GINA 2022); AND Individual has a positive skin test or in vitro reactivity to a perennial aeroallergen; AND Individual has a pretreatment forced expiratory volume in one second (FEV1 ) less than 80% predicted; AND Documentation is provided that individual has a serum Immunoglobulin E (IgE) level equal to or greater than 30 IU/mL. Continuation requests for Xolair (omalizumab) for moderate to severe persistent asthma may be if approved if the following criteria are met: I. Treatment with Xolair has resulted in clinical improvement in one or more of the following: A. Decreased utilization of rescue medications; OR B. Decreased frequency of exacerbations (defined as worsening of asthma that requires increase in inhaled corticosteroid dose or treatment with systemic corticosteroids); OR Increase in percent predicted FEV1 from pretreatment baseline; OR C. D. Reduction in reported asthma-related symptoms, such as but not limited to wheezing, shortness of breath, coughing, 2 fatigue, sleep disturbance, or asthmatic symptoms upon awakening. Initial requests for Xolair (omalizumab) for nasal polyps may be if approved if the following criteria are met: Individual is 18 years of age or older; AND Individual has a diagnosis of nasal polyps; AND I. II. III. Documentation is provided that presence of bilateral nasal polyps demonstrated on one of the following (AAO-HNS 2015): A. Anterior rhinoscopy; OR B. Nasal endoscopy; OR C. Computed tomography (CT); AND IV. Individual has had a trial and inadequate response to maintenance intranasal corticosteroids; AND V. Individual is refractory to or is ineligible or intolerant to the following (AAAAI/ACAAI 2014, JTFPP 2022): A. Systemic corticosteroids; OR B. Sinonasal surgery; AND VI. Individual is requesting Xolair as add-on therapy to maintenance intranasal corticosteroids; AND VII. Documentation is provided that individual has a serum Immunoglobulin E (IgE) level greater than or equal to 30 IU/mL. Continuation requests for Xolair (omalizumab) for nasal polyps may be if approved if the following criterion is met: I. Treatment with Xolair has resulted in clinically significant improvement in clinical signs and symptoms of disease (including but not limited to improvement in nasal congestion or reduced nasal polyp size; AND Individual continues to use Xolair in combination with maintenance intranasal corticosteroids. II. Initial requests for Xolair (omalizumab) for chronic idiopathic urticaria (CIU) may be approved if the following criteria are met: I. II. III. Individual is 12 years of age or older; AND Individual has a diagnosis of chronic idiopathic urticaria (CIU); AND Individual has had a trial and inadequate response or intolerance to H1 antihistamines and H2 antihistamines (AAAAI/ACAAI 2014); AND IV. Documentation is provided that individual has had a trial and inadequate response or intolerance to leukotriene receptor antagonists (AAAAI/ACAAI 2014). Continuation requests for Xolair (omalizumab) for chronic idiopathic urticaria (CIU) may be approved if the following criterion is met: I. Treatment with Xolair has resulted in clinically significant improvement or stabilization in clinical signs and symptoms of disease (including but not limited to itch severity and hive count). Xolair (omalizumab) may not be approved for the following; In combination with Cinqair, Dupixent, Fasenra, Nucala, or Tezspire; OR I. II. May not be approved with the above criteria are not met and for all other indications. Approval Duration Initial Requests: 6 months Continuation Requests: 12 months Quantity Limits Xolair (omalizumab) Quantity Limit Drug Limit Xolair (omalizumab) 150 mg vial, 75 mg and 150 mg syringes Asthma: 375 mg as frequently as every 2 weeks Nasal Polyps: 600 mg as frequently as every 2 weeks Chronic Idiopathic Urticaria: 300 mg every 4 weeks Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement 3 policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J2357 ICD-10 Diagnosis J33.0-J33.9 J44.0-J44.9 Injection, omalizumab, 5 mg [Xolair] Nasal polyp Other chronic obstructive pulmonary disease [with asthma] J45.20-J45.998 Asthma L50.0-L50.9 Urticaria Document History Revised: 2/24/2023