Medical Policy: 05.01.07
Original Effective Date: December 2003
Reviewed: April 2015
Revised: April 2014
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
The intent of the Xolair® (omalizumab) drug policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines, and clinical studies. Omalizumab is a recombinant DNA-derived humanized IgG1Ðº monoclonal antibody that selectively binds to human immunoglobulin E (IgE). IgE is the antibody responsible for activation of allergic reactions and is important to the pathogenesis of allergic diseases and the development and persistence of inflammation. Omalizumab is administered by subcutaneous injection.
Omalizumab has been approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe persistent asthma in patients 12 years of age or older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (ICS). More recently, omalizumab has received approval for the treatment of chronic urticaria in patients 12 years of age and older who remain symptomatic despite treatment with H1 antihistamine therapy.
Prior approval is required. Submit a prior approval/treatment request now
I. Omalizumab may be considered medically necessary for the treatment of moderate to severe persistent asthma when all of the following criteria are met:
• The patient is 12 years of age or older
• Allergic asthma has been confirmed by skin testing or in vitro reactivity (RAST) testing
• The pretreatment IgE level is within the range recommended in the product labeling
• The patient is currently using an inhaled corticosteroid (ICS) at a high dose with good compliance, unless high-dose ICS therapy is medically contraindicated
• The patient is currently using an inhaled long-acting beta-agonist (LABA) with good compliance, unless LABA therapy is medically contraindicated
• The patient is currently using a leukotriene receptor antagonist (LTRA) with good compliance, unless LTRA therapy is medically contraindicated
• The patient is experiencing inadequate control of asthma symptoms despite treatment of at least 6 weeks with the afore-mentioned therapies (unless otherwise contraindicated)
Initial approval will be for a period of 12 months. Continued treatment with omalizumab for subsequent 12 month periods is considered medically necessary when the following criteria are met:
• The patient is currently on and compliant with standard asthma therapies (such as a combination of an ICS, LABA, LTRA, theophylline, oral corticosteroids or an oral beta-agonist tablet) OR the patient has a medical contraindication to ALL standard therapies
• The patient has had a documented therapeutic response to omalizumab therapy
II. Omalizumab may be considered medically necessary for the treatment of moderate to severe chronic idiopathic urticaria (CIU) when all of the following criteria are met:
• The patient is 12 years of age or older
• The patient has been treated with at least two different high-dose H1-antihistamines (2 - 4 times normal dose daily dose), unless H1-antihistamine therapy is medically contraindicated
• The patient has been treated with a LTRA in combination with a high-dose H1-antihistamine, unless LTRA therapy is medically contraindicated
• The patient has been treated with an H2-antagonist in combination with a high-dose H1 antihistamine, unless H2-antagonist therapy is medically contraindicated
• The patient has been treated with an anti-inflammatory agent (e.g. dapsone, hydroxychloroquine, sulfasalazine) or an immunosuppressant agent (e.g. cyclosporine, mycophenolate) in combination with a high-dose antihistamine, unless ALL anti-inflammatory and immunosuppressant agents are medically contraindicated
• The patient continues to experience hives associated with itching despite adequate trials (minimum 4 weeks) of the afore-mentioned stacked therapies (unless otherwise contraindicated)
Initial approval will be for a period of 12 weeks. Continued treatment with omalizumab for subsequent 12 month periods is considered medically necessary for patients who have had a documented therapeutic response to omalizumab therapy.
III. Omalizumab is considered not medically necessary for patients who do not meet the criteria set forth above, including the following indications/use (NOT an all inclusive list), for which its efficacy and safety has not been established :
- Allergic rhinitis
- Atopic dermatitis
- Food allergy (including peanut
- Subcutaneous immunotherapy, adjunct
Omalizumab has been shown to be effective in reducing asthma exacerbations as an adjunctive therapy to inhaled steroids, and during steroid tapering phases of clinical trials. Improved asthma control was reflected by fewer symptoms, less need for rescue medications, and fewer exacerbations. Of note, data from omalizumab clinical trials did not support its efficacy in patients who had a baseline FEV1 greater than 80%, or who required oral steroids as maintenance therapy.
Current guidelines universally support omalizumab as an adjunctive treatment option in patients 12 years of age and older who have severe persistent allergic (IgE-mediated) asthma that is inadequately controlled with the combination of inhaled high-dose corticosteroids (ICS) and long-acting beta-agonists (LABAs). The National Institute for Health and Clinical Excellence (NICE) guidelines also support the use of leukotriene receptor antagonists (LTRAs), theophylline, and oral corticosteroids as adjunctive therapy in combination with ICS and LABA prior to initiating therapy with omalizumab.
There is insufficient peer-reviewed evidence to support both the efficacy and safety of omalizumab in persons with IgE levels greater than 700 IU/ml. Most of the literature on use in persons with higher IgE levels are to case reports,uncontrolled case series, unpublished abstracts, and observational and retrospective designs, further limited by small numbers of subjects studied.
Omalizumab is not FDA-approved for use in children under the age of 12. In 2011, the FDA Pediatric Advisory Committee conducted a pediatric focused safety review of omalizumab. The committee found that, due to the risk of anaphylaxis and malignancy seen in adult and adolescent patients treated with omalizumab and the modest efficacy of omalizumab seen in the randomized controlled trial in 6 to < 12 years patients, the risk-benefit assessment does not support the use of omalizumab in patients 6 to 11 years of age.
In March 2014, omalizumab received FDA approval for the treatment of chronic idiopathic urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine therapy. Clinical studies have demonstrated improved disease control, as reflected by a decrease in the weekly urticaria activity score (UAS7), in patients with moderate to severe chronic urticaria treated with omalizumab compared to placebo. However, consensus guidelines on chronic urticaria from leading allergy and immunology organizations classify omalizumab as fourth-line therapy for the treatment of chronic urticaria; it should only be considered for the treatment of patients who have failed or who are unable to use the recommended first-, second-, and third-line treatments (high-dose antihistamines, LTRAs, H2-antagonists, anti-inflammatory agents, and immunosuppressants).
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- J2357 Injection, omalizumab, 5mg
- "Xolair." [prescribing information] San Francisco, CA: Genentech, Inc., July 2010.
- Walker, S, et al. "Anti-IgE for chronic asthma in adults and children." Cochrane Database of Systematic Reviews 2 (2006): CD003559.
- National Heart, Lung, and Blood Institute (NHLBI). "National Asthma Education and Prevention Program Full Report of the Expert Panel: Guidelines for the Diagnosis and Management of Asthma (EPR-3)." Bethesda, MD: National Institutes of Health, 2007.
- Global Initiative for Asthma (GINA). "Global strategy for asthma management and prevention." Vancouver (WA): Global Initiative for Asthma (GINA), 2012.
- National Institute for Health and Clinical Excellence (NICE). "Omalizumab for treating severe persistent allergic asthma (review of technology appraisal guidance 133 and 201)." London (UK): National Institute for Health and Clinical Excellence (NICE), 2013.
- Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). "Pediatric Focused Safety Review: Xolair® (Omalizumab)." Presentation for the January 30, 2011 Meeting.
- Maurer, M, et al. "Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria." N Engl J Med 368, no. 10(2013):924-35.
- Saini, S, et al. "A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria." J Allergy Clin Immunol 128, no. 3 (2011): 567-73
- Zuberbier, T, et al. "EAACI/GA(2)LEN/EDF/WAO guideline: definition, classification and diagnosis of urticaria." Allergy 64, no. 10 (2009): 1417-26.
- Zuberbier, T, et al. "EAACI/GA(2)LEN/EDF/WAO guideline: management of urticaria." Allergy 64, no. 10 (2009): 1427-43.
Date Reason Action
June 2011 Annual review Policy revised
May 2012 Annual review Policy renewed
May 2013 Annual review Policy renewed
April 2014 Annual review Policy revised
April 2015 Annual review Policy renewed
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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and, therefore, cannot guarantee any results or outcomes.
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.