Omalizumab for Allergy Related Asthma*

Medical Policy: 05.01.07 
Original Effective Date: December 2003 
Reviewed: May 2012 
Revised: June 2011 

Benefit Application
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.

Description: 

The injectable drug omalizumab, marketed under the trade name Xolair®, is FDA approved for the treatment of allergy related asthma in a select group of patients. This genetically engineered monoclonal antibody is injected under the skin and is indicated for patients who are at least 12 years old; with moderate to severe persistent asthma who have had a positive skin test or in vitro reactivity to at least one perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. 

Moderate persistent and severe persistent asthma in patients not currently taking long-term control medications are classified by the National Heart, Lung, and Blood Institute and the National Asthma Education and Prevention Program as described below:

Moderate persistent asthma

• Symptoms occur daily
• Exacerbations limit normal activity
• Nighttime awakenings occur > 1 time per week but not nightly
• Lung function:
  • FEV₁ > 60% but < 80% predicted
  • FEV₁/FVC reduced 5%

Severe persistent asthma

• Symptoms occur throughout the day
• Exacerbations lead to extremely limited normal activity
• Nighttime awakenings occur often 7 times per week
• Lung function:
  • FEV₁ < 60% predicted
  • FEV₁/FVC reduced > 5%

Omalizumab is only recommended as a second-line treatment to be used after first-line treatments have failed.  Initial maintenance treatment for allergic asthma generally consists of inhaled corticosteroid medications with the addition of a long acting beta-2 agonist as needed for symptomatic control.  Desensitization treatment with injections of specific allergens has also been used for patients with asthma associated with specific allergens with variable response rates.

According to the FDA, only patients who have asthma caused by allergies can benefit from this treatment and the product’s labeling states that this type of asthma should be established by skin or blood testing before treatment is initiated.  In patients suffering from an allergic component to their asthma, antigen-specific IgE is bound to receptors on the surface of mast cells and basophils, and mediates the release of histamine, leukotrienes and other mediators.  These substances cause increased inflammation of the mucosa and spasms in the smooth muscle tissue comprising the airways of the lung.  The mechanism of action for omalizumab is thought to be the formation of molecular complexes with circulating free IgE, thereby preventing their binding with mast cells and basophils.

Per the labeling for omalizumab, the FDA has included safety warnings and precautions regarding anaphylaxis, malignancy, acute asthma symptoms, corticosteroid reductions, fever/arthralgia/rash, and eosinophilic conditions.

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Prior Approval: 

Prior approval is recommended. Submit a prior approval/treatment request now.  (130KB)

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Policy: 

Treatment with omalizumab may be considered medically necessary when all of the following criteria are met:

• Patient is at least 12 years old
• Moderate persistent  or severe persistent asthma
• A positive IgE-mediated intradermal or percutaneous skin test to a common perennial aeroallergen
• Continues to show signs of wheeze, cough, shortness of breath despite maximal anti-allergy therapy
• Chronic use of steroids and/or short-acting beta-2 agonists for rescue

Treatment with omalizumab is considered investigational when the criteria listed above are not met.

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Procedure Codes and Billing Guidelines: 

• To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
• J2357 Injection, omalizumab, 5mg

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Selected References: 

• Omalizumab (Xolair): An anti-IgE antibody for asthma. The Medical Letter, Vol. 45 (1163) August 18, 2003.
• Rosenwasser LJ, Nash DB, Incorporating omalizumab into asthma treatment guidelines:Consensus panel recommendations.  P&T Vol.28(6) June 2003; 400-410.
• Holgate S, et al. Efficacy of omalizumab, an anti-immunoglobulin E antibody, in patients with allergic asthma at high risk of serious asthma-related morbidity ad mortality.  Curr Med Res Opin. 2001;17(4):233-40.
• Walker S, Monteil M, et al.  Anti-IgE for chronic asthma in adults and children.  Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003559. Abstract viewed on line.
• Chipps B, Buhl R, et al.  Improvement in quality of life with omalizumab in patients with severe allergic asthma.  Curr Med Res Opin. 2006 Nov;22(11):2201-8.
• National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. 2007. U.S. Department of Health and Human Services; National Institutes of Health.
• Canadian Agency for Drugs and Technologies in Health. Omalizumab Treatment for Adults and Children with Allergic Asthma: Clinical Effectiveness, Cost-Effectiveness, and Guidelines. 2011 November 29. [Rapid Response Report: Summary of Abstracts]. Also available: http://www.cadth.ca/media/pdf/htis/nov-2011/RB0446-000%20Omalizumab.pdf.
• Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest. 2011 Jan;1 39(1):28-35.
• Hanania NA, Alpan O, Hamilos DL, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011 May 3; 154(9):573-82.
• Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2011 Jan; 27(1):163-9.
• Busse WW, Morgan WJ, Gergen PJ, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med. 2011 Mar 17; 364(11):1005-15. 

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Policy History: 

Date                                        Reason                               Action

June 2011                               Annual review                    Policy revised

May 2012                              Annual review                     Policy renewed

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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 partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical 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.