Xolair® (omalizumab) is indicated for use in patients who meet all the following criteria:

• greater than or equal to 12 years of age;
• moderate-to-severe persistent asthma in those who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids;
• baseline IgE titre greater than or equal to 30 IU/mL;
• baseline FEV 1 less than 80% of predicted; and
• does not require oral steroids for maintenance therapy.

Omalizumab has not been shown to alleviate acute asthma exacerbations and should not be used for the treatment of acute bronchospasm or status asthmaticus.

The recommended dosage of omalizumab is 150 mg to 375 mg subcutaneous every two to four weeks based on body weight and pre-treatment serum total IgE level. Limit injections to not more than 150 mg/site.

The use of omalizumab for any indication not listed on this policy is considered experimental/investigational, and therefore, not covered. A participating, preferred, or network provider can bill the member for the non-covered service.

Coverage for omalizumab is determined according to individual or group customer benefits. Omalizumab is not reimbursable under the prescription drug benefit.

Although the risk of anaphylaxis following administration of Omalizumab necessitates the need for observation, this is not separately reimbursable and is considered part of the administration of this drug.

Reconstitution and preparation of this drug is considered part of the administration and is not separately reimbursable.

A participating, preferred, or network provider cannot bill the member for observation, reconstitution, preparation, or other additional administration costs.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious life-threatening condition and when medically necessary and appropriate for the patient’s condition.

PRN References

12/2003, Omalizumab (Xolair®) coverage guidelines

Genentech, Xolair® (omalizumab) Package Insert. Genentech, Inc.; San Francisco, CA

Omalizumab, A Recombinant Humanized Anti-IgE Antibody, Reduces Asthma-related Emergency Room Visits and Hospitalizations in Patients with Allergic Asthma. Journal Allergy Clinical Immunology, Vol. 111, No. 1, 01/2003

Omalizumab Improves Asthma-related Quality of Life in Patients with Severe Allergic Asthma. Journal Allergy Clinical Immunology, Vol. 111, No. 2, 02/2003

Accuracy of US Food and Drug Administration-cleared IgE antibody assays in the presence of anti-IgE (Omalizumab), Journal of Allergy Clinical Immunology, Vol. 117, 2006

Omalizumab pretreatment Decreases Acute Reaction after Rush Immunotherapy for Ragweed-Induced Seasonal Allergic Rhinitis, Journal of Allergy Clinical Immunology, Vol. 117, 2006

Expert panel report 3: Guidelines for the Diagnosis and Management of Asthma (EPR.3 2007). Bethesda, MD: US Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute; National Asthma Education and Prevention Program, 2007

Rambasek TE, Lang DM, Kavuru MS. Omalizumab: Where Does it Fit into Current Asthma Management? Cleveland Clinic Journal of Medicine 2004 Mar; (3): 251-61

Wu AC, Paltiel AD, Kuntz KM, Weiss ST, Fuhlbrigge AL. Cost-effectiveness of Omalizumab in Adults with Severe Asthma: Results from the Asthma Policy Model. The Journal of Allergy and Clinical Immunology 2007 Sep 27; [Epub ahead of print]

Kuhn R. Immunoglobulin E Blockade in the Treatment of Asthma. Pharmacotherapy. 2007 Oct; 27(10): 1412-24

Morjaria JB, Gnanakumaran G, Babu KS. Anti-IgE in Allergic Asthma and Rhinitis: An Update. Expert Opinion on Biologic Therapy. 2007 Nov; 7(11): 1739-47.

Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (Omalizumab). Pediatrics. 2001;108(2):e36.

Lemanske RF, Nayak A, McAlary M, et al. Omalizumab improves asthma-related quality of life in children with allergic asthma. Pediatrics. 2002;110(5):e55.

Sicherer SH, Sampson HA. Peanut allergy: emerging concepts and approaches for an apparent epidemic. J Allerg Clin Immun. 2007;120(3):491-503.

Sampson HA. A phase II, randomized, double-blind, parallel-group, placebo-controlled, oral food challenge trial of Xolair® (omalizumab) in peanut allergy (TOPS). J Allerg Clin Immun. 2007;119(1) Supp:S117.

Khan S, Orenstein SR. Eosinophilic Gastroenteritis. Gastroenterol Clin N Am. 2008;37:333-348.

Omalizumab (Xolair)[package insert]. San Francisco, CA:Genentech Inc;2008.

Giezen TJ, Montel-Teeuwisse AJ, Straus SM, et al. Safety-related regulatory actions for biologicals approved in the United States and the European union. JAMA. 2008;300(16):1887-1896.

Kaplan AP, Joseph K, Maykut RF, et al. Treatment of chronic autoimmune urticaria with omalizumab. J Allergy Clin Immun. 2008;122:569-73.

Slavin RG, Ferioli C, Tannenbaum SJ, et al. Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing IgE and decreasing pharmacokinetic concentrations. J Allergy Clin Immun. 2009;123(1):107-113.

Fanta CH. Asthma. NEJM. 2009;360(10):1002-1014.

Reddel HK, Taylor DR, Bateman ED, et al. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations. Am J Resp Crit Care Med. 2009;180:59-99.

FDA issues early communication concerning safety of asthma drug Xolair. July 17, 2009. FDA News.