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Omalizumab (Xolair®)*

Effective Date:

October 28, 2008


Utilization Management
Xolair is reimbursable under Plans administered by QualCare, Inc. when used according to the criteria in this policy.

To assure proper and consistent reimbursement and to delineate circumstances under which a specific drug is covered. Procedure:
A. Individuals for whom Xolair® is reimbursable must be at least 12 years of age, have poorly controlled moderate-to-severe asthma (see below) and meet all of the following criteria: 1. There must be documentation of atopy either with a positive skin test or in vitro reactivity (by RAST or comparable testing) to at least one perennial airborne allergen OR a clearly documented history of asthma in response to an inhaled allergen 2. The pre-treatment IgE level must be at least 30 IU/mL 3. Symptoms must be poorly controlled with inhaled corticosteroids AND long-acting beta-agonists (e.g., salmeterol [Serevent®, Advair®]) or leukotriene inhibitors (e.g., montlukast [Singulair®]) for at least 3 months 4. Symptoms of wheezing, cough, or dyspnea occur daily and interfere with activities of daily living and/or sleep B. For the purposes of this policy, poor asthma control is characterized by at least one of the following: 1. Use of a short-acting inhaled beta2-agonist (“rescue” inhaler) more 2. Variation of peak expiratory flow rate of more than 30% over the 3. Peak expiratory flow rate less than 80% of highest recorded for the 4. Forced expiratory flow rate in 1 second (FEV1) less than 60% of 5. At least three events in 12 months, from the following list: a. Emergency room or urgent care center visit b. Inpatient hospital admission for asthma c. Requirement of systemic (oral or injectable) steroids for 6. In a patient taking Xolair®, worsening of asthma when it is C. Initial authorization of Xolair® will be for 6 months. To continue Xolair® beyond the first six months, there must be documentation of at least one of the following: 1. Decreased use of “rescue” inhaler 2. Decreased frequency of exacerbations 3. Improvement in FEV1 4. Improvement in at least one of the following symptoms: a. Sleep disturbance b. Shortness of breath c. Wheezing d. Chest tightness e. Frequency of asthma attacks f. Cough g. Fatigue D. Repeated measurement of IgE in individuals taking Xolair® will E. Xolair® is not reimbursable as initial therapy for asthma, non- allergic asthma, or allergy that is not accompanied by asthma. References NICE technology appraisal guidance 201: Omalizumab for the treatment of severe persistent allergic asthma in children aged 6 to 11 years. October 2010. Accessed online 02/10/11 at Prenner BM. Asthma 2008: Targeting Immunglobulin E To Achieve Disease Control. J Asthma 2008;45(6):429-436 (Aug) Sulliv SD, Turk F. An evaluation of the cost-effectiveness of omalizumab for the treatment of severe allergic asthma. Allergy 2008;63(6):670-684 (Jun) Barnes PJ. Anti-IgE therapy. UptoDate version 16.2. May 9, 2008. Available at http://www.uptodate. com/online/content/ Accessed 09/18/08 Krouse JH, Krouse HJ. Asthma: Guidelines-Based Control and Management. Otolaryngol Clin N Am 2008;41(2):397-409 (Apr) Wu AC, Paltiel AD, Kuntz KM, et al. Cost-effectiveness of omalizumab in adults with severe asthma: Results from the Asthma Policy Model. J Allergy Clin Immunol 2007;120(5):1146-1152 (Nov) Cox L, Platts-Mills TA, Finegold I et al. American Academy of Allergy, Asthma & Immunology/ American College of Allergy, asthma and Immunology Joint Task Force Report on omalizumab-associated anaphylaxis. J Allergy Clin Immunol 2007;120(6):1373-1377 (Dec) Kuhn R. Immunoglobulin E blockade in the treatment of asthma. Pharmacotherapy 2007;27(10):1412-1424 (Oct) Hendeles L, Sorkness CA. Anti-immunoglobulin E therapy with omalizumab for asthma. Ann Pharmacother 2007;41(9):1397-1410 (Sep) Waglie-Steffen AL, Kavanaugh AF, Wasserman SI. Biologic Therapies for the Treatment of Asthma. Clin Chest Med 2006;27(1):133-147 (Mar) Drafted By/Date: B. Fisher, MD 09/24/08 Approved By/Date: QM Committee 10/28/08 Revised By/Date: M. McNeil, MD 02/10/11 Approved By/Date: QM Committee 02/22/11 *Consistent with Summary Plan Description (SPD). When there is discordance between this policy and the SPD, the provisions of the SPD prevail.



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