Subject: Omalizumab (Xolair®)* Effective Date: October 28, 2008 Department(s): Utilization Management
Xolair is reimbursable under Plans administered by QualCare, Inc. when used according to the criteria in this policy.
Objective:
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 www.nice.org.uk/guidance/TA201. 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/topic.do?topicKey=asthma/18811&view=print. 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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