Xolair (omalizumab) Limitation of Use: Xolair is not indicated for treatment of other forms of urticaria.

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1 Xolair (omalizumab) Line(s) of Business: HMO; PPO; QUEST Integration Akamai Advantage Original Effective Date: 11/18/2003 Current Effective Date: 12/01/2017TBD POLICY A. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. FDA-Approved Indications Asthma Xolair is indicated for patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Limitations of Use: Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus. Xolair is not indicated for treatment of other allergic conditions. Chronic Idiopathic Urticaria (CIU) Xolair is indicated for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment. Limitation of Use: Xolair is not indicated for treatment of other forms of urticaria. B. REQUIRED DOCUMENTATION The following documentation from the medical record is necessary to initiate the prior authorization review: Allergic asthma, initial therapy: o Current medications (including doses) o Member current weight o Pre-treatment serum IgE (IU/mL) levels

2 Xolair 2 o Skin or blood test results confirming the diagnosis of allergic asthma o Clinical notes documenting failure of environmental controls and immune therapy o FEV1 results o Clinical notes documenting treatment of comorbidities o Quality of Life Measures Survey (available at vey.pdf) Chronic idiopathic urticaria (CIU), initial therapy: o Clinical notes supporting a diagnosis of CIU for at least 3 months o Clinical notes supporting trial and failure of all previous antihistamines, including length of courses Allergic asthma, continuation of therapy: o Either comparative FEV1 results or Quality of Life Measures Survey o Current medications (including doses) CIU, continuation of therapy: o Documentation supporting that the member has responded to therapy o For members demonstrating a complete response: documentation must support tapering of dose and/or withholding of therapy beyond the next dosing interval to see if symptoms return C. PRESCRIBER RESTRICTION For allergic asthma, Xolair must be recommended by an allergist, immunologist, or pulmonologist. For CIU, Xolair must be recommended by an allergist, immunologist, or dermatologist. D. INITIAL CRITERIA FOR APPROVAL 1. Allergic Asthma Authorization of 6 months may be granted to members who are prescribed Xolair when ALL of the following criteria are met: a. Prior to initiating therapy, the severity of the member s asthma is moderate or severe persistent b. The member is 12 years of age or older c. Xolair will be administered in a controlled healthcare setting with access to emergency medications if needed d. The member s asthma is inadequately controlled with the use of an inhaled corticosteroid at the optimized dose e. The member s asthma is inadequately controlled with the use of a long acting beta agonist at the optimized dose f. The member s current weight is less than or equal to 150 kg g. The member s pre-treatment IgE level is greater than or equal to 30 IU/mL h. The prescribed Xolair dose follows FDA-approved dosing recommendations (for dose and dosing frequency) based on pre-treatment serum IgE levels and body weight (See prescribing information at i. Prior to initiating therapy, the member has positive skin or in vitro reactivity to at least one perennial aeroallergen

3 Xolair 3 j. The member has failed environmental controls and standard immune therapy, unless there is evidence that immune therapy will trigger a severe allergic reaction k. The member s pre-treatment forced expiratory volume (FEV1) is less than 80% of predicted value l. The member s comorbidities have been evaluated and treated m. The member has a rapid-acting beta 2 agonist available for rescue therapy n. The member has completed a current HMSA Asthma Quality of Life Measures Survey (available at 2. Chronic idiopathic urticaria (CIU) Authorization of 3 months may be granted to members who are prescribed Xolair when ALL of the following criteria are met: a. Prior to initiating therapy, the severity of the member s CIU is moderate or severe b. The member is 12 years of age or older c. Xolair will be administered in a controlled healthcare setting with access to emergency medications if needed d. The member has been diagnosed with CIU for 3 months or longer e. The member has been evaluated for other causes of urticaria f. The member remained symptomatic despite treatment with at least 2 distinct courses of different high-dose second generation H1 antihistamines used continuously for at least 2 weeks, unless contraindicated (See Appendix) g. The member remained symptomatic despite treatment with a first generation H1 antihistamine (eg, hydroxyzine, doxepin) or an H2 antihistamine (eg, ranitidine) in combination with a high-dose second generation H1 antihistamine used continuously for at least 2 weeks, unless contraindicated (See Appendix) E. CONTINUATION OF THERAPY 1. No previous authorization/precertification: All members (including members currently receiving treatment without prior authorization) must meet criteria for initial approval in section D. Those continuing with therapy must also meet Reauthorization criteria below. 2. Reauthorization: B.A. Allergic asthma Authorization of 6 additional months may be granted to members who were previously authorized by HMSA when ALL of the following criteria are met. After the first year, authorization of 12 additional months may be granted to members when ALL of the following criteria are met: 1) The member has shown improvement (or sustained improvement) in one of the following measures since initiation of Xolair therapy: i. Improvement in forced expiratory volume (FEV1) ii. Decrease in hospitalizations or emergency room visits iii. Overall increase in quality of life measures based on the HMSA Quality of Life Measures Survey (available at urvey.pdf) 2) The member will continue to use inhaled corticosteroids

4 Xolair 4 C.B. Chronic idiopathic urticaria (CIU) Authorization of additional 6 months may be granted to members who were previously authorized by HMSA when either criterion a1) or b2) below is met. After the first year, authorization of 12 additional months may be granted to members when either criterion a1) or b2) below is met: 1) The member has demonstrated a partial response since initiation of Xolair therapy 2) The member has demonstrated a complete response since initiation of Xolair therapy AND symptoms returned when the dose was tapered or withheld beyond the next dosing interval F. DOSAGE AND ADMINISTRATION Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. G. APPENDIX High-dose second generation H1 antihistamines are defined as twice daily dosing of standard daily dosing (listed below): Cetirizine (Zyrtec ) 10 mg Levocetirizine (Xyzal ) 5 mg Fexofenadine (Allegra ) 180 mg Loratadine (Claritin ) 10 mg Desloratadine (Clarinex ) 5 mg H. ADMINISTRATIVE GUIDELINES Prior authorization is required. Please refer to the HMSA medical policy web site for the fax form. H.I. IMPORTANT REMINDER The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii s Patients Bill of Rights and Responsibilities Act (Hawaii Revised Statutes 432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA s determination as to medical necessity in a given case, the physician may request that CVS/caremark reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. I.J. REFERENCES 1. Xolair [package insert]. South San Francisco, CA: Genentech, Inc.; AugustJuly 2016.

5 Xolair 5 2. Busse, W. Anti-immunoglobulin E (omalizumab) therapy in allergic asthma. Am J Respir Crit Care Med. 2001; 164 (8 part 2):S12-S FDA Talk Paper. FDA approves first biologic for allergy-related asthma. June 20, Global strategy for asthma management and prevention. Updated Available at: 5. 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 and mortality. Curr Med Res Opin. 2001; 17(4): Kaplan A1, Ledford D, Ashby M, Canvin J, Zazzali JL, Conner E, Veith J, Kamath N, et.al J Allergy Clin Immunol. Omalizumab in patients with symptomatic chronic idiopathic/ spontaneous urticaria despite standard combination therapy Jul;132(1): Khan, DA. Chronic urticaria: Standard management and patient education. UpToDate Khan, DA. Chronic urticaria: Treatment of refractory symptoms. UpToDate Maurer M1, Rosén K, Hsieh HJ, Saini S, Grattan C, Gimenéz-Arnau A, Agarwal S, Doyle R, Canvin J, Kaplan A, Casale T. N Engl J Med. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria Mar 7;368(10): Epub 2013 Feb National Institutes of Health, National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program. NAEPP Expert Panel Report 3: Guidelines for the diagnosis and management of asthma. Bethesda, Maryland: U.S. Department of Health and Human Services; July Powell RJ, Du Toit GL, Siddique N, Leech SC, Dixon TA, Clark AT, Mirakian R, Walker SM, Huber PA, Nasser SM; British Society for Allergy and Clinical Immunology (BSACI). BSACI guidelines for the management of chronic urticaria and angio-oedema. Clin Exp Allergy May;37(5): Practice Parameters for Allergen Immunotherapy. IX. Safety of Immunotherapy. Summary Statement 12. Ann Allergy: 2003; 90:S (Third update is in draft as of 10/18/2010.) 13. Saini, S. Chronic urticaria: Clinical manifestations, diagnosis, pathogenesis, and natural history. UpToDate Soler M, Matz J, Townley R, et al. The anti-ige antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001; 18(2): Zuberbier T. World Allergy Organ J. A Summary of the New International EAACI/GA2LEN/EDF/WAO Guidelines in Urticaria Jan; 5 Suppl 1:S Zuberbier T1, Asero R, Bindslev-Jensen C, Walter Canonica G, Church MK, Giménez-Arnau AM, Grattan CE, Kapp A, Maurer M, Merk HF, et.al. EAACI/GA(2)LEN/EDF/WAO guideline: management of urticaria. Allergy Oct;64(10): Revised: September Document History 11/18/2003 Original effective date 10/01/2015 Revision effective date 08/2016 Label update 05/2017 Annual review 12/01/2017 Revision effective date