Omalizumab NDC CODE(S) 50242-0040-xx Xolair 150 MG SOLR (GENENTECH) DESCRIPTION Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody which selectively binds to immunoglobulin E (IgE). High serum levels of IgE are found in individuals with allergic disease and asthma. By binding with omalizumab, circulating IgE is inhibited from binding with high-affinity Fc receptors (FcεRI) on the surfaces of mast cells and basophils, key participants in allergic inflammation. This has been shown to diminish the release of mediators of the allergic response, decrease asthma exacerbations in individuals reactive to perennial aeroallergens and reduce the number of FcεRI receptors on basophils in atopic allergic hypersensitive individuals. POLICY Omalizumab for the treatment of the is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.) o Asthma o Urticaria Omalizumab for the treatment of other conditions/diseases is considered investigational. MEDICAL APPROPRIATENESS INITIAL APPROVAL Omalizumab is considered medically appropriate if ALL of the criteria are met: o Must not be used in combination with another monoclonal antibody (e.g., benralizumab, mepolizumab, reslizumab, etc.) o Diagnosis of ANY ONE of the : Moderate-to-severe persistent asthma if ALL of the : Individual is 6 years of age or older Individual has positive skin test or in vitro reactivity to a perennial aeroallergen Individual must weigh between 20 kg (44 lbs) and 150 kg (330 lbs) Serum IgE levels, measured before the start of treatment, of ANY ONE of the : 30 IU/mL and 700 IU/mL in individuals 12 years of age or older 30 IU/mL and 1300 IU/mL in individuals 6 to less than 12 years of age Individual has documented ongoing symptoms of moderate-to-severe asthma* with minimum 3 month trial on previous combination therapy including medium- or high-dose inhaled corticosteroids PLUS another controller medication (e.g., long-acting beta-2 agonist, leukotriene receptor antagonist, theophylline, etc.) Chronic idiopathic urticaria (CIU) if ALL of the : Individual is 12 years of age or older The underlying cause of the patient s condition is NOT considered to be any other allergic condition(s) or other form(s) of urticaria Individual is avoiding triggers (e.g., NSAIDs, etc.) Documented baseline score from an objective clinical evaluation tool, such as: urticaria activity score (UAS7), Angioedema Activity Score (AAS),Dermatology Life Quality Index (DLQI), Angioedema Quality of Life (AE-QoL), or Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL),
Individual has had an inadequate response to a one or more month trial on previous therapy with scheduled dosing of a second-generation H1 antihistamine product** Individual had an inadequate response to a one or more month trial on previous therapy with scheduled dosing of at least one of the : Updosing/dose advancement (up to 4-fold) of an second generation H1 antihistamine** Add-on therapy with a leukotriene antagonist s: (e.g., montelukast, zafirlukast, etc.) Add-on therapy with another H1 antihistamine** Add-on therapy with a H2-antagonist (e.g. ranitidine, etc.) Add-on therapy with ciclosporin A Renewal will require submission of score from an objective clinical evaluation tool (e.g., UAS7, AAS, DLQI, AE-QoL or CU-Q2oL) completed within 30 days of request *Components of severity for classifying asthma as moderate may include any of the (not all inclusive): Daily symptoms Nighttime awakenings > 1x/week but not nightly SABA use for symptom control occurs daily Some limitation to normal activities Lung function (percent predicted FEV1) >60%, but <80% Exacerbations requiring oral systemic corticosteroids are generally more frequent and intense relative to mild asthma *Components of severity for classifying asthma as severe may include any of the (not all inclusive): Symptoms throughout the day Nighttime awakenings, often 7x/week SABA use for symptom control occurs several times daily Extremely limited in normal activities Lung function (percent predicted FEV1) <60% Exacerbations requiring oral systemic corticosteroids are generally more frequent and intense relative to moderate asthma **H1 Antihistamine Products (not all inclusive) fexofenadine loratadine desloratadine cetirizine levocetirizine clemastine diphenhydramine chlorpheniramine hydroxyzine cyproheptadine brompheniramine triprolidine dexchlorpheniramine carbinoxamine
RENEWAL CRITERIA Omalizumab considered medically appropriate for renewal if ALL of the criteria are met: o Individual continues to meet initial approval criteria o Absence of unacceptable toxicity from the drug such as symptoms of anaphylaxis (bronchospasm, hypotension, syncope, urticaria, and/or angioedema); malignancy; symptoms similar to serum sickness (fever, arthralgia, and rash); parasitic (helminth) infection, eosinophilic conditions, including (e.g.vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroid), etc. o Diagnosis of ANY ONE of the : Moderate-to-severe persistent allergic asthma if ALL of the : Patient must weigh between 20 kg (44 lbs.) and 150 kg (330 lbs.) Treatment with Xolair (omalizumab) has resulted in clinical improvement as documented by ANY ONE of the : Decreased utilization of rescue medications Decreased frequency of exacerbations (defined as worsening of asthma that requires increase in inhaled corticosteroid dose or treatment with systemic corticosteroids) Improvement in lung function (increase in percent predicted FEV1 or PEF) from pre-treatment baseline Reduction in reported symptoms (e.g.,decrease in asthma symptom score), as evidenced by decreases in frequency or magnitude of one or more of the symptoms: Asthma attacks Chest tightness or heaviness Coughing or clearing throat Difficulty taking deep breath or difficulty breathing out Omalizumab Doses Administered Every 4 Weeks (mg) in patients 12 years Pre treatment serum IgE (IU/mL) Body weight (kg) 30 to 60 > 60 to 70 > 70 to 90 > 90 to 150 30 to 100 150 150 150 300 > 100 to 200 300 300 300 See the > 200 to 300 300 See the Shortness of breath Sleep disturbance, night wakening, or symptoms upon awakening Tiredness Wheezing/heavy breathing/fighting for air Chronic idiopathic urticaria (CIU) if ALL of the : See the See the Treatment with Xolair (omalizumab) has resulted in clinical improvement as documented by improvement from baseline using objective clinical evaluation tools such as the Urticaria Activity Score (UAS7), Angioedema Activity Score (AAS), Dermatology Life Quality Index (DLQI), Angioedema Quality of Life (AE-QoL), or Chronic Urticaria Quality of Life Questionnaire(CU-Q2oL)
Submitted current UAS7, AAS, DLQI, AE-QoL or Cu-Q2oL was recorded within the past 30 days INDICATION(S) DOSAGE & ADMINISTRATION Allergic Asthma 75 to 375 mg administered subcutaneously by a health care provider every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See tables below Chronic idiopathic urticaria 150 or 300 mg administered subcutaneously by a health care provider every 4 weeks. Dosing is not dependent on serum IgE (free or total) level or body weight. Omalizumab Doses Administered Every 2 Weeks (mg) in patients 12 years Pre treatment serum IgE (IU/mL) Body weight (kg) 30 to 60 > 60 to 70 > 70 to 90 > 90 to 150 > 100 to 200 See previous > 200 to 300 See previous See previous See previous 225 225 225 300 > 300 to 400 225 225 300 Do not dose. > 400 to 500 300 300 375 Do not dose. > 500 to 600 300 375 Do not dose. Do not dose. > 600 to 700 375 Do not dose. Do not dose. Do not dose
LENGTH OF AUTHORIZATION Coverage will be provided for six months and may be renewed. Click here to view DOSAGE LIMITS APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS BlueCross BlueShield of Tennessee s Medical Policy complies with Tennessee Code Annotated Section 56-7- 2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature. IMPORTANT REMINDER We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, and explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern. ADDITIONAL INFORMATION For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines ) published by the National Comprehensive Cancer Network, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information). SOURCES Diakow, Marla N, <D, James William D. MD et al Medscape Chronic Urticaria Guidelines 2017, May https://emedicine.medscape.com/article/1050052-guidelines Global Initiative for Asthma (GINA).Global Strategy for Asthma Management and Prevention. 20178 Update. Available from: http://www.ginasthma.org. Accessed October April 2018. Lexi-Comp Online. (2018). AHFS DI. Omalizumab. Retrieved July 3, 2018 from Lexi-Comp Online with AHFS. MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, June). Omalizumab. Retrieved July 3, 2018 from MICROMEDEX Healthcare Series. National Asthma Education and Prevention Program (NAEPP). Guidelines for the diagnosis and management of asthma. Expert Panel Report 3. Bethesda, MD: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI); August 2007. U. S. Food and Drug Administration. (2016, July). Center for Drug Evaluation and Research. Xolair (omalizumab). Retrieved July 3, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf. Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, et al. EAACI/GA (2) LEN/EDF/WAO guideline for the Definition, Classification, Diagnosis and Management of Urticaria. The 2017 Revision and Update.: management of urticaria. Allergy. 2018 Jan 15. doi: 10.1111/all.13397.2009 Oct;64(10):1427-43. doi: 10.1111/j.1398-9995.2009.02178.x. EFFECTIVE DATE 3/2/2019 ID_MRx