Line of Business: All Lines of Business Effective Date: August 16, 2017 Xolair (Omalizumab) Drug Prior Authorization Protocol (Medical Benefit & Part B Benefit) This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Policy/Criteria: Diagnosis: a. Moderate to severe persistent asthma OR b. Chronic idiopathic urticaria (CIU) Specialist: Allergist, Immunologist, Pulmonologist Criteria: a. Moderate to severe persistent asthma in members aged 6 and older: i. Documented positive skin test or in vitro reactivity to a year-round airborne substance (e.g. perennial aeroallergen) such as pollen or spores that triggers an allergic reaction; ii. Serum IgE level 30 IU/mL; iii. Asthma symptoms are inadequately controlled after regular use of high dose inhaled corticosteroids (ICS) given in combination with a long acting beta2- agonist (LABA); iv. Compliant on controller therapy (e.g. ICS, LABA) according to refills record for the past 6 months; v. Documentation of symptomatic asthma despite regular use of therapies as demonstrated by at least ONE of the following: 1) 2 or more asthma attacks (i.e. sudden worsening of asthma symptoms including shortness of breath, coughing, wheezing, etc.) requiring a course of systemic corticosteroids (e.g. prednisone) in the previous year
OR 2) Hospitalization due to asthma attack OR 3) Forced expiratory volume in one second (FEV1) less than 80% predicted b. Chronic idiopathic urticaria in members aged 12 years and older: i. Hives (e.g. urticaria) that has been continuously or intermittently present for at least 6 weeks; ii. Member is on optimal oral therapy for chronic urticaria: 1) Failed, intolerant or contraindicated to two oral antihistamines (e.g. loratadine, cetirizine); 2) Failed, intolerant or contraindicated to one oral antihistamine in combination with an H2 antihistamine (e.g. famotidine, ranitidine) a leukotriene modifier (e.g. montelukast); 3) Member is symptomatic with above therapies (i.e. persistent skin lesions despite maximum FDA-approved dose of anti-histamine) Re-Authorization Criteria: a. Moderate to severe persistent asthma in members aged 6 and older: i. Documentation of meeting therapeutic goal as demonstrated by at least ONE of the following: 1) Decreased rescue medication (e.g. albuterol) utilization OR 2) Decreased frequency of asthma attacks (e.g. systemic corticosteroid utilization, hospitalization, etc.) OR 3) Improved percent predicted FEV1 from pretreatment baseline (e.g. at least 5% improvement) OR 4) Reduction in asthma-related symptoms including but not limited to wheezing, shortness of breath, coughing, fatigue or asthmatic symptoms upon awakening ii. Used in combination with an inhaled corticosteroid controller medication iii. Requested dosage and administration are consistent with the FDA recommendation b. Chronic idiopathic urticaria in members aged 12 years and older: i. Documentation of meeting therapeutic goal (e.g. reduction in hives, improved skin condition, etc.) ii. Requested dosage and administration are consistent with the FDA recommendation
Formulary Status: Non-formulary, PA applies Duration of Authorization: May approve up to a period of 6 months at a time Clinical Justification: FDA Recommended Dosage:
2007 National Asthma Education and Prevention Program (NAEPP) Asthma Guidelines Omalizumab may be considered as adjunctive therapy in step 5 or 6 care for patients who have allergies and severe persistent asthma that is inadequately controlled with the combination of high-dose ICS and LABA (Evidence B). Step 5 Care, Long-Term Control Medications High-dose ICS and LABA is the preferred treatment (Evidence B). Omalizumab may be considered at this step for patients who have sensitivity to relevant perennial allergens (e.g. dust mites, cockroach, cat or dog) (Evidence B). Clinicians who administer omalizumab are advised to be prepared and equipped for the identification and treatment of anaphylaxis that may occur, to observe patients for an appropriate period of time following each omalizumab injection (the optimal length of the observation is not established), and to educate patients about the risks of anaphylaxis and how to recognize and treat it if it occurs (e.g. using prescription auto injectors for emergency self-treatment, and seeking immediate medical care).
Consultation with an asthma specialist is recommended for patients who require this step of therapy (Evidence D). Step 6 Care, Long-Term Control Medications Add oral corticosteroids to step 5 therapy. Patients who are not controlled on step 5 therapy may require regular oral corticosteroids to achieve well-controlled asthma. 2016 Expanded indication for use in patients 6 to <12 years old Omalizumab was studied in a randomized, double-blind, placebo-controlled trial that lead to an FDA approval for use in patients 6 to <12 years old. Inclusion criteria included: o Moderate to Severe asthma based on NAEPP guidelines o Total serum IgE level 30 to 1300 IU o Body weight between 20 to 150 kilograms o Positive prick skin test to at least one perennial allergen o Clinical features of moderate or severe asthma despite therapy with NAEPP step 3 or 4 recommendations Current guidelines have not addressed omalizumab in this patient population. U.S. Food and Drug Administration Drug Safety Communication, September 2014 The FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. The heart and brain blood vessel problems included mini-strokes known as transient ischemic attacks or TIA; heart attacks; sudden, unexpected chest pain; pulmonary hypertension; and blood clots in the lungs and veins. Due to weaknesses of safety study design, the FDA is unable to determine the exact increased level of these risks with Xolair. Subsequently, the Adverse Reactions section of the drug label was updated to include these potential risks. The FDA review of the 5-year safety study found no difference in the rates of cancer between patients being treated with Xolair and those who were not being treated with Xolair. Due to limitations in the 5-year study, the FDA cannot rule out a potential risk of cancer with Xolair. The Warning sand Precautions section of the drug label was updated to include this information. The Joint Task Force on Practice Parameters (JTFPP), American Academy of Allergy, Asthma & Immunology (AAAAI) and the American College of Allergy, Asthma & Immunology (ACAAI): The diagnosis and management of acute and chronic urticaria 2014 update The JTFPP recommends a step-care approach for the management of chronic urticaria. For patients not responding to a second generation antihistamine monotherapy, higher doses of second-generation antihistamines, addition of H2 antagonists or leukotriene receptor antagonists can be considered (step 2). Subsequently, hydroxyzine or doxepin
treatment can be considered in patients whose symptoms remain poorly controlled with step 2 interventions (step 3). Systemic corticosteroids are frequently used for patients with refractory CU, but no controlled studies have demonstrated efficacy. In some patients short-term use (e.g. 1-3 weeks duration) might be required to gain control of their disease until other therapies can achieve control. Because of the risk of adverse effects with systemic corticosteroids, long-term use for treatment of patients with CU should be avoided as much as possible. Omalizumab should be considered for refractory chronic urticaria (step 4) if this is favorable from the standpoint of balancing the potential for benefit with the potential for harm/burden and cost and the decision to proceed is consistent with patients values and preferences.
Adapted from 2007 National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 Adapted from 2007 National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3
Adapted from 2007 National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3
The Joint Task Force on Practice Parameters (JTFPP), American Academy of Allergy, Asthma & Immunology (AAAAI) and the American College of Allergy, Asthma & Immunology (ACAAI): The diagnosis and management of acute and chronic urticaria 2014 update References: 1. Holgate S, Bousqet J, Wenzel S, et al. Omalizumab improves disease control in patients at high risk of serious asthma related morbidity and mortality. Am J Respir Crit Care Med 2002;165:A187. 2. Milgrom H, Fick R, su J, et al. Treatment of allergic asthma with monoclonal anti-ige antibody. N Engl J Med 1999;341:1966-1973. 3. Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with antiimmunoglobulin E antibody. Pediatrics 2001;108:E36. 4. Finn A, Gross G, van Bavel J, et al. Omalizumab improves asthma-related quality of life in patients with severe allergic asthma. J Allergy Clin Immunol 2003; 111: 278-84. 5. 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: 254-61. 6. Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-ige recombinant humanized monoclonal antibody, for the treatment of severe allergic rhinitis. J Allergy Clin Immunol 2001; 108:184-90.
7. Corren J, Casale T, Deniz Y, et al. Omalizumab, a recombinant humanized ant-ige antibody, reduces asthma-related emergency room visits and hospitalizations in patients with allergic asthma. J Allergy Clin Immunol 2003; 111: 87-90. 8. Bernstein J, Lang D, Khan, D, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol 2014; 133:1270-1277 9. Saini S, Rosen K, Hsieh H, et al. A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin Immunol 2011; 128:567-573 10. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. NIH Publication Number 08-5846. October 2007. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.pdf. Accessed on July 26, 2016. 11. U.S. Food and Drug Administration (FDA). Updated Drug Safety Communication. September 26, 2014. Available at: http://www.fda.gov/drugs/drugsafety/ucm414911.htm. Accessed on June 4, 2015. 12. Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgEmediated) asthma. J Allergy Clin Immunol 2009;124:1210 1216. 13. Xolair [package insert]. South San Francisco, CA: Genentech; 2016. Change Control Date Change 08/16/2017 Revised criteria Added reauthorization criteria