XOLAIR (omalizumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. O444.14.docx Page 1 of 9
Description: Xolair (omalizumab) is a humanized monoclonal antibody produced by recombinant DNA technology that selectively binds to human immunoglobulin E (IgE). It is intended to reduce circulating IgE in individuals with persistent allergic asthma and symptoms that are uncontrolled with inhaled corticosteroids. It is also used in individuals with chronic idiopathic urticaria. Xolair is administered via subcutaneous injection. Definitions: Perennial: Continuing through the entire year Criteria: Allergic Asthma: Xolair for allergic asthma is considered medically necessary for non-pregnant, non-nursing individuals 6 years of age or older with documentation of ALL of the following: 1. Moderate to severe persistent allergic (e.g., relevant perennial allergens, dust mites, cockroach, cat, dog) asthma 2. Positive skin test or in vitro reactivity to a perennial or seasonal aeroallergen 3. Symptoms inadequately controlled with high-dose inhaled corticosteroids and long-acting beta-agonists or combination products 4. Body weight not less than 20 and not greater than 150 5. Baseline serum IgE levels not less than 30 IU/ml AND not greater than 700 IU/ml 6. Dosage calculated according to dosing tables 1 provided in the full prescribing information for Xolair and should be adjusted for significant changes in body weight 7. The need for continued therapy should be periodically (at least yearly) reviewed by the prescribing clinician based upon the individual s disease severity and level of asthma control 8. Xolair infusion will be administered in a controlled health care setting (i.e., physician s office, infusion center) that can provide emergency medical treatment due to the risk of anaphylaxis 9. Xolair is not being used concurrently with Nucala 10. Absence of severe hypersensitivity reaction to Xolair or any ingredient of Xolair O444.14.docx Page 2 of 9
Criteria: (cont.) Chronic Idiopathic Urticaria: See Resources section for FDA-approved dosage. Xolair for chronic idiopathic urticaria is considered medically necessary with documentation of ALL of the following: 1. Individual is 12 years of age and older 2. Symptoms despite H1 antihistamine treatment 3. Xolair is not being used concurrently with Nucala 4. Absence of severe hypersensitivity reaction to Xolair or any ingredient of Xolair All Other Indications: Xolair for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives. These indications include, but are not limited to: Treatment with dosing or frequency outside the FDA-approved dosing and frequency 1 See dosing tables in Resources section. O444.14.docx Page 3 of 9
Resources: Literature reviewed 08/29/17. We do not include marketing materials, poster boards and non-published literature in our review. The BCBS Association Medical Policy Reference Manual (MPRM) policy is included in our guideline review. References cited in the MPRM policy are not duplicated on this guideline. 1. American Academy of Allergy Asthma and Immunology. National Asthma Education and Prevention Program. Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma Update on Selected Topics, 2002. J Allergy Clin Immunol. 2002 Nov;110(5 Suppl):S141-219 2. Berger W, Gupta N, McAlary M, Fowler-Taylor, A. Evaluation of long-term safety of the anti-ige antibody, omalizumab, in children with allergic asthma. Ann Allergy Asthma Immunol. 2003 Aug 2003;91(2):182-188 3. Coffey MJ, Wilfond B, Ross LF. Ethical assessment of clinical asthma trials including children subjects. Pediatrics. 2004 Jan 2004;113(1 Pt 1):87-94 4. Drug Facts & Comparisons. Omalizumab. 2003 5. External Consultant Review. Allergy/Immunology. 02/09/2004 6. FDA Pulmonary Allergy Drugs Advisory Committee Meeting. Xolair (Omalizumab). 05/15/2003 7. FDA. Xolair Package Insert. 2016, 2015, 2014 8. Genentech I, Schmidt E, PharmD, Deperi C, PharmD. Letter: Asthma in children less than 12 years of age. 02/22/2006 9. Genentech Inc., C. Deperi, PharmD. Letter: Baseline IgE levels or weights outside range. 01/30/2004 10. Genentech Inc., P. Maheshwari, PharmD, C. Deperi, PharmD. Letter: Asthma in children less than 12 years old. 10/03/2005 11. Goldsobel, A. Supplement Article: Evaluation of long-term safety of the anti-ige antibody, omalizumab, in children with allergic asthma. Pediatrics. 08/2004;114(2):548-549 12. Lemanske R, Nayak A, McAlary M, Everhard F, Fowler-Taylor A, Gupta N. Omalizumab improves asthma-related quality of life in children with allergic asthma. Pediatrics. 11/2002;110(5):e55 O444.14.docx Page 4 of 9
Resources: (cont.) 13. Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics. 2001 Aug 2001;108(2):E36 14. National Heart, Lung, Blood Institute. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Asthma Education and Prevention Program. 2007 15. Rosenwasser L, Nash D. Incorporating omalizumab into asthma treatment guidelines: consensus panel recommendations. P & T. 06/2003; 28(6):400-410 16. Silkoff P, Romero F, Gupta N, Townley R, Milgrom H. Exhaled nitric oxide in children with asthma receiving xolair (omalizumab), a monoclonal anti-immunoglobulin E antibody. Pediatrics. 04/2004;113(4):e308-e312 FDA Product Approval Information for Xolair (omalizumab): - FDA-approved indication: 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. For FDA-approved dosage for this indication, refer to dosing tables 1-3. Xolair Package Insert: For adults and adolescents (12 years of age and older) with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment. FDA-approved dosage for this indication is 150 or 300 mg SC every 4 weeks. Important Limitations of Use: Not indicated for other allergic conditions or other forms of urticaria Not indicated for acute bronchospasm or status asthmaticus Indication Chronic Idiopathic Urtiaria Asthma Recommended Dose 150 or 300 mg SC every 4 weeks. Dosing in CIU is not dependent on serum IgE level or body weight. Refer to tables listed below. O444.14.docx Page 5 of 9
Resources: (cont.) Pre-treatment Serum IgE (IU/ml) Table 1 ADMINISTRATION EVERY 4 WEEKS Xolair Doses (milligrams) Administered by Subcutaneous Injection Every 4 Weeks for Individuals (12 Years of Age and Older) With Asthma Body Weight () 30-60 > 60-70 > 70-90 > 90-150 > 30-100 150 150 150 300 > 100-200 300 300 300 SEE TABLE 2 > 200-300 300 SEE TABLE 2 > 300-400 > 400-500 > 500-600 Pre-treatment Serum IgE (IU/ml) SEE TABLE 2 Table 2 ADMINISTRATION EVERY 2 WEEKS Xolair Doses (milligrams) Administered by Subcutaneous Injection Every 2 Weeks for Individuals (12 Years of Age and Older) With Asthma Body Weight () 30-60 > 60-70 > 70-90 > 90-150 > 30-100 SEE TABLE 1 > 100-200 SEE TABLE 1 225 > 200-300 SEE TABLE 1 225 225 300 > 300-400 225 225 300 > 400-500 300 300 375 > 500-600 300 375 DO NOT DOSE > 600-700 375 DO NOT DOSE DO NOT DOSE O444.14.docx Page 6 of 9
Resources: (cont.) Table 3 ADMINISTRATION EVERY 2 or 4 WEEKS Xolair Doses (milligrams) Administered by Subcutaneous Injection Every 2 or 4 Weeks for Pediatrics with Asthma who Begin Xolair Between the Ages of 6 to <12 Years of Age Table 3: Gray highlight: Subcutaneous doses to be administered every 4 weeks No highlight: Subcutaneous doses to be administered every 2 weeks Pre-treatment serum IgE (IU/mL) Dosing Freq. 20-25 >25-30 >30-40 >40-50 Body Weight >50-60 >60-70 >70-80 >80-90 >90-125 Dose (mg) 30-100 75 75 75 150 150 150 150 150 300 300 >100-200 150 150 150 300 300 300 300 300 225 300 >200-300 Every 150 150 225 300 300 225 225 225 300 375 >300-400 4 225 225 300 225 225 225 300 300 >400-500 weeks 225 300 225 225 300 300 375 375 >500-600 300 300 225 300 300 375 >600-700 300 225 225 300 375 >700-800 225 225 300 375 >800-900 Every 225 225 300 375 >900-1000 2 225 300 375 DO NOT DOSE >1000-1100 weeks 225 300 375 >1100-1200 300 300 >1200-1300 300 375 Tables source: FDA Prescribing Information >125-150 O444.14.docx Page 7 of 9
Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) 864-4884 for Spanish and (877) 475-4799 for all other languages and other aids and services. If you believe that BCBSAZ has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or sex, you can file a grievance with: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Box 13466, Phoenix, AZ 85002-3466, (602) 864-2288, TTY/TDD (602) 864-4823, crc@azblue.com. You can file a grievance in person or by mail or email. If you need help filing a grievance BCBSAZ s Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, 1 800 368 1019, 800 537 7697 (TDD). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html Multi-Language Interpreter Services: O444.14.docx Page 8 of 9
Multi-Language Interpreter Services: (cont.) O444.14.docx Page 9 of 9