Billing and Coding: Omalizumab and biosimilar, OMLYCLO® (omalizumab-igec)

This article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses. Abstract: Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Definitions: Moderate persistent asthma Moderate persistent asthma is defined by the National Heart, Lung, and Blood Institute (NHLBI) as: Daily symptoms Daily use of inhaled short-acting beta 2 -agonist Some limitation with normal activity Exacerbations requiring oral systemic corticosterioids > 2/year Nighttime symptoms greater than 1 time a week but not nightly FEV 1 >60% but FEF 1 /FVC reduced 5% Severe persistent asthma Severe persistent asthma is defined by the National Heart, Lung, and Blood Institute (NHLBI) as: Symptoms throughout the day Use of inhaled short-acting beta 2 -agonist several times per day Extremely limited normal activity Exacerbations requiring oral systemic corticosterioids > 2/year Nighttime symptoms often 7x/week FEV 1 FEV 1 /FVC reduced >5% NHLBI normal ranges by age for FEV 1 /FVC 8-19 years of age – 85%; 20-39 years of age – 80%; 40-59 years of age – 75%; 60-80 years of age – 70%. The presence of one of these features of severity (moderate or severe) is sufficient to place a patient in that category. These clinical features are based on pre-treatment symptoms and measurements. Because of the chance of anaphylaxis with omalizumab, patients should receive omalizumab treatment in a doctor's office or clinic setting and be observed for an appropriate period of time after each treatment. Omalizumab should only be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening. Omalizumab has not been shown to alleviate asthma exacerbations acutely and should not be used for the treatment of acute bronchospasm or status asthmaticus. Utilization: Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity. Omalizumab is covered when the drug is administered by a physician or incident to a physician’s service in a clinic or office setting. Omalizumab is not covered if self-administered by the patient. FDA and Compendia Review: American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD: 2007. Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 06/15/2021. Lexi-Drugs Web site. http://online.lexi.com/lco/action/home. Accessed 06/15/2021. National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 06/15/2021. Micromedex DrugDex® Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 06/15/2021. U.S. Food and Drug Administration label approved 06/20/2003. Drugs@FDA Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed 02/16/2022. United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.