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 <80% predicted
- 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 <60% predicted
- 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.