Omalizumab (Xolair)

Section: Injections
Effective Date: August 01, 2019
Revised Date: July 29, 2019


Omalizumab (Xolair) is a recombinant DNA-derived humanized IgG1k murine monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Omalizumab (Xolair) inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils, which limits the degree of release of mediators of the allergic response. Omalizumab (Xolair) is a healthcare administered subcutaneous (SC) injection. 

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.


Coverage is subject to the specific terms of the member's benefit plan. 

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the website. 

Omalizumab (Xolair) may be considered medically necessary for use in individuals with moderate to severe persistent asthma who meet ALL the following criteria:

  • Individuals must be compliant with current therapeutic regimen; and
  • Individual is greater than or equal to six (6) years of age; and
  • Have a positive skin test or in vitro reactivity to a perennial aeroallergen; and
  • Baseline IgE titer greater than or equal to 30 IU/mL; and
  • Symptoms are inadequately controlled despite a three month trial of the following: 
    • A medium or high-dose inhaled corticosteroid; or
    • A systemic corticosteroid;
    • A long-acting beta-agonists; or
    • A leukotriene receptor antagonist 

Procedure Codes


Omalizumab (Xolair) may be considered medically necessary for the treatment of chronic idiopathic urticaria (CIU) when ALL of the following criteria are met: 

  • Individual is greater than or equal to twelve (12) years of age; and
  • Documented failure, contraindication, or intolerance to a four-week trial of one second-generation non-sedating histamine receptor type 1 (H1) antihistamine at the maximum recommended doses (eg, cetirizine [Zyrtec], fexofenadine [Allegra], loratadine [Claritin, Alavert], desloratadine [Clarinex], levocetirizine [Xyzal]); and
  • Documented failure, contraindication, or intolerance to at least a two-week trial of ANY ONE of the following medications: 
    • Leukotriene receptor antagonist (eg, zafirlukast [Accolate], montelukast [Singulair], zileuton [Zyflo]) in addition to the non-sedating H1 antihistamine; or
    • Histamine H2-receptor antagonist (eg. cimetidine [Tagamet], famotidine [Pepcid], nizatidine [Axid], ranitidine [Zantac]) in addition to the non-sedating H1 antihistamine; or
    • First-generation (sedating) H1 antihistamine (eg, chlorpheniramine [Chlor-Trimeton], cyproheptadine [Periactin], diphenhydramine [Benadryl]) in addition to the non-sedating H1 antihistamine; or
    • Substitution to a different second-generation non-sedating H1 antihistamine. 

Procedure Codes


The use of omalizumab for any indication not listed on this policy is considered experimental/investigational, and therefore, not covered. Scientific evidence does not support the use of omalizumab for any other indications not listed above. 

The risk of anaphylaxis following administration of omalizumab necessitates the need for observation.

Diagnosis Codes

J44.0  J44.1  J44.9  J45.40  J45.41  J45.42  J45.50 
J45.51  J45.52  J45.901  J45.902  J45.909  J45.990  J45.991 
J45.998  L50.1

NOTE: Product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Place of Service:  Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Omalizumab (Xolair®) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.