Medical Policy

Effective Date:01/01/2006 Title:Xolair (Omalizumab)
Revision Date:01/01/2017 Document:BI151:00
CPT Code(s):J2357
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1.     Xolair requires prior authorization.

2.     Xolair is an injectable medication used in children and adolescents (6 yrs. of age or older) and adults who have severe asthma that is not responding to large doses of inhaled steroids or chronic urticaria that remains symptomatic after using antihistamines.

3.     Xolair is considered a specialty drug and must be obtained through a contracted specialty pharmacy.

Medical Statement
  1. Xolair (Omalizumab) is considered medically necessary for members (6 years of age and above) with moderate-to-severe persistent (year round) asthma (J45.40-J45.52) whose symptoms have been inadequately controlled with the highest appropriate dose of inhaled corticosteroids over the past 3 months and who meet all of the following criteria:
    1. Have a positive skin test or in vitro reactivity to a perennial aeroallergen (dust mite, mold, or cockroach) and;
    2. Member has daily symptoms (e.g., coughing, wheezing, and dyspnea) and/or exacerbations affecting activity (e.g., exercise) and sleep and any of the following signs of poor asthma control:

a)    Daily use of short-acting inhaled beta2-agonists; or

b)    Diurnal variation in peak expiratory flow (PEF) of greater than 30%; or

c)     PEF less than 80% of personal best; or

d)    Multiple visits to the emergency room because of acute exacerbations of asthma in the preceding 12 months and;

    1. Prescribed by allergist, immunologist or pulmonologist and;
    2. Baseline IgE level ≥30 IU/ml

Initial approval will be for 6 months.

Additional coverage for 1 year intervals will be granted if the following criteria are met:

    1. Peak flow is improved >20% or 12% improvement in FEV1 and;
    2. Decrease in use of rescue medications or corticosteroid use and;
    3. Decrease in ER visits, hospitalizations or physician visits due to asthma attacks or;
    4. Decrease in school or work absences.


  1. Xolair is considered medically necessary for members (6 years of age or older) who:
    1. Have a diagnosis of chronic idiopathic urticaria  AND
    2. Remain symptomatic after trial of at least two (2) different antihistamines.


  1. The use of Xolair (Omalizumab) as initial therapy for allergic asthma, for non-allergic asthma, and for allergic conditions other than those listed above without asthma is considered experimental and investigational because Omalizumab safety and effectiveness for these other indications has not been established.


Codes Used In This BI:


J2357           Injection, Omalizumab, 5mg

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  1. Global initiative for asthma (GINA), National Heart, Lung and Blood Institute (NHLBI), World Health Organization (WHO). Global strategy for asthma management and prevention. Global Initiative for Asthma (GINA). Bethesda, MD: Global Initiative for Asthma (GINA), National Heart, Lung and Blood Institute (NHLBI); February 2002. Available at: Accessed July 15, 2003.
  2. Babu KS, Arshad SH, Holgate ST. Omalizumab, a novel anti-IgE therapy in allergic disorders. Expert Opin Biol Ther. 2001; 1(6):1049-1058.
  3. Casale TB. Experience with monoclonal antibodies in allergic mediated disease: Seasonal allergic rhinitis. J Allergy Clin Immunol. 2001; 108(2 Suppl):S84-S88.
  4. D`Amato G. Treating atopic asthma with the anti-IgE monoclonal antibody. Monaldi Arch Chest Dis. 2002; 57(2):117-119.
  5. Owen CE. Anti-immunoglobulin E therapy for asthma. Pulm Pharmacol Ther. 2002; 15(5):417-424.
  6. Chung KF. Anti-IgE therapy of asthma. Curr Opin Investig Drugs. 2002; 3(8):1157-1160.
  7. Johansson SG, Haahtela T, O`Byrne PM. Omalizumab and the immune system: An overview of preclinical and clinical data. Ann Allergy Asthma Immunol. 2002; 89(2):132-138.
  8. No authors listed. Omalizumab: Anti-IgE monoclonal antibody E25, E25, humanized anti-IgE MAb, IGE 025, monoclonal antibody E25, Olizumab, Xolair, rhuMAb-E25. Bio Drugs. 2002; 16(5):380-386.
  9. Corren J, Casale T, Deniz Y, Ashby M. Omalizumab, a recombinant humanized anti-IgE antibody, reduces asthma-related emergency room visits and hospitalizations in patients with allergic asthma. J Allergy Clin Immunol. 2003; 111(1):87-90.
  10. Milgrom H. Is there a role for treatment of asthma with Omalizumab? Arch Dis Child. 2003; 88(1):71-74.
  11. Buhl R. Omalizumab (Xolair) improves quality of life in adult patients with allergic asthma: A review. Respir Med. 2003; 97(2):123-129.
  12. 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(2):278-284.
  13. Noga O, Hanf G, Kunkel G. Immunological and clinical changes in allergic asthmatics following treatment with Omalizumab. Int Arch Allergy Immunol. 2003; 131(1):46-52.
  14. Walker S, Monteil M, Phelan K, et al. Anti-IgE for chronic asthma. Cochrane Database Syst Rev. 2003 ;( 3):CD003559.
  15. Hellgren J, Karlsson G, Toren K. The dilemma of occupational rhinitis: Management options. Am J Respir Med. 2003; 2(4):333-341.
  16. Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Omalizumab for adult asthma. Emerging Drug List, No. 49. Ottawa, ON: CCOHTA; September 2003
  17. Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Omalizumab as add-on therapy to inhaled steroids for asthma. Issues in Emerging Technologies Bulletin, Issue 58. Ottawa, ON: CCOHTA; June, 2004. Available at:
  18.  Bang LM, Plosker GL. Omalizumab: A review of its use in the management of allergic asthma. Treat Respir Med. 2004; 3(3):183-199.
  19. Walker S, Monteil M, Phelan K, et al. Anti-IgE for chronic asthma in adults and children. Cochrane Database Syst Rev. 2004 ;( 2):CD003559.
  20. The allergy report, American Academy of Allergy Asthma and Immunology at:

Effective 01/01/2017: Updated age requirement to 6 years and older.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.