BlueCross and BlueShield of Montana Medical Policy/Codes
Xolair (Omalizumab)
Chapter: Drugs - Medical Benefit
Current Effective Date: July 18, 2013
Original Effective Date: November 01, 2003
Publish Date: April 18, 2013
Revised Dates: April 11, 2007, September 15, 2011; April 17, 2013

Asthma is a common condition in which the airways in the lungs become narrowed, making it difficult to breathe. Asthma caused by allergies results from the immune system's over-reaction to inhaled allergen, and this immune system reaction prompts inflammation that causes the airway narrowing and other symptoms (i.e., wheezing, chest tightness, and cough). Xolair, which blocks this immune response, received U.S. Food and Drug Administration (FDA) approval in June 2003 and is the first anti-IgE agent for the treatment of patients at high risk from their allergy related asthma.

The severity of asthma varies from mild intermittent to severe persistent. Most asthma is effectively treated based on the National Heart, Lung and Blood Institute (NHLBI) clinical guidelines. Xolair can be beneficial as adjunctive therapy in patients whose symptoms are inadequately controlled despite the regular use of maximum dose inhaled corticosteroids.

Xolair is a recombinant DNA-derived humanized IgGl monoclonal antibody that selectively binds to the human immunoglobulin E (IgE) antibody. Xolair prevents IgE from attaching to the mast cell and its subsequent activation.

Xolair is administered subcutaneously once or twice a month, and in some cases more than one injection at a time.

Recommended FDA labeled dosing:

Xolair (omalizumab) is usually administered 150 to 375 mg by subcutaneous (SC) injection every 2 or 4 weeks. Dose(s) (mg) and dosing frequency is determined by serum total IgE level (IU/mL), measured before the start of treatment, and by body weight (kg).


Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Medically Necessary

BCBSMT may consider Xolair® (Omalizumab) medically necessary when ALL the following criteria are met:

  • It is prescribed by an asthma specialist (pulmonologist, allergist/immunologist); AND
  • The patient is at least 12 years of age or older; AND
  • The patient has moderate to severe persistent allergic asthma with forced expiratory volume in one second (FEV1) <80% predicted; AND
  • There is documentation that the patient is compliant with Step Four of the National Heart, Lung and Blood Institute (NHLBI) guidelines for asthma treatment, which includes:
    1. Documented current use of an inhaled corticosteroid for at least three consecutive months; and
    2. Documented current use of a long-acting beta agonist or leukotriene inhibitor for at least three consecutive months; AND
  • There is documentation that compliance with Step four treatment for at least three months either:
    1. Has not been effective, as evidenced by continued exacerbations, acute attacks, frequent ER visits, hospitalizations or chronic oral corticosteroid use; OR
    2. Is not tolerated; AND
  • The patient's baseline serum total IgE >30IU/ml and <700IU/ml; AND
  • Body weight is 150 kg or less; AND
  • There is written documentation of at least one perennial aeroallergen by a positive skin prick test or an in-vitro specific IgE test, which correlated with the patient’s clinical history.

Authorization Limits:

  • Initial certification therapy that does not exceed administration of > 375 mg of Xolair (Omalizumab) every two weeks, may be authorized for up to 6 months. 
  • Recertification will be authorized for 12 months and annually thereafter if the patient demonstrates documented reduction or discontinuation of oral or inhaled steroids.

    Not Medically Necessary

    BCBSMT considers the use of Xolair (Omalizumab) not medically necessary for allergic rhinitis.


    BCBSMT considers the use of Xolair (Omalizumab) experimental, investigational and unproven for prevention of peanut or other food allergies, urticaria, eosinophilic gastroenteritis, and eosinophilic esophagitis.


    The current indication for Xolair is based principally on data from three multicenter, randomized, double-blind, placebo-controlled studies in over 1400 patients 12 years of age and older with moderate to severe persistent asthma for at least one year and a positive skin test reaction to a perennial aeroallergen.

    In these studies, patients stabilized on corticosteroid therapy (inhaled beclomethasone dipropionate in studies 1 and 2; inhaled fluticasone propionate with or without oral corticosteroids in study 3) were randomized to receive either Xolair or placebo for 16 weeks (stable corticosteroid phase); patients then entered a corticosteroid reduction phase for an additional 12 (studies 1 and 2) or 16 weeks (study 3) during which therapy with Xolair or placebo was continued while corticosteroid therapy was gradually tapered.  In 2 of the 3 studies (studies 1 and 2), treatment with Xolair was associated with a lower incidence of asthma exacerbations (defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline inhaled corticosteroid dosage) compared with placebo. No reduction in the incidence of asthma exacerbations was observed in patients with a baseline forced expiratory volume in one second (FEV) greater than 80% or in patients who required oral corticosteroids as maintenance therapy.

    These clinical trials have evaluated the ability of Xolair to reduce the number of significant asthma exacerbations and reduce the need for inhaled corticosteroids.  This reduces the need for rescue therapy, decreases hospitalizations and emergency visits and improves patient's quality of life.

    The safety and efficacy of Xolair in the management of other allergic conditions has not been established.

    A search and review of scientific literature conducted through July 2007 did not identify any published peer-reviewed literature that would alter the indications and/or limitations noted in the above discussion.

    2009 Update

    A search of peer reviewed literature through December 2009 identified no significant clinical trial publications or any additional information that would change the coverage position of this medical policy.

    2012 Update

    This medical policy has been updated with a literature review through May 2012. 

    FDA labeled indications remain unchanged from previous updates. The prescribing information on the manufacturer’s web site notes: “Patients whose pretreatment serum IgE level or body weight is outside the limits of the dosing table (<30 or >700 IU/mL and <30 or >150 kg, respectively) should not be dosed” (Xolair® Prescribing Information).

    Therapies, such as use of Xolair, for treatment of eosinophilic disorders (eosinophilic gastroenteritis and eosinophilic esophagitis) are directed at reducing the production of eosinophils, and the stimuli that attract them. Clinical trials using Xolair are currently ongoing for these conditions. Studies for use of Xolair for urticaria are ongoing (Thomson – DRUGDEX Evaluations).


    Disclaimer for coding information on Medical Policies          

    Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.           

    The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

    Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.  

    ICD-9 Codes

    493.00, 493.01, 493.02, 493.90, 493.91, 493.92

    ICD-10 Codes

    J45.20,  J45.21, J45.22, J45.901, J45.902, J45.909, J45.998

    Procedural Codes: J2357
    1. Guidelines for the Diagnosis and Management of Asthma National Institutes of Health, Expert Panel Report 2, National Heart, Lung, and Blood Institute, NIH Publication 97-4051(1997 July).
    2. Guidelines for the Diagnosis and Management of Asthma, Update on Selected Topics (2002), NIH Publication No. 02-5075.
    3. Buhl R, Omalizumab (Xolair) improves quality of life in adult patients with allergic asthma: a review. Respir Med (2003 Feb) 97(2):123-9.
    4. U.S. Food and Drug Administration, FDA Talk Paper, June 20, 2003, FDA Approves First Biologic for Allergy-Related Asthma.
    5. Lanier BQ, Corren J, et al, Omalizumab is effective in the long-term control of severe allergic asthma, Ann Allergy Asthma Immunol (2003 Aug) 91 (2):154-9.
    6. Food and Drug Administration (FDA) – Xolair® Omalizumab Label -– BLA 103976/5102(1994). Available at (accessed - 2007 August 8).
    7. McEvoy GK, ed. AHFS 2009 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists, Inc; 2009.
    8. Micromedex ® Healthcare Series, DRUGDEX Evaluations – Omalixumab (December 2009). .
    9. Molimard, M., Buhl, R., et al. Omalizumab reduces oral corticosteroid use in patients with severe allergic asthma: Real-life data. Respiratory Medicine Volume 104, Issue 9, Pages 1381-5, September 2010.
    10. Xolair® (omalizumab) Prescribing Information– Genentech, Inc. July 2010 (accessed April 2012).
    11. Costello, R.W., Long, D. A., et al. Therapy with omalizumab for patients with severe allergic asthma improves asthma control and reduces overall healthcare costs.  Ir J Med Sci. 2011 Sep; 180(3):637-41.
    12. Domingo, C., Moreno, A, et al. Omalizumab in the management of oral corticosteroid-dependent IGE-mediated asthma patients. Curr Med Res Opin. 2011 Jan; 27(1):45-53.
    13. Thomson – DRUGDEX Evaluations (MICROMEDEX 2.0 [Health Care Series]) Drug Information for the Health Care Professional (25th Edition). Xolair. Available at (accessed April 2012).
     September 2011 Updated policy: Added rationale, references, and investigational statement. Medically Necessary and Not Medically Necessary statements unchanged. Coding remains the same.
    April 2013 Title changed from "Omalizumab (Xolair)" to "Xolair (Omalizumab)".  Added criteria to Medically Necessary statement.  Added authorization limits.   Policy formatting and language revised.
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    Xolair (Omalizumab)