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Coverage criteria policies

Omalizumab (Xolair®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Xolair requires prior authorization through Pharmacy Administration.


Omalizumab (Xolair) is generally covered when the following criteria are met:

Severe Asthma:

  1. Age, weight & IgE levels per FDA-approved prescribing guidelines – generally for adults and adolescents (6 years of age and above) meeting certain weight and IgE level requirements.
  2. A positive skin test or in vitro (test tube) reactivity to a perennial aeroallergen (air born substance that causes allergies, such as pollen),
  3. Xolair is reserved for patients with poor asthma control (see criteria #4) and significant symptoms despite the following standard therapies:
    1. regular use of inhaled steroids (such as Flovent));
    2. regular use of a long-acting beta-agonist (such as Serevent);
    3. regular use or a trial of a leukotriene antagonist (such as Singulair);
    4. regular or periodic use of oral steroids.
  4. Poor asthma control despite standard therapies is defined as one of the following:
    1. At least 2 exacerbations requiring oral systemic corticosteroids in the last 12 months,
    2. At least 1 exacerbation treated in hospital or requiring mechanical ventilation in the last 12 months

Chronic Urticaria:

  1. Patient is followed by an allergist or dermatologist, and
  2. Patient has hives/ urticaria longer than 6 weeks, and
  3. Patient has tried and failed all standard therapies including
    1. H1 antihistamines
    2. H2 antihistamines
    3. Leukotriene inhibitors
    4. Multiple courses of or dependent on a steroid (e.g., prednisone)

All authorizations will be for two years. Renewals will be provided with documentation that the medication is effective.


Xolair (omalizumab) is an anti-IgE antibody indicated for:

  1. Moderate to severe persistent asthma in patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids.
  2. Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 anthistamine treatment.

Limitations of use - Xolair is not indicated for other allergic conditions or other forms of urticarial and not indicated for acute bronchospasm or status asthmaticus.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.





Injection, omalizumab, 5 mg

CPT Code




Therapeutic, prophylactic or diagnostic injection; subcutaneous or intramuscular

NDC Codes




150mg single dose vial

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.


This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.


  1. Xolair Prescribing Information. Genentech, Inc., South San Francisco, CA July 2016.

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Policy activity

  • 12/09/2003 - Date of origin
  • 12/01/2017 - Effective date
Review date
  • 02/2018
Revision date
  • 11/06/2017

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