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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

Omalizumab (Xolair) requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

Omalizumab (Xolair) is generally covered subject to the indications below when all of the following criteria are met, and per member plan documents:

Initial authorizations:

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; and,
  2. A positive skin test or in vitro (test tube) reactivity to a perennial aeroallergen (air born substance that causes allergies, such as pollen); and,
  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); and,
    2. regular use of a long-acting beta-agonist (such as Serevent); and,
    3. regular use or a trial of a leukotriene antagonist (such as Singulair); and,
    4. regular or periodic use of oral steroids; and,
  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; or,
    2. At least 1 exacerbation treated in hospital or requiring mechanical ventilation in the last 12 months; and,
  5. Patient is not currently using another biologic therapy for the treatment of asthma such as Cinqair, Dupixent, Fasenra or Nucala; and,
  6. Prescribed within FDA approved dosing regimen

Initial authorizations will be provided for 12 months.

Reauthorizations:

  1. Patient has been seen by provider within the past 12 months; and,
  2. Patient has been adherent to therapy; and,
  3. Patient has not experienced unacceptable toxicity from the drug such as parasitic (helminth) infection or herpes zoster infection; and,
  4. Patient has a clinically meaningful response to the medication as defined:
    1. Decreased frequency of exacerbations defined as:
      1. Improvement of asthma control, demonstrated by decreased use of oral or systemic corticosteroids; or,
      2. Less frequent hospitalizations; or,
      3. Reduced frequency of emergency department visits; or,
    2. Improvement in lung function measured in FEV1; and,
  5. Xolair is prescribed within the FDA-approved dosing regimen.

Reauthorizations will be provided for 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; and,
    2. H2 antihistamines; and,
    3. Leukotriene inhibitors; and,
    4. Multiple courses of or dependent on a steroids (e.g., prednisone)

Initial authorizations will be provided for 12 months.

Reauthorizations:

  1. Patient has been seen by provider within the past 12 months; and,
  2. Patient has been adherent to therapy; and,
  3. Patient has a documented benefit from therapy defined as reduced symptoms of urticaria; and, ,
  4. Xolair is prescribed within the FDA-approved dosing regimen.

Reauthorizations will be provided for 12 months.

Definitions

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 antihistamine 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.

HCPCS Code

Codes

Description

J2357

Injection, omalizumab, 5 mg

NDC Codes

Codes

Description

5024204062

Xolair 150 MG SOLR

50242021401

Xolair 75 MG/0.5ML SOSY

50242021501

Xolair 150 MG/ML SOSY

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

Products

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.

References

  1. Xolair Prescribing Information. Genentech, Inc., South San Francisco, CA September 2018.

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Policy activity

  • 12/09/2003 - Date of origin
  • 04/01/2019 - Effective date
Review date
  • 02/2019
Revision date
  • 02/04/2019

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