Highmark Medical Policy Bulletin
Section: Injections
Number: I-53
Topic: Omalizumab (Xolair®)
Effective Date: January 1, 2004
Issued Date: January 5, 2004
Date Last Reviewed: 10/2003

General Policy Guidelines

Indications and Limitations of Coverage

Xolair® (omalizumab) is indicated for use in patients who meet all the following criteria:

  • greater than or equal to 12 years of age;
  • moderate-to-severe persistent asthma in those who have a positive skin test or in vitro reactivity to a perennial aeroallergen (493.00-493.02) and whose symptoms are inadequately controlled with inhaled corticosteroids;
  • baseline IgE titre greater than or equal to 30 IU/mL;
  • baseline FEV 1 less than 80% of predicted; and
  • does not require oral steroids for maintenance therapy.

The recommended dosage of omalizumab is 150 mg to 375 mg subcutaneous every two to four weeks based on body weight and pre-treatment serum total IgE level.  Limit injections to not more than 150 mg/site.

The use of omalizumab for any indication not listed on this policy is considered experimental/investigational, and therefore, not covered.  A participating, preferred, or network provider can bill the member for the denied service.

Coverage for omalizumab is determined according to individual or group customer benefits.  Omalizumab is not reimbursable under the prescription drug benefit.


NOTE:
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.

Procedure Codes

S0107     

Traditional (UCR/Fee Schedule) Guidelines

Refer to General Policy Guidelines

FEP Guidelines

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious life-threatening condition and when medically necessary and appropriate for the patient’s condition.

Also refer to General Policy Guidelines

Comprehensive / Wraparound / PPO / Major Medical Guidelines

Refer to General Policy Guidelines

Any reference in this bulletin to non-billable services by a network provider may not be applicable to Major Medical.

Managed Care (HMO/POS) Guidelines

Refer to General Policy Guidelines

Publications

PRN References

12/2003, Omalizumab (Xolair®) coverage guidelines

References

Genentech, Xolair® (omalizumab) Package Insert. Genentech, Inc.; San Francisco, CA

Omalizumab, A Recombinant Humanized Anti-IgE Antibody, Reduces Asthma-related Emergency Room Visits and Hospitalizations in Patients with Allergic Asthma. Journal Allergy Clinical Immunology, Vol. 111, No. 1, 01/2003

Omalizumab Improves Asthma-related Quality of Life in Patients with Severe Allergic Asthma. Journal Allergy Clinical Immunology, Vol. 111, No. 2, 02/2003

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[Version 001 of I-53]

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Glossary




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.