Omalizumab for Allergy Related Asthma*

Medical Policy: 05.01.07
Original Effective Date: December 2003
Reviewed: November 2008
Revised: April 2006

This policy applies to all products unless specific contract limitations, exclusions or exceptions apply. Please refer to the member's coverage manual for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply.

Description:

The injectable drug omalizumab, marketed under the trade name Xolair®, is FDA approved for the treatment of allergy related asthma in a select group of patients. This genetically engineered monoclonal antibody is injected under the skin and is indicated for patients who are at least 12 years old; with moderate to severe persistent asthma who have had a positive skin test or in vitro reactivity to at least one perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Omalizumab is only recommended as a second-line treatment to be used after first-line treatments have failed. Initial maintenance treatment for allergic asthma generally consists of inhaled corticosteroid medications with the addition of a long acting beta-2 agonist as needed for symptomatic control. Desensitization treatment with injections of specific allergens has also been used for patients with asthma associated with specific allergens with variable response rates.

According to the FDA, only patients who have asthma caused by allergies can benefit from this treatment and the product’s labeling states that this type of asthma should be established by skin or blood testing before treatment is initiated. In patients suffering from an allergic component to their asthma, antigen-specific IgE is bound to receptors on the surface of mast cells and basophils, and mediates the release of histamine, leukotrienes and other mediators. These substances cause increased inflammation of the mucosa and spasms in the smooth muscle tissue comprising the airways of the lung. The mechanism of action for omalizumab is thought to be the formation of molecular complexes with circulating free IgE, thereby preventing their binding with mast cells and basophils.

Policy:

Treatment with injectable omalizumab may be considered medically necessary when the following criteria are met:

Patient is at least 12 years old
With moderate to severe persistent asthma and a positive IgE mediated intradermal or percutaneous skin test to a common perennial aeroallergen
Documented compliance with adequately dosed inhaled corticosteroids and
Hospitalization for asthma, with or without intubation in the past two years, or ER visits more than twice a year in the past year or oral steroid use more than four weeks in the past year for exacerbations of asthma

Moderately Persistent Asthma Defined:

Symptoms are persistent on a daily basis
Exacerbations affect activities of daily living and sleep
Nocturnal symptoms are present more than once a week and
Daily use of an inhaled short acting beta-2 agonist with
- FEV₁ 60% to 80% of predicted or PEF 60% to 80% of personal best and
- PEF or FEV₁ variability is greater than 30%

Severe Persistent Asthma Defined:

Daily symptoms
Frequent exacerbations
Frequent nocturnal symptoms
Limitation of physical activities with
- FEV₁ less than or equal to 60% to 80% of predicted or PEF less than or equal to 60% to 80% of personal best and
- PEF or FEV₁ variability is greater than 30%

Treatment with omalizumab is considered investigational and is not a covered benefit when the criteria listed above are not met.

Prior Approval is recommended. Submit a prior approval/treatment request now.

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Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT** codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
HCPCS code J2357, Injection, omalizumab, 5mg

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Selected References:

The Medical Policy Reference manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
Omalizumab (Xolair): An anti-IgE antibody for asthma. The Medical Letter, Vol. 45 (1163) August 18, 2003.
Rosenwasser LJ, Nash DB, Incorporating omalizumab into asthma treatment guidelines:Consensus panel recommendations. P&T Vol.28(6) June 2003; 400-410.
Holgate S, et al. Efficacy of omalizumab, an anti-immunoglobulin E antibody, in patients with allergic asthma at high risk of serious asthma-related morbidity ad mortality. Curr Med Res Opin. 2001;17(4):233-40.
Walker S, Monteil M, et al. Anti-IgE for chronic asthma in adults and children. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003559. Abstract viewed on line.
Chipps B, Buhl R, et al. Improvement in quality of life with omalizumab in patients with severe allergic asthma. Curr Med Res Opin. 2006 Nov;22(11):2201-8.

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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:

Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309

*Prior Approval is recommended for this policy.

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.