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IgE, or immunoglobulin E, plays a central role in allergic inflammatory disorders such as allergic asthma. IgE worsens allergic conditions by causing mast cells to degranulate or dissolve. IgE antibodies bind to special receptors on mast cells. When a patient comes into contact with an allergen, the allergen enters the bloodstream and binds to IgE. This causes the mast cell to degranulate and release small proteins and molecules that lead to a typical allergic reaction including coughing, bronchoconstriction, mucus secretion, itching, and tear production. Bronchoconstriction leads to difficulty breathing and the coughing and wheezing associated with an asthmatic attack.

Omalizumab (Xolair®) works by binding to circulating free IgE. The IgE-omalizumab complex that is formed is then unable to bind to mast cells. Because this complexed IgE cannot bind to mast cells, it can no longer cause them to degranulate and no allergic reaction occurs. In addition to this, when mast cells are exposed to lower levels of free circulating IgE for a period of time, the number of IgE receptors on the mast cells decrease. This is beneficial because it further decreases the chances of mast cell degranulation by uncomplexed IgE. (revised 10-28-2005)

FDA APPROVED INDICATIONS

Omalizumab (Xolair®) is indicated for use in adults and adolescents, 12 years of age or older, with moderate to severe allergic asthma, that is inadequately controlled using traditional therapies such as inhaled corticosteroids. (revised 10-28-2005)

IDENTIFICATION

Generic Name: Omalizumab
Brand Name: Xolair®

Omalizumab (Xolair®) will be covered under the following conditions: (revised 10-28-2005)

1. The patient is 12 years of age or older with moderate to severe allergic asthma (has a strong IgE mediated component) for a minimum of one year.

• Criteria that indicate moderate persistent asthma include the following:
  • Symptoms daily
  • Exacerbations may affect activity and sleep
  • Nocturnal symptoms more than once a week
  • Daily use of short acting  b₂-agonist
  • FEV₁ or PEF 60%-80% of predicted
  • PEF or FEV₁ variability greater than 30%
• Criteria that indicate severe persistent asthma include the following:
  • Symptoms daily
  • Frequent exacerbations
  • Frequent nocturnal asthma symptoms
  • Limitation of physical activities
  • FEV₁ or PEF £ 60% predicted
  • PEF or FEV₁ variability greater than 30%

2. The patient has been compliant with traditional asthma therapy adequate for moderate to severe persistent asthma for a minimum period of six months and has had an inadequate response to this therapy, including inhaled corticosteroids and a long acting β-agonist or a leukotriene modifier or theophylline.

3. Patient’s weight and baseline IgE levels must strictly correspond to the following dosing charts:

Table 1: Administration Every 4 Weeks

**  See Table 2

Table 2: Administration Every 2 Weeks

Xolair®  Doses (milligrams) Administered by Subcutaneous Injection Every 2 Weeks for Adults and Adolescents (12 years of Age and Older) with Asthma

* See Table 1
X Do Not Dose

• The patient must have a definite diagnosis of asthma made by an asthma specialist (pulmonologist, allergist or immunologist) in order to be eligible for omalizumab therapy. The clinician must determine that episodic symptoms of airflow obstruction are present, airflow obstruction is at least partially reversible, and that alternative diagnoses have been ruled out.

• After 6 months of therapy, documentation of patient’s improvement must be submitted for continuation of treatment. This should include a decrease in hospitalizations, a decrease in the number of asthma exacerbations and a decrease in the use of inhaled corticosteroids and rescue medications. Improvements in FEV₁ or PEF should be observed.

None

9/24/2004: Code Reference section updated, HCPCS S0107 added, note added HCPCS J3490

3/21/2005: Preferred provider changed from Nova Factor to Accredo, # 2 "The patient has been compliant with traditional asthma therapy adequate for moderate to severe persistent asthma for a minimum period of six months and has had an inadequate response to this therapy, including inhaled corticosteroids, long acting b-agonist, and a leukotriene modifier or theophylline." changed to "The patient has been compliant with traditional asthma therapy adequate for moderate to severe persistent asthma for a minimum period of six months and has had an inadequate response to this therapy, including inhaled corticosteroids and a long acting b-agonist or a leukotriene modifier or theophylline." Table 1: Administration Every 4 Weeks ** See Table 2 added, Table 2: Administration Every 2 Weeks changes * See Table 1 and x Do Not Dose added

3/22/2005: Code Reference section updated, HCPCS J3490 deleted, HCPCS J2357 with effective date of 1/1/2005 added, HCPCS S0107 effective date of 1/1/2004 and deletion date of 3/31/2005 added

10/28/2005: Description section updated. Policy section updated to add Xolair® and change the Accredo telephone # from 1-866-839-2162 to 1-866-240-3373. Policy Guidelines section updated to remove Omalizumab information. Sources updated; Xolair added.

11/3/2005: Code Reference section updated, IDC9 diagnosis codes 493.00, 493.10, 493.11, 493.12, 493.20, 493.90 deleted.

11/2005: Approved by Pharmacy & Therapeutics (P & T) Committee

8/8/2008: Off labeled indications removed from description section

01/01/2009: Accredo preferred provider information removed. BCBSMS information added.

Johansson, S.G.O. MD, PhD; Haahtela, Tari MD, PhD; O’Byrne, Paul M. MD. Omalizumab and the immune system: an overview of preclinical and clinical data. American College of Allergy, Asthma, and Immunology. Aug 2002; 89(8): 132-138.

National Heart, Lung, and Blood Institute. Guidelines for the Diagnosis and Management of Asthma: Expert Panel Report 2. July 1997.

National Heart, Lung, and Blood Institute. Global Strategy for Asthma Management and Prevention. 2002.

Xolair® Prescribing Information (added 10-28-2005)

Covered Codes

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