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DESCRIPTIONOmalizumab (Xolair®) is a monoclonal anti-IgE antibody that is used in moderate to severe persistent asthma. It is made with recombinant DNA technology using human and mouse genes. Omalizumab is given as a subcutaneous injection every 2 or 4 weeks, depending on the severity of the patient’s condition, patient’s body weight and IgE levels.
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.
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.
POLICYPrior authorization is required.
Omalizumab (Xolair®) will be covered under the following conditions:
Table 1: Administration Every 4 Weeks
Xolair® Doses (milligrams) Administered by Subcutaneous Injection Every 4 Weeks for Adults and Adolescents (12 Years of Age and Older) with Asthma.
** 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
POLICY GUIDELINESThe coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/15/2003: Approved by the Pharmacy & Therapeutics (P & T) Committee
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.
02/19/2014: The policy statement was revised to add the following requirement: The patient has a positive skin test or in vitro reactivity to a perennial aeroallergen.
SOURCE(S)Berger, William E. MD, MBA. Monoclonal anti-IgE antibody: a novel therapy for allergic airways disease. American College of Allergy, Asthma, and Immunology. Feb 2002; 88(2): 152-161.
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
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.