Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

Description

Xolair (Omalizumab) is a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E (IgE).  It is produced by a Chinese hamster ovary cell suspension culture in a nutrient medium containing the antibiotic gentamicin which is not detectable in the final product according to the product insert.

 Omalizumab inhibits the binding of IgE to the high-affinity on the surface of mast cells and basophils.  Reduction in surface-bound IgE on the receptor (FceRI bearing) cells limits the degree of release of mediators of the allergic response.  Treatment also reduces the number of FceRI receptors on basophils of allergic patients.

Omalizumab is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test.  Xolair has been shown to decrease the incidence of asthma exacerbations in these patients.  Safety and efficacy have not been established in other allergic conditions.

Background

According to the global strategy for asthma management and prevention of the National Heart, Lung and Blood Institute (NHLBI), patients with moderate persistent asthma exhibit some of the following characteristics:

The preferred therapy for patients with moderate persistent asthma is regular treatment with a combination of inhaled corticosteroids and a long-acting inhaled beta2-agonist twice daily. For patients with severe persistent asthma, the primary therapy includes inhaled corticosteroids at higher doses plus a long-acting inhaled beta2-agonist twice daily. Furthermore, according to the NHBLI guidelines, control of asthma is defined as:

• Minimal (ideally not) chronic symptoms, including nocturnal symptoms
• Minimal (infrequent) exacerbations
• No visits to the emergency room
• Minimal (ideally no) use of p.r.n. (as needed) beta2-agonist
• No limitations on activities, including exercise
• PEF diurnal variation of less than 20%
• (Near) normal PEF
• Minimal (or no) adverse effects from medicine.

Appendex A: Estimated Comparative Daily Doseages for Inhaled Corticosteroids

Appendix B: Dosing Schedule for Subcutaneously Administered Omalizumab

Policy

Omalizumab is considered medically necessary when all of the following conditions are met:

• The request for approval comes from an allergist, immunologist, or pulmonologist who is currently treating the patient.
• The patient is an adult or adolescent (12 years of age or above).
• The patient has moderate or severe persistent asthma as defined by the current NAEPP clinical guidelines for the management of asthma.
• The patient has a positive skin test or in vitro reactivity to a specific perennial aeroallergen.
• The patient's symptoms are inadequately controlled with appropriate doses of inhaled corticosteroids
• There is documentation of poor asthma control or recurrent exacerbations such as those that require hospitalizations or treatment with repeated courses of oral corticosteroids.
• Triggers of asthma to which the patient is exposed are appropriately managed

Omalizumab is considered not medically necessary when used for the following conditions:

-allergic rhinitis

-prevention or therapy for peanut or other food allergies

Omalizumab is considered investigational when used for all other conditions.

Administration may not exceed 375 mg every 2 weeks. Omalizumab is not a self-injectable medication.

Continued treatment with omalizumab beyond six months is considered medically necessary for members who meet all of the following criteria:

• Member had met criteria for omalizumab set forth by BCI at initiation of omalizumab therapy; and
• treatment with omalizumab has resulted in clinical improvement as documented by one or more of the following:
  • Decreased utilization of rescue medications; or
  • Decreased frequency of exacerbations (defined as worsening of asthma that requires increase in inhaled corticosteroid does or treatment with systemic corticosteroids); or
  • Increase in percent predicted FEV-1 from pretreatment baseline; or
  • Reduction in reported symptoms (decrease in asthma symptom score), as evidenced by decreases in frequency or magnitude of one or more of the following symptoms:
    • Sleep disturbances, night wakening, or symptoms upon wakening; or
    • Shortness of breath; or
    • Wheezing/heavy breathing/fighting for air; or
    • Chest tightening or heaviness; or
    • Asthma attacks; or
    • Difficulty taking deep breath or difficulty breathing out; or
    • Coughing or clearing throat; or
    • Tiredness; and
• Member has not exhibited symptoms of anaphylaxis (bronchospasm, hypotension, syncope, urticara, and/or angioedema) after administration of omalizumab.

Policy Guidelines

Omalizumab is considered medically necessary as a second line treatment, when all of the following conditions are met:

• The request for approval comes from an allergist, immunologist, or pulmonologist who is currently treating the patient.
• The patient is an adult or adolescent (12 years of age or above).
• The patient has moderate or severe persistent asthma as defined by the current NAEPP clinical guidelines for the management of asthma.
• The patient has a positive skin test or in vitro reactivity to a specific perennial aeroallergen.
• The patient’s symptoms are inadequately controlled with appropriate doses of inhaled corticosteroids.
• There is documentation of poor asthma control or recurrent exacerbations such as those that require hospitalizations or treatment with repeated courses of oral corticosteroids.
• Triggers of asthma to which the patient is exposed are appropriately managed
• Moderate persistent asthma has daily daytime symptoms and nighttime symptoms >1 night/week and a PEF or FEV1 of greater than 60% - less than 80% and PEF variability if greater than 30%.
• Since clinical trials involved patients 12 to 76 years of age, administration is limited to those age groups.
• Clinical trials did not involve patients who weighed more than 150 kg and there is no evidence of efficacy for patients above that weight.
• Total serum IgE levels should be between 30 and 700 international units/mL, but no higher than 700 international units.
• Dosage is to be determined by pre-treatment IgE level as noted in the product insert.
• Omalizumab is not indicated for conditions other than asthma.
• Cost effectiveness is unlikely unless the patient has severe persistent asthma with frequent exacerbations requiring hospitalization.

References:

· Xolair (Omalizumab) product insert – Genentech, Inc./ Novartis Pharmaceuticals Corporation   April 2006
· NAEPP Stepwise Approach for Managing Asthma in Adults and Children Older than 5 Years of Age: Treatment   May 2003

'The Allergy Report' American Academy of Allergy, Asthma and Immunology. http://www.theallergyreport.org/reportindex.html.

· Easthope, S and Garvis, B 'Omalizumab' Drugs 2001;61(2):253-60.

· Prenner, BM 'Asthma 2008: targeting immunoglobulin E to achieve disease control.' J Asthma. 2008 Aug;45(6):429-36.

· National Asthma Education and Prevention Program (NAEPP). Guidelines for the diagnosis and management of asthma. Expert Panel report 3. Bethesda, MD: National Institutes of Health (NIH), National Heart, Lung and Blood Institute (NHLBI); August 2007.

· National Institute for Health and Clinical Excellence (NICE). Omalizumab for severe persistent allergic asthma. Technology Appraisal Guidance No 133. London, UK: NICE; November 2007.

· Strunk RC, Bloomberg GR. Omalizumab for asthma. N Engl J Med. 2006;354(25):2689-2695

Codes

Policy History