• Allergic Asthma: For patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids (ICS). Xolair has been shown to decrease the incidence of asthma exacerbations in these patients.

Table 1
ADMINISTRATION EVERY 4 WEEKS
Xolair Doses (milligrams) Administered by Subcutaneous (SC) Injection
Every 4 Weeks for Adults and Adolescents (12 Years of Age and Older) with Asthma

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

• Prescribed by a Pulmonologist or Allergist

AND

• Diagnosis of moderate to severe (see general information) perennial allergic asthma in patients > 6 years old

AND

• Patient has a positive skin test or in vitro reactivity to a perennial aeroallergen (see general information)

AND

• Patient has a documented total serum IgE level greater than 30 IU/ml

AND

• Use of an inhaled or oral corticosteroid AND a long-acting beta-agonist (LABA). If a long-acting beta-agonist is contraindicated, a second controller agent must be used in combination with an inhaled corticosteroid. Patients must be compliant with controller medication therapy.

AND

• Patient experiences two (2) exacerbations requiring a course of oral/systemic corticosteroids, hospitalization or an emergency room visit in a twelve (12) month period; or one exacerbation requiring intubation.

OR

• Diagnosis of chronic idiopathic urticaria in patients 12 years and older

AND

• Failure or clinically significant adverse effects to TWO H₁ Antihistamines (Such as hydroxyzine, diphenhydramine, loratadine, etc.)

• Xolair is not indicated for treatment of other allergic conditions or other forms of urticaria other than allergic asthma and chronic idiopathic urticaria.
• Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus.
• Xolair is not indicated for use in pediatric patients less than 12 years of age.
• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

Allergic Asthma

• Xolair has been shown to be marginally effective in decreasing the incidence of asthma exacerbations in patients who have met all the criteria described above.
• Xolair provides little therapeutic benefit over existing therapies. Use in patients on inhaled corticosteroids or chronic oral steroids plus or minus a second controller agent decreased asthma exacerbation by 0.5 to 1 per year. Use of rescue beta-agonists declined by 1 inhalation per day. Small changes in pulmonary function tests were also seen. An analysis of unpublished data indicated that hospital admissions declined by 3 per hundred patient years, emergency department (ED) visits by 2 per hundred patient years, and unscheduled physician office visits by 14 per one hundred patient years.
• The National Heart, Lung and Blood Institute's Expert Panel Report 3 (EPR3) Guidelines for the Diagnosis and Management of Asthma recommend Xolair may be considered as adjunct therapy for patients 12 years and older with allergies and Step 5 or 6 (severe) asthma whose symptoms have not been controlled by ICS and LABA.
• The four perennial aeroallergens most commonly tested for in the clinical trials were dog dander, cat dander, cockroach, and house dust mite.
• The definition of moderate to severe allergy varied among the clinical trials. The definition most often used was a patient who required oral systemic steroid bursts or unscheduled physician office visits for "uncontrolled" asthma exacerbations despite maintenance inhaled steroid use. Patients in the clinical trials most often were required to have an FEV1 between 40% and 80% of predicted. No patients were enrolled with an FEV1 greater than 80% of predicted.
• Serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair have been reported. Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis -with onset two to 24 hours or even longer-after receiving Xolair treatment. Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose.

• Chronic idiopathic urticaria is classified as spontaneous onset of wheals, angioedema, or both, for more than 6 weeks due to an unknown cause.
• Clinical studies have shown that Xolair 150 mg and 300 mg significantly improved the signs and symptoms of chronic idiopathic urticaria compared to placebo in patients who had remained symptomatic despite the use of approved dose of H₁- antihistamine.
• The EAACI/GA2LEN/EDF/AAAAI/WAO Guideline for the Management of Urticaria recently updated their guideline to include Xolair in addition to H₁-Antihistamines as a third line treatment option in patients who have failed to respond to higher doses of H₁-Antihistamines.
• Xolair is the first medicine in its class approved for CIU since non-sedating antihistamines.
• The use of Over the Counter H₁ Antihistamines may not be a benefit to the treatment of chronic idiopathic urticarial. Credit will be given for its use, but will not be covered under plan.
• Anaphylaxis has occurred as early as after the first dose of Xolair, but also occurred beyond 1 year after beginning regularly administered treatment.