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    Xolair

    Drug - Xolair® (omalizumab)

    January 2017

    Therapeutic area - Asthma

    Initial approval criteria

    • Patients must be 6 years of age or older
    • IgE level must be >30 IU/mL
    • Patient must have severe persistent asthma with evidence of reversibility
    • Evidence must be provided showing that the patient has been compliant with adequate trials of high-dose inhaled corticosteroids (ICS) combined with long-acting inhaled beta-agonists (LABA) – unless the patient demonstrates a contraindication to one of those drugs. If patient has tried high dose ICS/LABA combo, there is no need for a concomitant trial with Serevent or Foradil OR
    • Patients must be 12 years of age or older AND
    • Patient has been diagnosed with chronic idiopathic urticaria AND
    • Patient has tried and failed loratadine, cetirizine, diphenhydramine and montelukast AND
    • At time of request, provide baseline FEV1 and frequency of asthma exacerbation per month
    • Initial approval will be for 6 months in duration

    Severe persistent asthma is defined as: 

    • Asthma symptoms that have required urgent care or unscheduled services or hospitalization at least two times in the past 12 months
    • Asthma that requires high dose inhaled corticosteroid with concomitant use of a long-acting inhaled beta-agonist

    Adequate trial of inhaled corticosteroid is defined as: 

    • 8 weeks of therapy with good compliance of daily administration of medications
    • Patient is required to demonstrate a response to Xolair therapy for subsequent refills

    Renewal criteria

    • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following:
      • Parasitic (helminth) infection
      • Malignancy
      • Headache
      • Injection site reaction
      • Upper respiratory infection
      • Fatigue
    • Treatment has resulted in clinical improvement as documented by at least ONE of the following:
      • Decreased frequency of exacerbations (defined as  improvement of asthma  as demonstrated by decreased use of oral/systemic corticosteroids and/or less frequent hospitalizations and/or reduced frequency of ER visits) OR
      • Improvement in lung function, measured in FEV1
    • Renewal approval will be for 12 months in duration

    Quantity limits

    • Asthma: 750 mg per 28 days
    • Chronic Idiopathic Urticaria: 300 mg per 28 days

    Denial criteria

    Concurrent use with Cinqair or Nucala

    Billing of Xolair

    Xolair should be reconstituted and administered by a healthcare professional. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended by the manufacturer. Xolair is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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