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DrugXolair® (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.


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

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