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Limited coverage criteria – omalizumab for severe allergic asthma

Last updated on March 4, 2026

 

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Generic name

omalizumab

Brand name

 Omlyclo™

Strength & form

75 mg/0.5 mL, 150 mg/1 mL pre-filled syringe

Special Authority criteria

Approval period

Initial

For the add-on maintenance treatment of severe persistent asthma in patients aged 12 years and older that meet the following criteria:

  • Special Authority request is submitted by a respirologist or allergist with experience in treating asthma1

AND

  • Patient's symptoms are inadequately controlled with high-dose inhaled corticosteroids2 for a minimum of 6 months AND 1 or more additional optimally dosed asthma controllers3 for a minimum of 3 months (e.g., long-acting beta agonists [LABA])

AND

  • Asthma Control Questionnaire-5 (ACQ-5) has been completed within 90 days prior to omalizumab treatment

AND

  • Patient either:
    • Has experienced 2 or more clinically significant asthma exacerbations4 in the past 12 months, OR
    • Is currently receiving maintenance treatment with oral corticosteroids for a minimum of 6 months5

AND

  • Patient has a positive skin test or in vitro activity to a perennial aeroallergen within the past 12 months

AND

  • There is documentation of the patient's IgE (immunoglobulin E) and weight prior to initiation of omalizumab7,8

1 year

First renewal

Renewal of coverage submitted by a respirologist or allergist with experience in treating asthma1 will be considered for patients aged 12 years and older who meet the following criteria:

  • Pre-omalizumab ACQ-5 has improved by the minimal clinically important difference6 at 12 months since initiation of treatment

AND

  • Number of clinically significant exacerbations has not increased at 12 months since initiation of treatment

OR

  • Maintenance treatment with oral corticosteroids has had a reduction in oral corticosteroid dose in 12 months since initiation of treatment
 1 year

Second and subsequent renewals

Renewal of coverage submitted by a respirologist or allergist with expertise in treating asthma1 will be considered for patients aged 12 years and older who meet the following criteria:

  • ACQ-5 achieved after the first 12 months of therapy has been maintained

AND

  • Number of clinically significant exacerbations has not increased within the past 12 months

OR

  • Reduction in maintenance dose of oral corticosteroids at the first 12 months of treatment has been maintained
 1 year

Practitioner exemptions

  • None

Special notes

  • 1Patients aged 12 to 17 years should be managed by a respirologist or allergist with experience in treating asthma in pediatric patients
  • 2High-dose inhaled corticosteroid is defined as ≥ 500 mcg of fluticasone propionate or equivalent daily
  • 3Minimum duration of continuous trial is 6 months of high-dose inhaled corticosteroids and 3 months of additional asthma controller medication
  • 4A clinically significant asthma exacerbation is defined as worsening of asthma symptoms, requiring administration of systemic corticosteroids (i.e., intravenous steroids or oral corticosteroids for at least 3 days), and/or an emergency department visit, and/or hospitalization
  • 5An adequate trial of maintenance treatment with oral corticosteroids is defined as ≥ 5 mg of prednisone or its equivalent per day for a minimum of 6 months
  • 6The minimal clinically important difference of the ACQ-5 is a decrease of  ≥ 0.5 points of the mean score compared to pre-treatment mean score
  • 7As per the omalizumab monograph, the appropriate dose and frequency for severe allergic asthma is determined by baseline IgE (30-700 IU/mL) and the patient's weight (20-150 kg). PharmaCare will provide coverage of omalizumab in accordance with the product monograph, using the patient's baseline IgE and weight, up to a maximum dose of 375 mg every 2 weeks. Dose increases upon renewal are only permitted if there has been an increase in the patient's body weight
  • 8Baseline IgE must be collected within 12 months prior to initiating omalizumab
  • PharmaCare covers a maximum supply of 28 days per fill for omalizumab
  • Coverage of omalizumab will not be provided for use in combination with other biologics for the treatment of chronic rhinosinusitis with nasal polyps, asthma, or chronic idiopathic urticaria

Special Authority requests