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Limited coverage drugs – benralizumab

Last updated on February 28, 2025

Generic name

benralizumab

Strength & form

30 mg/mL solution for subcutaneous injection

Special Authority criteria

Approval period

Initial

For the add-on maintenance treatment of adult patients with severe eosinophilic asthma meeting ALL the following criteria:

  • Requested by a respirologist or allergist with expertise in treating asthma
  • Patient’s symptoms are inadequately controlled with high-dose inhaled corticosteroids1 and one or more optimally dosed additional asthma controllers2 (e.g. LABA)
  • Asthma questionnaire has been completed: acceptable validated questionnaire is Asthma Control Questionnaire-5 (ACQ-5)
  • Patient has one of the following:
    • blood eosinophil count of  ≥300 cells/µl in the past 12 months and the patient has experienced 2 or more clinically significant asthma exacerbations3 in the past 12 months, or
    • blood eosinophil count of ≥150 cells/µl and is currently receiving maintenance treatment with oral corticosteroids4

1 year

First renewal

Renewal of coverage requested by a respirologist or allergist with expertise in treating asthma will be considered for adult patients whose:

  • Baseline asthma control questionnaire has improved by the minimal clinically important difference5 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 renewal

Renewal of coverage requested by a respirologist or allergist with expertise in treating asthma will be considered for adult patients whose:

  • Asthma control questionnaire score achieved after the first 12 months of therapy has been maintained

AND

  • Number of clinically significant exacerbations has not increased within the previous 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

  • High-dose inhaled corticosteroids is defined as ≥500 mcg of fluticasone propionate or equivalent daily
  • Minimum duration of continuous trial is 6 months of high dose inhaled corticosteroids and 3 months of additional asthma controller medication
  • 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
  • An 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
  • Minimal clinically important difference of the Asthma Control Questionnaire-5 (ACQ-5) is a decrease of ≥0.5 points of the mean score compared to pre-treatment mean score
  • PharmaCare covers a maximum supply of 56 days per fill for benralizumab (coverage limited to 30 mg at 0, 4 and 8 weeks for loading doses, then every 8 weeks for maintenance doses)
  • Benralizumab should not be used in combination with other biologics used to treat asthma

Special Authority request form