More topics

Limited coverage criteria – mepolizumab

Last updated on March 19, 2025

 

Return to Special Authority drug list 

Generic name

 mepolizumab

Strength & form

 100 mg/mL lyophilized powder 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 (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 difference7 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

  • 1High-dose inhaled corticosteroids is defined as ≥500 mcg of fluticasone propionate or equivalent daily
  • 2Minimum duration of continuous trial is 6 months of high dose inhaled corticosteroids and 3 months of additional asthma controller medication
  • 3Clinically 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
  • 4An 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
  • 5PharmaCare covers a maximum supply of 28 days per fill for mepolizumab Coverage is limited to 100mg per 28 days
  • 6Mepolizumab should not be used in combination with other biologics used to treat asthma
  • 7Minimal 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

Special Authority request form(s)