Limited Coverage Drugs - mepolizumab


Generic Name
mepolizumab

Strength
100 mg/mL

Form
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:

  1. Requested by a respirologist.
  2. Patient’s symptoms are inadequately controlled with high-dose inhaled corticosteroids1 and one or more optimally dosed additional asthma controllers2 (e.g. LABA).
  3. Asthma questionnaire has been completed (acceptable validated questionnaire is Asthma Control Test-5 (ACT-5).
  4. Patient has one of the following:

a) 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

b) blood eosinophil count of  ≥150 cells/µl and is currently receiving maintenance treatment with oral corticosteroids.4

1 year

FIRST RENEWAL

Renewal of coverage requested by a respirologist will be considered for adult patients whose:

  • baseline asthma control questionnaire has improved by the minimal clinically important difference8 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 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

  1. High-dose inhaled corticosteroids is defined as ≥500 mcg of fluticasone propionate or equivalent daily.
  2. Minimum duration of continuous trial is 6 months of high dose inhaled corticosteroids and 3 months of additional asthma controller medication.
  3. 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.
  4. 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.
  5. PharmaCare covers a maximum supply of 28 days per fill for this drug.
  6. Mepolizumab should not be used in combination with other biologics used to treat asthma.
  7. Renewal request for coverage must be submitted by respirologists.
  8. Minimal clinically important difference of the Asthma Control Test (ACT) is an increase of ≥3 points.

Special Authority Request Form