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 (when criteria 1–4 are met):

  1. When requested by a respirologist.
    AND
  2. The patient’s symptoms are inadequately controlled with high-dose inhaled corticosteroids and 1 or more optimally dosed additional asthma controllers1 (e.g. LABA).
    AND
  3. The patient currently has a blood eosinophil count of ≥150 cells/μL OR has had ≥300 cells/μL in the past 12 months.
    AND
  4. The patient has experienced 2 or more clinically significant asthma exacerbations2 in the past 12 months and shows reversibility (at least 12% and 200 mL) on pulmonary function tests (i.e., spirometry).
    OR
    The patient is currently treated with daily oral corticosteroids.3

1 year

RENEWAL

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

  • Who experience a decrease in the number of clinically significant exacerbations2 over the past 12 months compared to baseline.
    OR
  • Whose dose of oral corticosteroids has reduced by at least 25% from baseline.
1 year

Practitioner Exemptions

  • None

Special Notes

  1. Minimum duration of continuous trial is 6 months of high dose inhaled corticosteroids and 3 months of additional asthma controller medication.
  2. 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.
  3. An adequate trial of daily oral corticosteroids is defined as ≥5 mg of prednisone or its equivalent per day for a minimum of 6 months.
  4. PharmaCare covers a maximum supply of 28 days per fill for this drug.

Special Authority Request Form