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Limited coverage drugs – dupilumab for ages 12 and up

Last updated on October 17, 2023

Generic name

dupilumab

Strength

200 mg/1.14 mL prefilled syringe or prefilled pen

300 mg/2 mL prefilled syringe or prefilled pen

Form

solution for subcutaneous injection

Special Authority criteria

Approval period

INITIAL

For the add-on maintenance treatment of patients aged 12 years and up with severe eosinophilic asthma meeting ALL the following criteria:

  1. Requested by a respirologist or allergist with expertise in treating asthma1
  2. Patient’s symptoms are inadequately controlled with high-dose inhaled corticosteroids2 and one or more optimally dosed additional asthma controllers3 (e.g., LABA)
  3. Asthma questionnaire has been completed (acceptable validated questionnaire is Asthma Control Questionnaire-5 [ACQ-5])
  4. 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 exacerbations4 in the past 12 months
      OR
    • blood eosinophil count of ≥ 150 cells/µl and is currently receiving maintenance treatment with oral corticosteroids5
 1 year

FIRST RENEWAL

Renewal of coverage requested by a respirologist or allergist with expertise in treating asthma1 will be considered for patients aged 12 years and up whose:

  • baseline asthma control questionnaire 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 RENEWAL

Renewal of coverage requested by a respirologist or allergist with expertise in treating asthma1 will be considered for patients aged 12 years and up 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. For patients aged 12 to 17 years of age, patients should be managed by a physician with expertise in treating asthma in pediatric patients.
  2. High-dose inhaled corticosteroids is defined as ≥500 mcg of fluticasone propionate or equivalent daily.
  3. Minimum duration of continuous trial is 6 months of high dose inhaled corticosteroids and 3 months of additional asthma controller medication.
  4. 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.
  5. 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.
  6. 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. 
  7. PharmaCare covers a maximum supply of 28 days per fill for this drug.
  8. Dupilumab should not be used in combination with other biologics used to treat asthma.

Special Authority request form(s)