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Limited coverage criteria – dupilumab for ages 6 years to 11 years

Last updated on March 24, 2025

 

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Generic name

dupilumab

Strength & form

200 mg/1.14 mL prefilled syringe

300 mg/2 mL prefilled syringe

solution for subcutaneous injection

Special Authority criteria

Approval period

Initial

For the add-on maintenance treatment in patients 6 years to 11 years of age with severe eosinophilic asthma AND 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. Baseline asthma questionnaire has been completed (acceptable validated questionnaire is Asthma Control Questionnaire-5 [ACQ-5])
  4. Patient has a blood eosinophil count of ≥ 150 cells/µl
  5. Patient has experienced uncontrolled asthma in the past 12 months, defined as one hospitalization or emergency room visit in the past 12 months OR two or more courses of systemic corticosteroids in the past 12 months
 1 year

First renewal

Renewal of coverage requested by a respirologist or allergist with expertise in treating asthma1 will be considered for patients 6 years to 11 years of age whose:

  • Baseline asthma control questionnaire has improved by the minimal clinically important difference4 at 12 months since initiation of treatment
    AND
  • The number of clinically significant exacerbations has not increased at 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 6 years to 11 years of age 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
 1 year

Practitioner exemptions

  • None

Special notes

  1. Patients should be managed by a respirologist or allergist with expertise in treating asthma in pediatric patients
  2. High-dose inhaled corticosteroids is defined as ≥400 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. Systemic corticosteroids is defined as intravenous steroids or oral corticosteroids for at least 3 days per course of therapy
  5. 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
  6. PharmaCare covers a maximum supply of 28 days per fill for this drug
  7. Dupilumab should not be used in combination with other biologics used to treat asthma

Special Authority request form(s)