More topics

Limited coverage criteria – tezepelumab

Last updated on March 26, 2025

 

Return to Special Authority drug list 

Generic name

tezepelumab

Strength & form

210 mg/1.91 mL, pre-filled syringe
210 mg/1.91 mL, pre-filled pen

Special Authority criteria

Approval period

Initial

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

  • Requested by a respirologist or allergist with expertise in treating asthma1
  • Asthma symptoms inadequately controlled with high-dose inhaled corticosteriods2 AND one or more optimally dosed additional asthma controller(s)3 (e.g., LABAs)
  • Asthma questionnaire has been completed prior to tezepelumab treatment (acceptable validated questionnaire is Asthma Control Questionnaire-5 [ACQ-5])
  • Patient has one of the following:
    • Experienced 2 or more clinically significant asthma exacerbations4 in the past 12 months
      ​OR
    • Currently receiving maintenance treatment with oral corticosteroids for a minimum of 6 months5

Note: Coverage of tezepelumab will not be provided for use in combination with other biologics for the treatment of asthma

1 year

First renewal

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

  • Baseline asthma control questionnaire has improved by the minimal clinically important difference (decrease of  ≥ 0.5 points of the mean score)6 at 12 months since initiation of treatment

AND

Meeting one of the following:

  • 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 corticosteriod dose in 12 months since initiation of treatment

1 year

Second and subsequent renewal

Second and subsequent renewal of coverage must be requested by a respirologist or allergist with expertise in treating asthma1 , and will be considered for patients aged 12 years and older with severe asthma whose:

  • Asthma control questionnaire score achieved after the first 12 months of therapy has been subsequently maintained

AND

Meeting one of the following:

  • Number of clinically significant exacerbations has not increased within the past 12 months
    OR
  • Reduction in maintenance dose of oral corticosteriods at the first 12 months of treatments has been maintained or improved subsequently

1 year

Practitioner exemptions

  • None

Special notes

  • 1For patients aged 12 to 17 years of age, patients should be managed by a respirologist or allergist with expertise in treating asthma in pediatric patients
  •  2High-dose inhaled corticosteroids is defined as ≥ 500 mcg of fluticasone propionate or equivalent daily
  • 3Minimum duration of continuous trial is 6 months of high dose inhaled corticosteroids and 3 months of additional asthma controller medication
  • 4Clinically 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
  • 5An 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
  • 6The 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
  • PharmaCare covers a maximum supply of 28 days per fill for this drug. PharmaCare coverage is limited to 210 mg of tezepelumab every four weeks

Special Authority request form(s)