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Limited Coverage Drugs – tezepelumab

Last updated on September 27, 2024

Generic name

tezepelumab

Strength and 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 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

  1. For 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
  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. The 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. PharmaCare coverage is limited to 210 mg of tezepelumab every four weeks

Special Authority requests