Tezspire

Tezepelumab

• Brand(s): Tezspire
• Dosage Form/Strength: 210 mg/1.91 mL PFS and prefilled pen
• Effective date: November 27, 2023

Initiation Criteria:

For the treatment of severe asthma in patients meeting the following criteria;

1. Patient is 12 years of age or older;
   AND
2. Tezepelumab is being used as an add-on maintenance therapy;
   AND
3. Patient’s asthma is inadequately controlled with high-dose inhaled corticosteroids (ICSs), defined as greater than or the same as 500 mcg of fluticasone propionate or equivalent daily, and one or more additional asthma controller(s) (e.g., long acting beta agonists (LABAs)) (Notes 1 and 2);
   AND
4. Experienced 2 or more clinically significant asthma exacerbations in the 12 months prior to the start of tezepelumab (Note 3);
   (The approximate dates/timelines and a brief description of at least two asthma exacerbations and how they were managed (e.g. urgent care visit, hospitalization, corticosteroids, drug therapy changes etc) must be included with the request application).
   AND
5. Tezepelumab is not being used in combination with other biologics used to treat asthma.
6. Request is submitted by a specialist in respirology, or allergy/clinical immunology, or by a physician with expertise in the treatment of asthma, unless the request confirms that the patient does not have access to such specialists, in which case the request may be submitted by an authorized prescriber.

Notes:

1. A baseline assessment of asthma symptom control using a validated asthma control questionnaire (i.e., ACQ or ACT) before initiation of tezepelumab treatment must be completed and submitted with the initial application. The effects of treatment should be assessed every 12 months using the same asthma control questionnaire that was used as baseline to evaluate response to treatment with Tezepelumab when requesting renewal of funding.
2. The names, doses, and approximate timelines and durations of use of all drugs used for the treatment of the patient’s asthma must be included in the application. This includes information regarding the maintenance of interim use of oral corticosteroids to manage the patient’s asthma.
3. A clinically significant asthma exacerbation is defined as a worsening of asthma that required one of the following:
   i) Required treatment with a burst of systemic corticosteroid (SCS) therapy for at least 3 days or a single depot-injectable corticosteroid dose
   ii) Resulted in an Urgent care or Emergency department visit which required treatment with systemic corticosteroid therapy
   iii) Resulted in inpatient hospitalization due to asthma
   iv) For patients on a stable maintenance dose of oral corticosteroid, the exacerbation resulted in a temporary increase in dose of the corticosteroid for at least 3 days.

Patients with one severe asthma exacerbation resulting in hospitalization within the 12 months before initiation of tezepelumab may be considered on a case-by-case basis.

Renewal Criteria:

Renewals will be considered on a case-by-case basis for patients who do not meet any of the following discontinuation/stopping criteria:

1. Patient’s 12-month follow-up asthma control questionnaire score using the same validated asthma control questionnaire completed at baseline does not show improvement, such as a decrease of less than 0.5 points on the ACQ or an increase of less than 3 points on the ACT;
2. The asthma control questionnaire score achieved after the first 12 months of therapy has not been maintained subsequently.
3. The number of clinically significant asthma exacerbations has increased within the previous 12 months.
4. In patients on maintenance treatment with oral corticosteroids (OCSs), there has been no decrease in the OCS dose in the first 12 months of treatment with tezepelumab
5. In patients on maintenance treatment with OCSs, the reduction in the dose of OCS is not maintained or improved after the first 12 months of tezepelumab treatment.

Approval duration of initial and renewals: 1 year

Recommended dose: 210 mg subcutaneous injection every 4 weeks