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    Tezspire™

    Drug - Tezspire™ (tezepelumab-ekko) [Amgen Inc.]

    October 2022

    Therapeutic area - Immunomodulators, Asthma

    Initial approval criteria

    • Patient must be at least 12 years of age AND
    • Patient must have a diagnosis of severe asthma AND
    • Evidence of severe disease indicated by ≥ 1 of the following:
      • Symptoms throughout the day OR
      • Nighttime awakenings, often 7x/week OR
      • SABA use for symptom control occurs several times per day OR
      • Extremely limited normal activities OR
      • Lung function (percent predicted FEV1) < 60% OR
      • Exacerbations requiring oral systemic corticosteroids are generally more frequent and intense relative to moderate asthma AND
    • Must be used for add-on maintenance treatment in patients regularly receiving BOTH of the following: 
      • Medium- to high-dose inhaled corticosteroids AND
      • An additional controller medication (e.g., long-acting beta agonist, leukotriene modifiers) AND
    • Patient must have had, in the previous year, ≥ 2 exacerbations requiring oral or injectable corticosteroid treatment (in addition to the regular maintenance therapy defined above) OR one exacerbation resulting in a hospitalization AND
    • Baseline measurement of ≥ 1 of the following for assessment of clinical status:
      • Use of systemic corticosteroids OR
      • Use of inhaled corticosteroids OR
      • Number of hospitalizations, ER visits, or unscheduled visits to healthcare provider due to condition OR
      • FEV1 AND
    • Will NOT be used for the relief of acute bronchospasm or status asthmaticus AND
    • Must not be used in combination with anti-IgE, anti-IL4, or anti-IL5 monoclonal antibody agents (e.g., benralizumab, omalizumab, mepolizumab, reslizumab, dupilumab) AND
    • Patient must not have hypersensitivity to tezepelumab-ekko or any of its excipients AND
    • Patient does not have an active or untreated helminth infection AND
    • Must not be administered concurrently with live vaccines
    • Initial approval is for 6 months

    Renewal criteria

    • Patient must continue to meet the above criteria AND
    • Improvement in asthma symptoms, asthma exacerbations, or airway function as evidenced by decrease in ≥ 1 of the following:
      • Use of systemic corticosteroids OR
      • Two-fold or greater decrease in inhaled corticosteroid use for at least 3 days OR
      • Hospitalizations OR
      • ER visits OR
      • Unscheduled visits to healthcare provider OR
      • Improvement from baseline in FEV1 AND
    • Patient has not experienced any treatment-restricting adverse effects (e.g., parasitic [helminth] infection, severe hypersensitivity reactions)
    • Renewal approval is for 6 months

    Quantity limits

    • 1 prefilled syringe (210 mg/1.91 mL) per 28 days

    Billing for Tezspire

    • Tezspire must be billed as a medical claim

    Questions?

    MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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