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DrugTezspire™ (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


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

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