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Tezspire (tezepelumab-ekko)Medical Mutual

Severe asthma

Initial criteria

  • Patient is age ≥ 12 years; AND
  • Will not be used in combination with other anti-IgE, anti-IL4, or anti-IL5 monoclonal antibody agents (e.g., benralizumab, omalizumab, mepolizumab, reslizumab, dupilumab, etc.); AND
  • Will not be administered concurrently with live vaccines; AND
  • Will NOT be used for the relief of acute bronchospasm or status asthmaticus; AND
  • Patient has severe disease; AND
  • Will 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, long-acting muscarinic agent, leukotriene modifiers, etc.); AND
  • Patient must have had two or more exacerbations in the previous year requiring oral or injectable corticosteroid treatment OR one exacerbation resulting in a hospitalization; AND
  • Baseline measurement of at least one 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 forced expiratory volume in 1 second (FEV1)

Reauthorization criteria

  • Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug (examples include parasitic [helminth] infection, severe hypersensitivity reactions such as rash and allergic conjunctivitis); AND
  • Improvement in asthma symptoms or exacerbations as evidenced by decrease in one or more of: use of systemic corticosteroids, two-fold or greater decrease in inhaled corticosteroid use for at least 3 days, hospitalizations, ER visits, or unscheduled visits to healthcare provider; OR
  • Improvement from baseline in forced expiratory volume in 1 second (FEV1)

Approval duration

6 months initial, 12 months renewal