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