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