Tezspire (tezepelumab-ekko) — Medica
Asthma
Initial criteria
- Patient is age ≥ 12 years; AND
 - Patient has received at least 3 consecutive months of combination therapy with BOTH of the following (a and b): a) an inhaled corticosteroid; AND b) at least one additional asthma controller or maintenance medication (e.g., inhaled long-acting beta-agonist, inhaled long-acting muscarinic antagonist, or monoclonal antibody therapy for asthma); AND
 - Patient has asthma that is uncontrolled or was uncontrolled at baseline as defined by ONE of the following (a–e): a) two or more asthma exacerbations requiring systemic corticosteroids in the previous year; OR b) one or more asthma exacerbations requiring hospitalization, emergency department, or urgent care visit in the previous year; OR c) forced expiratory volume in 1 second (FEV₁) < 80% predicted; OR d) FEV₁/forced vital capacity (FVC) < 0.80; OR e) asthma worsens upon tapering of oral corticosteroid therapy; AND
 - Medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist
 
Reauthorization criteria
- Patient has already received at least 6 months of therapy with Tezspire; AND
 - Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler; AND
 - Patient has responded to therapy as determined by the prescriber (e.g., decreased exacerbations or symptoms, improved lung function, or decreased need for oral corticosteroids)
 
Approval duration
initial: 6 months; reauthorization: 12 months