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XolairMedica

Asthma

Initial criteria

  • Patient is ≥ 6 years of age
  • Patient has a diagnosis of moderate-to-severe persistent asthma
  • Patient has a positive skin test or in vitro reactivity to a perennial aeroallergen
  • Patient has received at least 3 consecutive months of combination therapy with BOTH of the following: (a) an inhaled corticosteroid; AND (b) at least one additional asthma controller or asthma maintenance medication
  • Patient has asthma that is uncontrolled or was uncontrolled at baseline as defined by ONE of the following: (a) two or more asthma exacerbations requiring systemic corticosteroids in the previous year; OR (b) one or more asthma exacerbation(s) 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
  • Medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist

Reauthorization criteria

  • Patient has already received at least 4 months of therapy with Xolair
  • Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler
  • Patient has responded to therapy as determined by the prescriber (e.g., decreased asthma exacerbations, symptoms, hospitalizations, urgent visits, rescue medication use, or improved lung function parameters)

Approval duration

initial 6 months; reauthorization 1 year