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Fasenra (benralizumab) — United Healthcare

Severe asthma

Initial criteria

  • EITHER of the following:
  • 1) ALL of the following:
  • - Patient has been established on therapy with Fasenra under an active UnitedHealthcare medical benefit prior authorization for the treatment of severe asthma
  • - Documentation of positive clinical response to Fasenra therapy as demonstrated by AT LEAST ONE of the following: reduction in frequency of exacerbations; decreased utilization of rescue medications; increase in percent predicted FEV1 from pretreatment baseline; reduction in severity or frequency of asthma-related symptoms; reduction in oral corticosteroid requirements
  • - Fasenra is being used in combination with an inhaled corticosteroid (ICS)-containing maintenance medication [e.g., Advair/AirDuo (fluticasone/salmeterol), Breo Ellipta (fluticasone furoate/vilanterol), Symbicort (budesonide/formoterol), Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol)]
  • - Patient is NOT receiving Fasenra in combination with ANY of the following for the same indication: Anti-interleukin 5 therapy [e.g., Cinqair (reslizumab), Nucala (mepolizumab)]; Anti-IgE therapy [e.g., Xolair (omalizumab)]; Anti-interleukin 4 therapy [e.g., Dupixent (dupilumab)]; Thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)]
  • - Prescribed by an Allergist OR Immunologist OR Pulmonologist
  • 2) ALL of the following:
  • - Diagnosis of severe asthma
  • - Classification of asthma as uncontrolled or inadequately controlled as shown by AT LEAST ONE of: poor symptom control (ACQ > 1.5 or ACT < 20); two or more bursts of systemic corticosteroids for ≥3 days each in the previous 12 months; asthma-related emergency treatment; airflow limitation (post-bronchodilator FEV1 < 80% predicted and reduced FEV1/FVC ratio); or current dependence on oral corticosteroids for asthma
  • - Medical records confirming eosinophilic phenotype with baseline blood eosinophil level ≥ 150 cells/μL
  • - Fasenra will be used in combination with ONE of the following: (i) one maximally dosed combination ICS/LABA [e.g., Advair/AirDuo Respiclick, Symbicort, Breo Ellipta], OR (ii) combination therapy including one maximally dosed ICS [e.g., Alvesco, Asmanex, QVAR] AND one additional controller medication [e.g., LABA (Striverdi, Arcapta); leukotriene receptor antagonist (Singulair); theophylline]
  • - Patient is NOT receiving Fasenra in combination with Anti-IL5, Anti-IgE, Anti-IL4, or TSLP inhibitor therapies as above
  • - Prescribed by an Allergist OR Immunologist OR Pulmonologist

Reauthorization criteria

  • ALL of the following:
  • - Documentation of positive clinical response to Fasenra therapy as demonstrated by AT LEAST ONE of: reduction in frequency of exacerbations; decreased use of rescue medication; increase in FEV1 from baseline; reduction in asthma-related symptoms; reduction in oral corticosteroid requirements
  • - Fasenra used in combination with an ICS-containing maintenance medication [e.g., Advair/AirDuo, Breo Ellipta, Symbicort, Trelegy Ellipta]
  • - Patient is NOT receiving Fasenra in combination with ANY of: Anti-interleukin 5 therapy [e.g., Cinqair, Nucala]; Anti-IgE therapy [e.g., Xolair]; Anti-interleukin 4 therapy [e.g., Dupixent]; TSLP inhibitor [e.g., Tezspire]

Approval duration

12 months