WHA

FASENRA (benralizumab) 

Autoinjector:
Self-Administration – subcutaneous injection 

Prefilled syringe:
Office-Administration – subcutaneous injection

Diagnosis considered for coverage: 
  • Indicated for the add-on maintenance treatment of patients with severe asthma aged 6 years and older, and with an eosinophilic phenotype
  • Limitations of use: Not for treatment of other eosinophilic conditions. Not for relief of acute bronchospasm or status asthmaticus
Coverage Criteria:

For diagnosis of severe asthma:

  • Dose does not exceed 30 mg once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter; AND
  • Patient has a documented diagnosis of severe asthma; AND
  • Prescribed by or in consultation with a pulmonologist or allergist/immunologist; AND
  • Asthma is an eosinophilic phenotype as defined by a baseline (pre-treatment) peripheral blood eosinophil level greater than or equal to 150 cells per microliter; AND
  • Patient meets one of the following:
    • Patient has had at least two or more asthma exacerbations requiring systemic corticosteroids (e.g., prednisone) within the past 12 months
    • Prior asthma-related hospitalization within the past 12 months; AND
  • Will not be used in combination with other biologic medications for severe asthma (e.g., Xolair (omalizumab), Cinqair (reslizumab), Nucala (mepolizumab), Dupixent (dupilumab)); AND
  • Patient is 6 years of age or older but less than 12 years of age and has paid claims or is currently being treated with one of the following unless there is a contraindication or intolerance to these medications (A or B):
    • A) Both of the following:
      • Medium-dose inhaled corticosteroid (e.g., greater than 100 – 200 mcg fluticasone propionate equivalent/day) 
      • Additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium]) 
    • B) One medium dosed combination ICS/LABA product (e.g., Advair Diskus [fluticasone propionate 100mcg/ salmeterol 50mcg], Symbicort [budesonide 80mcg/ formoterol 4.5mcg] Breo Ellipta [fluticasone furoate 50 mcg/ vilanterol 25 mcg]) 
  • OR
  • Patient is 12 years of age or older and has paid claims or is currently being treated with one of the following unless there is a contraindication or intolerance to these medications (A or B):
    • A) Both of the following:
      • High-dose inhaled corticosteroid (ICS) (e.g., greater than 500 mcg fluticasone propionate equivalent/day)
      • Additional asthma controller medication (e.g., leukotriene receptor antagonist [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], tiotropium)
    • B) One maximally-dosed combination ICS/LABA product (e.g., Advair [fluticasone propionate/salmeterol], Symbicort [budesonide/formoterol], Breo Ellipta [fluticasone/vilanterol])
Reauthorization Criteria:

For diagnosis of severe asthma:

  • Dose does not exceed 30 mg once every 8 weeks; AND
  • Documentation of positive clinical response to therapy (e.g., reduction in exacerbations, improvement in forced expiratory volume in 1 second [FEV1], decreased use of rescue medications); AND
  • Patient continues to be treated with an inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide) with or without additional asthma controller medication (e.g., leukotriene receptor antagonist [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], tiotropium) unless there is a contraindication or intolerance to these medications; AND
  • Prescribed by or in consultation with a pulmonologist or allergist/immunologist; AND
  • Will not be used in combination with other biologic medications for severe asthma (e.g., Xolair (omalizumab), Cinqair (reslizumab), Nucala (mepolizumab), Dupixent (dupilumab))
Dosing:
  • 30 mg once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter
Coverage Duration: 
  • Initial: 6 months
  • Reauthorization: 1 year
Dosing: 
  • 30 mg once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter
  • Children 6 to <12 years:
    • <35 kg: 10 mg every 4 weeks for the first 3 doses, then once every 8 weeks
    • ≥35 kg: 30 mg every 4 weeks for the first 3 doses, then once every 8 weeks
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • The prefilled syringe is for administration by a healthcare provider
  • Fasenra Pen is intended for administration by patients/caregivers. Patients/caregivers may inject after proper training in subcutaneous injection technique, and after the healthcare provider determines it is appropriate.
Policy Updates:
  • 1/16/2018 – New policy approved by P&T.
  • 6/1/2023 – Criteria updated as a part of a class review for severe asthma medications
  • 9/1/2024 – Update criteria, indication, and dosing to include those 6 years of age and older (P&T 8/20/2024) (P&T Meeting August)
References:
  1. Fasenra Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. April 2024. 
  2. FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128-2141. 
  3. Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting Beta two agonist (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. 
  4. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43:343-373. 
  5. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2023 update). 2023 www.ginasthma.org. Accessed April 2024. 
  6. Nair P, Wenzel S, Rabe KF, et al. ZONDA Trial Investigators. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376(25):2448-2458. 
  7. Institute for Clinical and Economic Review (ICER). Biologic therapies for treatment of asthma associated with type 2 inflammation: effectiveness, value, and value-based price benchmarks. https://icer.org/wp-content/uploads/2020/10/ICER_Asthma-Final-Report_Unredacted_08122020.pdf. Published December 20, 2018. Accessed April 15, 2022.
  8. Wedner HJ, Fujisawa T, Guilbert TW, Ikeda M, Mehta V, Tam JS, Lukka PB, Asimus S, Dur?y?ski T, Johnston J, White WI, Shah M, Werkström V, Jison ML; all TATE investigators. Benralizumab in children with severe eosinophilic asthma: Pharmacokinetics and long-term safety (TATE study). Pediatr Allergy Immunol. 2024 Mar;35(3): e14092.

Last review date: September 1, 2024