FASENRA (benralizumab)

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 12 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
• Patient is 12 years of age or older; 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
• Patient 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]); AND
• Will not be used in combination with other biologic medications for severe asthma (e.g., Xolair (omalizumab), Cinqair (reslizumab), Nucala (mepolizumab), Dupixent (dupilumab))

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

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

References:

• Fasenra Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. February 2021. 
• 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. 
• 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. 
• 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. 
• Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2021 update). 2021 www.ginasthma.org. Accessed April 15, 2022. 
• 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. 
• 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.