Last Review Date: 10/03/2024

Date of Origin: 12/12/2017

Dates Reviewed: 12/2017, 03/2018, 06/2018, 10/2018, 11/2019, 01/2020, 10/2020, 03/2021, 08/2021, 10/2022, 10/2023, 05/2024, 10/2024

1. Length of Authorization

Initial coverage will be provided for 6 months and may be renewed annually thereafter.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Fasenra 10 mg single-dose prefilled syringe
  • Load: 1 syringe every 28 days for 3 doses
  • Maintenance: 1 syringe every 56 days
• Fasenra 30 mg single-dose prefilled syringe
  • 1 syringe every 28 days
• Fasenra Pen 30 mg single-dose autoinjector
  • 1 autoinjector every 28

B. Max Units (per dose and over time) [HCPCS Unit]:

• Severe Asthma
  • Load: 30 billable units every 28 days for 3 doses
  • Maintenance: 30 billable units every 56 days
• Eosinophilic Granulomatosis with Polyangiitis (EGPA)
  • 30 billable units every 28 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

Universal Criteria ¹

• Will not be used in combination with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (e.g., omalizumab, mepolizumab, reslizumab, dupilumab, tezepelumab, etc.); AND

• Will NOT be used for either of the following:
  • Treatment of other eosinophilic conditions (e.g., allergic bronchopulmonary aspergillosis/mycosis, hypereosinophilic syndrome, etc.)
  • Relief of acute bronchospasm or status asthmaticus; AND

Severe Asthma † ^{1,2,5,7-9,11,12,16}

• Patient is at least 6 years of age; AND
• Patient has severe* disease; AND
• Patient has asthma with an eosinophilic phenotype indicated by blood eosinophils ≥150 cells/µL; AND
• Used for add-on maintenance treatment in patients regularly receiving BOTH of the following:
  • Medium to high-dose inhaled corticosteroids; AND
  • An additional controller medication (e.g., long-acting beta agonist, long-acting muscarinic agent, leukotriene modifiers, etc.); AND
• Patient must have two or more exacerbations in the previous year requiring daily oral corticosteroids for at least 3 days (in addition to the regular maintenance therapy defined above); AND
• Baseline measurement of at least one of the following for assessment of clinical status:
  • Use of systemic corticosteroids
  • Use of inhaled corticosteroids
  • Number of hospitalizations, ER visits, or unscheduled visits to healthcare provider due to condition
  • Forced expiratory volume in 1 second (FEV₁)

Eosinophilic Granulomatosis with Polyangiitis (EGPA)/Churg-Strauss Syndrome † ^1,17

• Patient is at least 18 years of age; AND
• Patient has a confirmed diagnosis of EGPA§ (aka Churg-Strauss Syndrome); AND
• Patient has relapsing or refractory disease; AND
• Patient has received prior treatment with oral corticosteroids with or without immunosuppressive therapy; AND
• Patient has been on a stable dose of oral corticosteroid therapy for at least 4 weeks prior to starting treatment; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool (e.g., Birmingham Vasculitis Activity Score [BVAS], history of asthma symptoms and/or exacerbations, duration of remission, or rate of relapses, etc.)

† FDA Approved indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,7,8

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: parasitic (helminth) infection, severe hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash), etc.; AND

Severe Asthma

• Improvement in asthma symptoms or asthma exacerbations as evidenced by a decrease in one or more of the following:
  • Use of systemic corticosteroids
  • Two-fold or greater decrease in inhaled corticosteroid use for at least 3 days
  • Hospitalizations
  • ER visits
  • Unscheduled visits to healthcare provider; OR
• Improvement from baseline in forced expiratory volume in 1 second (FEV₁)

Eosinophilic Granulomatosis with Polyangiitis (EGPA)/Churg-Strauss Syndrome

• Disease response as indicated by improvement in signs and symptoms compared to baseline as evidenced by one or more of the following:
  • Patient is in remission [defined as Birmingham Vasculitis Activity Score (BVAS)=0 (no active vasculitis) plus prednisolone/prednisone dose ≤7.5 mg/day or equivalent]
  • Decreased frequency in the occurrence of relapses
  • Decrease in the daily oral corticosteroid dose
  • Improvement on a disease activity scoring tool [e.g., Vasculitis Damage Index (VDI), Birmingham Vasculitis Activity Score (BVAS), Forced vital capacity (FVC), Forced Expiratory Volume during first second (FEV1), Asthma Control Questionnaire (6-item version) (ACQ-6), etc.]

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J0517 - Injection, benralizumab, 1 mg; 1 billable unit = 1 mg

NDC(s):

• Fasenra 10 mg/0.5 mL single-dose prefilled syringe: 00310-1745-xx
• Fasenra 30 mg/mL single-dose prefilled syringe: 00310-1730-xx
• Fasenra 30 mg/mL single-dose autoinjector FASENRA PEN: 00310-1830-xx

7. References

1. Fasenra [package insert]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; September 2024. Accessed September 2024.
2. National Asthma Education and Prevention Program (NAEPP). Guidelines for the diagnosis and management of asthma. Expert Panel Report 3. Bethesda, MD: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI); August 2007.
3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2019 Update. Available from: http://www.ginasthma.org. Accessed September 2020.
4. Walford HH, Doherty TA. Diagnosis and management of eosinophilic asthma: a US perspective. J Asthma Allergy. 2014; 7: 53–65.
5. Goldman M, Hirsch I, Zangrilli JG, et al. The association between blood eosinophil count and benralizumab efficacy for patients with severe, uncontrolled asthma: subanalyses of the Phase III SIROCCO and CALIMA studies. Curr Med Res Opin. 2017 Sep;33(9):1605-1613. Doi: 10.1080/03007995.2017.1347091. Epub 2017 Jul 19.
6. The Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, 2017. Available from: www.ginasthma.org.
7. 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.
8. Holguin F, Cardet JC, Chung KF, et al. Management of severe asthma: a European

Respiratory Society/American Thoracic Society guideline. Eur Respir J 2020; 55: 1900588 [https://doi.org/10.1183/13993003.00588-2019].

9. National Asthma Education and Prevention Program (NAEPP). 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. Bethesda, MD: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI); December 2020.
10. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2021 Update. Available from: http://www.ginasthma.org. Accessed June 2021.
11. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2022 Update. Available from: http://www.ginasthma.org. Accessed September 2023.
12. Global Initiative for Asthma (GINA) Report: Global Strategy for Asthma Management and Prevention. 2023 Update. Available from: http://www.ginasthma.org/2023-gina-main-report. Accessed September 2023.
13. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5. PMID: 27609408.
14. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomized, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128-2141. Doi: 10.1016/S0140-6736(16)31322-8. Epub 2016 Sep 5. PMID: 27609406.
15. 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 Jun 22;376(25):2448-2458. doi: 10.1056/NEJMoa1703501. Epub 2017 May 22. PMID: 28530840.
16. Global Initiative for Asthma (GINA) Report: Global Strategy for Asthma Management and Prevention. 2024 Update. Available from: http://www.ginasthma.org. Accessed August 2024.
17. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2024 Mar 7;390(10):911-921. doi: 10.1056/NEJMoa2311155. Epub 2024 Feb 23. PMID: 38393328.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A