Medical Drug Criteria (MDC)

Policy Num:       P1.002.002
Policy Name:     Fasenra® (benralizumab)
Policy ID:          [P1.002.002]  [Ac / Mg / M+ / P+]  [0.00.00]

Last Review:       December 17, 2024
Next Review:      December 20, 2025
 

Related MDC: NONE

Fasenra® (benralizumab)

Summary

Benralizumab is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) for the add-on maintenance treatment of severe asthma in patients age 12 years and older with an eosinophilic phenotype.

POLICY STATEMENT

Coverage is provided in the following conditions:

Universal Criteria  

 Must not be used in combination with another anti-IgE, anti-IL4, or anti-IL5 monoclonal antibody (e.g., omalizumab, mepolizumab, reslizumab, dupilumab, etc.); AND

 Must NOT be used for either of the following:

o Treatment of other eosinophilic conditions (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome, etc.)

o Relief of acute bronchospasm or status asthmaticus; AND

POLICY GUIDELINES

Coverage eligibility for benralizumab (Fansera) will be considered when the following criteria are met:

Coverage is provided for six months and is eligible for renewal.

Must not be used in combination with another anti-IgE, anti-IL4, or anti-IL5 monoclonal antibody (e.g., omalizumab, mepolizumab, reslizumab, dupilumab, etc.); AND

 Must NOT be used for either of the following:

o Treatment of other eosinophilic conditions (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome, etc.)

o Relief of acute bronchospasm or status asthmaticus; AND

Severe Asthma 

• add-on maintenance treatment of adult and pediatric patients aged 6 years and older with
severe asthma, and with an eosinophilic phenotype.

• treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 

Limitations of Use:

Not for relief of acute bronchospasm or status asthmaticus

 Patient is at least 12 years of age; AND

 Patient must have severe* disease; AND

 Patient must have asthma with an eosinophilic phenotype defined as blood eosinophils ≥150 cells/µL within 6 weeks of dosing OR the patient is dependent on systemic corticosteroids AND

 Must be used for add-on maintenance treatment in patients regularly receiving BOTH of the following:

o Medium to high-dose inhaled corticosteroids; AND

o An additional controller medication (e.g., long-acting beta agonist, 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

DOSAGE/ADMINISTRATION

Severe Asthma with eosinophilic phenotype

30 mg administered subcutaneously every 4 weeks for the first three doses and then once every 8 weeks thereafter .

Asthma Adult and Adolescent Patients 12 Years of Age and Older:

• Recommended dosage is 30 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter.

Pediatric Patients 6 Years to 11 Years of Age:

Weighing Less Than 35 kg: the recommended dosage is 10 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter.

Weighing 35 kg or More: the recommended dosage is 30 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter.

EGPA Recommended dosage is 30 mg every 4 weeks.

REQUIRED MEDICAL INFORMATION

Baseline measurement of at least one of the following for assessment of clinical status:

o Use of systemic corticosteroids

o Use of inhaled corticosteroids

o Number of hospitalizations, ER visits, or unscheduled visits to healthcare provider due to condition

o Forced expiratory volume in 1 second (FEV1)

EXCLUSION CRITERIA

None

BENEFIT APPLICATION

As stated in the policy.

OTHER CRITERIA

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan

References

1. Fasenra [package insert]. Wilmington, DE; AstraZeneca Pharmaceuticals; February 2021. Accessed June 2021.

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

Codes

Applicable Modifiers

Some modifiers.

Policy History