Subject: Fasenra 2413-A SGM P2022

Drug

FASENRA  (benralizumab)

Policy:

I.    INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indication
Fasenra is 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

All other indications are considered experimental/investigational and not medically necessary.

II.  DOCUMENTATION 

Submission of the following information is necessary to initiate the prior authorization review:
A.   For initial requests:
      1.   Member’s chart or medical record showing pretreatment blood eosinophil count, dependance on
            systemic corticosteroids if applicable.
      2.   Chart notes, medical record documentation, or claims history supporting previous medications tried
            including drug, dose, frequency, and duration.
B.   For continuation requests: Chart notes or medical record documentation supporting improvement in asthma control.

III. PRESCRIBER SPECIALTIES 

This medication must be prescribed by or in consultation with an allergist/immunologist or pulmonologist.

IV. CRITERIA FOR INITIAL APPROVAL 

Authorization of 6 months may be granted for treatment of asthma when all of the following criteria are met:
A.   Member is 12 years of age or older.
B.   Member meets either of the following criteria:
      1.   Member has a baseline blood eosinophil count of at least 150 cells per microliter; or
      2.   Member is dependent on systemic corticosteroids
C.   Member has uncontrolled asthma as demonstrated by experiencing at least one of the following
      within the past year:
      1.   Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment.
      2.   One or more asthma exacerbation resulting in hospitalization or emergency medical care visit.
      3.   Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking
            due to asthma).
D.   Member has inadequate asthma control despite current treatment with both of the following medications
      at optimized doses:
      1.   High dose inhaled corticosteroid
      2.   Additional controller (i.e., long acting beta₂-agonist, long acting muscarinic antagonist, leukotriene
            modifier, or sustained-release theophylline)
E.   Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional
      controller) in combination with Fasenra.
F.   Member will not use Fasenra concomitantly with other biologics indicated for asthma (e.g., Cinqair,
     Dupixent, Nucala, Tezspire, Xolair).

V.  CONTINUATION OF THERAPY 

Authorization of 12 months may be granted for treatment of asthma when all of the following criteria are met:
A.   Member is 12 years of age or older.
B.   Asthma control has improved on Fasenra treatment as demonstrated by at least one of the following:
      1.   A reduction in the frequency and/or severity of symptoms and exacerbations
      2.   A reduction in the daily maintenance oral corticosteroid dose
C.   Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional
      controller) in combination with Fasenra.
D.   Member will not use Fasenra concomitantly with other biologics indicated for asthma (e.g., Cinqair,
      Dupixent, Nucala, Tezspire, Xolair).

VI. OTHER 

Note: If the member is a current smoker or vaper, they should be counseled on the harmful effects of smoking and vaping on pulmonary conditions and available smoking and vaping cessation options.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Fasenra [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021.
2. Nair P, Wenzel S, Rabe K, et al. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.
3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2021 update. Available at: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. Accessed March 11, 2022.
4. American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Virtual Annual Meeting. Available at: https://annualmeeting.aaaai.org/. Accessed March 14, 2022.
5. Cloutier MM, Dixon AE, Krishnan JA, et al. Managing asthma in adolescents and adults: 2020 asthma guideline update from the National Asthma Education and Prevention Program. 2020;324(22): 2301-2317.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 01, 2022