00310-1730-XX Fasenra 30 MG/ML SOSY (ASTRAZENECA)
Benralizumab is a humanized alpha-directed cytolytic monoclonal antibody (IgG1, kappa) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα). The IL-5 receptor is expressed on the surface of eosinophils and basophils.
By binding to the IL-5Rα chain, benralizumab reduces eosinophils through antibody-dependent cell-mediated cytotoxicity (ADCC). A reduction in blood eosinophil counts was observed 24 hours post dosing; however the actual mechanism of benralizumab action in asthma has not been definitively established.
Benralizumab is considered medically necessary for the treatment of asthma if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Benralizumab for the treatment of other conditions/diseases is considered investigational including but not limited to the following:
Treatment of other eosinophilic conditions
Relief of acute bronchospasm or status
Benralizumab is considered medically appropriate if ALL of the following criteria are met:
Individual is 12 years of age or older
Individual is NOT used in combination with another monoclonal antibody (e.g., omalizumab mepolizumab, reslizumab, etc.)
Diagnosis of asthma if ALL of the following criteria are met:
Treatment is add-on maintenance
Individual has severe disease (see chart below)
Eosinophilic phenotype indicated by blood eosinophils ≥ 150 cells/μL within 6 weeks of dosing
Used for add-on maintenance treatment in an individual regularly receiving BOTH of the following:
Medium- to high-dose inhaled corticosteroids
An additional controller medication (e.g., long acting beta-2 agonist, leukotriene receptor antagonist, etc.)
Individual had ANY ONE of the following:
Two or more asthma exacerbation over the past 12 months
Required daily oral corticosteroids for a minimum of 3 days in addition to the regular maintenance therapy defined above
Administration is by subcutaneous injection by a healthcare professional
|Components of Disease Severity as classified by components of ANY of the following (not all inclusive):|
|Symptoms throughout the day|
|Nighttime awakenings often 7x/week|
|SABA use for symptom control occurs several times per day|
|Extremely limited normal activities|
|Lung function (percent predicted FEV1) < 60%|
|Exacerbations requiring oral systemic corticosteroids are generally more frequent and intense relative to moderate asthma|
Benralizumab is considered medically appropriate for renewal ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the drug such as malignancy, parasitic (helminth) infection, hypersensitivity reactions including anaphylaxis, etc.
Treatment has resulted in clinical benefit, including, but not limited to:
Improvement in asthma symptoms or asthma exacerbations as evidenced by 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
Unscheduled visits to healthcare provider
Improvement from baseline in forced expiratory volume in 1 second (FEV1)
DOSAGE & ADMINISTRATION
Severe asthma with eosinophilic phenotype
30 mg administered subcutaneously, by a healthcare professional, every 4 weeks for the first 3 doses, followed by once every 8 weeks thereafter
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months and may be renewed
Refer to DOSAGE LIMITS below
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Lexi-Comp Online. (2018). AHFS Dl. Benralizumab. Retrieved August 29, 2018 from Lexi Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, November). Laronidase. Retrieved August 29, 2018 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2017, November). Center for Drug Evaluation and Research. Fasenra® (benralizumab) injection, for intravenous use. Retrieved August 29, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 1/18/2018
MOST RECENT REVIEW DATE: 10/9/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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Maximum billable units per dose and over time by indication as a Medical Benefit