Benralizumab (Fasenra®)
IMPORTANT REMINDER
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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 aged 6 years and older with severe asthma, 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 notes or medical record showing pretreatment blood eosinophil count, or 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
A. Authorization of 6 months may be granted for members 6 years of age or older who have previously received a biologic drug (e.g., Dupixent, Nucala) indicated for asthma.
B. Authorization of 6 months may be granted for treatment of severe asthma when all of the following criteria are met:
1. Member is 6 years of age or older.
2. Member meets either of the following criteria:
i. Member has a baseline blood eosinophil count of at least 150 cells per microliter
ii. Member is dependent on systemic corticosteroids
3. Member has uncontrolled asthma as demonstrated by experiencing at least one of the following within the past year:
i. Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment.
ii. One or more asthma exacerbation resulting in hospitalization or emergency medical care visit.
iii. Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma).
4. Member has inadequate asthma control despite current treatment with both of the following medications at optimized doses:
i. High dose inhaled corticosteroid
ii. Additional controller (i.e., long acting beta2-agonist, long acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline)
5. Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional controller) in combination with the requested medication.
V. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for treatment of severe asthma when all of the following criteria are met:
A. Member is 6 years of age or older.
B. Asthma control has improved on the requested medication 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 the requested medication.
VI. OTHER
Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
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.
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Fasenra (Benralizumab) |
Asthma |
Route of Administration: Subcutaneous ≥12 Years Initial: 30mg every 4 weeks for 3 doses Maintenance: 30mg every 8 weeks |
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
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.
ADDITIONAL INFORMATION
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).
REFERENCES
1. Fasenra [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; April 2024.
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. 2023 update. Available at: https://ginasthma.org/wp-content/uploads/2023/07/GINA-Full-Report-23_07_06-WMS.pdf. Accessed March 8, 2024.
4. American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Virtual Annual Meeting. Available at: https://annualmeeting.aaaai.org/. Accessed March 8, 2024.
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. JAMA. 2020;324(22): 2301-2317.
ORIGINAL EFFECTIVE DATE: 1/18/2018
MOST RECENT REVIEW DATE: 10/1/2024
ID_CHS
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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