Subject: Fasenra 2413-A SGM P2023
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 notes 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
A. Authorization of 6 months may be granted for members 12
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 12 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 12 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.
Place of Service:
Outpatient
The above policy is based on the following references:
- Fasenra [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021.
- 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.
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2022 update. Available at: https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf. Accessed March 1, 2023.
- American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Virtual Annual Meeting. Available at: https://annualmeeting.aaaai.org/. Accessed March 1, 2023.
- 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.
September 27, 2023
