Subject: Fasenra 2413-A SGM P2024a
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:
A. Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with
severe asthma, and with an eosinophilic phenotype
Limitations of Use:
Not indicated for the relief of acute bronchospasm or status asthmaticus
B. Treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA)
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. Asthma:
1. For initial requests:
i. Chart notes or medical record documentation showing baseline blood eosinophil
count, or dependence on systemic corticosteroids, if applicable.
ii. Chart notes, medical record documentation, or claims history supporting previous
medications tried including drug, dose, frequency and duration.
2. For continuation requests: Chart notes or medical record documentation supporting
improvement in asthma control.
B. EGPA
1. For initial requests:
i. Chart notes or medical record documentation showing pretreatment blood eosinophil
count.
ii. Chart notes, medical record documentation, or claims history supporting previous
medications tried including drug, dose, frequency and duration. If therapy is not
advisable, documentation of clinical reason to avoid therapy.
2. For continuation requests: Chart notes or medical record documentation supporting
improvement in EGPA control.
III. PRESCRIBER SPECIALTIES
For the indication of asthma: This medication must be prescribed by or in consultation with an
allergist/immunologist or pulmonologist.
IV. CRITERIA FOR INITIAL APPROVAL
A. Asthma
1. 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 in the
past year.
2. Authorization of 6 months may be granted for treatment of severe asthma when all of the
following criteria are met:
i. Member is 6 years of age or older.
ii. Member meets either of the following criteria:
a. Member has a baseline blood eosinophil count of at least 150 cells per microliter.
b. Member is dependent on systemic corticosteroids.
iii. Member has uncontrolled asthma as demonstrated by experiencing at least one of
the following within the past year:
a. Two or more asthma exacerbations requiring oral or injectable corticosteroid
treatment
b. One or more asthma exacerbation(s) resulting in hospitalization or emergency
medical care visit(s)
c. Poor symptom control (frequent symptoms or reliever use, activity limited by
asthma, night waking due to asthma)
iv. Member has inadequate asthma control despite current treatment with both of the
following medications at optimized doses:
a. High-dose inhaled corticosteroid
b. Additional controller (i.e., long-acting beta2-agonist, long-acting muscarinic
antagonist, leukotriene modifier, or sustained-release theophylline)
v. Member will continue to use maintenance asthma treatments (e.g., inhaled
corticosteroid, additional controller) in combination with the requested medication.
B. Eosinophilic granulomatosis with polyangiitis (EGPA)
Authorization of 12 months may be granted for treatment of EGPA when all of the following
criteria are met:
1. Member is 18 years of age or older.
2. Member has a history or the presence of a blood eosinophil count of more than 1000
cells per microliter or a blood eosinophil level of greater than 10%.
3. Member is currently taking oral corticosteroids, unless contraindicated or not tolerated.
4. Member has at least two of the following disease characteristics of EGPA:
i. Biopsy showing histopathological evidence of eosinophilic vasculitis, perivascular
eosinophilic infiltration, or eosinophil-rich granulomatous inflammation
ii. Neuropathy, mono or poly (motor deficit or nerve conduction abnormality)
iii. Pulmonary infiltrates, non-fixed
iv. Sino-nasal abnormality
v. Cardiomyopathy (established by echocardiography or magnetic resonance imaging)
vi. Glomerulonephritis (hematuria, red cell casts, proteinuria)
vii. Alveolar hemorrhage (by bronchoalveolar lavage)
viii. Palpable purpura
ix. Anti-neutrophil cytoplasmic anti-body (ANCA) positive (Myeloperoxidase or
proteinase 3)
5. Member has had at least one relapse (i.e., requiring increase in oral corticosteroid dose,
initiation/increased dose of immunosuppressive therapy or hospitalization) within 2 years
prior to starting treatment with the requested medication or has a refractory disease.
V. CONTINUATION OF THERAPY
A. Asthma
Authorization of 12 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. Asthma control has improved on the requested medication as demonstrated by at least
one of the following:
i. A reduction in the frequency and/or severity of symptoms and exacerbations
ii. A reduction in the daily maintenance oral corticosteroid dose
3. Member will continue to use maintenance asthma treatments (e.g., inhaled
corticosteroid, additional controller) in combination with the requested medication.
B. Eosinophilic granulomatosis with polyangiitis (EGPA)
Authorization of 12 months may be granted for continuation of treatment of EGPA when all
of the following criteria are met:
1. Member is 18 years of age or older.
2. Member has a beneficial response to treatment with the requested medication as
demonstrated by any of the following:
i. A reduction in the frequency of relapses
ii. A reduction or discontinuation of daily oral corticosteroid dose
iii. No active vasculitis
V. OTHER
For all indications: 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; September 2024.
- 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. 2023 update. Available at: https://ginasthma.org/wp-content/uploads/2023/07/GINA-Full-Report-23_07_06-WMS.pdf. Accessed March 8, 2024.
- American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Virtual Annual Meeting. Available at: https://annualmeeting.aaaai.org/. Accessed March 8, 2024.
- 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.
- Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab. (MANDARA) Available from https://clinicaltrials.gov/ct2/show/record/NCT04157348. NLM identifier: NCT04157348. Accessed September 20, 2024.
- Groh M, Pagnoux C, Baldini C, et al. Eosinophilic granulomatosis with polyangiitis (Churg–Strauss) (EGPA) Consensus Task Force Recommendations for evaluation and management. Eur J Intern Med. 2015;26(7):545-553.
- Chung SA, Langford CA, Maz M, et al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Rheumato 2021;73(8):1366-1383.
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.
November 04, 2024
