CurrentBlue Cross Blue Shield - IowaPolicy 05.02.32

Fasenra (benralizumab) — coverage criteria for severe eosinophilic asthma and EGPA

Defines medical necessity criteria, prior authorization, and documentation requirements for Fasenra (benralizumab) for treatment of severe eosinophilic asthma in patients ≥6 years and eosinophilic granulomatosis with polyangiitis (EGPA) in adults. Applies to Wellmark/Blue Cross Blue Shield - Iowa members when benefit exists.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyFasenra (benralizumab) — coverage criteria for severe eosinophilic asthma and EGPA

Policy CodePolicy 05.02.32

Change TypeNo material change

Effective DateJan 1, 2026

Next Review DateOct 1, 2025

Key ActionObtain prior authorization with documentation of pretreatment blood eosinophil count and prior medication history for initial requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization (asthma)

12 monthsauthorization (EGPA/continuation)

J0517HCPCS

≥150asthma eosinophil threshold

>1000

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Coverage Criteria for Fasenra (benralizumab)

Initial Therapy — Severe Eosinophilic Asthma

Covered when ALL of the following are met

Asthma initial criteria: A. Member is 6 years of age or older; B. Member meets either of the following: (i) baseline blood eosinophil count >= 150 cells/µL, or (ii) is dependent on systemic corticosteroids; C. Member has uncontrolled asthma demonstrated by at least one of the following within the past year: (i) two or more exacerbations requiring oral or injectable corticosteroid treatment, (ii) one or more exacerbation resulting in hospitalization or emergency medical care visit, or (iii) poor symptom control (frequent symptoms or reliever use, activity limitation, or night waking due to asthma); D. Member has inadequate asthma control despite current treatment with BOTH of the following at maximally tolerated doses: (i) medium-to-high dose inhaled corticosteroid, and (ii) an additional controller (e.g., 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 and additional controller) in combination with Fasenra; F. Member will not use Fasenra concomitantly with other biologics indicated for asthma.age >=6; eosinophils >=150 or systemic steroid dependence

Authorization of 6 months may be granted for members who have previously received a biologic or when criteria met

Continuation Therapy — Severe Eosinophilic Asthma

Covered when ALL of the following are met

Asthma continuation criteria: 1. Member is 6 years of age or older; 2. Asthma control has improved on Fasenra as demonstrated by at least one of the following: (a) a reduction in the frequency and/or severity of symptoms and exacerbations, or (b) a reduction in the daily maintenance oral corticosteroid dose; 3. Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid and additional controller) in combination with Fasenra; 4. Member will not use Fasenra concomitantly with other biologics indicated for asthma.improvement on therapy

Authorization length: 12 months

Initial Therapy — EGPA

Covered when ALL of the following are met

EGPA initial criteria: 1. Member is 18 years of age or older; 2. Member has a history or presence of an eosinophil count >1000 cells/µL or a blood eosinophil level >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: (a) biopsy with histopathological evidence of eosinophilic vasculitis, perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation, (b) neuropathy (mono or poly), (c) pulmonary infiltrates non-fixed, (d) sino-nasal abnormality, (e) cardiomyopathy, (f) glomerulonephritis, (g) alveolar hemorrhage, (h) palpable purpura, (i) ANCA positivity; 5. Member has had at least one relapse within 2 years prior to starting Fasenra or has refractory disease; 6. Documentation of prior medications tried or clinical justification for avoiding them.age >=18; eosinophils >1000 or >10%

Authorization of 12 months may be granted

Continuation Therapy — EGPA

Covered when ALL of the following are met

EGPA continuation criteria: 1. Member is 18 years of age or older; 2. Member has a beneficial response to treatment with Fasenra demonstrated by any of the following: (a) a reduction in the frequency of relapses, (b) a reduction or discontinuation of daily oral corticosteroid dose, or (c) no active vasculitis; 3. Dosing and quantity consistent with specified regimens.beneficial response

Authorization of 12 months may be granted; specified dosing varies by formulation

Fasenra (benralizumab) is not indicated for the treatment of other eosinophilic conditions outside the specified covered indications. It is not for relief of acute bronchospasm or status asthmaticus. In addition, the member must not receive Fasenra concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Requests will be considered not medically necessary when required diagnostic thresholds, prior therapy, or documentation of inadequate control or benefit are not met. Examples include failure to document the qualifying eosinophil thresholds (e.g., asthma baseline <150 cells/µL when systemic corticosteroid dependence is not present, or EGPA eosinophils not >1000 cells/µL or >10%), lack of documented prior controller therapy at maximally tolerated doses for asthma, or absence of required prior medication history or clinical justification for EGPA. Concomitant use of Fasenra with another biologic for the same indication is also not supported.

Coding and Lab Thresholds

Covered HCPCS CodesHCPCSCovered

J0517

Fasenra, Injection, benralizumab, 1mg

Eosinophil count thresholds

Asthma baseline thresholdBaseline blood eosinophil count ≥150 cells/µL OR systemic corticosteroid dependence

EGPA absolute count thresholdEosinophil count >1000 cells/µL

EGPA percentage thresholdBlood eosinophils >10%

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorizations for asthma when criteria are met may be granted for 6 months; authorizations for EGPA and many continuation approvals may be granted for 12 months.

Asthma: authorization up to 6 months for eligible members age ≥6
EGPA: authorization up to 12 months for eligible members age ≥18
Continuation approvals: commonly granted for 12 months for EGPA and for some continuation asthma approvals

Step Therapy

Step Therapy Requirements for Asthma

For severe eosinophilic asthma, step therapy requires that the member has inadequate asthma control despite being on a medium-to-high dose inhaled corticosteroid plus an additional controller at maximally tolerated doses before granting authorization for Fasenra.

Required controller regimen before biologic: medium-to-high dose inhaled corticosteroid AND an additional controller (long-acting beta2-agonist, long-acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline)

Indications and Limitations — Definitions

Fasenra indications and limitations

Indicated usesAdd-on maintenance treatment of severe eosinophilic asthma in patients aged ≥6 years and treatment of adult EGPA

Not indicated for other eosinophilic conditionsFasenra is not for treatment of other eosinophilic conditions

Not for acute bronchospasm/status asthmaticusNot indicated for relief of acute bronchospasm or status asthmaticus

Concomitant biologic useMember must not use Fasenra concomitantly with other biologic drugs for the same indication

Age limitsAsthma: age ≥6 years; EGPA: adults (age ≥18 years for EGPA criteria)

Background

Benralizumab (Fasenra) is an anti‑eosinophil monoclonal antibody approved as an add‑on maintenance treatment for patients with severe eosinophilic asthma aged 6 years and older and for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in adults. Its labeled indications do not include treatment of other eosinophilic disorders, nor is it indicated for relief of acute bronchospasm or status asthmaticus.