CurrentCignaPolicy IP0421

Fasenra

Defines prior authorization, clinical coverage criteria, dosing, approval durations, and exclusions for Fasenra (benralizumab subcutaneous injection) for asthma and eosinophilic granulomatosis with polyangiitis (EGPA) across Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyFasenra

Policy CodePolicy IP0421

Change TypeAnnual and Selected Revisions (2024–2025)

Effective DateJul 15, 2025

Next Review Date

Key ActionObtain prior authorization and ensure specialist prescribing/consultation and documentation of prior therapy and response per the policy.

POLICY UPDATE CHANGES

Policy Name changed from 'Benralizumab' to 'Immunologicals - Fasenra'; asthma approval age lowered from ≥12 to ≥6 years; diagnostic criteria for asthma updated; dosing information added; initial therapy duration changed from 12 months to 6 months; atopic dermatitis exclusion removed.

Asthma eosinophil requirement clarified to allow level ≥150 cells/µL either within previous 6 weeks OR prior to treatment with a monoclonal antibody that may alter eosinophil levels.

New approval criteria for EGPA were added including age requirement, non-severe disease, corticosteroid trial, eosinophil requirement, and specialist involvement.

Chronic spontaneous urticaria added to Conditions Not Recommended.

Examples of monoclonal antibody therapies were updated (Ebglyss and Nemluvio added then later removed for asthma examples).

2Covered Indications

4Not Covered Examples

150

Coverage Summary & Indications

FDA-Approved Indication - Asthma

Approve Fasenra for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy (approve for 6 months)

Age: Patient is ≥ 6 years of age
Eosinophil requirement
- Option 1: Patient has a blood eosinophil level ≥ 150 cells per microliter within the previous 6 weeks≥ 150 cells/µL
- Option 2: Patient has a blood eosinophil level ≥ 150 cells per microliter prior to treatment with Fasenra or another monoclonal antibody therapy that may alter blood eosinophil levels≥ 150 cells/µL
Background asthma therapy: Patient has received at least 3 consecutive months of combination therapy with BOTH: a medium- or high-dose inhaled corticosteroid; AND at least one additional asthma controller or asthma maintenance medication3 months
Use of a combination inhaler containing both a medium- or high-dose inhaled corticosteroid and additional controller would fulfill both requirements
History / Lung function criteria (one of the following)
- Option a: FEV1 < 80% predicted AND FEV1/FVC < 0.80
  Reduced FEV1 should not be due to smoking-related COPD
- Option b (one of 1-5)
  - b1: Increase of > 12% and > 200 mL in FEV1 following administration of a standard dose of a short-acting bronchodilator>12% and >200 mL
  - b2: Increase of > 12% and > 200 mL in FEV1 between prescriber visits>12% and >200 mL
Uncontrolled asthma definition (one of a-c)
- a: Two or more asthma exacerbations requiring systemic corticosteroids in the previous year2 exacerbations
- b: One or more asthma exacerbations requiring hospitalization, emergency department visit, or urgent care visit in the previous year1 event
- c: Asthma that worsens upon tapering of oral (systemic) corticosteroid therapy
Specialist prescriber requirement: Medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist

B) Patient is Currently Receiving Fasenra (approve for 1 year)

Prior duration: Patient has already received at least 6 months of therapy with Fasenra≥ 6 months
Continued background therapy: Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler
Response to therapy: Patient has responded to therapy as determined by the prescriber
Examples: decreased exacerbations, symptoms, hospital/ED visits, or oral corticosteroid requirement

FDA-Approved Indication - Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Approve Fasenra for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy (approve for 9 months)

Age: Patient is ≥ 18 years of age
Disease severity: Patient has active, non-severe disease
Non-severe = vasculitis without life- or organ-threatening manifestations; examples: rhinosinusitis, asthma, mild systemic symptoms, uncomplicated cutaneous disease, mild inflammatory arthritis
Systemic corticosteroid trial: Patient is currently receiving a systemic corticosteroid and has been on therapy for a minimum of 4 weeks≥ 4 weeks
Eosinophil requirement

Conditions Not Covered (Not Medically Necessary)

Fasenra for any other use is considered not medically necessary, including the following:

Excluded conditions

COPD: Chronic Obstructive Pulmonary Disease (COPD): Fasenra is not indicated for COPD
Chronic Spontaneous Urticaria: Fasenra is not indicated
Concurrent monoclonal antibody therapy: Concurrent use of Fasenra with another monoclonal antibody therapy: efficacy and safety not established
Hypereosinophilic Syndrome: considered investigational (not covered) at this time

Dosing & Administration (Covered Regimens)

EGPA Dosing

Covered dosing for EGPA

EGPA dosing regimen: 30 mg administered subcutaneously once every 4 weeks30 mg q4wk

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for Fasenra. Approvals are time-limited per indication: initial asthma approvals are for 6 months; continuing asthma approvals are for 1 year; initial EGPA approvals are for 9 months; continuing EGPA approvals are for 1 year.

J0517

Documentation Required

Specialist involvement required

Fasenra must be prescribed by or in consultation with an appropriate specialist. For asthma, the prescriber should be an allergist, immunologist, or pulmonologist. For EGPA, the prescriber should be an allergist, immunologist, pulmonologist, or rheumatologist.

Applicable Billing Codes

Considered Medically Necessary when criteria metHCPCSCovered

J0517

Injection, benralizumab, 1 mg

Clinical Evidence Summary

Asthma pivotal trials showed that adding Fasenra to existing therapy reduced annualized exacerbation rates in patients with baseline blood eosinophils ≥ 300 cells/µL. The benefit was greater in those with higher baseline eosinophil counts compared with patients with lower levels. For EGPA, the pivotal study evaluated patients with relapsing or refractory disease on stable systemic corticosteroids and used as its primary endpoint the proportion of patients in remission at Week 36 and Week 48.

Background & Definitions

Fasenra (benralizumab) is an IL-5 receptor alpha-directed cytolytic monoclonal antibody indicated as add-on maintenance treatment for severe eosinophilic asthma in patients ≥ 6 years of age and for eosinophilic granulomatosis with polyangiitis (EGPA) in adults. Asthma efficacy is greater in patients with higher baseline blood eosinophils (larger improvements observed in those with baseline eosinophils ≥ 300 cells/µL versus lower levels). EGPA data support use in relapsing or refractory, non-severe disease when used in combination with corticosteroids, with trials requiring patients to have been on a stable systemic corticosteroid dose prior to enrollment.

Term	Definition
{"text":"Baseline","status":""},{"text":"Defined as prior to receiving Fasenra or another monoclonal antibody therapy for asthma.","status":""}
{"text":"Non-severe EGPA","status":""},{"text":"Vasculitis without life- or organ-threatening manifestations (examples: rhinosinusitis, asthma, mild systemic symptoms, uncomplicated cutaneous disease, mild inflammatory arthritis).","status":""}

Policy Revision History

09/01/2024annual_revision

12/15/2024selected_revision

Asthma eosinophil requirement clarified to allow level ≥150 cells/µL either within the previous 6 weeks OR prior to treatment with a monoclonal antibody that may alter eosinophil levels.

12/15/2024selected_revision

New approval criteria for EGPA were added including age requirement (≥18 years), active non-severe disease, requirement for at least 4 weeks of systemic corticosteroid therapy, eosinophil requirement (≥150 cells/µL within previous 4 weeks or prior to monoclonal antibody therapy), and requirement that medication be prescribed by or in consultation with a specialist (allergist, immunologist, pulmonologist, or rheumatologist).