ModifiedCignaPolicy IP0421

Fasenra

Coverage and prior authorization criteria for Fasenra (benralizumab) for asthma and eosinophilic granulomatosis with polyangiitis (EGPA) under Cigna-administered benefit plans. Applies to prescribers and payers administering pharmacy benefits.

Policy Summary

PayerCigna

PolicyFasenra

Policy CodePolicy IP0421

Change TypeMaterial revisions (age, authorization duration, eosinophil timing, new EGPA criteria)

Effective DateJul 15, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age, qualifying eosinophil level (≥150 cells/µL within required timing), prior therapies, and specialist involvement as applicable.

SourceLink

POLICY UPDATE CHANGES

Asthma: Age of approval was reduced from ≥ 12 years to ≥ 6 years.

Authorization Duration: initial therapy duration updated from 12 months to 6 months.

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

New approval criteria for eosinophilic granulomatosis with polyangiitis (EGPA) were added, including age, active non-severe disease, prior trial of systemic corticosteroid, eosinophil level, and specialist involvement.

Chronic spontaneous urticaria was added as a 'Condition Not Recommended' for approval.

≥6minimum age (asthma)

≥18minimum age (EGPA)

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Coverage Criteria for Fasenra (benralizumab)

Asthma (FDA-approved indication)

Asthma — Approve Fasenra when ONE of the following is met (A or B):

Asthma A or B: A) Initial Therapy OR B) Currently Receiving Fasenra

Asthma B - Currently Receiving Fasenra: Already received ≥6 months of Fasenra; continues one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler; AND has responded to therapy as determined by the prescriber.

Approve for 1 year.

EGPA (FDA-approved indication)

Eosinophilic Granulomatosis with Polyangiitis (EGPA) — Approve Fasenra when ONE of the following is met (A or B):

EGPA A or B: A) Initial Therapy OR B) Currently Receiving Fasenra

EGPA A - Initial Therapy: Patient is ≥ 18 years; AND has active, non-severe disease; AND is currently receiving systemic corticosteroid for ≥4 weeks AND meets blood eosinophil criterion; AND prescribed by or in consultation with an allergist, immunologist, pulmonologist, or rheumatologist.

Approve for 9 months; dosing: 30 mg every 4 weeks.

EGPA B - Currently Receiving Fasenra: Already received ≥9 months of Fasenra; AND has responded to therapy as determined by the prescriber.

Approve for 1 year.

Dosing

Dosing options included in policy:

Dosing by weight: If patient weighs <35 kg: 10 mg SC once every 4 weeks for first 3 doses OR 10 mg SC once every 8 weeks. If patient weighs ≥35 kg: 30 mg SC once every 4 weeks for first 3 doses OR 30 mg SC once every 8 weeks.

EGPA dosing: 30 mg SC once every 4 weeks.

Initial Therapy (Asthma) - summary

Covered for severe eosinophilic asthma when ALL of the following are met

Asthma criteria (summary): Patient meets age requirement (>= 6 years); has documented eosinophil level ≥ 150 cells/µL measured either within the previous 6 weeks OR prior to treatment with a monoclonal antibody that may alter eosinophil levels; and other indication-specific diagnostic and prior therapy requirements as detailed in the policy.see eosinophil >=150 cells/µL

Initial authorization duration 6 months.

Initial Therapy (EGPA) - summary

Covered for EGPA when ALL of the following are met

EGPA initial criteria: Patient meets age requirement; disease is active and non-severe; prior trial of a systemic corticosteroid has been attempted; eosinophil level requirement met; specialist involvement documented.

Full criteria in policy body; initial approval duration 9 months.

Fasenra (benralizumab) is considered not medically necessary for several non‑approved uses. Specifically, it is not indicated for treatment of Chronic Obstructive Pulmonary Disease (COPD); clinical trials (Phase IIa and Phase III GALATHEA and TERRANOVA) did not show statistically significant reductions in annualized COPD exacerbation rates or consistent lung function improvement compared with placebo. Numerical, non‑significant benefit was seen only in subgroups with higher baseline eosinophils. [[see citations]]

Fasenra is not indicated for chronic spontaneous urticaria; randomized trial data (ARROYO Phase IIb) demonstrated no significant differences versus placebo in primary symptomatic endpoints despite marked eosinophil depletion.

The concurrent use of Fasenra with another monoclonal antibody therapy is not supported by established efficacy or safety data; combinations with other biologics (examples listed in the policy) have not been evaluated and therefore are considered not medically necessary.

Fasenra is not indicated for other eosinophilic conditions outside the approved indications; where evidence is limited or early-phase only (for example, hypereosinophilic syndrome), the therapy is considered investigational and not medically necessary pending more definitive data.

Fasenra is not indicated for treatment of eosinophilic conditions other than its approved indications. Evidence in rare eosinophilic disorders is limited: a small Phase II randomized trial in platelet‑derived growth factor receptor alpha (PDGFRA)‑negative hypereosinophilic syndrome (n = 20) showed biologic activity (reduction in absolute eosinophil count) but the World Health Organization and consensus guidance continue to regard Fasenra as investigational for this population.

Given the limited patient numbers, early‑phase data, and the absence of completed Phase III evidence at this time, use of Fasenra for eosinophilic syndromes other than asthma or EGPA remains investigational / not medically necessary for coverage purposes until further high‑quality evidence is available.

Chronic spontaneous urticaria is explicitly listed as a condition for which Fasenra is not recommended for approval. The ARROYO Phase IIb randomized, placebo‑controlled study (n = 155) found no significant improvement in primary outcomes (Itch Severity Score 7, Urticaria Activity Score 7) or secondary endpoints despite near‑complete depletion of blood eosinophils.

Based on these trial results and the policy revision, requests to use Fasenra for chronic spontaneous urticaria are not supported and may be denied as not covered.

Fasenra is not indicated for Chronic Obstructive Pulmonary Disease (COPD). A Phase IIa study (n = 101) and two Phase III trials (GALATHEA and TERRANOVA) did not show statistically significant reductions in annualized COPD exacerbation rates or consistent lung function improvement versus placebo. Although numerical, non‑significant improvements were observed in subgroups with higher baseline eosinophil counts, overall trial outcomes do not support use of Fasenra for COPD.

Fasenra is not indicated for chronic spontaneous urticaria. The ARROYO Phase IIb study showed no significant difference between Fasenra and placebo for the primary symptomatic endpoints at Week 12 (Itch Severity Score 7 and Urticaria Activity Score 7) and no benefit on secondary endpoints despite profound eosinophil depletion. These trial results do not support approval for this indication.

The safety and efficacy of combining Fasenra with another monoclonal antibody therapy have not been established. The policy notes that concurrent use with other biologics (examples include dupilumab, mepolizumab, tezepelumab, omalizumab, and others) lacks supporting data, and therefore concurrent use is considered not medically necessary until evidence demonstrates acceptable efficacy and safety.

Hypereosinophilic syndrome has been investigated in small trials but remains investigational and not medically necessary for coverage purposes. A small randomized Phase II trial showed a greater proportion of patients treated with Fasenra achieved substantial reductions in absolute eosinophil counts versus placebo, and some patients had sustained responses during open‑label follow‑up. However, the World Health Organization and consensus guidance continue to consider Fasenra investigational for this condition pending Phase III evidence.

Use of Fasenra for hypereosinophilic syndrome is considered investigational and not medically necessary for coverage decisions at this time. Although early studies report hematologic and clinical responses in a subset of patients, the evidence base is limited (small sample sizes, early‑phase trials) and regulatory‑level validation in larger trials is pending; therefore coverage is not supported outside of clinical studies.

Coding and Key Clinical Thresholds

Coding information (codes listed in policy)mixed

No codes listed

Considered Medically Necessary when criteria metHCPCSCovered

J0517

Injection, benralizumab, 1 mg

blood eosinophil count — key threshold values referenced in policy

Primary eosinophil threshold≥ 150 cells/µL (required within the previous 6 weeks OR prior to treatment with Fasenra/another monoclonal antibody that may alter eosinophil levels)

Higher-response subgroup noted in trialsBaseline blood eosinophils ≥ 300 cells/µL associated with larger reductions in annualized asthma exacerbation rates

Timing options for measurementMeasurement may be within the previous 6 weeks or prior to monoclonal antibody exposure that could alter eosinophils

eosinophil subgroup with larger benefit

Subgroup with larger clinical benefit>= 300 cells/µL

Evidence source

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for prescription benefit coverage of Fasenra (benralizumab, J0517). All approvals are provided for the durations below. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Fasenra, the medication must be prescribed by or in consultation with a specialist (e.g., allergist, immunologist, pulmonologist, rheumatologist) familiar with the condition being treated.

Prior authorization required for benralizumab (J0517) pending meeting clinical criteria.
Approvals are issued for the durations specified in the policy (months = 30 days).
Prescriber requirement: prescribed by or in consultation with a specialist experienced in the condition.

Documentation Required

Required Documentation

Submit documentation to support the requested therapy including: patient age, indication, relevant specialist consultation or involvement, blood eosinophil level (see indication-specific timing thresholds), prior and current therapies (including dates and durations), evidence of response or intolerance to prior therapies where applicable, and dosing information.

Initial Therapy Criteria by Indication

Initial therapy

Initial therapy criteria for each FDA-approved indication:

Asthma initial: Patient ≥ 6 years; blood eosinophil criterion met (≥150 cells/µL within previous 6 weeks OR ≥150 cells/µL prior to treatment with Fasenra/another monoclonal antibody that may alter eosinophils); received ≥3 months of medium- or high-dose inhaled corticosteroid plus ≥1 additional controller; meets lung function or bronchial challenge criteria; asthma uncontrolled per exacerbation history or worsens on steroid taper; prescribed by or in consultation with an allergist, immunologist, or pulmonologist.

Approve for 6 months.

EGPA initial: Patient ≥ 18 years; active, non-severe disease; currently receiving systemic corticosteroid for ≥4 weeks AND blood eosinophil ≥150 cells/µL within previous 4 weeks or prior to antibody therapy; prescribed by or in consultation with an allergist, immunologist, pulmonologist, or rheumatologist.

Approve for 9 months; dosing 30 mg every 4 weeks.

Initial Therapy (summary)

Initial therapy requirements (summary):

Continuation and Renewal Criteria

Continuation therapy

Continuation (patients currently receiving Fasenra):

Asthma continuation: Patient has already received ≥6 months of Fasenra; continues inhaled corticosteroid therapy; AND has responded to therapy as determined by prescriber.

Approve for 1 year.

EGPA continuation: Patient has already received ≥9 months of Fasenra; AND has responded to therapy as determined by prescriber.

Approve for 1 year.

Continuation Therapy (summary)

Continuation/renewal considerations (summary):

Renewal: Ongoing approval likely requires evidence of clinical benefit and continued specialist involvement as applicable; authorization intervals updated to align with initial durations (e.g., 1-year approvals for continuation).

Step Therapy Requirements

Step therapy required?
Yes

Indication	Required prior therapy
Eosinophilic Granulomatosis with Polyangiitis (EGPA)	Prior trial of systemic corticosteroid (patient must currently be receiving systemic corticosteroid for ≥4 weeks)

Background on Fasenra

Fasenra (benralizumab) is an interleukin‑5 receptor alpha (IL‑5Rα)‑directed cytolytic monoclonal antibody. It is approved as add‑on maintenance therapy for severe eosinophilic asthma and for eosinophilic granulomatosis with polyangiitis (EGPA) in adults; dosing and approval criteria differ by indication.

Definitions and Key Terms

Fasenra (benralizumab) — drug definition/key mechanism

Drug name and classFasenra (benralizumab), an interleukin-5 receptor alpha (IL‑5Rα)-directed cytolytic monoclonal antibody

Mechanism of actionTargets IL‑5 receptor alpha on eosinophils leading to antibody-dependent cell-mediated cytotoxicity and eosinophil depletion

FDA-approved uses (policy)Add-on maintenance therapy for severe eosinophilic asthma (≥ 6 years) and treatment of EGPA in adults

Severe asthma — definition used in policy

Policy definition of severe asthmaAsthma that is uncontrolled despite adherence to optimized high‑dose ICS/LABA therapy or that worsens when high‑dose treatment is decreased

Clinical features indicating severe phenotypeMay include frequent/severe exacerbations, low lung function, adult‑onset asthma, nasal polyps, or maintenance oral corticosteroid requirement

Policy Revision History

2025-07-15Annual RevisionLatest

Added chronic spontaneous urticaria as a 'Condition Not Recommended' for approval.

2024-12-15Selected Revision

Added new approval criteria for eosinophilic granulomatosis with polyangiitis (EGPA), including age requirement, active non-severe disease, trial of systemic corticosteroid, eosinophil level requirement, and specialist involvement; added examples of monoclonal antibody therapies to notes.

2024-09-01

Policy Summary

PayerCigna

PolicyFasenra

Policy CodePolicy IP0421

Change TypeMaterial revisions (age, authorization duration, eosinophil timing, new EGPA criteria)

Effective DateJul 15, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age, qualifying eosinophil level (≥150 cells/µL within required timing), prior therapies, and specialist involvement as applicable.

SourceLink

On This Page

Documentation of blood eosinophil level ≥ 150 cells/µL with timing per indication (as specified in criteria).
For asthma: documentation of at least 3 consecutive months of combination therapy with a medium- or high-dose inhaled corticosteroid plus at least one additional asthma controller/maintenance medication.
For EGPA: documentation of current systemic corticosteroid therapy for a minimum of 4 weeks and evidence the disease is active, non-severe.
Include prior authorization forms, relevant clinic notes, and any prior biologic therapy records (dates, agents).

Step Therapy

Asthma Initial Therapy Prerequisite

For asthma initial therapy, patient must be ≥ 6 years of age and have met one of the eosinophil criteria, and must have 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 maintenance medication.

Age: ≥ 6 years.
Eosinophil: ≥ 150 cells/µL within the previous 6 weeks OR ≥ 150 cells/µL documented prior to treatment with a monoclonal antibody that may alter eosinophil levels.
Prior therapy: ≥ 3 consecutive months of medium- or high-dose ICS plus at least one additional controller (e.g., LABA, LAMA, or prior monoclonal antibody).

Step Therapy

Step Therapy Notes

Step therapy expectations vary by indication. For asthma, trials of appropriate inhaled controller therapies (medium- or high-dose ICS plus another controller) are required prior to initial approval. For EGPA, a trial of systemic corticosteroid therapy (minimum 4 weeks) is required before approval. Provide documentation of trials, durations, and response or intolerance to prior therapies.

Asthma: ≥ 3 consecutive months of combination therapy with medium- or high-dose ICS and at least one additional controller.
EGPA: currently receiving systemic corticosteroid (e.g., prednisone) and on therapy for a minimum of 4 weeks prior to approval.
Document lack of adequate control, adverse effects, or other clinical rationale if step therapy cannot be completed.

Initial therapy summary: Patient meets minimum age (>=6 years for asthma); documented eosinophil level ≥150 cells/µL within required timing (within previous 6 weeks OR prior to treatment with a monoclonal antibody that may alter eosinophil levels); requisite prior therapies or diagnostic confirmation per indication; and specialist involvement when required.eosinophil >=150 cells/µL

Initial authorization duration: 6 months for asthma; 9 months for EGPA.