CurrentCignaPolicy CNF421

Immunologicals – Fasenra Prior Authorization Policy - (CNF421)

Cigna prior authorization policy for Fasenra (benralizumab) describing medical necessity criteria for FDA‑approved indications (asthma and eosinophilic granulomatosis with polyangiitis), conditions considered not medically necessary, specialist prescribing requirements, approval durations, and related clinical thresholds.

Policy Summary

PayerCigna

PolicyImmunologicals – Fasenra Prior Authorization Policy - (CNF421)

Policy CodePolicy CNF421

Change TypeAnnual and selected revisions (age expansion, criteria clarifications, EGPA additions)

Effective Date

Next Review Date

Key ActionPrior authorization is required; document blood eosinophil levels and prior/concomitant use of required therapies and ensure specialist prescribing or consultation as specified.

SourceLink

POLICY UPDATE CHANGES

Age of approval for asthma was reduced from ≥ 12 years to ≥ 6 years of age.

Eosinophil level requirement clarified to require ≥ 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 EGPA were added (age requirement, active non-severe disease, corticosteroid trial, eosinophil requirement, and specialist involvement).

Chronic spontaneous urticaria was added as a condition not recommended for approval.

Throughout the policy, additional monoclonal antibody examples (Ebglyss, Nemluvio, Exdensur) were added to notes.

Leukotriene receptor antagonists were removed as an example of additional asthma controller or maintenance medications.

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3Not covered examples

150 cells/µLPrimary eosinophil threshold

Coverage Summary

Fasenra (benralizumab) is covered with specific medical necessity criteria for its FDA‑approved indications of severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). The policy adopts a covered_with_criteria stance and requires meeting indication‑specific thresholds (e.g., age and blood eosinophil levels), specialist involvement, and prior controller or corticosteroid therapy as applicable. Policy number CNF421 is listed as CURRENT.

Key thresholds & quick facts

Asthma blood eosinophil level≥ 150 cells/µL (within previous 6 weeks or prior to monoclonal antibody therapy)

EGPA blood eosinophil level≥ 150 cells/µL (within previous 4 weeks or prior to monoclonal antibody therapy)

Age thresholdsAsthma ≥ 6 years; EGPA ≥ 18 years

Continuation durationsAsthma continuation ≥ 6 months; EGPA continuation ≥ 9 months

Covered Indications2

Conditions listed as not covered (examples)3 (COPD, Chronic Spontaneous Urticaria, concurrent use with another monoclonal antibody)

Asthma — FDA‑Approved Indication

Asthma - FDA‑Approved Indication

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

ANY of the following

A) Initial Therapy
- Age: Patient is ≥ 6 years of age≥ 6 years
- blood eosinophil
  - Patient has a blood eosinophil level ≥ 150 cells per microliter within the previous 6 weeks≥ 150 cells/µL within 6 weeks

Eosinophilic Granulomatosis with Polyangiitis (EGPA) — FDA‑Approved Indication

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

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

ANY of the following

A) Initial Therapy
- Age: Patient is ≥ 18 years of age≥ 18 years
- disease severity: Patient has active, non-severe disease (non-severe defined as vasculitis without life- or organ-threatening manifestations; examples: rhinosinusitis, asthma, mild systemic symptoms, uncomplicated cutaneous disease, mild inflammatory arthritis)

Specialist Prescribing Requirement

Initial approval requires specialist involvement

Specialist Prescribing Requirement: Fasenra must be prescribed by or in consultation with a physician who specializes in the condition being treated (asthma: allergist/immunologist/pulmonologist; EGPA: allergist/immunologist/pulmonologist/rheumatologist)

Not Medically Necessary / Not Covered Uses

Uses considered not medically necessary and excluded from coverage include treatment of Chronic Obstructive Pulmonary Disease (COPD), Chronic Spontaneous Urticaria (CSU), and concurrent use of Fasenra with another monoclonal antibody therapy. The policy also denies coverage for other non‑FDA indications or any use not meeting the stated criteria. The history notes that CSU was added to the Conditions Not Covered list in an annual revision.

Denial Risk

Not medically necessary for other uses

Claims for uses outside the policy criteria — including COPD, chronic spontaneous urticaria, or concurrent use with another monoclonal antibody therapy — are considered not medically necessary and will be denied.

COPD; chronic spontaneous urticaria; concurrent use with another monoclonal antibody therapy

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Fasenra; approvals are provided for the specified initial and continuation durations in the policy, and when durations are expressed in months, 1 month = 30 days.

Initial and continuation approval durations differ by indication (e.g., Asthma initial: 6 months; Asthma continuation: 1 year; EGPA initial: 9 months; EGPA continuation: 1 year).

Documentation Required

Document eosinophil levels and prior therapies

Document blood eosinophil levels according to the indication-specific timing windows and record prior or concomitant use of inhaled corticosteroids and additional controller medications; for EGPA also document current systemic corticosteroid use of at least the required duration.

Asthma eosinophil timing: ≥ 150 cells/µL within the previous 6 weeks or prior to treatment with a monoclonal antibody that may alter eosinophil levels.

Coding

Drug (HCPCS/J-code not specified in document)HCPCS

No codes listed

Background & Evidence

Fasenra is an IL‑5 receptor α–directed cytolytic monoclonal antibody indicated for add‑on maintenance treatment of severe eosinophilic asthma in patients ≥ 6 years of age and for EGPA in adults. Pivotal asthma trials (SIROCCO and CALIMA, plus an oral glucocorticoid‑sparing trial) demonstrated reductions in exacerbation rates, especially in patients with higher baseline blood eosinophils (notably ≥ 300 cells/µL in the trials; policy thresholds use ≥ 150 cells/µL for eligibility). The EGPA trial evaluated adults with relapsing or refractory disease who had been on stable oral corticosteroids and used a primary endpoint of proportion of patients in remission at both Week 36 and Week 48. COPD trials (GALATHEA and TERRANOVA) did not show statistically significant reductions in COPD exacerbations.

Evidence summary

Asthma pivotal trialsSIROCCO, CALIMA, and oral glucocorticoid‑sparing trials showed reduced exacerbation rates, especially with baseline eosinophils ≥ 300 cells/µL (and benefit in OCS‑treated patients with ≥ 150 cells/µL)

EGPA trial endpointPrimary endpoint: proportion of patients in remission at both Week 36 and Week 48

COPD trialsGALATHEA and TERRANOVA did not show statistically significant reduction in COPD exacerbations

Definitions

Baseline: defined as prior to receiving Fasenra or another monoclonal antibody therapy for asthma.

Non‑severe EGPA: defined as vasculitis without life‑ or organ‑threatening manifestations (examples: rhinosinusitis, asthma, mild systemic symptoms, uncomplicated cutaneous disease, mild inflammatory arthritis).

Revision History

04/22/2026revisedLatest

Age of approval for asthma was reduced from ≥ 12 years to ≥ 6 years of age.

04/09/2025revised

Leukotriene receptor antagonists were removed as an example of additional asthma controller or maintenance medications.

10/02/2024revised

Policy Summary

PayerCigna

PolicyImmunologicals – Fasenra Prior Authorization Policy - (CNF421)

Policy CodePolicy CNF421

Change TypeAnnual and selected revisions (age expansion, criteria clarifications, EGPA additions)

Effective Date

Next Review Date

Key ActionPrior authorization is required; document blood eosinophil levels and prior/concomitant use of required therapies and ensure specialist prescribing or consultation as specified.

SourceLink

On This Page

Patient had 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 prior to mAb therapy

Examples of monoclonal antibody therapies that may alter eosinophil levels are listed in policy notes

prior controller therapy

An inhaled corticosteroid
At least one additional asthma controller or asthma maintenance medication
Examples include inhaled LABA, inhaled LAMA, or monoclonal antibody therapies for asthma (policy lists examples)

baseline uncontrolled asthma (ONE of)

Two or more asthma exacerbations requiring treatment with systemic corticosteroids in the previous year
One or more asthma exacerbation(s) requiring a hospitalization, an emergency department visit, or an urgent care visit in the previous year
Forced expiratory volume in 1 second (FEV1) < 80% predictedFEV1 < 80% predicted
FEV1/forced vital capacity (FVC) < 0.80FEV1/FVC < 0.80
Asthma that worsens upon tapering of oral (systemic) corticosteroid therapy

specialist: The medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist

Initial approval requires specialist involvement

B) Currently Receiving Fasenra

treatment duration: Patient has already received at least 6 months of therapy with Fasenra≥ 6 months
Patients with < 6 months or restarting should be considered under Initial Therapy
ongoing ICS: Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler
response: Patient has responded to therapy as determined by the prescriber (examples: decreased exacerbations, decreased symptoms, decreased hospital/ED/urgent care visits, decreased requirement for oral corticosteroid therapy)

systemic corticosteroid trial:

Patient is currently receiving a systemic corticosteroid and has been on therapy for a minimum of 4 weeks

Examples: prednisone, prednisolone, methylprednisolone, hydrocortisone

blood eosinophil

Patient has a blood eosinophil level ≥ 150 cells per microliter within the previous 4 weeks≥ 150 cells/µL within 4 weeks
Patient had 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 prior to mAb therapy
Examples of monoclonal antibody therapies that may alter eosinophil levels are listed in policy notes

specialist: The medication is prescribed by or in consultation with an allergist, immunologist, pulmonologist, or rheumatologist

Initial approval requires specialist involvement

B) Currently Receiving Fasenra

treatment duration: Patient has already received at least 9 months of therapy with Fasenra≥ 9 months
Patients with < 9 months or restarting should be considered under Initial Therapy
response: Patient has responded to therapy as determined by the prescriber (examples: reduced rate of relapse, corticosteroid dose reduction, reduced eosinophil levels)

EGPA eosinophil timing: ≥ 150 cells/µL within the previous 4 weeks or prior to treatment with a monoclonal antibody that may alter eosinophil levels.

Asthma controller therapy: at least 3 consecutive months of combination therapy with an inhaled corticosteroid AND ≥1 additional controller/maintenance medication.

EGPA systemic corticosteroid: currently receiving systemic corticosteroid therapy for a minimum of 4 weeks.

Documentation Required

Specialist involvement required

Initial approval requires the medication be prescribed by or in consultation with an appropriate specialist; the required specialty depends on the indication.

Asthma: allergist, immunologist, or pulmonologist.
EGPA: allergist, immunologist, pulmonologist, or rheumatologist.

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

10/02/2024added

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

04/09/2025added

Chronic spontaneous urticaria was added as a condition not recommended for approval.

04/22/2026revised

Additional monoclonal antibody examples (Ebglyss, Nemluvio, Exdensur) were added to notes throughout the policy.