ModifiedCentenePolicy CP.PHAR.373

Benralizumab (Fasenra) coverage for severe eosinophilic asthma and EGPA

Defines medical necessity criteria, prior authorization requirements, and approval durations for benralizumab (Fasenra) as add-on maintenance therapy for severe eosinophilic asthma and for eosinophilic granulomatosis with polyangiitis (EGPA) for Centene-affiliated health plans (Commercial and Medicaid).

Policy Summary

PayerCentene

PolicyBenralizumab (Fasenra) coverage for severe eosinophilic asthma and EGPA

Policy CodePolicy CP.PHAR.373

Change TypeAdded EGPA indicationpediatric age/formulation expansionapproval duration updatesexclusion of Tezspire for concurrent use

Effective DateJun 1, 2018

Next Review DateN/A

Key ActionSubmit prior authorization demonstrating diagnosis, eosinophil count, specialist involvement, adherence to controller therapy, and exacerbation history.

SourceLink

POLICY UPDATE CHANGES

Added criteria for newly approved indication of EGPA.

Expanded age indication to include patients 6 years and older and added a new 10 mg prefilled syringe formulation.

For both indications, revised initial approval duration for Medicaid from 6 to 12 months and updated Commercial initial approval language.

Added Tezspire as another agent with which Fasenra should not be used concurrently.

≥150minimum baseline blood eosinophil count

≥2required exacerbations prior 12 mo

≥6 yrsmin age severe asthma

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≥18 yrsmin age EGPA

12 moMedicaid approval duration

6 moCommercial approval duration

Coverage Criteria for Benralizumab (Fasenra)

Initial Therapy, Severe Asthma

Covered when ALL of the following are met:

Severe Asthma Initial Criteria: 1) Diagnosis of asthma; 2) Absolute blood eosinophil count ≥ 150 cells/mcL within the past 3 months; 3) Prescribed by or in consultation with a pulmonologist, immunologist, or allergist; 4) Age ≥ 6 years; 5) Member has experienced ≥ 2 exacerbations within the last 12 months requiring oral/systemic corticosteroid treatment or urgent care/ER visit or hospital admission despite adherent controller therapy (medium- to high-dose ICS plus either a LABA or LTRA if LABA contraindicated); 6) Fasenra is prescribed concurrently with an ICS plus either a LABA or LTRA; 7) Not prescribed concurrently with Cinqair, Nucala, Dupixent, Xolair, or Tezspire; 8) Dose does not exceed: (a) Age 6–11 & weight <35 kg: 10 mg every 4 weeks for first 3 doses, then every 8 weeks; (b) Age ≥6 & weight ≥35 kg: 30 mg every 4 weeks for first 3 doses, then every 8 weeks thereafter.

Refer to HIM.PA.SP70 for California Exchange and NY CHIP plans.

Initial Therapy, EGPA

Covered when ALL of the following are met:

EGPA Initial Criteria: 1) Diagnosis of EGPA with active, non-severe disease; 2) Eosinophilia evidenced by eosinophils >1,000 cells/mcL and/or >10% of leukocytes within the past 3 months; 3) Prescribed by or in consultation with a pulmonologist, rheumatologist, immunologist, or nephrologist; 4) Age ≥ 18 years; 5) Failure of a 4-week trial of a glucocorticoid unless contraindicated or intolerant; 6) Not prescribed concurrently with Cinqair, Nucala, Dupixent, Xolair, or Tezspire; 7) Dose does not exceed 30 mg every 4 weeks.

Continuation Therapy, Severe Asthma

Covered when ALL of the following are met:

Severe Asthma Continued Therapy: 1) Member currently receiving medication via Centene benefit or previously met initial criteria OR has continuity of care; 2) Demonstrated adherence to asthma controller therapy as evidenced by PDC ≥ 0.8 in the last 6 months; 3) Member is responding positively to therapy (examples include reduction in exacerbations or corticosteroid dose, improved FEV1, reduced rescue use); 4) Not prescribed concurrently with Cinqair, Nucala, Dupixent, Xolair, or Tezspire; 5) If request is for a dose increase, new dose does not exceed age/weight-based limits listed for initial therapy.PDC ≥ 0.8 in last 6 months

Examples of response include reduction in exacerbations or steroid dose, improved FEV1, or reduced rescue use.

Continuation Therapy, EGPA

Covered when ALL of the following are met:

EGPA Continued Therapy: 1) Member currently receiving medication via Centene benefit or previously met initial criteria OR has continuity of care; 2) Member is responding positively to therapy (examples include reduction of relapses or reduction in glucocorticoid dose); 3) Not prescribed concurrently with Cinqair, Nucala, Dupixent, Xolair, or Tezspire; 4) If request is for a dose increase, new dose does not exceed 30 mg every 4 weeks.

EGPA remission is defined as stable prednisone dose ≤ 7.5 mg/day per EULAR and pivotal trial.

Initial Therapy - Severe Eosinophilic Asthma

Covered when ALL of the following are met:

Asthma initial criteria: Patient has severe asthma defined by exacerbations despite regular use of high-dose ICS plus an additional controller (eg, LABA or LTRA) with or without oral corticosteroids.

Pivotal trials defined severe asthma as ≥2 exacerbations despite high-dose ICS+controller.

Exacerbation evidence: History of clinically significant exacerbation leading to systemic corticosteroids, ED/urgent care visit, or inpatient hospitalization.

Clinical definition of exacerbation provided in Appendix D.

Eosinophil threshold: Baseline blood eosinophil count ≥150 cells/µL (trials powered for ≥300 cells/µL but pooled analysis shows benefit at ≥150 cells/µL).BEC ≥150 cells/µL

Baseline BEC is a predictor of response to therapy.

Pediatric Dosing Eligibility

Covered for pediatric patients when dosing and weight criteria are met:

Age/weight dosing: For pediatric patients 6–11 years: if weight <35 kg use 10 mg SC every 4 weeks for the first 3 doses, then 10 mg every 8 weeks; if weight ≥35 kg use 30 mg SC every 4 weeks for the first 3 doses, then 30 mg every 8 weeks thereafter.

RT4 expanded age to 6+ years and added 10 mg prefilled syringe formulation.

Initial Therapy - EGPA (alternate/location-specific)

Covered when ALL of the following are met:

EGPA baseline therapy: 1) Patient receiving standard of care including oral glucocorticoids and unable to taper prednisone to ≤7.5 mg/day despite appropriate therapy; 2) Failure of a 4-week trial of a glucocorticoid unless contraindicated or intolerant; 3) Prescribed by or in consultation with a pulmonologist, rheumatologist, immunologist, or nephrologist; 4) Age ≥ 18 years.

EGPA SOC and remission definition per EULAR and pivotal trial.

EGPA dosing: Benralizumab 30 mg SC every 4 weeks (dose does not exceed 30 mg every 4 weeks).

Newly approved EGPA indication added to policy (RT4).

The policy explicitly excludes use of benralizumab (Fasenra) for acute bronchospasm or status asthmaticus. These settings are not indications for maintenance biologic therapy and are listed under diagnoses/indications for which coverage is not authorized.

Requests for benralizumab for non‑FDA approved (off‑label) indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety consistent with the payer's off‑label use policies (see CP.CPA.09 for Commercial and CP.PMN.53 for Medicaid) or other evidence of coverage supporting the indication.

Concurrent use of benralizumab with other asthma biologics is not supported by this policy. The policy specifically disallows concurrent prescribing with agents including Tezspire and Xolair (among others listed), reflecting insufficient data to support combination biologic therapy.

Use of benralizumab for acute bronchospasm or status asthmaticus is explicitly considered not medically necessary and therefore not an authorized indication under this policy.

Patients without evidence of an eosinophilic phenotype or without prior appropriate controller therapy are not eligible for coverage. The policy requires documentation of a baseline blood eosinophil count ≥ 150 cells/µL (with trials powered at higher thresholds) and evidence that the member remained uncontrolled despite adherent controller therapy (eg, high‑dose ICS plus LABA or LTRA); continuation criteria also require demonstrated adherence (PDC ≥ 0.8 over the prior 6 months).

Coding and Key Clinical Thresholds

Policy Identifiermixed

CP.PHAR.373

Policy reference number (internal)

HCPCS CodesHCPCS

J0517

Injection, benralizumab, 1 mg

Baseline blood eosinophil count (severe asthma)

Baseline BEC threshold≥ 150 cells/mcL (measured within the past 3 months)

ContextUsed as eligibility criterion for initial severe asthma therapy; predictor of response to benralizumab

Trial notePivotal trials were powered for ≥300 cells/µL, but pooled analyses show benefit ≥150 cells/µL

EGPA eosinophilia threshold

EGPA eosinophilia threshold> 1,000 cells/mcL (>1 x 10^9/L) and/or >10% of leukocytes within the past 3 months

Age requirementApplies to patients age ≥ 18 years for EGPA indication

Required Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for initial therapy with Fasenra. Providers must submit a PA request and include documentation demonstrating the medical necessity criteria are met (see list of required clinical documentation). Approval durations: Medicaid — 12 months; Commercial — 6 months or to the member's renewal period, whichever is longer.

PA required for initial therapy
Approval duration: Medicaid 12 months; Commercial 6 months or member's renewal period

Documentation Required

Required Clinical Documentation

Provider must submit office chart notes, relevant lab results (including blood eosinophil count), and other clinical information that supports the member meets all approval criteria. Incomplete documentation may result in denial or a request for additional information.

Include office notes and labs (baseline and recent BEC)

Definitions and Measurement Thresholds

Definition of blood eosinophil count (BEC)

AbbreviationBEC = blood eosinophil count

UsageUsed throughout policy as biomarker for eosinophilic phenotype and response prediction

UnitsReported as cells/mcL (cells per microliter)

Definition of PDC and numeric example

PDC definitionPDC = proportion of days covered (sum of days covered ÷ days in timeframe)

Numeric examplePDC ≥ 0.8 = 144/180 days (at least 5 of last 6 months)

Use in policy

Background

Benralizumab (Fasenra) is an interleukin‑5 receptor alpha (IL‑5Rα)–directed monoclonal antibody used as add‑on maintenance therapy for severe eosinophilic asthma (now indicated down to age ≥ 6 years) and for eosinophilic granulomatosis with polyangiitis (EGPA) in adults. Its mechanism targets the IL‑5 receptor alpha on eosinophils, producing cytolytic effects that reduce peripheral eosinophil counts and contribute to reduced exacerbations in appropriately selected patients.

Revision History and Policy Changes

2024-11-24indication_added

Added eosinophilic granulomatosis with polyangiitis (EGPA) as a covered indication with corresponding approval criteria and 30 mg SC every 4 weeks dosing.

2024-04-26pediatric_and_formulation_update

Expanded age indication to include pediatric patients aged ≥6 years and added a 10 mg prefilled syringe formulation for use in children <35 kg as part of dosing regimen.

2022-10-31exclusion_update

Added Tezspire to the list of biologics with which Fasenra should not be used concurrently (concurrent use with other asthma biologics remains unsupported).

Policy Summary

PayerCentene

PolicyBenralizumab (Fasenra) coverage for severe eosinophilic asthma and EGPA

Policy CodePolicy CP.PHAR.373

Change TypeAdded EGPA indicationpediatric age/formulation expansionapproval duration updatesexclusion of Tezspire for concurrent use

Effective DateJun 1, 2018

Next Review DateN/A

Key ActionSubmit prior authorization demonstrating diagnosis, eosinophil count, specialist involvement, adherence to controller therapy, and exacerbation history.

SourceLink

On This Page

Prior controller therapy: Documentation of ongoing controller therapy (eg, high-dose ICS/LABA) and adherence as applicable.PDC ≥ 0.8 for continuation

PDC defined as at least 144 days covered in the last 180 days (≈5 of 6 months).

Prescriber specialtyPrescribed by or in consultation with pulmonologist, rheumatologist, immunologist, or nephrologist

Adherence (PDC) definition used for continuation

Adherence definition for continuationProportion of days covered (PDC) ≥ 0.8 over the last 6 months

Clinical evidence of adherenceEquivalent to receiving controller therapy for at least 5 of the last 6 months (≈144/180 days)

Required controller regimenICS plus either a LABA or LTRA as evidence of controller therapy

Baseline eosinophil threshold as predictor of response

Predictive baseline BECBaseline BEC ≥ 150 cells/µL is associated with positive treatment effect

Trials powered noteSIROCCO and CALIMA were powered for ≥300 cells/µL; pooled analysis found benefit at ≥150 cells/µL

Clinical implicationConsider BEC when assessing likelihood of response to benralizumab

Proportion of days covered (PDC) numeric threshold

PDC numeric thresholdPDC ≥ 0.8

TimeframeCalculated over the last 6 months (180 days)

InterpretationMeets threshold if controller therapy received for ≥144 of the last 180 days

Include past medication history and exacerbation records

Incomplete or missing documentation can trigger denial or delay

Denial Risk

Documentation Insufficiency or Non‑FDA Indications

Requests lacking required documentation or those for non‑FDA indications not addressed in this policy will be denied unless sufficient evidence for off‑label use is provided per off‑label policies (CP.CPA.09 for commercial, CP.PMN.53 for Medicaid) or other evidence of coverage documents are supplied.

Non‑FDA indications require adherence to CP.CPA.09 (commercial) or CP.PMN.53 (Medicaid)
Requests missing required documentation will be denied or routed per off‑label policy

Step Therapy

Controller Therapy Requirement and Adherence

Member must be on, and demonstrate adherence to, controller asthma therapy (an ICS plus either a LABA or an LTRA if LABA contraindicated/intolerant) prior to approval. For continuation, adherence is defined as a proportion of days covered (PDC) ≥ 0.8 over the last 6 months, and continued benefit must be demonstrated (eg, fewer exacerbations, reduced steroid use, improved FEV1).

Initial approval: prescribed concurrently with an ICS + (LABA or LTRA)
Continuation: PDC ≥ 0.8 over the last 6 months (≈144/180 days)
Continuation requires documented positive response to therapy

Note

Adjunct Therapy and Biologic Combination

Fasenra is intended as adjunct therapy to inhaled controller regimens. Concurrent use with other biologic agents for asthma (Cinqair, Nucala, Dupixent, Xolair, Tezspire) is not supported by this policy and will not be approved.

Fasenra is adjunctive to ICS-based controller therapy
Do not prescribe concurrently with Cinqair, Nucala, Dupixent, Xolair, or Tezspire

Applied to demonstrate adherence to controller therapy for continuation criteria

Definition of clinically significant exacerbation

Clinically significant exacerbationAn exacerbation leading to (1) use of systemic corticosteroids, (2) emergency department/urgent care visit, or (3) inpatient hospital stay

ContextUsed to qualify prior-year exacerbation history for severe asthma eligibility

Trial alignmentReflects definitions used in pivotal trials and pooled analyses

Clinically significant asthma exacerbation (alternate phrasing)

Alternate phrasingClinically significant asthma exacerbation = worsening asthma leading to systemic corticosteroids, ED/urgent care visit, or hospitalization

Policy useRequired: ≥2 such exacerbations in prior 12 months despite adherent controller therapy for severe asthma initial approval

ExamplesIncludes oral/systemic steroid courses, urgent care/ER visits, or hospital admissions

EGPA remission definition

EGPA remission definitionStable prednisone dose ≤ 7.5 mg/day as per EULAR and the pivotal trial

Clinical contextPatients unable to taper to ≤7.5 mg/day may be considered for additional immunosuppressive therapy or benralizumab per policy

Induction/taperInduction with prednisone 1 mg/kg/day for 2–3 weeks followed by gradual tapering to minimal effective dose

2025-11-12annual_reviewLatest

1Q 2026 annual review: no significant clinical changes; references reviewed and updated.