Centene benralizumab Coverage & Prior Auth

Coverage Criteria

inv-01: Initial Therapy - Severe Asthma

Covered when ALL of the following are met for Severe Asthma:

Severe Asthma initial criteria: 1) Diagnosis of asthma; 2) Prescribed by or in consultation with a pulmonologist, immunologist, or allergist; 3) Absolute blood eosinophil count ≥ 150 cells/mcL within the past 3 months; 4) Age ≥ 6 years; 5) Member has experienced ≥ 2 exacerbations within the last 12 months despite adherent controller therapy (i.e., medium- to high-dose inhaled corticosteroid plus either a long-acting beta agonist or leukotriene modifier) as evidenced by systemic corticosteroid use or ER/urgent care visit or hospitalization; 6) Fasenra is prescribed concurrently with an ICS plus either a LABA or LTRA; 7) Fasenra is not prescribed concurrently with Cinqair (reslizumab), Nucala (mepolizumab), Dupixent (dupilumab), Xolair (omalizumab), or Tezspire (tezepelumab); 8) Dose does not exceed age/weight-based limits (see dosing criteria).

Exacerbation defined as systemic corticosteroid use, ED/urgent care visit, or hospitalization.

inv-02: Dose Limits - Severe Asthma

Dosing limits (must not exceed):

Dosing by age/weight: a) Age 6–11 years and weight <35 kg: 10 mg SC every 4 weeks for the first 3 doses, then 10 mg every 8 weeks thereafter; b) Age ≥6 years and weight ≥35 kg (including adolescents and adults): 30 mg SC every 4 weeks for the first 3 doses, then 30 mg every 8 weeks thereafter; c) EGPA indication: 30 mg SC every 4 weeks (maximum dosing for EGPA).

Maximum dose per indication as specified in product dosing guidance.

inv-03: Initial Therapy - EGPA

Covered when ALL of the following are met for EGPA:

EGPA initial criteria: 1) Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) with active, non-severe disease (no life- or organ-threatening manifestations); 2) Prescribed by or in consultation with a pulmonologist, rheumatologist, immunologist, or nephrologist; 3) Eosinophilia evidenced by eosinophils >1 x 10^9/L and/or ≥10% of leukocytes within the past 3 months; 4) Age ≥ 18 years; 5) Failure of a 4-week trial of a glucocorticoid unless contraindicated or clinically significant adverse events; 6) Fasenra is not prescribed concurrently with Cinqair, Nucala, Dupixent, Xolair, or Tezspire; 7) Dose does not exceed 30 mg every 4 weeks.

Approval duration: 6 months.

inv-04: Continued Therapy - Severe Asthma

Continued therapy — Severe Asthma (must meet all):

Severe Asthma continued criteria: 1) Member is currently receiving medication via the Centene benefit or previously met initial approval criteria; 2) Demonstrated adherence to asthma controller therapy (ICS plus either a LABA or LTRA) with proportion of days covered (PDC) ≥ 0.8 in the last 6 months; 3) Member is responding positively to therapy (examples include reduction in exacerbations or corticosteroid dose, improvement in FEV1, reduced rescue inhaler use); 4) Fasenra is not prescribed concurrently with Cinqair, Nucala, Dupixent, Xolair, or Tezspire; 5) If request is for a dose increase, the new dose does not exceed the age/weight-based limits (see dosing).

Approval duration: Medicaid 12 months; Commercial 6 months or member's renewal period.

inv-05: Continued Therapy - EGPA

Continued therapy — EGPA (must meet all):

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

Approval durations align with payer line of business.

inv-06: Initial and Indication Criteria

Covered when meeting indication-specific dosing and clinical context

Severe asthma initial criteria: Patient is a candidate per trial/policy definitions: ≥2 exacerbations despite regular use of high-dose ICS plus an additional controller (e.g., LABA or LTRA) with or without oral corticosteroids; baseline blood eosinophil count predictive of response (benefit seen ≥150 cells/µL; trials powered at ≥300 cells/µL).BEC >= 150 cells/µL preferred

GINA recommends consideration for patients ≥12 years with exacerbations or poor control despite high-dose ICS/LABA and eosinophilic biomarkers.

EGPA criteria: Standard of care includes oral glucocorticoids; consider benralizumab for patients unable to taper prednisone to <7.5 mg/day after 3 months of therapy. Benralizumab dosing for EGPA is 30 mg SC every 4 weeks.Prednisone inability to taper to <7.5 mg/day after 3 months

Refer to EULAR and EGPA consensus guidance.

Age and dosing:

Use of benralizumab (Fasenra) for relief of acute bronchospasm or status asthmaticus is not indicated. Coverage is not authorized for these acute emergency indications.

Known hypersensitivity to benralizumab or its components is a contraindication and an exclusion to therapy; requests for members with documented hypersensitivity will be denied.

Non–FDA approved (off‑label) indications are not authorized unless they are specifically addressed in this policy or supported by appropriate clinical documentation consistent with the plan's off‑label use procedures.

Use of benralizumab outside populations studied in pivotal trials (for example, patients receiving only medium‑dose inhaled corticosteroids without demonstrated benefit as noted in CALIMA) or concurrent use with other biologic therapies is not supported by available evidence and is not authorized. Combination biologic therapy has not been studied and is not recommended.

Initial Authorization Requirements

inv-26: Initial Therapy — Initial authorization requirements by indication

Initial authorization requirements by indication:

Severe Asthma initial: Diagnosis of asthma; specialist prescriber or consultation; absolute blood eosinophil count ≥150 cells/mcL within 3 months; age ≥6 years; ≥2 exacerbations in prior 12 months despite medium- to high-dose ICS plus LABA or LTRA; Fasenra prescribed with ICS plus LABA or LTRA; not used concurrently with other named biologics; dosing within specified age/weight limits.

Approval duration 6 months.

EGPA initial: Diagnosis of active, non-severe EGPA; specialist prescriber or consultation; eosinophilia (>1 x10^9/L or ≥10% leukocytes) within 3 months; age ≥18 years; failure of 4-week glucocorticoid trial unless contraindicated; not used concurrently with other named biologics; dose ≤30 mg every 4 weeks.

Approval duration 6 months.

inv-27: Initial Dosing — Dosing regimens for initial approval depend on indication and age/weight.

Dosing regimens for initial approval depend on indication and age/weight.

Continuation / Reauthorization Criteria

inv-28: Continued Therapy - All Indications

Criteria for continuation of therapy for covered indications:

Continued Therapy - All Indications: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria; 2) Demonstrated adherence to controller therapy (PDC ≥ 0.8 over the prior 6 months) where applicable; 3) Clinical response demonstrated (e.g., fewer exacerbations, reduced steroid requirement, improved lung function); 4) Fasenra not prescribed concurrently with other specified biologics; 5) Dosing limits respected and any requested dose increase does not exceed regimen limits.PDC >= 0.8

Commercial approval typically 6 months; Medicaid 12 months.

inv-29: Continuation Therapy — Continuation criteria reference adherence and prior response.

Continuation criteria reference adherence and prior response.

Continuation criteria: Continuation may require evidence of adherence to controller therapy (defined as PDC ≥ 0.8 over the prior 6 months) and evidence of clinical benefit (reduction in exacerbations or corticosteroid dose, improved FEV1 or reduced rescue use).

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must document that all approval criteria are met, including diagnosis, specialist involvement, baseline eosinophil count, exacerbation history, and that Fasenra is being used as add-on/step therapy after appropriate controller treatment. Requests lacking required documentation may be denied.

Prior authorization required for benralizumab (HCPCS J0517).
Provider must document member meets ALL approval criteria (diagnosis of severe asthma, specialist prescribing or consultation, baseline absolute blood eosinophil count ≥150 cells/mcL within the past 3 months, age criteria, and exacerbation history).
Documentation should include office chart notes, relevant lab results (blood eosinophil count), and records of exacerbations or systemic corticosteroid use.
Baseline blood eosinophil lab results may be converted using the manufacturer calculator (e.g., https://www.fasenrahcp.com/m/fasenraeosinophil-calculator.html).
Adherence to controller therapy should be documented (PDC or equivalent) and evidence that Fasenra is being used as add-on therapy after high-dose ICS plus an additional controller (e.g., LABA or LTRA) per guideline/criteria.

Coding and Clinical Thresholds

Policy Identifiermixed

CP PHAR.373

Clinical Policy reference number for Benralizumab (Fasenra)

HCPCS CodesHCPCS

J0517

Injection, benralizumab, 1 mg

Blood eosinophil count (BEC) — ≥ 150 cells/mcL

ThresholdAbsolute blood eosinophil count (BEC) ≥ 150 cells/mcL within the past 3 months

ContextRequired as part of initial severe asthma criteria alongside diagnosis, specialist involvement, age ≥6 years, and exacerbation history

Source trials notePooled analyses and trials showed treatment effect at BEC ≥150 cells/µL; pivotal trials were powered at higher thresholds (see baseline BEC entry)

Baseline blood eosinophil count — trial and predictive thresholds

Baseline BEC predictive thresholdBaseline blood eosinophil count ≥ 150 cells/µL (treatment effect seen)

Trials powered at

Step Therapy and Therapeutic Alternatives

Step	Requirement
Therapeutic alternatives referenced (see Appendix B)
Formulary/off-formulary pathways: follow applicable plan policies (e.g., commercial CP CPA.190; Medicaid CP PMN.16)
Off-label uses require referral to the off-label use policy for the relevant line of business (CP CPA.09 for commercial; CP PMN.53 for Medicaid) when the requested use is not listed in exclusions

Prior optimization	Documentation / Assessment
Prior optimization on high‑dose ICS plus an additional controller (e.g., LABA or LTRA) is expected before biologic therapy for severe asthma
Adherence assessment may be used: PDC ≥ 0.8 over the prior 6 months to confirm adequate controller adherence (equates to ~144 of last 180 days)

Quantity and Product Limits

Benralizumab (Fasenra) — product dosing and presentations

Product presentationsSingle‑dose autoinjector (Fasenra Pen) 30 mg/mL; single‑dose prefilled syringe 10 mg/0.5 mL and 30 mg/mL

Adult/adolescent dosing (reference)30 mg SC every 4 weeks for first 3 doses then every 8 weeks (ages ≥12) — per dosing section

Pediatric presentation10 mg prefilled syringe formulation available for pediatric dosing (for lower weight cohorts)

Site of Care

Note

Product available for home, office, or infusion center administration

Benralizumab is available as a subcutaneous single‑dose autoinjector and prefilled syringe and may be administered in outpatient settings (home, office, or infusion center); the policy does not restrict these administration sites beyond standard requirements.

Product presentations: single‑dose autoinjector (30 mg) and prefilled syringe (10 mg and 30 mg).
No site‑of‑care restriction specified in the policy.

Background

Benralizumab (Fasenra) is an anti‑IL‑5 receptor alpha monoclonal antibody indicated as add‑on maintenance therapy for severe eosinophilic asthma in patients aged ≥ 6 years and for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in adults. It is not indicated for relief of acute bronchospasm or status asthmaticus. Baseline blood eosinophil count is a predictor of response; trials demonstrated treatment effect at ≥ 150 cells/µL (with many trials powered at ≥ 300 cells/µL). Laboratory eosinophil results may be converted to cells/mcL using the manufacturer's calculator.

Definitions

Severe asthma (per policy/trials) — definition and context

DefinitionSevere asthma: ≥2 exacerbations despite regular use of high‑dose ICS plus an additional controller (e.g., LABA or LTRA), with or without oral corticosteroids

Clinical contextPivotal trials defined severe asthma this way; CALIMA included some medium‑dose ICS patients who did not show benefit

Guideline noteGINA recommends considering Fasenra for patients ≥12 years with exacerbations or poor control despite high‑dose ICS/LABA and eosinophilic biomarkers

Clinically significant exacerbation — operational definition

DefinitionClinically significant exacerbation: worsening of asthma leading to one of the following — use of systemic corticosteroids, an emergency department/urgent care visit, or inpatient hospitalization

Trial usage

OpenPayer

Benralizumab (Fasenra) — coverage criteria for severe asthma and EGPA