Benralizumab (medical benefit) coverage — criteria for severe/eosinophilic asthma and EGPA
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Criteria for medical-benefit coverage and quantity limits for benralizumab when used to treat severe/eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA) under the payer's medication utilization policy, affecting prescribers and beneficiaries in NC.
No material clinical or coverage changes in this revision.
Coverage Criteria for Benralizumab (medical benefit)
Initial Therapy - Asthma
Covered when ALL of the following are met for initial approval (Asthma):
Initial approval criteria for asthma
- Age: Patient is >= 6 years of age
- Prescriber: Prescribed by, or in consultation with, an allergist, pulmonologist, or immunologist
- Diagnosis of severe asthma
- Eosinophilic phenotype: Diagnosis of eosinophilic asthma with a provided baseline blood eosinophil concentration >= 150 cells/µL>= 150 cells/µL
- Exacerbation history: History of >= 2 asthma exacerbations requiring systemic corticosteroids or emergency department visit or hospitalization for asthma within the past year despite adherent use of an inhaled corticosteroid (ICS) plus one additional controller or maximally tolerated ICS/LABA
- Attestations: Prescriber attests patient adherence to controller medications and that benralizumab will not be used in combination with another targeted immunomodulator product used for asthma
Initial Therapy - EGPA
Covered when ALL of the following are met for initial approval (EGPA):
Initial approval criteria for EGPA
- Age: Patient is >= 18 years of age
- Prescriber: Prescribed by, or in consultation with, a rheumatologist, allergist, pulmonologist, or immunologist
- Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA; Churg-Strauss Syndrome)
- Eosinophil criteria: Either baseline absolute eosinophil count > 1000 cells/µL OR baseline eosinophil percentage > 10% of total leukocyte count> 1000 cells/µL; > 10%
- Corticosteroid trial: Trial of oral corticosteroid therapy equivalent to prednisone 7.5 mg/day for >= 4 weeks was ineffective, contraindicated, or not tolerated>= 4 weeks at prednisone 7.5 mg/day equivalent
Continuation Therapy - Asthma
Covered when ALL of the following are met for continuation (Asthma):
Continuation criteria for asthma
- Diagnosis of eosinophilic asthma
- Response: Positive clinical response has been achieved
Positive clinical response is required but not explicitly defined in the policy
- Concomitant therapy: Will not be used in combination with another targeted immunomodulator product used for asthma
Continuation Therapy - EGPA
Covered when ALL of the following are met for continuation (EGPA):
Continuation criteria for EGPA
- Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA; Churg-Strauss Syndrome)
- Response: Positive clinical response has been achieved
Positive clinical response is required but not explicitly defined in the policy
Benralizumab is not permitted to be used concurrently with another targeted immunomodulator product for the treatment of asthma. This restriction applies at both initiation and continuation of therapy and must be attested to by the prescriber for initial approval. The policy does not list other specific exclusions beyond the non-concurrent targeted immunomodulator requirement.
Prescriber attestation of non-concurrent use is a required part of the documentation for prior authorization and is included among the conditions that may trigger denial if not provided.
Therapy will be considered not medically necessary when the patient fails to meet any of the initial approval requirements. For asthma, examples include: patient age < 6 years, the medication is not prescribed by or in consultation with an allergist, pulmonologist, or immunologist, absence of a diagnosis of severe asthma or eosinophilic phenotype, baseline blood eosinophil concentration < 150 cells/µL, or lack of documented history of ≥ 2 exacerbations in the prior year despite adherent use of an inhaled corticosteroid plus an additional controller or maximally tolerated ICS/LABA. Initial approval also requires a prescriber attestation of medication adherence and that benralizumab will not be used with another targeted immunomodulator for asthma.
For eosinophilic granulomatosis with polyangiitis (EGPA), therapy is not supported if the patient is < 18 years of age, the prescriber is not an appropriate specialist or consultant, the diagnosis of EGPA is not documented, neither eosinophil criterion is met (absolute count > 1000 cells/µL or eosinophils > 10% of total leukocytes), or there is no documentation that a trial of oral corticosteroid therapy equivalent to prednisone 7.5 mg/day for ≥ 4 weeks was ineffective, contraindicated, or not tolerated.
Coding and Baseline Parameters
| J0517 | Injection, benralizumab, 1 mg |
Prescriber Requirements and Documentation
Prior Authorization Required
Prior authorization is required for initiation of therapy for eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). Requests must meet indication- and age-specific criteria and will be reviewed against documented baseline eosinophil counts, prior controller therapy and exacerbation history, and specialist prescriber or documented consultation.
- Indications: eosinophilic asthma (age ≥ 6 years) or EGPA (age ≥ 18 years)
- Prescriber: board-certified allergist, pulmonologist, immunologist, or rheumatologist (for EGPA) or documented consultation with one of these specialists
- Baseline labs: blood eosinophil count (see indication thresholds below)
- Quantity/authorization limits: loading and maintenance dosing as per policy; initial approval up to 6 months
Controller Therapy Requirement
Approval is contingent on prior controller therapy and evidence of adherence. For asthma, the patient must have used an inhaled corticosteroid (ICS) plus one additional controller or a maximally tolerated ICS/LABA combination and continued to experience exacerbations despite adherence. The prescriber must attest to adherence and that the product will not be used with another targeted immunomodulator for asthma.
- Required prior therapy for asthma: documented trial and adherence to ICS + ≥1 additional controller OR maximally tolerated ICS/LABA
- Exacerbation requirement: ≥2 exacerbations in past 12 months requiring systemic corticosteroids or ED visit or hospitalization despite adherent controller use
Required Documentation
Documentation must be submitted with the prior authorization request to support the diagnosis, baseline eosinophil counts, prior therapies and adherence, exacerbation history, and specialist involvement. Incomplete documentation may delay review or lead to denial.
- Diagnosis: severe asthma with eosinophilic phenotype or EGPA (Churg-Strauss)
- Age: asthma ≥ 6 years; EGPA ≥ 18 years
- Baseline labs: blood eosinophil count (asthma ≥ 150 cells/µL; EGPA: >1000 cells/µL OR >10% of total leukocytes)
- Prior therapy and adherence: records showing trial of and adherence to ICS + additional controller or maximally tolerated ICS/LABA; for EGPA, trial of oral corticosteroid therapy (prednisone 7.5 mg/day equivalent for ≥4 weeks) shown ineffective, contraindicated, or not tolerated
- Exacerbation history: documentation of ≥2 exacerbations in prior 12 months requiring systemic corticosteroids or ED/hospital treatment (for asthma)
- Specialist prescriber or consultation note: attestation by or documentation of consultation with allergist, pulmonologist, immunologist, or rheumatologist (for EGPA)
- Prescriber attestation: patient adherence to controller meds and no concurrent use with another targeted immunomodulator for asthma
Triggers for Denial
Requests will be denied if key eligibility or documentation criteria are not met. Common triggers for denial include failure to meet age or diagnosis criteria, inadequate or missing eosinophil data, lack of documented prior controller therapy and adherence, insufficient exacerbation history, or absence of specialist prescriber/consultation and required attestation.
- Age not met: asthma < 6 years or EGPA < 18 years
- Diagnosis not documented or inconsistent with severe eosinophilic asthma or EGPA
- Missing or below-threshold baseline eosinophil count: asthma < 150 cells/µL; EGPA not meeting >1000 cells/µL or >10% leukocytes
- No documentation of prior controller therapy trial and adherence (ICS + additional controller or maximally tolerated ICS/LABA)
- Exacerbation history insufficient: fewer than 2 qualifying events in prior 12 months for asthma
- No specialist prescriber or documented consultation (allergist, pulmonologist, immunologist, or rheumatologist where required)
- No prescriber attestation that therapy will not be combined with another targeted immunomodulator for asthma
Background
Benralizumab is a monoclonal antibody biologic that targets eosinophils to reduce eosinophil-mediated inflammation. The policy addresses benralizumab for two clinical indications: severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). For asthma, coverage requires demonstration of an eosinophilic phenotype with a baseline blood eosinophil concentration of at least 150 cells/µL, specialist involvement, and a history of exacerbations despite adherence to appropriate controller therapy. For EGPA, coverage requires specialist prescriber involvement, documentation of EGPA, elevated baseline eosinophils (either an absolute count > 1000 cells/µL or > 10% of total leukocytes), and an inadequate, contraindicated, or not tolerated trial of oral corticosteroid therapy.
Prior authorization is required for both indications and continuation of therapy requires documentation of a positive clinical response. Initial authorization periods and quantity limits differ by indication (initial approval for 6 months; continuation approvals for up to 1 year), and dosing quantities authorized are specified in the policy.
Definitions and Key Terms
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