CurrentNeighborhood Health Plan of Rhode IslandPolicy 2413-A

Fasenra (benralizumab) coverage for severe asthma and EGPA

Defines prior authorization criteria, documentation, prescriber specialty, duration, continuation criteria, and concomitant therapy restrictions for benralizumab (Fasenra) for treatment of severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). Applies to benefits administered/managed by Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFasenra (benralizumab) coverage for severe asthma and EGPA

Policy CodePolicy 2413-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart notes showing baseline pretreatment eosinophil count and prior medication history for initial requests; provide documentation of clinical improvement for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthspossible initial authorization duration when prior biologic used (asthma)

12 monthsstandard authorization duration for most approvals/continuations

>=150asthma baseline eosinophil threshold (one pathway)

>1000EGPA eosinophil threshold

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Indications and Medical Necessity Criteria

Fasenra (benralizumab) is an anti-eosinophil monoclonal antibody indicated as add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged 6 years and older, and for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in adults. The medication is intended for maintenance therapy and is not indicated for relief of acute bronchospasm or status asthmaticus.

Indications - Covered when ALL approval criteria are met

FDA-approved indications covered when the following criteria are met; all other indications considered experimental/investigational.

Indications covered

Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and an eosinophilic phenotype
Treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA)

Asthma - Initial authorization (6 months may be granted if prior biologic used; otherwise 12 months)

Authorization may be granted when ALL of the following are met:

ALL of the following

Member is 6 years of age or older
Either of the following (one required)
- Baseline blood eosinophil count of at least 150 cells per microliter>= 150 cells/µL
- Member is dependent on systemic corticosteroids
- Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment
- One or more asthma exacerbation(s) resulting in hospitalization or emergency medical care visit(s)

Asthma - Continuation authorization (12 months)

Continuation may be granted when ALL of the following are met:

ALL of the following

Member is 6 years of age or older
- A reduction in the frequency and/or severity of symptoms and exacerbations
- A reduction in the daily maintenance oral corticosteroid dose
Member will continue maintenance asthma treatments in combination with Fasenra

EGPA - Initial authorization (12 months)

Authorization may be granted when ALL of the following are met:

ALL of the following

Member is 18 years of age or older
History or presence of a blood eosinophil count of more than 1000 cells per microliter or a blood eosinophil level of greater than 10%>1000 cells/µL or >10%
Member is currently taking oral corticosteroids, unless contraindicated or not tolerated
- Biopsy showing histopathological evidence of eosinophilic vasculitis, perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation

EGPA - Continuation authorization (12 months)

Continuation may be granted when ALL of the following are met:

ALL of the following

Member is 18 years of age or older
ANY of the following
- A reduction in the frequency of relapses
- A reduction or discontinuation of daily oral corticosteroid dose
- No active vasculitis

Other - Concomitant therapy restriction

For all indications:

ALL of the following

Member cannot use Fasenra concomitantly with any other biologic drug or targeted synthetic drug for the same indication

Laboratory thresholds

Asthma eosinophil threshold>= 150 cells/µL

Asthma corticosteroid-dependence alternativeMember may qualify if dependent on systemic corticosteroids (alternative pathway to eosinophil threshold)

EGPA eosinophil thresholds>1000 cells/µL or >10%

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior authorization required with documentation

Submit chart notes or medical records showing baseline pretreatment blood eosinophil count (as applicable) and prior medication history (drug, dose, frequency, duration) for initial requests; for continuation requests, submit chart notes or medical record documentation supporting clinical improvement in asthma or EGPA control.

Initial requests: baseline blood eosinophil count and prior medication history with drug, dose, frequency, duration.
Continuation requests: documentation demonstrating clinical improvement (e.g., reduced exacerbations, reduced oral corticosteroid dose).

Prior Authorization

Prescriber specialty requirement (asthma)

For the indication of asthma, Fasenra must be prescribed by or in consultation with an allergist/immunologist or pulmonologist.

Documentation Required

EGPA prior therapy documentation

For EGPA initial requests, provide chart notes, medical record documentation, or claims history documenting prior medications tried including drug, dose, frequency and duration; if a therapy is not advisable, include clinical rationale for avoiding that therapy.

Document specific prior agents, doses, frequency and duration attempted, or an explanation why a given therapy was contraindicated or not tolerated.

Documentation Required

Concomitant biologic prohibition

Document that the member will not receive Fasenra concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Denial Risk

Not medically necessary for non-FDA/compendial indications

Requests for indications other than the FDA‑approved or compendial uses listed (severe eosinophilic asthma age ≥6 and EGPA in adults) are considered experimental/investigational and are not medically necessary.

Policy Identifier and Coding References

Reference/Policy identifiermixed

2413-A

Reference number / policy identifier for Fasenra coverage criteria

Document footer identifiermixed

2413-A

Reference number / policy identifier for Fasenra coverage criteria

Defined Terms

Definitions

Uncontrolled asthmaDocumented by exacerbations requiring systemic corticosteroids, hospitalization/ED visits, or poor symptom control (frequent symptoms/reliever use, activity limitation, night waking)

Relapse (EGPA)An event requiring increase in oral corticosteroid dose, initiation/increase of immunosuppressive therapy, or hospitalization within the prior 2 years

EGPA high eosinophil burdenHistory or presence of blood eosinophil count >1000 cells/µL or >10% supports diagnosis and eligibility

Clinical and Policy Background

Clinically, Fasenra targets disorders driven by eosinophilic inflammation. For severe eosinophilic asthma the focus is on patients with a measurable eosinophil burden and persistent symptoms despite optimized inhaled therapy and additional controller therapy; authorization pathways emphasize baseline eosinophil thresholds and prior exacerbation history. In EGPA, selection centers on adults with a high eosinophil burden (documented historical or current counts) and features of systemic vasculitis: authorization criteria require both elevated eosinophils and at least two characteristic disease manifestations (for example biopsy evidence of eosinophilic vasculitis, neuropathy, pulmonary infiltrates, sino‑nasal disease, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, or ANCA positivity), as well as active disease that is corticosteroid‑dependent or has relapsed within the prior 2 years.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFasenra (benralizumab) coverage for severe asthma and EGPA

Policy CodePolicy 2413-A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma)

High-dose inhaled corticosteroid
Additional controller (e.g., long-acting beta2-agonist, long-acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline)

Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional controller) in combination with Fasenra

Neuropathy, mono or poly (motor deficit or nerve conduction abnormality)

Pulmonary infiltrates, non-fixed

Sino-nasal abnormality

Cardiomyopathy (established by echocardiography or magnetic resonance imaging)

Glomerulonephritis (hematuria, red cell casts, proteinuria)

Alveolar hemorrhage (by bronchoalveolar lavage)

Anti-neutrophil cytoplasmic antibody (ANCA) positive (Myeloperoxidase or proteinase 3)

Member has had at least one relapse (i.e., requiring increase in oral corticosteroid dose, initiation/increased dose of immunosuppressive therapy or hospitalization) within 2 years prior to starting treatment with the requested medication or has a refractory disease

OpenPayer

Fasenra (benralizumab) coverage for severe asthma and EGPA

Indications and Medical Necessity Criteria

Prior Authorization, Documentation, and Prescriber Requirements

Policy Identifier and Coding References

Defined Terms

Clinical and Policy Background

Policy Updates