CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Benralizumab (Fasenra) — Coverage Criteria

Defines coverage, prior authorization, and continuation criteria for Fasenra (benralizumab) for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBenralizumab (Fasenra) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2018

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals may be granted for 6 months when indication-specific criteria and required documentation are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications covered

6 moInitial auth duration

12 moContinuation auth duration

J0517HCPCS code

YesQuantity/syringe limits

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Coverage Criteria for Benralizumab (Fasenra)

Initial therapy — Severe Asthma

Covered when ALL of the following are met

Severe asthma initial criteria: A. Member is 6 years of age or older. B. Member has clinically documented severe asthma. C. Member has an eosinophilic phenotype with a documented blood eosinophil count >= 150 cells/µL within 6 weeks of starting therapy OR is dependent on systemic corticosteroids. D. Member is receiving add-on maintenance treatment and is regularly receiving BOTH: (1) medium- to high-dose inhaled corticosteroids AND (2) an additional controller medication (e.g., long-acting beta agonist, long-acting muscarinic agent, leukotriene modifiers). E. Documentation of inadequate asthma control with two or more exacerbations in the previous year requiring daily oral corticosteroids for at least 3 days (in addition to regular maintenance therapy). F. Baseline measurement of at least one of the following for assessment of clinical status: (1) use of systemic corticosteroids, (2) use of inhaled corticosteroids, (3) number of hospitalizations/ER/unplanned visits due to asthma, or (4) FEV1.see node text

Authorization of 6 months may be granted.

Initial therapy — EGPA

Covered when ALL of the following are met

EGPA initial criteria: A. Member is 18 years of age or older. B. Documentation of a confirmed diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA). C. Documentation that the disease is relapsing or refractory. D. Member has received prior treatment with oral corticosteroids with or without immunosuppressive therapy. E. Member has been on a stable dose of oral corticosteroid therapy for at least 4 weeks prior to starting treatment. F. Physician has documentation of assessed baseline disease severity utilizing an objective measure/tool (e.g., BVAS, history of asthma symptoms/exacerbations, duration of remission, or rate of relapses).see node text

Authorization of 6 months may be granted.

Continuation therapy — Severe Asthma

Covered for continuation when ONE of the following improvement criteria is met AND universal/initial criteria remain met

Severe asthma continuation: A. Improvement in asthma symptoms or exacerbations as evidenced by a decrease in one or more of: use of systemic corticosteroids; two-fold or greater decrease in inhaled corticosteroid use for at least 3 days; hospitalizations; ER visits; or unscheduled visits to a healthcare provider; OR B. Improvement from baseline in FEV1.see node text

Authorization of 12 months may be granted.

Continuation therapy — EGPA

Covered for continuation when ONE of the following disease response criteria is met AND universal/initial criteria remain met

EGPA continuation: Disease response as evidenced by one or more of the following: a) remission defined as BVAS = 0 plus prednisone/prednisolone daily dose <= 7.5 mg; b) decreased frequency of relapses; c) decrease in the daily oral corticosteroid dose; d) improvement on a disease activity scoring tool (e.g., VDI, BVAS, FVC, FEV1, ACQ-6).see node text

Authorization of 12 months may be granted.

Fasenra (benralizumab) is not indicated for use outside the covered eosinophilic indications listed in this policy. Specifically, it is not for treatment of other eosinophilic conditions (for example, allergic bronchopulmonary aspergillosis/mycosis or hypereosinophilic syndrome), and it is not for relief of acute bronchospasm or status asthmaticus. All other indications outside those expressly listed are considered experimental/investigational and are not a covered benefit.

Use of Fasenra for eosinophilic conditions other than the covered indications or for acute bronchospasm/status asthmaticus is considered not medically necessary / not covered. The policy explicitly requires that the member not receive Fasenra concomitantly with other biologic monoclonal antibodies targeting IgE, IL‑4, or IL‑5 pathways, and reiterates that treatment for other eosinophilic disorders or for relief of acute bronchospasm is outside the scope of coverage.

Coding and Administration Details

HCPCS/CPT CodesHCPCS

J0517

Injection, benralizumab, 1 mg

Blood eosinophil threshold

Threshold>= 150 cells per µL

TimingWithin 6 weeks of starting therapy

Alternate qualificationOr systemic corticosteroid dependence (as an alternative to eosinophil threshold)

Pediatric weight threshold and dosing

Age rangePediatric patients 6 to 11 years

Weight <35 kg dosing10 mg (one injection) every 4 weeks x3 doses, then every 8 weeks (loading and maintenance schedule)

Weight >=35 kg dosing30 mg (one injection) every 4 weeks x3 doses, then every 8 weeks (loading and maintenance schedule)

Prior Authorization, Documentation, and Prescriber Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial therapy. Initial approvals may be granted for up to 6 months when indication-specific criteria are met (age and diagnosis documented, eosinophil counts or systemic corticosteroid dependence when applicable, prior controller therapy and exacerbation history for severe asthma, or confirmed EGPA with prior corticosteroid/immunosuppressive therapy and documented relapsing/refractory disease).

Initial approvals: up to 6 months when all indication-specific criteria are satisfied
Severe asthma: member ≥6 years, documented severe eosinophilic asthma, blood eosinophils ≥150 cells/µL within 6 weeks of initiation OR systemic corticosteroid dependence, on medium–high dose ICS plus an additional controller, inadequate control with ≥2 exacerbations in prior year requiring oral corticosteroids, baseline objective measures documented
EGPA: member ≥18 years, confirmed diagnosis, relapsing/refractory disease, prior oral corticosteroid ± immunosuppressive therapy, stable steroid dose ≥4 weeks, baseline disease severity documented

Step Therapy

Step Therapy Note

Step therapy provisions and exemptions.

Members enrolled in the Medicare-Medicaid Plan (MMP) who have received this medication within the prior 365 days are exempt from step therapy requirements
All other members should follow applicable step therapy expectations unless clinical justification for bypass is provided

Denial Risk

Concomitant Therapy Exclusion

Concomitant therapy with other specified monoclonal antibodies is not permitted.

Member must not use Fasenra concomitantly with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (examples: Dupixent, Nucala, Xolair, Tezspire)
Use is not authorized for other eosinophilic conditions (e.g., allergic bronchopulmonary aspergillosis/mycosis, hypereosinophilic syndrome) or for relief of acute bronchospasm/status asthmaticus

Background on Benralizumab

Benralizumab is an anti–IL‑5 receptor alpha monoclonal antibody that depletes eosinophils and has demonstrated reductions in exacerbations, improved lung function, and oral corticosteroid–sparing effects in severe eosinophilic asthma; clinical trials also showed non‑inferiority to mepolizumab for remission outcomes in eosinophilic granulomatosis with polyangiitis (EGPA). Common adverse reactions include headache, pharyngitis, and injection site reactions.

Definitions and Clinical Components

Severe asthma (components)

Daily symptomsSymptoms throughout the day may indicate severe asthma

Nocturnal awakeningsFrequent nighttime awakenings (often nightly)

SABA useShort-acting beta agonist use several times per day

Activity limitationMarkedly limited normal activities (extremely limited)

Lung functionFEV1 percent predicted < 60%

Exacerbation frequencyFrequent, intense exacerbations often requiring systemic oral corticosteroids

EGPA (definition)

Required historyHistory of presence of asthma

Eosinophil thresholdBlood eosinophil >10% OR absolute eosinophil count >1000 cells/mm^3

Additional features (need >=2)Two or more: eosinophilic vasculitis/histopathology, neuropathy, pulmonary infiltrates, sinonasal abnormalities, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, or ANCA positivity