CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Fasenra (benralizumab) — Coverage Criteria

Defines medical specialty coverage criteria, authorization durations, dosing, and quantity limits for benralizumab (Fasenra) 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

PolicyFasenra (benralizumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date12/2018

Next Review DateN/A

Key ActionSubmit prior authorization; initial approvals are granted for 6 months when indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization period for treatment

12 monthscontinuation authorization period when improved

J0517HCPCS code for benralizumab (1 mg)

≥150 cells/µLeosinophil threshold (severe asthma)

1 syringe/56 daysstandard quantity limit

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Coverage Criteria for Fasenra (benralizumab)

Severe Asthma - Initial Therapy

Authorization of 6 months may be granted when ALL of the following are met:

Severe Asthma Initial Criteria: A. Member is 6 years of age or older. B. Clinically documented severe asthma. C. Eosinophilic phenotype with documentation of blood eosinophil count ≥150 cells/µL within 6 weeks of starting therapy OR systemic corticosteroid dependence. D. Receiving add-on maintenance therapy while regularly using 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 modifier). E. Inadequate asthma control defined by two or more exacerbations in the previous year requiring daily oral corticosteroids for at least 3 days despite maintenance therapy. F. Baseline measurement of at least one objective marker for assessment of clinical status (use of systemic corticosteroids, use of inhaled corticosteroids, number of hospitalizations/ER/unscheduled visits due to condition, or FEV1).

From chunk 5

EGPA - Initial Therapy

Authorization of 6 months may be granted 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 EGPA. C. Documentation of relapsing or refractory disease. D. Prior treatment with oral corticosteroids with or without immunosuppressive therapy. E. Stable dose of oral corticosteroid therapy for at least 4 weeks prior to starting treatment. F. Physician documentation of assessed baseline disease severity using an objective measure/tool (e.g., BVAS, history of asthma symptoms/exacerbations, duration of remission, or rate of relapses).

From chunk 6

Severe Asthma - Continuation of Therapy

Authorization of 12 months may be granted when ANY of the following evidence of improvement is met:

Asthma Continuation Criteria: A. Improvement in asthma symptoms or exacerbations evidenced by a decrease in one or more of the following: (a) use of systemic corticosteroids; (b) two-fold or greater decrease in inhaled corticosteroid use for at least 3 days; (c) hospitalizations; (d) ER visits; (e) unscheduled visits to a healthcare provider; OR B. Improvement from baseline in forced expiratory volume in 1 second (FEV1).

From chunk 8

EGPA - Continuation of Therapy

Authorization of 12 months may be granted when disease response is documented by ONE or more of the following:

EGPA Continuation Criteria: a. Remission defined as BVAS = 0 plus prednisone/prednisolone ≤7.5 mg/day; 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).

From chunk 9

Universal Criteria

Conditions that apply to all requests:

Universal: A. Member will not use Fasenra concomitantly with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents. B. Must NOT be used for: (a) treatment of other eosinophilic conditions (e.g., allergic bronchopulmonary aspergillosis/mycosis, hypereosinophilic syndrome, etc.); (b) relief of acute bronchospasm or status asthmaticus. C. MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements.

From chunk 4

Fasenra (benralizumab) is subject to specific coverage limits. It must not be used concomitantly with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents. The medication is not for the treatment of other eosinophilic conditions (for example, allergic bronchopulmonary aspergillosis, hypereosinophilic syndrome) and must not be used for relief of acute bronchospasm or status asthmaticus. Requests that do not meet the indication-specific criteria for severe eosinophilic asthma or EGPA (including required baseline documentation and eosinophil thresholds) may be denied.

Use of Fasenra for indications outside the FDA-approved or compendial uses (that is, for other eosinophilic conditions not listed in the policy) is considered experimental/investigational and is not a covered benefit.

Coding and Laboratory Thresholds

HCPCS/CPT CodeHCPCS

J0517

Injection, benralizumab, 1mg

Eosinophil thresholds — Severe asthma and EGPA blood eosinophil thresholds and timing

Severe asthma eosinophil thresholdBlood eosinophil count ≥150 cells/µL within 6 weeks of starting therapy (or systemic corticosteroid dependence)

Timing for asthma eosinophil measurementEosinophil count must be documented within 6 weeks prior to initiation of therapy

EGPA percent thresholdBlood eosinophil level >10%

EGPA absolute thresholdAbsolute eosinophil count >1000 cells/mm3

EGPA diagnostic timing/contextEosinophil thresholds apply as part of EGPA definition alongside history of asthma and ≥2 organ-specific criteria

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required; initial approval = 6 months

Prior authorization is required for benralizumab (Fasenra). When the policy's indication-specific criteria are met, initial approvals are granted for 6 months; MMP members previously treated with this medication within the past 365 days are exempt from step therapy requirements.

Initial authorization duration: 6 months when criteria are met (Severe asthma or EGPA).
MMP members with prior receipt of Fasenra within 365 days are not subject to step therapy.

Step Therapy

Step therapy expectations and MMP exemptions

Step therapy is expected for asthma requests unless the member is an MMP member who has received Fasenra within the past 365 days (those members are exempt). For asthma, the policy expects prior use of medium-to-high dose inhaled corticosteroids plus an additional controller before meeting initial criteria.

MMP members previously treated with Fasenra within 365 days: no step therapy (exempt).

Definitions

Severe eosinophilic asthma — Definition, age criteria, and eosinophil phenotype thresholds

DefinitionSevere eosinophilic asthma: asthma in patients aged ≥6 years with an eosinophilic phenotype (blood eosinophils ≥150 cells/µL within 6 weeks of therapy start or systemic corticosteroid dependence) receiving medium-to-high dose inhaled corticosteroids plus an additional controller with inadequate control

Age criterionPatient age ≥6 years for indication of Fasenra in severe asthma

Eosinophil phenotype thresholdBlood eosinophils ≥150 cells/µL within 6 weeks of starting therapy (alternative: systemic corticosteroid dependence)

Required background therapyReceiving both medium-to-high dose inhaled corticosteroids and an additional controller medication

Clinical control requirementInadequate control evidenced by ≥2 exacerbations in prior year requiring daily oral corticosteroids for ≥3 days despite maintenance therapy

Background

Benralizumab (Fasenra) is a monoclonal antibody that targets the interleukin-5 receptor on eosinophils, producing antibody-dependent cell-mediated cytotoxicity that leads to near-complete depletion of blood eosinophils. This mechanism reduces eosinophilic airway inflammation and has been associated with reductions in asthma exacerbations and decreases in oral corticosteroid requirements in patients with severe eosinophilic asthma. Clinical trial evidence in EGPA demonstrated comparable effects on remission and steroid-sparing when evaluated against other anti–IL-5 agents. Common adverse reactions reported include headache, pharyngitis, and injection site reactions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFasenra (benralizumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date12/2018

Next Review DateN/A

Key ActionSubmit prior authorization; initial approvals are granted for 6 months when indication-specific criteria are met.

SourceLink

On This Page

For severe asthma, member must be regularly receiving both medium-to-high dose inhaled corticosteroids and an additional controller medication prior to approval.

Documentation Required

Required documentation for authorization requests

Requests must include patient age, confirmed diagnosis (asthma or confirmed EGPA when applicable), blood eosinophil count for eosinophilic asthma, prior and current controller therapies, history of exacerbations or steroid dependence, and baseline objective measures of disease severity.

Age: ≥6 years for severe asthma; ≥18 years for EGPA.
Confirmed diagnosis: clinically documented severe asthma (see Appendix) or confirmed EGPA (see Appendix).
Blood eosinophil count: ≥150 cells/µL within 6 weeks of starting therapy for eosinophilic asthma (or systemic corticosteroid dependence alternative).
Prior/current controller therapies: documentation of medium-to-high dose inhaled corticosteroid plus an additional controller for asthma; prior oral corticosteroids ± immunosuppressive therapy for EGPA.
Exacerbation history/steroid dependence: ≥2 exacerbations in prior year requiring daily oral corticosteroids ≥3 days for asthma; documentation of relapsing/refractory disease and stable oral steroid dose ≥4 weeks for EGPA.
Baseline objective measures: systemic steroid use, inhaled steroid use, hospitalizations/ER/unscheduled visits, FEV1, or objective disease activity scoring (e.g., BVAS) for EGPA.

Denial Risk

Denial triggers for noncompliance with criteria

Requests failing to meet the policy's indication-specific criteria or missing required documentation/laboratory data may be denied.

Use for other eosinophilic conditions or for relief of acute bronchospasm/status asthmaticus — not covered and will be denied.
Absence of required eosinophil count for eosinophilic asthma (≥150 cells/µL within 6 weeks) or lack of documentation of systemic corticosteroid dependence when applicable.
Insufficient documentation of prior controller therapy (medium-to-high dose inhaled corticosteroid plus additional controller for asthma) or lack of prior oral corticosteroid/immunosuppressive therapy for EGPA.
Missing baseline objective measures (e.g., FEV1, hospitalizations/ER visits, BVAS) or failure to document relapsing/refractory disease for EGPA.

EGPA (Eosinophilic Granulomatosis with Polyangiitis) — Definition and diagnostic features

DefinitionEGPA: adult disorder characterized by history of asthma plus blood eosinophil level >10% or absolute eosinophil count >1000 cells/mm3 and two or more organ-specific criteria

Key diagnostic featuresRequires history of asthma and elevated eosinophils in blood

Organ-specific criteria (examples)Histopathologic eosinophilic vasculitis or perivascular eosinophilic infiltration; neuropathy; pulmonary infiltrates; sinonasal abnormalities; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; or ANCA positivity

Age criterionIndication for EGPA treatment in adults (per FDA-approved indication)