CurrentCignaPolicy N/A

Immunologicals - Fasenra Prior Authorization Policy

Defines Cigna prior authorization requirements, coverage indications, and exclusion criteria for Fasenra (benralizumab subcutaneous injection) including FDA-approved uses for asthma and eosinophilic granulomatosis with polyangiitis (EGPA), required baseline testing, specialist prescribing, duration of approvals, and not-covered indications.

Policy Summary

PayerCigna

PolicyImmunologicals - Fasenra Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified, Revised, Added (see changes)

Effective Date

Next Review DateApr 9, 2025

Key ActionPrior authorization is recommended/required; document specialist involvement, required eosinophil results and prior treatment history, and follow approval durations for initial and continued therapy.

SourceLink

POLICY UPDATE CHANGES

Conditions Not Covered criteria updated to clarify that use of Fasenra with another monoclonal antibody therapy is specific to Cinqair, Nucala, Dupixent, Tezspire, Xolair, and Adbry.

Asthma age of approval previously reduced from ≥ 12 years to ≥ 6 years (historical change noted).

Eosinophil level requirements for asthma clarified to require ≥ 150 cells/µL either within previous 6 weeks OR prior to treatment with a monoclonal antibody that may alter eosinophil levels.

EGPA initial approval criteria were added (age, active non-severe disease, systemic corticosteroid trial, eosinophil requirement, specialist involvement).

Chronic spontaneous urticaria was added as a Condition Not Recommended for Approval.

2FDA-approved indications covered

4Not-covered conditions (examples)

150 cells/µL

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Eosinophil threshold

Coverage Summary

Scope: This policy defines Cigna prior authorization requirements, coverage indications, and exclusion criteria for Fasenra (benralizumab subcutaneous injection). Payer: Cigna. Product: Fasenra (benralizumab). Coverage stance: covered_with_criteria. FDA‑approved indications covered by the policy: severe eosinophilic asthma (patients ≥ 6 years) and eosinophilic granulomatosis with polyangiitis (EGPA) in adults. Examples of named conditions explicitly identified as not covered include COPD, chronic spontaneous urticaria, hypereosinophilic syndrome (among other eosinophilic disorders).

Medical Necessity Criteria

Prescriber Specialty Requirement

Initial approval requires Fasenra to be prescribed by or in consultation with a physician who specializes in the condition being treated (allergist, immunologist, pulmonologist, or rheumatologist as applicable)

Because of specialized skills required for evaluation and monitoring, specialist prescriber or consultation is required for initial approval

Not Medically Necessary / Exclusions

Conditions listed as not covered include Chronic Obstructive Pulmonary Disease (COPD) — supported by negative/insufficient findings in Phase II and Phase III (GALATHEA, TERRANOVA) trials — Chronic Spontaneous Urticaria (no significant benefit in ARROYO Phase IIb), and Hypereosinophilic Syndrome (considered investigational despite small trials). The policy also excludes concurrent use of Fasenra with another monoclonal antibody therapy because efficacy and safety of combinations have not been established. The policy names the monoclonal antibodies referenced in this exclusion: Cinqair (reslizumab), Nucala (mepolizumab), Dupixent (dupilumab), Tezspire (tezepelumab), Xolair (omalizumab), and Adbry (tralokinumab).

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Fasenra. Approvals are provided for specific durations depending on indication: initial asthma — 6 months; continued (currently receiving) asthma — 1 year; initial EGPA — 9 months; continued (currently receiving) EGPA — 1 year.

Documentation Required

Specialist involvement documentation

Document that Fasenra was prescribed by or in consultation with an appropriate specialist. Required specialties include allergist, immunologist, pulmonologist, or rheumatologist as applicable to the condition being treated.

Documentation Required

Prior eosinophil measurement

Provide blood eosinophil level results within the required timeframes or documentation of a prior level before receipt of a monoclonal antibody that may alter eosinophil counts. For asthma initial therapy the requirement is ≥ 150 cells/µL within the previous 6 weeks or a recorded level ≥ 150 cells/µL prior to treatment with Fasenra or another monoclonal antibody that may alter eosinophil levels. For EGPA initial therapy the requirement is ≥ 150 cells/µL within the previous 4 weeks or a recorded level ≥ 150 cells/µL prior to treatment with Fasenra or another monoclonal antibody that may alter eosinophil levels.

Coding

No specific procedure/drug billing codes listed in policy bodymixed

No codes listed

Background & Evidence

Background: Fasenra (benralizumab) is an IL‑5 receptor alpha–directed cytolytic monoclonal antibody. FDA indications in the policy are: add‑on maintenance treatment for severe eosinophilic asthma in patients ≥ 6 years and treatment of EGPA in adults. Clinical trials demonstrated greater benefit in patients with higher baseline blood eosinophils (e.g., ≥ 300 cells/µL in pivotal asthma trials), and evidence for use in other eosinophilic conditions and COPD is described as insufficient or negative (COPD trials GALATHEA and TERRANOVA showed no significant reduction in exacerbations; chronic spontaneous urticaria showed no therapeutic effect in ARROYO; hypereosinophilic syndrome remains investigational).

Revision History

03/22/2023clarified

Conditions Not Covered criteria updated to clarify that use of Fasenra with another monoclonal antibody therapy is specific to Cinqair, Nucala, Dupixent, Tezspire, Xolair, and Adbry.

03/22/2023revised

Asthma age of approval reduced from ≥ 12 years to ≥ 6 years (historical change noted).

04/19/2024clarified

Asthma eosinophil level requirements clarified to require ≥ 150 cells/µL either within the previous 6 weeks OR prior to treatment with a monoclonal antibody that may alter blood eosinophil levels.

Policy Summary

PayerCigna

PolicyImmunologicals - Fasenra Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified, Revised, Added (see changes)

Effective Date

Next Review DateApr 9, 2025

SourceLink

On This Page

Documentation Required

Treatment history documentation

Document at least 3 consecutive months of combination therapy with BOTH an inhaled corticosteroid AND at least one additional asthma controller or asthma maintenance medication prior to initiation for the asthma indication. Examples of additional controllers include inhaled long-acting beta2-agonists, inhaled long-acting muscarinic antagonists, monoclonal antibody therapies for asthma, or a combination inhaler containing both an inhaled corticosteroid and an additional controller.

Denial Risk

Not medically necessary exclusions

Not medically necessary exclusions — claims may be denied for uses not covered by the policy, including specific non-covered conditions and concurrent monoclonal antibody use. Examples of non-covered conditions: Chronic Obstructive Pulmonary Disease (COPD), Chronic Spontaneous Urticaria, Hypereosinophilic Syndrome. Concurrent use of Fasenra with another monoclonal antibody therapy (examples listed in policy) is also considered not medically necessary.

Concurrent use with another monoclonal antibody therapy is not established and is a not-covered exclusion.
Examples of non-covered conditions: COPD; Chronic Spontaneous Urticaria; Hypereosinophilic Syndrome.

10/02/2024addedLatest

EGPA initial approval criteria added (age ≥ 18, active non-severe disease, systemic corticosteroid trial ≥ 4 weeks, eosinophil requirement ≥ 150 cells/µL within previous 4 weeks or prior to monoclonal antibody therapy, and specialist involvement). [MATERIAL]

04/09/2025addedLatest

Chronic spontaneous urticaria added as a Condition Not Recommended for Approval. [MATERIAL]