CurrentUnitedHealthcarePolicy N/A

Fasenra (benralizumab) — Prior Authorization and Reauthorization Criteria for Prefilled Autoinjector

Prior authorization and reauthorization criteria for Fasenra (benralizumab) prefilled autoinjector under UnitedHealthcare Pharmacy Clinical Pharmacy Programs; covers use for severe eosinophilic asthma (age 6+) and eosinophilic granulomatosis with polyangiitis (EGPA) and affects providers requesting pharmacy/medical benefit coverage.

Policy Summary

PayerUnitedHealthcare

PolicyFasenra (benralizumab) prior authorization and reauthorization for prefilled autoinjector

Policy CodePolicy N/A

Change TypeAdded EGPApediatric age expansionformulation specified

Effective DateOct 1, 2025

Next Review DateJul 1, 2025

Key ActionObtain prior authorization for the Fasenra prefilled autoinjector and provide documentation of positive clinical response and concomitant maintenance therapy; confirm patient is not receiving excluded biologics.

SourceLink

POLICY UPDATE CHANGES

Added indication and criteria for eosinophilic granulomatosis with polyangiitis (EGPA).

Background updated to reflect indication for patients 6 years and older with severe asthma and eosinophilic phenotype.

Program updated to apply specifically to the prefilled autoinjector formulation.

>=6minimum age for severe asthma indication

EGPAnew covered indication

12 moauthorization duration for reauthorization

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Coverage Criteria

Initial Therapy — Severe Asthma

Initial authorization for severe asthma will be approved when ONE of the following is met:

Pathway A: ALL of the following: patient established on therapy with Fasenra under an active UnitedHealthcare medical benefit authorization for the treatment of severe asthma; documentation of positive clinical response to Fasenra therapy; Fasenra will be used in combination with maintenance asthma therapy (for example: Advair/AirDuo [fluticasone/salmeterol], Breo Ellipta [fluticasone furoate/vilanterol], Symbicort [budesonide/formoterol], Trelegy Ellipta [fluticasone furoate/umeclidinium/vilanterol]); patient is not receiving Fasenra in combination with any of the following for treatment of the same indication: anti-IL-5 therapies (e.g., reslizumab, mepolizumab), anti-IL-4 therapy (dupilumab), anti-IgE therapy (omalizumab), or TSLP inhibitor therapy (tezepelumab).

Pathway B: ALL of the following: diagnosis of severe asthma (eosinophilic phenotype); Fasenra will be used in combination with maintenance asthma therapy (for example: Advair/AirDuo [fluticasone/salmeterol], Breo Ellipta [fluticasone furoate/vilanterol], Symbicort [budesonide/formoterol], Trelegy Ellipta [fluticasone furoate/umeclidinium/vilanterol]); patient is not receiving Fasenra in combination with any of the following for treatment of the same indication: anti-IL-5 therapies (e.g., reslizumab, mepolizumab), anti-IL-4 therapy (dupilumab), anti-IgE therapy (omalizumab), or TSLP inhibitor therapy (tezepelumab).

Initial Therapy — EGPA

Initial authorization for EGPA will be approved when ONE of the following is met:

EGPA Pathway A: ALL of the following: patient has been established on therapy with Fasenra under an active UnitedHealthcare medical benefit prior authorization for the treatment of EGPA; documentation of positive clinical response to Fasenra therapy; patient is not receiving Fasenra in combination with any of the following for treatment of the same indication: anti-IL-5 therapies (e.g., reslizumab, mepolizumab), anti-IL-4 therapy (dupilumab), anti-IgE therapy (omalizumab), or TSLP inhibitor therapy (tezepelumab).

EGPA Pathway B: ALL of the following: diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA); patient is not receiving Fasenra in combination with any of the following for treatment of the same indication: anti-IL-5 therapies (e.g., reslizumab, mepolizumab), anti-IL-4 therapy (dupilumab), anti-IgE therapy (omalizumab), or TSLP inhibitor therapy (tezepelumab).

Reauthorization

Reauthorization for either indication will be approved when ALL of the following are met:

Reauthorization criteria: Documentation of positive clinical response to Fasenra therapy; continued use in combination with maintenance therapy (for asthma); patient is not receiving Fasenra in combination with any of the following for treatment of the same indication: anti-IL-5 therapies (e.g., reslizumab, mepolizumab), anti-IL-4 therapy (dupilumab), anti-IgE therapy (omalizumab), or TSLP inhibitor therapy (tezepelumab); authorization will be issued for 12 months.

Use of Fasenra (benralizumab) in combination with other specified biologic agents for the treatment of the same indication is excluded. Specifically, Fasenra should not be used concurrently with anti–interleukin‑5 agents (for example, reslizumab, mepolizumab), anti–interleukin‑4/13 therapy (dupilumab), anti‑IgE therapy (omalizumab), or thymic stromal lymphopoietin (TSLP) inhibitor therapy (tezepelumab). Coverage decisions assume Fasenra is being used as the biologic therapy for the patient’s indicated condition rather than in combination with these agents.

Fasenra is not indicated for the treatment of eosinophilic conditions other than the covered indications and is not appropriate for relief of acute bronchospasm or management of status asthmaticus. Requests for coverage should align with the labeled indications and not be submitted for other eosinophilic disorders or for emergency/acute symptom relief.

Initial Therapy

Initial Therapy — Covered Indications

Initial authorization for covered indications will be approved when ONE of the following initial pathways is met:

Severe asthma initial - established use: Patient established on therapy with Fasenra under an active UnitedHealthcare medical benefit prior authorization for severe asthma; documentation of positive clinical response to Fasenra; Fasenra used in combination with maintenance asthma therapy; patient is not receiving Fasenra in combination with any excluded biologic for the same indication (examples: reslizumab, mepolizumab, dupilumab, omalizumab, tezepelumab).

Severe asthma initial - new start: Diagnosis of severe asthma (eosinophilic phenotype); Fasenra used in combination with maintenance asthma therapy; patient is not receiving Fasenra in combination with any excluded biologic for the same indication (examples: reslizumab, mepolizumab, dupilumab, omalizumab, tezepelumab).

EGPA initial - established use: Patient established on therapy with Fasenra under an active UnitedHealthcare medical benefit prior authorization for EGPA; documentation of positive clinical response to Fasenra; patient is not receiving Fasenra in combination with any excluded biologic for the same indication (examples: reslizumab, mepolizumab, dupilumab, omalizumab, tezepelumab).

Continuation / Reauthorization Criteria

Continuation/Reauthorization

Reauthorization/continuation will be approved when ALL of the following evidence elements are provided:

Continuation/Reauthorization: Documentation of positive clinical response to Fasenra; continued use in combination with maintenance therapy for asthma (when applicable); no concurrent excluded biologic therapy (anti-IL-5, anti-IL-4, anti-IgE, or TSLP inhibitor agents); authorize for 12 months upon approval.

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Fasenra (benralizumab) prefilled autoinjector prior to coverage under the UnitedHealthcare medical benefit. Submit an active prior authorization request and include indication-specific documentation; approval pathways include continuation from an existing UHC authorization for Fasenra or initial authorization when all clinical criteria are met.

Effective date: 2025-10-01
Applies to Fasenra prefilled autoinjector

Denial Risk

Concurrent Biologic Therapy Exclusion — Denial Risk

Fasenra must not be used concurrently with other biologic therapies for the same indication. Coverage may be denied if Fasenra is prescribed in combination with any of the listed biologics for the same treated condition.

Anti‑interleukin‑5 therapies: Cinqair (reslizumab), Nucala (mepolizumab)

Coding and Billing Notes

Billing Rule

Site-of-care / benefit assignment — medical benefit for prefilled syringe

The prefilled syringe formulation is typically billed under the medical benefit; verify site-of-care and benefit applicability with UnitedHealthcare Medical Benefit policies.

Check UnitedHealthcare Medical Benefit policy for assignment of benefit and applicable site-of-care (e.g., infusion center) before submitting claims.
Supply limitations and medical necessity edits may apply under medical benefit programs.

Step Therapy / Biologic Combination Policy

Restriction	Details
Concurrent biologic therapy prohibition	Fasenra must not be used in combination with any of the following biologic agents for treatment of the same indication: anti–interleukin‑5 therapies (e.g., Cinqair [reslizumab], Nucala [mepolizumab]); anti‑interleukin‑4 therapy (Dupixent [dupilumab]); anti‑IgE therapy (Xolair [omalizumab]); thymic stromal lymphopoietin (TSLP) inhibitor therapy (Tezspire [tezepelumab]).

Background

Benralizumab (Fasenra) is an interleukin‑5 receptor alpha–directed cytolytic monoclonal antibody approved as add‑on maintenance therapy for patients with severe eosinophilic asthma aged 6 years and older and for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). It targets the IL‑5 receptor on eosinophils to reduce eosinophil-mediated airway inflammation and is intended for chronic maintenance use rather than for acute bronchospasm or status asthmaticus.

Definitions

Eosinophilic phenotype

DefinitionAsthma characterized by elevated eosinophils and associated clinical features indicating responsiveness to anti–IL-5 pathway therapies.

Clinical relevanceIdentifies patients with severe asthma who may benefit from benralizumab (Fasenra) add-on maintenance therapy.

Age implicationIncluded as an indication for patients age 6 years and older when asthma is of the eosinophilic phenotype.

Treatment implicationSupports use of anti–IL-5 pathway biologics (e.g., benralizumab) rather than acute bronchodilator or rescue therapies.

ExclusionsFasenra is not indicated for other eosinophilic conditions or for relief of acute bronchospasm or status asthmaticus.