CurrentUnitedHealthcarePolicy CS2026D0055Y

Respiratory Interleukins (Cinqair®, Fasenra®, & Nucala®)

Medical Benefit Drug Policy governing provider-administered reslizumab (Cinqair), benralizumab (Fasenra), and mepolizumab (Nucala) for UnitedHealthcare members (with certain state-specific exceptions). It defines medical necessity criteria, administration setting, prescriber specialties, and authorization durations for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA).

Policy Summary

PayerUnitedHealthcare

PolicyRespiratory Interleukins (Cinqair®, Fasenra®, & Nucala®)

Policy CodePolicy CS2026D0055Y

Change TypeNo material change

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization with documentation that the patient meets indication-specific clinical criteria before provider-administered therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3drugs referenced (Cinqair, Fasenra, Nucala)

≥150eosinophil threshold for asthma

12 motypical initial auth (Fasenra, Cinqair)

6 moNucala EGPA initial auth

AZ, FL, IN, KS, NC, OH, PA, TX, WA

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states with exceptions

Coverage Criteria

Fasenra/Nucala — severe eosinophilic asthma (provider-admin)

Fasenra and Nucala for provider administration are proven and medically necessary for severe eosinophilic asthma when ALL of the following criteria are met:

ALL of the following

Diagnosis of severe asthma
Asthma classified as uncontrolled or inadequately controlled as defined by at least one of the following: poor symptom control (e.g., ACQ >1.5 or ACT <20); two or more bursts of systemic corticosteroids for ≥3 days each in the previous 12 months; asthma-related emergency treatment (ER visit, hospitalization, or unscheduled urgent visit); airflow limitation (post-bronchodilator FEV1 <80% predicted with reduced FEV1/FVC); or current dependence on maintenance oral corticosteroids
Asthma is an eosinophilic phenotype defined by baseline (pre-treatment) peripheral blood eosinophil level ≥ 150 cells/µL
Used in combination with one of the following: a maximally-dosed combination ICS/LABA product; or a maximally-dosed ICS plus one additional asthma controller medication
One of the following: physician attestation that patient/caregiver cannot or is physically unable to self-administer the FDA-labeled product; or documented history of severe hypersensitivity reaction to the product within the past 6 months requiring professional administration and monitoring; or patient is new to therapy and requires the initial dose to be administered and directly monitored by a healthcare professional (authorization for 1 dose)
Patient is not receiving Fasenra or Nucala in combination with other biologic therapies for the same indication (e.g., anti-IL-4, anti-IgE, other anti-IL-5 agents, TSLP inhibitors)
Dosing is in accordance with U.S. FDA-approved labeling
Prescribed by a pulmonologist, allergist/immunologist, or (for Fasenra EGPA requests) rheumatologist as applicable
Initial authorization will be for no more than 12 months (for Nucala EGPA initial auth may be up to 6 months per EGPA-specific criteria)

Asthma — Reauthorization/Continuation

Reauthorization/Continuation criteria for asthma biologic therapy (Fasenra, Nucala, Cinqair) — ALL of the following must be met:

ALL of the following

Documentation of positive clinical response as demonstrated by at least one of: reduction in frequency of exacerbations; decreased utilization of rescue medications; increase in percent predicted FEV1 from pretreatment baseline; or reduction in severity or frequency of asthma-related symptoms (e.g., wheezing, shortness of breath, coughing)
Therapy is continued as add-on maintenance in combination with an ICS-containing maintenance medication
Patient is not receiving the product in combination with any of the following for treatment of the same indication: another anti-IL-5 therapy, anti-IgE therapy (omalizumab), anti-IL-4 therapy (dupilumab), or a TSLP inhibitor (tezepelumab)
Dosing is in accordance with U.S. FDA-approved labeling

HES — Initial Therapy (provider administration)

Nucala for provider administration is proven and medically necessary for Hypereosinophilic Syndrome (HES) initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of HES for ≥ 6 months
No identifiable non-hematologic secondary cause of HES (e.g., drug hypersensitivity, parasitic helminth infection, HIV, non-hematologic malignancy)
HES is not FIP1L1-PDGFRα kinase-positive
One of the following: physician attestation that patient/caregiver cannot or is physically unable to self-administer; documented history of severe hypersensitivity reaction to Nucala within the past 6 months requiring professional administration and monitoring; or patient is new to therapy and requires the initial dose to be directly monitored by a healthcare professional (authorization for 1 dose)

HES — Reauthorization/Continuation

Nucala for HES — Reauthorization/Continuation of Care will be approved when ALL of the following criteria are met:

ALL of the following

Documentation of positive clinical response as demonstrated by at least one of: reduction in frequency of HES flares; or maintenance or reduction in background HES therapy requirements
One of the following: physician attestation that patient/caregiver cannot or is physically unable to self-administer; or documented history of severe hypersensitivity reaction to Nucala within the past 6 months requiring professional administration and monitoring
Patient is not receiving Nucala in combination with other biologic therapies for the same indication (e.g., other anti-IL-5 agents, anti-IgE, anti-IL-4, TSLP inhibitors)
Dosing is in accordance with U.S. FDA-approved labeling

CRSwNP — Initial Therapy (provider administration)

Nucala for provider administration is proven and medically necessary for CRSwNP initial therapy when ALL of the following criteria are met:

ALL of the following

Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) defined by two or more symptoms for >12 weeks: nasal mucopurulent discharge; nasal obstruction/blockage/congestion; facial pain/pressure/fullness; or reduction/loss of smell
One of the following endoscopic/CT findings: purulent mucus or edema in middle meatus/ethmoid regions; polyps in nasal cavity or middle meatus; or radiographic imaging demonstrating mucosal thickening or opacification of paranasal sinuses
One of: presence of bilateral nasal polyposis; or prior surgical removal of bilateral nasal polyps
One of: prior sinus surgery; or systemic corticosteroids for CRSwNP in prior 2 years; or failure of two classes of therapies (nasal saline irrigations, intranasal corticosteroids, antileukotriene agents)

CRSwNP — Reauthorization/Continuation

Nucala for CRSwNP — Reauthorization/Continuation will be approved when ALL of the following criteria are met:

ALL of the following

Documentation of positive clinical response to Nucala therapy
Patient will continue to receive Nucala as add-on maintenance therapy in combination with intranasal corticosteroids
One of: physician attestation that patient/caregiver cannot or is physically unable to self-administer; or documented history of severe hypersensitivity reaction to Nucala within the past 6 months requiring professional administration and monitoring; or patient is ≤ 11 years of age
Patient is not receiving Nucala in combination with other biologic therapies for the same indication (e.g., other anti-IL-5 agents, anti-IgE, anti-IL-4, TSLP inhibitors)

COPD — Initial Therapy (provider administration)

Nucala for provider administration is proven and medically necessary for Chronic Obstructive Pulmonary Disease (COPD) initial therapy when ALL of the following criteria are met:

ALL of the following

Diagnosis of COPD defined by post-bronchodilator FEV1/FVC ratio < 0.7 and post-bronchodilator FEV1 % predicted between 20% and 80%
Eosinophilic phenotype defined by baseline (pre-mepolizumab) peripheral blood eosinophil level ≥ 300 cells/µL
Uncontrolled or inadequately controlled COPD demonstrated by at least one of: two or more COPD exacerbations in the previous year requiring systemic corticosteroids and/or antibiotics; or one or more exacerbations resulting in hospitalization or observation >24 hours in past year
Exacerbations occurred while receiving maintenance therapy with either triple therapy (LAMA+LABA+ICS) or dual therapy (LAMA+LABA) with failure/contraindication/intolerance to an ICS

COPD — Reauthorization/Continuation

Nucala for COPD — Reauthorization/Continuation of Care will be approved when ALL of the following criteria are met:

ALL of the following

Documentation of positive clinical response to Nucala therapy
Nucala is being used in combination with maintenance therapy (examples: ICS-containing combos, dual/triple bronchodilator regimens such as Advair/AirDuo, Bevespi Aerosphere, Breo Ellipta, Symbicort, Trelegy Ellipta)
One of: physician attestation that patient/caregiver cannot or is physically unable to self-administer; or documented history of severe hypersensitivity reaction to Fasenra or Nucala within the past 6 months requiring professional administration and monitoring
Patient is not receiving Nucala in combination with other biologic therapies for the same indication (e.g., other anti-IL-5 agents, anti-IgE, anti-IL-4, TSLP inhibitors)

Reauthorization — Nucala (mepolizumab) for COPD — continuation-of-care criteria

Reauthorization — Nucala (mepolizumab) for COPD — continuation-of-care criteria:

ALL of the following

Patient is already established on Nucala for COPD with documented prior authorization under prior plan/payer (continuation-of-care situation)
Documentation of ongoing clinical benefit as per COPD reauthorization criteria (see COPD — Reauthorization/Continuation)
Dosing and clinician specialty consistent with initial authorization (allergist/immunologist or pulmonologist)
Patient is not receiving concurrent biologic therapy for same indication
Reauthorization will be for no more than 12 months

Unproven / Not Medically Necessary

Unproven / Not Medically Necessary uses and exclusions — the following are considered unproven, investigational, or not medically necessary:

ANY of the following

Other eosinophilic conditions not supported by robust randomized controlled trial evidence (e.g., outside listed FDA indications)
Acute bronchospasm or status asthmaticus (explicit exclusion)
Granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis
Organ- or life-threatening EGPA
Use of Cinqair (reslizumab) or Fasenra (benralizumab) for COPD is unproven and not medically necessary

Reslizumab (Cinqair) — Severe eosinophilic asthma (adults)

Reslizumab (Cinqair) — Severe eosinophilic asthma (adults) — covered when ALL of the following are met:

ALL of the following

Age ≥ 18 years
Diagnosis of severe asthma with eosinophilic phenotype
Baseline (pre-reslizumab) peripheral blood eosinophil level ≥ 150 cells/µL (per Cinqair criteria; trials used ≥400 cells/µL for many endpoints)
Uncontrolled or inadequately controlled asthma demonstrated by at least one of: poor symptom control (e.g., ACQ >1.5 or ACT <20); ≥2 bursts of systemic corticosteroids for ≥3 days each in prior 12 months; asthma-related emergency treatment; airflow limitation; or maintenance OCS dependence
Used as add-on maintenance therapy in combination with appropriate ICS-containing controller regimens

Mepolizumab — Indications beyond asthma (HES, EGPA, CRSwNP, COPD)

Mepolizumab (Nucala) — Indications beyond asthma (covered when matching trial or labeled populations and ALL criteria below are met):

ALL of the following

For EGPA: diagnosis of relapsing or refractory EGPA with required clinical features, patient on standard therapy (systemic glucocorticoids ± immunosuppressive therapy), and meeting EGPA-specific criteria including relapsing/refractory disease as defined in EGPA section; not used in combination with other biologics for same indication; dosing per FDA label; prescribed by appropriate specialist
For HES: diagnosis ≥6 months, no identifiable non-hematologic secondary cause, FIP1L1-PDGFRα negative, baseline blood eosinophils ≥1,000 cells/µL, stable background HES therapy, and other HES initial/reauthorization criteria met
For CRSwNP: CRSwNP diagnostic criteria and prior therapy/surgery requirements as in CRSwNP section; Nucala used as add-on to intranasal corticosteroids; dosing and specialist requirements met
For COPD: COPD diagnostic criteria, eosinophilic phenotype (≥300 cells/µL), prior exacerbation history and prior maintenance therapy failure/intolerance as per COPD section; used as add-on maintenance in combination with appropriate maintenance therapy; dosing and specialist requirements met

FDA-Indicated Uses

FDA-Indicated Uses — coverage when FDA indication and age criteria are met:

ANY of the following

Fasenra (benralizumab): FDA-approved for add-on maintenance treatment of severe asthma in patients aged ≥6 years with an eosinophilic phenotype; also indicated for adult EGPA
Nucala (mepolizumab): FDA-approved for add-on maintenance treatment of severe asthma in patients aged ≥6 years with an eosinophilic phenotype; indicated for EGPA (adult), HES (≥12 years and older for ≥6 months meeting criteria), add-on maintenance for adult COPD with eosinophilic phenotype, and add-on maintenance for adult CRSwNP (≥18 years)
Cinqair (reslizumab): FDA-approved for add-on maintenance treatment of severe asthma in patients aged ≥18 years with an eosinophilic phenotype; not indicated for other eosinophilic conditions or for acute bronchospasm/status asthmaticus

Coding

Procedure/Drug HCPCS CodesHCPCS

J0517	Injection, benralizumab, 1 mg
J2182	Injection, mepolizumab, 1 mg
J2786	Injection, reslizumab, 1 mg

Diagnosis ICD-10 CodesICD-10

D72.11	Hypereosinophilic Syndrome
J31.0	Chronic rhinitis
J32.0	Chronic maxillary sinusitis
J32.1	Chronic frontal sinusitis
J32.2	Chronic ethmoidal sinusitis
J32.3	Chronic sphenoidal sinusitis
J32.4	Chronic pansinusitis
J32.8	Other chronic sinusitis
J32.9	Chronic sinusitis, unspecified
J33.0	Polyp of nasal cavity

1–10 of 24

1/3

No explicit codes listed in this sectionmixed

No codes listed

Peripheral blood eosinophil threshold — key value

Peripheral blood eosinophil threshold>= 150 cells/µL

Use contextUsed to define eosinophilic phenotype for severe asthma and eligibility for IL‑5 pathway biologics

Source guidanceERS/ATS guidance supports a blood eosinophil cut‑point ≥150 cells/µL to guide anti‑IL‑5 initiation in adults

Baseline peripheral blood eosinophil level by indication

Asthma baseline eosinophil>= 150 cells/µL

COPD baseline eosinophil>= 300 cells/µL

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization and Initial Approval Duration

Prior authorization is required for mepolizumab (Nucala), benralizumab (Fasenra), reslizumab (Cinqair) and other indicated biologics. Initial approvals: Fasenra and Cinqair — up to 12 months; Nucala — up to 6 months for EGPA and up to 12 months for most other FDA‑indicated uses. Dosing must follow FDA labeling and prescribers must be specialty appropriate per indication.

Initial authorization durations: Fasenra — ≤ 12 months; Cinqair (reslizumab) — ≤ 12 months; Nucala (mepolizumab) — ≤ 6 months for EGPA, ≤ 12 months for other FDA indications

Documentation Required

Reauthorization — Nucala (mepolizumab)

Reauthorization of Nucala requires documentation of a positive clinical response specific to the treated indication and confirmation of ongoing maintenance therapy where applicable. Reauthorizations are typically granted for up to 12 months when criteria are met.

Required evidence of positive response examples: reduction in exacerbation frequency; decreased rescue medication use; improved percent predicted FEV1; reduction in severity/frequency of disease‑specific symptoms (e.g., HES flares, CRSwNP nasal obstruction)

Background

These therapies are monoclonal antibodies targeting the interleukin‑5 pathway or its receptor. Benralizumab (Fasenra) targets the IL‑5 receptor α on eosinophils, leading to antibody‑dependent cell‑mediated cytotoxicity and eosinophil depletion; mepolizumab (Nucala) and reslizumab (Cinqair) target IL‑5 itself to reduce eosinophil activity. They are used as add‑on maintenance treatments for patients with a confirmed eosinophilic phenotype and uncontrolled severe asthma or for specific labeled eosinophilic conditions (e.g., EGPA, HES) where indicated and supported by trial data.

Definitions

Relapsing or refractory EGPA — definition and timeframe

Relapsing EGPA definition≥1 EGPA relapse within past 2 years requiring additional or escalated corticosteroids, immunosuppressant, or hospitalization

Refractory EGPA definitionFailure to attain remission within prior 6 months following induction treatment with standard therapy regimens

Required featuresDiagnosis of EGPA plus history/presence of asthma and at least two EGPA‑characteristic features (e.g., eosinophilic vasculitis, neuropathy, pulmonary infiltrates)

Uncontrolled or inadequately controlled severe asthma — examples of definition

Poor control examplesACQ >1.5 or ACT <20; or ≥2 systemic corticosteroid bursts (≥3 days) in prior 12 months; or asthma‑related ER/hospital visits

Airflow limitation metric

Revision History

2026-04-01policy_effectiveLatest

Policy effective date (Medical Benefit Drug Policy CS2026D0055Y) established as April 1, 2026; document includes template update and removal of Louisiana-specific language.

Policy Summary

PayerUnitedHealthcare

PolicyRespiratory Interleukins (Cinqair®, Fasenra®, & Nucala®)

Policy CodePolicy CS2026D0055Y

Change TypeNo material change

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization with documentation that the patient meets indication-specific clinical criteria before provider-administered therapy.

SourceLink

On This Page

For Fasenra or Nucala reauthorization: one of the following applies — physician attestation that patient/caregiver cannot or is physically unable to self-administer; or documented history of severe hypersensitivity reaction within the past 6 months requiring professional administration and monitoring; or for Nucala requests only, patient is ≤ 11 years of age

For Cinqair reauthorization only: history of failure to a 4-month trial of Fasenra or Nucala or contraindication/intolerance to Fasenra or Nucala

Reauthorization will be for no more than 12 months

Submission of medical records documenting both: baseline (pre-mepolizumab) blood eosinophil level ≥ 1,000 cells/µL within the past 4 weeks; and patient is currently receiving a stable dose of background HES therapy (e.g., oral corticosteroid, immunosuppressor, or cytotoxic therapy)

Patient is not receiving Nucala in combination with other biologic therapies for the same indication (e.g., other anti-IL-5 agents, anti-IgE, anti-IL-4, TSLP inhibitors)

Dosing is in accordance with U.S. FDA-approved labeling

Prescribed by an allergist, immunologist, hematologist, cardiologist, or pulmonologist

Initial authorization will be for no more than 12 months

Reauthorization will be for no more than 12 months

Nucala will be used as add-on maintenance therapy in combination with intranasal corticosteroids

One of: physician attestation that patient/caregiver cannot or is physically unable to self-administer; or documented history of severe hypersensitivity reaction to Nucala within past 6 months requiring professional administration; or patient is new to therapy and requires initial dose monitoring (authorization for 1 dose); or patient is ≤ 11 years of age

Patient is not receiving Nucala in combination with other biologic therapies for the same indication (e.g., other anti-IL-5 agents, anti-IgE, anti-IL-4, TSLP inhibitors)

Dosing is in accordance with U.S. FDA-approved labeling

Prescribed by an allergist/immunologist, otolaryngologist, or pulmonologist

Initial authorization will be for no more than 12 months

Dosing is in accordance with U.S. FDA-approved labeling

Reauthorization will be for no more than 12 months

Nucala will be used as add-on maintenance therapy in combination with appropriate maintenance bronchodilator therapy (triple or dual as specified)

One of: physician attestation that patient/caregiver cannot or is physically unable to self-administer; documented history of severe hypersensitivity reaction to Nucala within the past 6 months requiring professional administration and monitoring; or patient is new to therapy and requires initial dose monitoring (authorization for 1 dose)

Patient is not receiving Nucala in combination with other biologic therapies for the same indication (e.g., other anti-IL-5 agents, anti-IgE, anti-IL-4, TSLP inhibitors)

Dosing is in accordance with U.S. FDA-approved labeling

Prescribed by an allergist/immunologist or pulmonologist

Initial authorization will be for no more than 12 months

Dosing is in accordance with U.S. FDA-approved labeling

Reauthorization will be for no more than 12 months

Use of Nucala or Cinqair for indications not FDA-approved is investigational pending statistically robust randomized controlled trials

One of the following: history of failure to a 4-month trial of Fasenra or Nucala; or contraindication or intolerance to Fasenra or Nucala

Patient is not receiving Cinqair in combination with other biologic therapies for the same indication (anti-IL-4, anti-IL-5, anti-IgE, TSLP inhibitors)

Dosing is in accordance with U.S. FDA-approved labeling and prescribed by a pulmonologist or allergist/immunologist

Initial authorization will be for no more than 12 months

Not to be used in combination with other biologic therapies for the same indication

HES baseline eosinophil>= 1,000 cells/µL (documented within past 4 weeks)

FEV1 thresholds — spirometry thresholds referenced

Asthma FEV1 criterionPost‑bronchodilator FEV1 <80% predicted with reduced FEV1/FVC (supports classification as uncontrolled)

COPD spirometry criteriaPost‑bronchodilator FEV1/FVC <0.7 and post‑bronchodilator FEV1 20–80% predicted

Use in assessmentsAirflow limitation on spirometry is among metrics used to define uncontrolled disease for biologic eligibility

Blood eosinophil thresholds referenced in trials

Trial-referenced eosinophil cutoffs>= 150 cells/µL; >= 300 cells/µL; >= 400 cells/µL

Mepolizumab trialsIncluded thresholds ≥150 cells/µL at screening or ≥300 cells/µL within prior 12 months in some studies

Reslizumab pivotal studiesReslizumab trials enrolled patients with blood eosinophils ≥400/µL in key studies

Eosinophil thresholds used in trials/guidelines

Reslizumab (Cinqair) trial cutoff>= 400 cells/µL

Mepolizumab (HES) trial cutoff>= 1,000 cells/µL (HES screening requirement in HES trial)

ERS/ATS guidance cutoff>= 150 cells/µL recommended to guide anti‑IL‑5 initiation in adults

For COPD and most other indications: reauthorization generally limited to ≤ 12 months

Prior Authorization

Biologic Prior Authorization for Severe Eosinophilic Asthma

For severe eosinophilic asthma and other FDA‑listed eosinophilic indications, prior authorization requires submission of disease‑specific evidence (e.g., uncontrolled severe asthma parameters, eosinophil counts, exacerbation history) and confirmation that biologic use is additive to optimized controller therapy.

Severe eosinophilic asthma evidence: uncontrolled disease (e.g., ACQ>1.5 or ACT<20), ≥2 systemic corticosteroid bursts in past 12 months, asthma‑related ER/hospital visits, airflow limitation, or maintenance OCS dependence
Eosinophil thresholds referenced: commonly ≥150 cells/µL for benralizumab/mepolizumab/reslizumab indications; many pivotal reslizumab trials required ≥400 cells/µL; COPD uses often require ≥300 cells/µL

Prior Authorization

Indication‑ and Age‑Based Prior Authorization

Prior authorization decisions require that the requested use matches the FDA‑labeled indication and age criteria, and that the submitted documentation supports the indicated phenotype and age.

Confirm FDA indication and patient age for the requested biologic (e.g., reslizumab: adults ≥18; benralizumab: ≥6 years; mepolizumab: ≥6 years for asthma, ≥12 years for HES, ≥18 years for CRSwNP)
Requests not meeting FDA age/indication criteria should be supported by clinical rationale or will be at risk for denial

Denial Risk

Triggers for denial — insufficient phenotype or control documentation

Insufficient documentation of the required eosinophilic phenotype, control status, or prior therapy optimization are common triggers for denial.

Examples of insufficient documentation: blood eosinophil below required threshold for the indication (e.g., <150 cells/µL for many asthma indications), no documentation of uncontrolled disease or exacerbations, or lack of evidence of optimized controller therapy (maximized high‑dose ICS/LABA where appropriate)
Missing specialty prescriber designation or absence of required baseline labs (e.g., eosinophil counts) may also lead to denial

Denial Risk

Triggers for Denial

Denial may also be issued for concurrent/duplicate biologic therapy for the same indication, use for unproven or non‑FDA indicated conditions, incorrect dosing, or lack of demonstrated clinical benefit on reauthorization.

Concurrent biologic therapy exclusion: requests combining two or more biologics targeting the same indication (e.g., anti‑IL‑5 agents together, anti‑IL‑5 with anti‑IL‑4, anti‑IgE, or anti‑TSLP for the same condition) are not allowed
Unproven/not medically necessary uses include acute bronchospasm, status asthmaticus, certain other eosinophilic conditions, organ or life‑threatening EGPA
Reauthorization denials: absence of objective evidence of positive response, ongoing need for maintenance therapy confirmation, or incorrect/unsupported dosing

Prior Authorization

Reslizumab indication limits

Reslizumab (Cinqair) is limited to add‑on maintenance treatment of adults (≥18 years) with severe eosinophilic asthma and specific eosinophil and exacerbation history per trial evidence; not indicated for other eosinophilic conditions or acute bronchospasm/status asthmaticus.

FDA age limit: ≥18 years for reslizumab
Indication limits: add‑on maintenance for severe eosinophilic asthma only; trial evidence typically required blood eosinophils ≥400 cells/µL and ≥1 exacerbation requiring systemic corticosteroids in past 12 months

Prior Authorization

Mepolizumab HES indication limits and baseline labs

HES requests for mepolizumab must match trial populations: HES duration ≥6 months, exclusion of identifiable non‑hematologic secondary causes and FIP1L1‑PDGFRα kinase‑positive disease, baseline eosinophil ≥1,000 cells/µL, and stable background HES therapy.

Baseline (pre‑treatment) blood eosinophil ≥1,000 cells/µL within the past 4 weeks is required for initial HES authorization
Document that the patient has been on a stable dose of background HES therapy (e.g., oral corticosteroid, immunosuppressant, or cytotoxic)
HES initial therapy duration: disease present ≥6 months; exclude secondary causes and FIP1L1‑PDGFRα positivity

Denial Risk

Contraindicated Use

Use of biologics for acute bronchospasm or status asthmaticus is not an indicated use and is considered unproven/not medically necessary; such requests are at high risk of denial.

Acute bronchospasm/status asthmaticus is explicitly not an indicated use for Fasenra, Nucala, or Cinqair

Step Therapy

Conservative therapy trial for CRSwNP

For CRSwNP, conservative therapy trials and prior interventions must be documented before biologic initiation, and reauthorization requires continued benefit and intranasal corticosteroid maintenance.

CRSwNP conservative therapy requirement: trial and failure of two classes of conservative therapies (e.g., adequate duration of intranasal corticosteroids and at least one other conservative measure) and documentation of prior nasal corticosteroid use for ≥8 weeks pre‑screening
Prior surgery history: documentation of prior polypectomy(s) within the previous 10 years where applicable
Reauthorization requirements: documented positive clinical response, continued add‑on use with intranasal corticosteroids, and specific objective baseline scores (e.g., bilateral NPS and nasal obstruction VAS)

Documentation Required

Required Clinical Documentation

Prior authorization submissions must include comprehensive clinical documentation: diagnosis, supporting characteristic findings (e.g., EGPA features), specialty prescriber attestation, relevant baseline labs (eosinophil counts with dates), exacerbation history, prior medication trials, and rationale for step‑therapy exceptions.

Required clinical documentation: diagnosis details, EGPA or HES history where applicable, objective findings (histopathology, imaging, neuropathy, organ involvement), and specialty prescriber designation (pulmonologist, allergist/immunologist, rheumatologist, hematologist or cardiologist as indicated)
Eosinophil lab documentation: include baseline/pre‑treatment absolute eosinophil count with date (e.g., ≥1,000 cells/µL within 4 weeks for HES; indication‑specific thresholds for asthma/COPD)
Prior therapy documentation: evidence of optimization of controller therapy (maximized high‑dose ICS/LABA where applicable), failure of prior biologics when required (e.g., Cinqair requires failure of Fasenra or Nucala or documented contraindication)

Step Therapy

Step Therapy and Optimize Controller Therapy Before Biologic

Step therapy and optimization of controller therapy are expected before initiation of biologic therapy for severe asthma; where step‑therapy rules apply (e.g., Cinqair), documentation of prior biologic failure or contraindication must be provided.

Optimize controller therapy: documentation that inhaled controller regimens have been maximized per guidelines (e.g., high‑dose ICS/LABA) and adherence/inhaler technique addressed prior to biologic initiation
Cinqair step therapy: evidence of failure to a 4‑month trial of Fasenra or Nucala, or a documented contraindication/intolerance to those agents, is required before approving reslizumab
Note: Policy may use step therapy in other contexts; absence of specific step details requires documentation of clinical rationale

Denial Risk

Concurrent Biologic Use

Concurrent use of multiple biologics for the same indication is not permitted. Requests that propose combination biologic therapy for a single disease state will be denied unless a clear, evidence‑based rationale is provided and the therapies are for distinct, non‑overlapping indications.

Prohibited concurrent biologics examples: anti‑IL‑5 agents together (mepolizumab, benralizumab, reslizumab) for the same indication; anti‑IL‑5 with anti‑IL‑4, anti‑IgE, or anti‑TSLP for the same condition

Post‑bronchodilator FEV1 <80% predicted with reduced FEV1/FVC

Dependence on OCSCurrent dependence on maintenance oral corticosteroids qualifies as uncontrolled

Eosinophilic phenotype — baseline eosinophil thresholds vary by indication

DefinitionEosinophilic phenotype defined by baseline (pre‑treatment) peripheral blood eosinophil thresholds that vary by indication

Asthma threshold>= 150 cells/µL

COPD and HES thresholdsCOPD >=300 cells/µL; HES >=1,000 cells/µL (HES within past 4 weeks)

Poor symptom control — examples

Symptom control thresholdsACQ score >1.5 or ACT score <20 indicate poor symptom control

Frequent systemic steroid burstsTwo or more systemic corticosteroid bursts (≥3 days each) in prior 12 months as example of poor control

Airflow limitationPost‑bronchodilator FEV1 <80% predicted with reduced FEV1/FVC as objective example

EGPA — short definition and characteristic features

Short definitionEosinophilic granulomatosis with polyangiitis (EGPA) is a systemic small‑vessel vasculitis characterized by asthma, sinusitis, pulmonary infiltrates, neuropathy, and eosinophilic vasculitis

Standard therapySystemic glucocorticoids are standard treatment; biologics studied for steroid‑refractory or relapsing disease

Typical disease featuresEGPA diagnostic features include eosinophilic vasculitis, pulmonary infiltrates, neuropathy, and sino‑nasal abnormalities

HES — definition summary and relation to mepolizumab evidence

HES summaryHypereosinophilic syndrome (HES) is sustained eosinophilia causing end‑organ damage; patients often have >1,500 cells/µL for 6 months

Mepolizumab evidenceMepolizumab reduced HES flares in a randomized 32‑week trial enrolling patients with screening eosinophils ≥1,000/µL and ≥2 flares in prior 12 months

Trial exclusionsHES trials excluded non‑hematologic secondary causes and FIP1L1‑PDGFRα‑positive disease

CRSwNP — definition and when biologics considered

CRSwNP definitionChronic rhinosinusitis with nasal polyps: persistent paranasal sinus inflammation ≥12 weeks with symptoms and objective endoscopy/CT findings

When biologics consideredBiologics considered when intranasal and systemic corticosteroids and surgery fail to sufficiently reduce polyp burden

Required prior therapies in trialsTrial‑mirroring requirements include prior intranasal corticosteroids and prior polypectomy history or systemic corticosteroids in past 2 years

Uncontrolled / Severe asthma — combined definition

Combined definitionUncontrolled/severe asthma defined by both poor symptom control (ACQ/ACT criteria) and/or frequent exacerbations (≥2/year or ≥1/year requiring hospitalization), despite optimized high‑dose ICS‑LABA

Requirement for biologicsAdd‑on biologic therapy recommended when severe asthma remains uncontrolled despite optimized maximal therapy per GINA

Objective measuresExamples include steroid bursts, ER visits, airflow limitation (FEV1 metrics) and OCS dependence

Blood eosinophil cut‑points — guidance and trial enrichment

ERS/ATS guidance cut‑pointERS/ATS suggests blood eosinophil cut‑point ≥150 cells/µL to guide anti‑IL‑5 initiation in adults

Higher trial cut‑offs for enrichmentHigher thresholds (e.g., ≥300–400 cells/µL) were used in pivotal trials to enrich for responsive patients

Trial examplesBenralizumab pivotal trials stratified by ≥300 cells/µL; reslizumab pivotal studies enrolled patients with ≥400/µL

eosinophilic phenotype — short label/definition duplicate

Short labelEosinophilic phenotype: defined by elevated peripheral blood eosinophils meeting indication‑specific cutoffs

Clinical relevanceIdentification of eosinophilic phenotype is required to determine eligibility for IL‑5 pathway biologics

Thresholds vary by indicationCommon thresholds include ≥150 (asthma), ≥300 (COPD), ≥1,000 (HES)