CurrentUnitedHealthcarePolicy IEXDO055.14

Respiratory interleukin biologics (Cinqair / Fasenra / Nucala)

UnitedHealthcare medical benefit drug policy for provider-administered formulations of reslizumab (Cinqair), benralizumab (Fasenra), and mepolizumab (Nucala) describing coverage criteria for indications including severe eosinophilic asthma, EGPA, HES, CRSwNP, and COPD; applies to Individual Exchange plans in most states (exclusions noted).

Policy Summary

PayerUnitedHealthcare

PolicyRespiratory interleukin biologics (Cinqair / Fasenra / Nucala)

Policy CodePolicy IEXDO055.14

Change TypeCoverage criteria revised (COPD added); exclusions clarified

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit diagnostic and treatment records including baseline eosinophil counts and spirometry to support prior authorization and document any inability to self-administer or need for monitored initial dose.

POLICY UPDATE CHANGES

Replaced criterion requiring 'the patient is not receiving any of [the listed therapies] in combination with Cinqair/Fasenra/Nucala' with 'the patient is not receiving any of [listed therapies] in combination with Cinqair/Fasenra/Nucala for treatment of the same indication'.

Added language indicating Nucala for provider administration is proven for patients who meet defined COPD diagnostic, eosinophil, and exacerbation criteria.

Added ICD-10 diagnosis codes J44.0, J44.1, and J44.9 to Applicable Codes

Removed language indicating Nucala is unproven and not medically necessary for the treatment of COPD.

Clarified administration/monitoring exceptions (patient/caregiver inability to self-administer, hypersensitivity history, initial supervised dose) and limited initial supervised authorization to 1 dose when applicable.

Supporting information updated: Background, Clinical Evidence, FDA, and References sections updated to reflect current information.

7Indications with coverage criteria in part

Coverage summary & scope

High-level coverage stance: Provider-administered Cinqair, Fasenra, and Nucala are covered when medical necessity criteria in this policy are met for their FDA‑approved and specified off‑label indications (for example, add‑on therapy for severe eosinophilic asthma and treatment of eosinophilic granulomatosis with polyangiitis [EGPA]). Initial authorizations are generally limited to a maximum of 12 months and reauthorization/continuation requires documented clinical benefit (see reauthorization criteria).

States excluded from this medical benefit policy (Massachusetts, Nevada, New York) may have different coverage determinations or benefit handling; verify state‑specific guidance as needed.

General applicability

Covered when ALL of the following applicability criteria are met. Includes both initial and continuation/reauthorization applicability notes.

ALL of the following

Applies to UnitedHealthcare Individual Exchange medical benefit plans unless member resides in an excluded state (Massachusetts, Nevada, New York).
Applies to provider‑administered formulations of Cinqair (reslizumab), Fasenra (benralizumab), and Nucala (mepolizumab).
Self‑administered subcutaneous formulations of Fasenra and Nucala are processed under the pharmacy benefit and are not governed by this medical policy.
Coverage scenario
- Initial coverage for FDA‑labeled indications such as severe eosinophilic asthma (add‑on therapy) and EGPA when all diagnosis‑specific medical necessity criteria are met.
- Reauthorization/Continuation for EGPA or asthma when documentation shows clinical benefit (see reauthorization criteria: reduction in relapse frequency/severity, decreased corticosteroid/immunosuppressant use, symptom improvement, or disease remission).
- Revised/expanded initial coverage criteria specifically address Nucala (mepolizumab) for COPD when provider‑administered formulations meet the policy’s medical necessity requirements (see policy body for detailed COPD initial criteria).
Provider billing note: administration by a healthcare professional (medical benefit) requires appropriate administration coding and prior authorization as indicated by the plan; check benefit for prior authorization requirements and documentation expectations.
Reauthorization / Continuation - COPD (Nucala)
- Continuation approvals require documentation of clinical benefit since initiation (reduction in exacerbations, decreased corticosteroid use, or clinical improvement).
- Member must not be receiving Nucala in combination with other specified biologics for the same indication (eg, other anti–IL‑5 agents, anti‑IL‑4, anti‑IgE, or TSLP inhibitors) as outlined by the policy.
- Dosing and administration must be consistent with FDA labeling or documented rationale for deviation.
Revised coverage criteria for Nucala (mepolizumab) for COPD - Initial coverage
- Diagnosis of COPD with eosinophilic phenotype as defined by elevated peripheral blood eosinophil count per policy thresholds or provider documentation supporting eosinophilic COPD phenotype.
- Inadequate control on maximally tolerated inhaled therapies and other standard COPD management as documented in the medical record.
- Evidence of frequent exacerbations or persistent symptoms despite optimized therapy (eg, multiple exacerbations requiring systemic corticosteroids or hospitalization in the prior 12 months).
- Patient is not receiving Nucala in combination with other biologic therapies for the same indication (eg, other anti–IL‑5 agents, anti‑IL‑4, anti‑IgE, or TSLP inhibitors).
- Therapy initiation must be prescribed by an appropriate specialist (eg, pulmonologist) and initial authorization will be time‑limited (typically up to 12 months) with reauthorization contingent on documented clinical benefit.

Initial therapy criteria (by indication & product)

EGPA - Fasenra (benralizumab) - Initial therapy

Fasenra for provider administration is proven and medically necessary when ALL criteria are met:

EGPA - Fasenra initial therapy

Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA)
Relapsing or refractory EGPA definition
- Histopathological evidence (at least TWO of): Presence of at least TWO of: eosinophilic vasculitis; eosinophil-rich granulomatous inflammation; perivascular eosinophilic infiltration; neuropathy (mono or poly) (motor deficit or nerve conduction abnormality); pulmonary infiltrates, non-fixed
- Additional EGPA features: Sino-nasal abnormality; glomerulonephritis (hematuria, red cell casts, proteinuria); cardiomyopathy (echocardiography or MRI); alveolar hemorrhage; ANCA positive; palpable purpura

Reauthorization / continuation criteria

Reauthorization / Continuation - EGPA (Fasenra or Nucala)

Authorization for continued use will be approved based on ALL of the following:

EGPA reauthorization - Fasenra or Nucala

Clinical response: Documentation of reduction in frequency and/or severity of relapses
Documentation of positive clinical response (at least ONE): At least ONE of: reduction or discontinuation of doses of corticosteroids and/or immunosuppressant; reduction in severity or frequency of EGPA-related symptoms; disease remission
Concomitant therapy exclusion at reauthorization: Patient is NOT receiving the product in combination with the following for treatment of the same indication: (for Fasenra reauth: other anti-IL-5 e.g., reslizumab, mepolizumab; for Nucala reauth: reslizumab, benralizumab), anti-IgE (omalizumab), anti-IL-4 (dupilumab), TSLP inhibitor (tezepelumab)

Unproven / not medically necessary indications

Applicable codes

HCPCS J-codes (provider-administered biologics)HCPCS

J0517	Injection, benralizumab, mg; NDC(s): 00310-1730-30; 00310-1745-01; 00310-1830-30
J2182	Injection; mepolizumab, 1 mg; NDC(s): 00173-0881-01; 00173-0892-01; 00173-0892-42; 00173-0904-42
J2786	Injection; reslizumab, 1 mg; NDC: 59310-0610-31

Diagnosis codes referencedICD-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

Added ICD-10 diagnosis codes supporting COPD coverageICD-10Covered

J44.0	Chronic obstructive pulmonary disease with acute lower respiratory infection
J44.1	Chronic obstructive pulmonary disease with (acute) exacerbation
J44.9	Chronic obstructive pulmonary disease, unspecified

Provider actions & documentation requirements

Prior Authorization

Prior authorization required with initial limits

Prior authorization is required. Initial approvals will be limited to a 12-month authorization period. Affected specialties: pulmonologist, rheumatologist, and allergist/immunologist. Initial 12-month limit: authorization duration up to 12 months.

Affected specialties: pulmonologist; rheumatologist; allergist/immunologist
Initial authorization limit: up to 12 months

Documentation Required

Submit diagnostic and treatment records

Submit diagnostic and treatment records to support medical necessity. Required documentation includes baseline peripheral blood eosinophil count, spirometry results, prior therapy documentation (including trials and intolerances of other biologics when applicable), evidence of stable background therapy for HES/EGPA, and a provider attestation when an administration exception is requested (see administration monitoring exceptions).

Clinical evidence & trial highlights

HR 0.34HES trial: hazard ratio for first HES flare (Nucala vs placebo)

28% vs 56%HES trial: incidence of HES flare (Nucala vs placebo)

75% vs 25%ZONDA: median % reduction in daily OCS dose (benralizumab vs placebo)

54% vs 33%Mepolizumab OCS trial: % achieving ≥50% prednisone reduction (mepolizumab vs placebo)

RR 0.79 / 0.82COPD (MATINEE / METREX): annualized exacerbation rate ratios (mepolizumab vs placebo)

Benralizumab — EGPA: A randomized trial comparing benralizumab and mepolizumab in patients with relapsing or refractory EGPA demonstrated noninferiority of benralizumab for remission at weeks 36 and 48 (trial enrolled patients with asthma, eosinophilia, and relapsing/refractory disease on background glucocorticoids ± immunosuppressants).

Mepolizumab — EGPA: Phase 3 data (Wechsler et al.) showed that subcutaneous mepolizumab significantly increased accrued weeks of remission and reduced relapse rate versus placebo in relapsing or refractory EGPA and enabled steroid dose reductions.

Background & definitions

Background — disease indications: Asthma (including a severe eosinophilic phenotype), EGPA (Churg–Strauss), HES, CRSwNP, and COPD are discussed as eosinophil‑associated respiratory conditions that may benefit from anti‑IL‑5 pathway therapies. The policy notes that approximately half of patients with severe asthma have an eosinophilic phenotype and that EGPA, HES, and CRSwNP involve eosinophil‑mediated inflammation with organ‑specific manifestations.

Mechanisms of action: Mepolizumab binds IL‑5 to inhibit eosinophil production and survival; reslizumab similarly targets IL‑5; benralizumab targets the IL‑5 receptor on eosinophils and basophils and induces antibody‑dependent cell‑mediated cytotoxicity leading to eosinophil apoptosis.

Rationale and prevalence: HES is rare (estimated prevalence cited); eosinophilic asthma comprises a substantial subset of severe asthma with morbidity and unmet need; EGPA and CRSwNP feature eosinophilic inflammation where reducing eosinophils can improve disease control. These pathophysiologic considerations underpin the use of anti‑IL‑5/IL‑5R agents across these indications.

Provider‑administered formulations rationale: The policy distinguishes provider‑administered IV/SC formulations from self‑administered pharmacy products and provides coverage criteria for administration in the healthcare setting (including circumstances requiring direct monitoring such as prior severe hypersensitivity or inability to self‑administer), consistent with product safety (e.g., anaphylaxis risk for IV reslizumab) and FDA labeling.

Eosinophilic phenotype: Asthma or airway disease characterized by elevated peripheral blood eosinophil counts; indication‑specific thresholds are specified in the policy (examples include ≥150 cells/µL for severe eosinophilic asthma, and >300 cells/µL for COPD).

Relapsing EGPA: A past history within 2 years of at least one EGPA relapse requiring additional or escalated corticosteroids or immunosuppressant therapy, or hospitalization.

Revision history

2025-09-01effectiveLatest

Policy effective date. Material revisions summarized: COPD coverage for Nucala (mepolizumab) for provider administration added/clarified with diagnostic spirometry thresholds (post-bronchodilator FEV1/FVC < 0.7; FEV1 % predicted 30%–70%), eosinophil threshold (>300 cells/µL), exacerbation history and maintenance therapy context; ICD-10 diagnosis codes J44.0, J44.1, and J44.9 added to Applicable Codes; combination therapy exclusion language revised to specify 'for treatment of the same indication'; administration/monitoring exceptions clarified including patient/caregiver inability to self-administer, documented severe hypersensitivity history, and allowance for one initial supervised dose when applicable; removal of prior language that Nucala was unproven/not medically necessary for COPD.

2025-09-01material_editLatest

Replaced prior blanket combination-therapy exclusion with a targeted restriction: the patient must not be receiving listed biologics in combination with Cinqair/Fasenra/Nucala for treatment of the same indication.

Policy Summary

PayerUnitedHealthcare

PolicyRespiratory interleukin biologics (Cinqair / Fasenra / Nucala)

Policy CodePolicy IEXDO055.14

Change TypeCoverage criteria revised (COPD added); exclusions clarified

Effective DateSep 1, 2025

Next Review Date

On This Page

EGPA - Nucala (mepolizumab) - Initial therapy

Nucala for provider administration is proven and medically necessary when ALL criteria are met:

EGPA - Nucala initial therapy

Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA)
Relapsing or refractory EGPA definition
- Histopathological evidence (at least TWO of): Presence of at least TWO of: eosinophilic vasculitis; eosinophil-rich granulomatous inflammation; perivascular eosinophilic infiltration; neuropathy (mono or poly); sino-nasal abnormality; pulmonary infiltrates, non-fixed; cardiomyopathy (echocardiography or MRI); alveolar hemorrhage; glomerulonephritis; palpable purpura; ANCA positive
Background therapy requirement: Patient is currently taking standard therapy (systemic glucocorticoids with or without immunosuppressive therapy e.g., cyclophosphamide, rituximab)
Anti-IL-5 therapy status noted (e.g., Cinqair, Fasenra) - documented
Concomitant therapy exclusions: Patient is NOT receiving Nucala in combination with the following for treatment of the same indication: anti-IgE therapy (omalizumab); TSLP inhibitor (tezepelumab); anti-IL-4 therapy (dupilumab)
Dosing and authorization: Dosing is in accordance with FDA-approved labeling; initial authorization will be for no more than 12 months; prescribed by a pulmonologist, rheumatologist, or allergist-immunologist

Cinqair (reslizumab) - Severe eosinophilic asthma - Initial therapy

Cinqair IV is proven and medically necessary for add-on therapy when ALL criteria are met:

Cinqair - severe eosinophilic asthma initial therapy

Diagnosis and symptom control: Diagnosis of severe asthma; poor symptom control (e.g., ACQ > 1.5 or ACT < 20)
Uncontrolled asthma classification: At least ONE of: two or more bursts of systemic corticosteroids (≥3 days each) in prior 12 months; airflow limitation post-bronchodilator FEV1 < 80% predicted with reduced FEV1/FVC; asthma-related emergency treatment (ER visit, hospitalization, unscheduled urgent visit)
Maintenance OCS dependence: Patient is currently dependent on maintenance oral corticosteroids for treatment of asthma
Eosinophilic phenotype and concomitant therapy: Asthma is eosinophilic phenotype defined by baseline peripheral blood eosinophil level ≥ 150 cells/µL; used in combination with one maximally-dosed ICS/LABA product and one additional asthma controller medication
Prior therapy requirements: History of failure to a 4-month trial of Fasenra or Nucala
Alternate prior therapy options: Alternatively: contraindication/intolerance to Fasenra or Nucala; contraindication/intolerance to Tezspire; or history of failure to a 4-month trial of Tezspire
Concomitant therapy exclusions: Patient is NOT receiving Cinqair in combination with the following for treatment of the same indication: anti-IgE (omalizumab); other anti-IL-5 therapies (mepolizumab, benralizumab); anti-IL-4 (dupilumab); TSLP inhibitor (tezepelumab)
Dosing and authorization: Dosing is in accordance with FDA-approved labeling; initial authorization will be for no more than 12 months; prescribed by a pulmonologist or allergist-immunologist

Fasenra (benralizumab) - Severe eosinophilic asthma - Initial therapy

Fasenra for provider administration is proven and medically necessary for add-on therapy when ALL criteria are met:

Fasenra - severe eosinophilic asthma initial therapy

Classification of uncontrolled asthma: At least ONE of: diagnosis of severe asthma; poor symptom control (ACQ > 1.5 or ACT < 20); asthma-related emergency treatment (ER visit, hospital admission, unscheduled urgent visit); two or more bursts of systemic corticosteroids (≥3 days each) in prior 12 months; airflow limitation post-bronchodilator FEV1 < 80% predicted with reduced FEV1/FVC
Maintenance OCS dependence: Patient is currently dependent on maintenance oral corticosteroids for asthma
Eosinophilic phenotype and concomitant therapy: Asthma is eosinophilic phenotype defined by baseline peripheral blood eosinophil level ≥ 150 cells/µL; used in combination with one maximally-dosed ICS/LABA product and one additional asthma controller medication
Concomitant therapy exclusions: Patient is NOT receiving Fasenra in combination with the following for treatment of the same indication: anti-IgE (omalizumab); other anti-IL-5 therapy (Nucala, Cinqair); anti-IL-4 (dupilumab); TSLP inhibitor (tezepelumab)
Dosing and authorization: Dosing is in accordance with FDA-approved labeling; initial authorization will be for no more than 12 months; prescribed by a pulmonologist or allergist-immunologist

Nucala (mepolizumab) - Severe eosinophilic asthma - Initial therapy

Nucala for provider administration is proven and medically necessary for add-on therapy when ALL criteria are met:

Nucala - severe eosinophilic asthma initial therapy

Classification of uncontrolled asthma: At least ONE of: diagnosis of severe asthma; poor symptom control (ACQ > 1.5 or ACT < 20); two or more bursts of systemic corticosteroids (≥3 days each) in prior 12 months; asthma-related emergency treatment (ER visit, hospital admission, unscheduled urgent visit); patient currently dependent on maintenance oral corticosteroids; airflow limitation post-bronchodilator FEV1 < 80% predicted with reduced FEV1/FVC
Eosinophilic phenotype threshold: Asthma is eosinophilic phenotype defined by baseline peripheral blood eosinophil level ≥ 150 cells/µL≥ 150 cells/µL
Required concomitant therapy: Used in combination with one maximally-dosed combination ICS/LABA product or one maximally-dosed ICS product AND one additional asthma controller medication
Concomitant therapy exclusions: Patient is NOT receiving Nucala in combination with the following for treatment of the same indication: anti-IgE (omalizumab); other anti-IL-5 therapy (reslizumab, benralizumab); anti-IL-4 (dupilumab); TSLP inhibitor (tezepelumab)
Dosing and authorization: Dosing is in accordance with FDA-approved labeling; initial authorization will be for no more than 12 months; prescribed by a pulmonologist or allergist-immunologist

Hypereosinophilic Syndrome (HES) - Nucala

Nucala for provider administration is proven and medically necessary when ALL criteria are met:

HES - Nucala initial therapy

Entry criteria: Diagnosis of hypereosinophilic syndrome (HES) for ≥ 6 months; no identifiable non-hematologic secondary cause of HES
Exclusion and documentation: HES is not FIP1L1-PDGFRA kinase-positive; submission of medical records documenting patient is currently receiving a stable dose of background HES therapy (e.g., oral corticosteroid, immunosuppressor, or cytotoxic therapy) and baseline (pre-mepolizumab) blood eosinophil level ≥ 1000 cells/µL within the past 4 weeks≥ 1000 cells/µL
Concomitant therapy exclusions & prescriber: Patient is NOT receiving Nucala in combination with the following for treatment of the same indication: anti-IgE (omalizumab); other anti-IL-5 (reslizumab, benralizumab); anti-IL-4 (dupilumab); TSLP inhibitor (tezepelumab). Prescribed by an allergist, immunologist, hematologist, cardiologist, or pulmonologist
Dosing and authorization: Dosing is in accordance with FDA-approved labeling; initial authorization will be for no more than 12 months

Chronic rhinosinusitis with nasal polyps (CRSwNP) - Nucala

Nucala for provider administration is proven and medically necessary when ALL criteria are met:

CRSwNP - Nucala initial therapy

Symptom duration and diagnostic criteria: Two or more symptoms for > 12 weeks; diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) defined by nasal mucopurulent discharge; facial pain/pressure/fullness; nasal obstruction/blockage/congestion; reduction or loss of sense of smell
Objective findings (one required): One of: polyps in the nasal cavity or middle meatus on nasal endoscopy; purulent mucus or edema in the middle meatus or ethmoid regions; radiographic imaging demonstrating mucosal thickening or partial/complete opacification of paranasal sinuses
Bilateral polyposis and prior interventions: Presence of bilateral nasal polyposis and one of: prior required surgical removal of bilateral nasal polyps; required systemic corticosteroids for CRSwNP in previous 2 years; prior sinus surgery
Prior medical therapy trials: Failure to obtain symptom relief after trial of two of the following classes: intranasal corticosteroids, nasal saline irrigations, antileukotriene agents
Concomitant therapy and prescriber: Patient will receive Nucala as add-on maintenance therapy in combination with intranasal corticosteroids; patient is NOT receiving Nucala in combination with the following for treatment of the same indication: anti-IgE (omalizumab); other anti-IL-5 (reslizumab, benralizumab); anti-IL-4 (dupilumab); TSLP inhibitor (tezepelumab). Prescribed by an allergist-immunologist, otolaryngologist, or pulmonologist
Dosing and authorization: Dosing is in accordance with FDA-approved labeling; initial authorization will be for no more than 12 months

Nucala for provider administration is proven and medically necessary for COPD

Nucala for provider administration is proven and medically necessary for COPD when ALL criteria are met:

COPD - Nucala initial coverage criteria

Diagnostic spirometry criteria: Post-bronchodilator FEV1/FVC ratio < 0.7 AND post-bronchodilator FEV1 % predicted ≥ 30% and ≤ 70%FEV1/FVC < 0.7; FEV1 % predicted 30%-70%
Eosinophil threshold: Patient has an eosinophilic phenotype defined by baseline (pre-mepolizumab) peripheral blood eosinophil level > 300 cells/µL> 300 cells/µL
Exacerbation history: Two or more COPD exacerbations in previous year requiring systemic corticosteroids and/or antibiotics OR one or more exacerbation(s) resulting in hospitalization or observation >24 hours in ED/urgent care in past year
Maintenance therapy context: Exacerbations occurred while receiving maintenance triple therapy (LAMA+LABA+ICS) OR dual therapy (LAMA+LABA) with failure/contraindication/intolerance to an ICS; Nucala will be used as add-on maintenance therapy in combination with triple or dual therapy as specified
Symptom duration note: Symptoms of chronic productive cough for at least 3 months in the past year (appears as additional criterion)
Concomitant therapy exclusions and prescriber: Patient is NOT receiving Nucala in combination with the following for treatment of the same indication: other anti-IL-5 (reslizumab, benralizumab); anti-IL-4 (dupilumab); anti-IgE (omalizumab); TSLP inhibitor (tezepelumab). Prescribed by an allergist-immunologist or pulmonologist
Dosing, monitoring and authorization limits: Dosing is in accordance with FDA-approved labeling; provider must document baseline eosinophil count and post-bronchodilator spirometry values; administration/monitoring exceptions allowed (patient/caregiver inability to self-administer, recent severe hypersensitivity to Nucala requiring monitored administration, or new-to-therapy initial supervised dose — initial supervised authorization limited to 1 dose). Initial authorization will be for no more than 12 months

Reauthorization / Continuation - HES (Nucala)

Authorization for continued use will be approved based on ALL of the following:

HES reauthorization - Nucala

Clinical response: Documentation of reduction in frequency of HES flares
Documentation of positive clinical response (at least ONE): At least ONE of: maintenance or reduction in background HES therapy requirements
Concomitant therapy exclusions: Patient is NOT receiving Nucala in combination with the following for treatment of the same indication: anti-IgE (omalizumab); other anti-IL-5 (reslizumab, benralizumab); anti-IL-4 (dupilumab); TSLP inhibitor (tezepelumab)
Dosing and authorization: Dosing is in accordance with FDA-approved labeling; reauthorization will be for no more than 12 months

Reauthorization / Continuation - CRSwNP (Nucala)

For patients currently on Nucala for CRSwNP:

CRSwNP reauthorization - Nucala

Maintenance context: Patient will continue Nucala as add-on maintenance therapy in combination with intranasal corticosteroids
Clinical response: Documentation of positive clinical response to Nucala therapy
Concomitant therapy exclusions: Patient is NOT receiving Nucala in combination with the following for treatment of the same indication: anti-IgE (omalizumab); other anti-IL-5 (reslizumab, benralizumab); anti-IL-4 (dupilumab); TSLP inhibitor (tezepelumab)
Dosing and reauth: Dosing is in accordance with FDA-approved labeling; reauthorization will be for no more than 12 months

Reauthorization / Continuation - Severe eosinophilic asthma (Cinqair, Fasenra, Nucala)

Reauthorization for patients currently on Cinqair, Fasenra, or Nucala for severe eosinophilic asthma will be approved based on ALL of the following:

Asthma reauthorization - Cinqair, Fasenra, Nucala

Clinical response: Documentation of reduction in frequency of exacerbations
Documentation of positive clinical response (at least ONE): At least ONE of: decreased utilization of rescue medications; reduction in severity or frequency of asthma-related symptoms (wheezing, shortness of breath, coughing); increase in percent predicted FEV1 from pretreatment baseline
Concomitant therapy exclusion at reauthorization: Patient is not receiving the product in combination with other listed biologics for the same indication (anti-IL-5, anti-IL-4, anti-IgE, TSLP inhibitor)
Cinqair-specific reauth requirements: For Cinqair reauthorization specific additional requirements may include history of failure to a 4-month trial of Fasenra or Nucala or contraindication/intolerance to those agents and/or Tezspire as applicable
Dosing and reauth duration: Dosing is in accordance with FDA-approved labeling; reauthorization duration note ambiguous but elsewhere limited to no more than 12 months

Reauthorization / Continued use for COPD

For patients currently on Nucala for COPD, authorization for continued use will be approved based on ALL of the following:

COPD reauthorization - Nucala

Maintenance therapy: Nucala is being used in combination with maintenance therapy (examples provided: Advair/AirDuo, Bevespi Aerosphere, Breo Ellipta, Symbicort, Trelegy Ellipta)
Clinical response: Documentation of positive clinical response to Nucala therapy
Concomitant therapy exclusions: Patient is NOT receiving Nucala in combination with the following for treatment of the same indication: other anti-IL-5 (Cinqair, Fasenra); anti-IL-4 (Dupixent); anti-IgE (Xolair); TSLP inhibitor (Tezspire)
Dosing and reauth duration: Dosing is in accordance with FDA-approved labeling; reauthorization will be for no more than 12 months

Documentation Required

Baseline eosinophil verification & spirometry

Baseline eosinophil verification and spirometry must be provided with initial requests. Thresholds: for asthma-related indications, baseline peripheral blood eosinophils ≥ 150 cells/µL (policy references specify ≥150 cells/µL as eosinophilic phenotype); for HES/EGPA, submit eosinophil counts and supporting histopathology/clinical criteria as outlined in the clinical criteria. Spirometry: report FEV1/FVC and FEV1 percent predicted (FEV1 % predicted) with bronchodilator withholding as required per protocol.

Asthma eosinophil threshold: baseline peripheral blood eosinophils ≥ 150 cells/µL
HES/EGPA: baseline eosinophil count and supporting histopathology or clinical documentation per EGPA/HES criteria
Spirometry parameters required: FEV1/FVC (report value) and FEV1 % predicted (report value)

Documentation Required

Administration monitoring exceptions requiring provider attestation

Certain administration monitoring exceptions require a signed provider attestation. Initial supervised administration is limited to one dose when an exception is approved. Provider attestation must state the reason for the exception (eg, patient inability to self-administer, documented hypersensitivity history, or other clinically justified reason).

Initial supervised dose limited to 1 dose when exception approved
Attestation required if patient cannot self-administer
Attestation required for history of hypersensitivity or other administration safety concerns

Denial Risk

Combination biologic exclusion & reauthorization risk

Claims may be denied if the product is used concurrently with other listed biologics for the same indication. Reauthorization requests must include documentation of a positive clinical response (reduction in frequency/severity of relapses, reduction or discontinuation of corticosteroids or immunosuppressants, reduction in severity or frequency of disease-related symptoms, or disease remission). Failure to provide required reauthorization documentation may result in denial of continued coverage.

Claims may be denied if product used in combination with other biologics for the same indication (see billing rule for classes/agents)
Reauthorization requires documentation of positive clinical response (eg, reduced relapses, steroid-sparing effect, symptom reduction, or remission)
Insufficient reauthorization documentation may lead to denial of continued therapy

Billing Rule

Combination therapy exclusion for same indication

Do not bill this product in combination with other biologics for the same indication. Affected biologic classes include anti-IgE (eg, omalizumab), anti–IL-5 agents (eg, mepolizumab, reslizumab, benralizumab), anti–IL-4/IL-13 agents (eg, dupilumab), and TSLP inhibitors (eg, tezepelumab). Claims combining these agents for the same indication are subject to denial under this policy.

Billing denial rule: combination therapy for the same indication with listed biologics is not allowed and may be denied
Affected biologic classes: anti-IgE; anti–IL-5; anti–IL-4/IL-13; TSLP inhibitors
Examples of agents: omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab

COPD exacerbation (policy context): An event requiring systemic corticosteroids and/or antibiotics, or resulting in hospitalization or observation greater than 24 hours in an emergency department or urgent care setting; policy also specifies spirometric thresholds (post‑bronchodilator FEV1/FVC < 0.7 and post‑bronchodilator FEV1 % predicted ≥ 30% and ≤ 70%) and an eosinophil threshold of > 300 cells/µL for Nucala coverage in COPD.