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    v1.0.28
    OpenPayerPolicy UpdatesPulmonologySecurity Health Nucala Prior Auth | OpenPayer
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    CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-P0260

    Nucala (mepolizumab) Subcutaneous Therapy

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    This policy governs prior authorization, initial approval, renewal, dosing, and concomitant-use requirements for subcutaneous Nucala in severe eosinophilic asthma, COPD, EGPA, HES, CRSwNP, and other FDA-labeled or compendia-supported indications for Security Health Plan members.

    Policy Summary
    PayerSecurity Health Plan of Wisconsin, Inc.
    PolicyNucala (mepolizumab) Subcutaneous Therapy
    Policy CodePolicy SHP-P0260
    Change TypeNo material change
    Effective DateN/A
    Last ReviewMar 3, 2026
    Next Review DateN/A
    Key ActionDocument the requested indication and supporting clinical evidence, including relevant laboratory results, diagnostic testing, treatment history, and adherence.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsAuthorization validity
    100 units/28 daysDose for asthma, COPD, and CRSwNP
    300 units/28 daysDose for EGPA and HES
    5Disease-specific pathways

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    22Covered diagnosis codes

    Medical Necessity and Coverage Criteria

    General initial approval

    Initial approval requires all applicable general and indication-specific criteria.

    • Continuation or new indication: Continuation therapy or an applicable FDA-labeled or compendia-supported indication must be met.
    • General safeguards: Required maintenance therapy, specialist involvement, concomitant-use compatibility, and absence of FDA-labeled contraindications must be documented.

    Severe eosinophilic asthma

    Covered for severe eosinophilic asthma when all of the following are met.

    • Eosinophilic confirmation: Baseline blood eosinophils are at least 150 cells/microliter; or FeNO is at least 20 parts per billion while on high-dose inhaled corticosteroids or daily oral corticosteroids; or sputum eosinophils are at least 2% while on high-dose inhaled corticosteroids or daily oral corticosteroids; or the member is dependent on systemic corticosteroids.150 cells/microliter; 20 parts per billion; 2%
    • Disease severity or prior biologic: Uncontrolled asthma is demonstrated by at least 2 systemic-steroid bursts in 12 months, a serious exacerbation requiring hospitalization, mechanical ventilation, emergency or urgent care, worsening during steroid taper, or baseline FEV1 below 80% predicted; alternatively, the member used an asthma biologic immunomodulator in the past 12 months.2 or more steroid bursts in 12 months; FEV1 <80% predicted

    Chronic obstructive pulmonary disease

    Covered for COPD when all of the following are met.

    • Diagnostic and phenotype requirements: Postbronchodilator FEV1/FVC is less than 0.7 and baseline blood eosinophils are at least 300 cells/microliter.FEV1/FVC <0.7; eosinophils >=300 cells/microliter
    • Disease severity or prior biologic: The member has at least 2 moderate COPD exacerbations requiring one or more systemic corticosteroid courses in the past 12 months, a severe exacerbation requiring hospitalization, mechanical ventilation, emergency or urgent care in the past 12 months, or COPD biologic use in the past 12 months.2 or more moderate exacerbations in 12 months
    • Background therapy: The member is currently treated with LAMA/LABA dual therapy for at least 3 months with adherence for 90 days within the past 120 days, unless an exception applies, and will continue ICS/LAMA/LABA triple therapy or LAMA/LABA dual therapy with Nucala.

    Eosinophilic granulomatosis with polyangiitis

    Covered for EGPA when all of the following are met.

    • Eosinophil threshold: Baseline blood eosinophils are at least 1000 cells/microliter or at least 10% of the white blood cell differential.>=1000 cells/microliter or >=10%
    • Disease and treatment conditions: The member has asthma, lacks severe organ- or life-threatening manifestations, and either has used oral corticosteroids for at least 4 weeks within the past 90 days and will continue oral corticosteroids with Nucala, has intolerance or hypersensitivity to an EGPA oral corticosteroid, or has an FDA-labeled contraindication to all oral corticosteroids.Oral corticosteroids for at least 4 weeks within past 90 days when applicable
    • Treatment purpose: Treatment is for relapsing or refractory disease or maintenance of disease remission.

    Hypereosinophilic syndrome

    Covered for HES when all of the following are met.

    • Diagnostic confirmation: There is either peripheral blood eosinophils of at least 1000 cells/microliter, bone marrow eosinophils exceeding 20% of nucleated cells, marked eosinophil granule protein deposition, or extensive tissue eosinophil infiltration in the pathologist's opinion, and hypereosinophilia-related organ involvement has been evaluated.>=1000 cells/microliter; bone marrow >20%
    • Exclusions and disease activity: No non-hematologic secondary or reactive cause is identified, FIP1L1-PDGFRA-positive disease is absent, and at least 2 HES flares occurred within the past 12 months.At least 2 flares in 12 months
    • Prior treatment or contraindication: The member had inadequate response to oral corticosteroids, hydroxyurea, interferon-alpha, or another immunosuppressive agent; or has intolerance or hypersensitivity to one of these therapies; or has FDA-labeled contraindications to hydroxyurea, interferon-alpha, all oral corticosteroids, and applicable immunosuppressive agents.

    Chronic rhinosinusitis with nasal polyps

    Covered for CRSwNP when all of the following are met.

    • Qualifying symptoms: Nasal discharge, nasal obstruction or congestion, decreased sense of smell, or facial pressure or pain.At least 2 symptoms
    • Objective confirmation: Anterior rhinoscopy, nasal endoscopy, or CT of the sinuses confirms the diagnosis.
    • Intranasal corticosteroid history: Inadequate response after at least 4 weeks of one intranasal corticosteroid, intolerance or hypersensitivity to one, or FDA-labeled contraindication to all intranasal corticosteroids.At least 4 weeks when inadequate response is claimed

    Background therapy and safety

    Additional therapy and safety requirements apply when the corresponding diagnosis is present.

    Background therapy and safety: For severe eosinophilic asthma, required inhaled corticosteroid and additional controller therapy must be used or an allowed intolerance or contraindication exception must apply, and asthma control therapy continues with Nucala. For COPD, required ICS and LAMA/LABA therapy must be used or an allowed exception must apply, and inhaled maintenance therapy continues. For HES, existing HES therapy continues. For CRSwNP, standard nasal polyp maintenance therapy continues.

    Renewal criteria

    Renewal requires all of the following.

    Renewal

    • Clinical response and maintenance: The member has clinical benefit and, when applicable, is treated within the past 90 days and compliant with asthma control therapy, COPD maintenance therapy, continued HES therapy, or continued CRSwNP maintenance therapy.Current treatment within past 90 days when applicable
    • Safety and prescribing requirements: Specialist involvement or consultation, acceptable concomitant-use status, and absence of FDA-labeled contraindications are required.

    Coverage is excluded when HES has an identifiable non-hematologic secondary or reactive cause, including infection (such as HIV or parasitic helminth infection), allergy or atopy, medication hypersensitivity, collagen vascular disease, metabolic disease such as adrenal insufficiency, or a nonhematologic malignancy such as a solid tumor or lymphoma.

    Coverage is excluded for FIP1L1-PDGFRA-positive hypereosinophilic syndrome.

    Coverage is excluded for EGPA with severe organ- or life-threatening disease, including alveolar hemorrhage, glomerulonephritis, central nervous system vasculitis, mononeuritis multiplex, cardiac involvement, mesenteric ischemia, or limb/digit ischemia.

    Nucala may not be used with another immunomodulatory agent unless the requested agent's prescribing information does not limit the combination and supporting evidence is submitted, such as clinical-trial results, a phase III study, or applicable guideline support.

    Concomitant use of Nucala is excluded with agents identified in the policy's Agents NOT to be used Concomitantly / Contraindicated as Concomitant Therapy table. The listed products include other biologics, immunomodulators, and targeted therapies such as Dupixent, Fasenra, Tezspire, Xolair, TNF inhibitors, JAK inhibitors, interleukin-directed therapies, Nucala, and the other products specified in the table.

    Billing Codes and Clinical Thresholds

    Covered HCPCS CodesHCPCSCovered
    J2182Injection, mepolizumab, 1 mg; 1 billable unit = 1 mg
    NDC Product Presentation CodesNDC
    00173-0881-xxNucala 100 mg/mL lyophilized powder single-dose vial
    00173-0892-xxNucala 100 mg/mL single-dose prefilled autoinjector or syringe (cartons of 1)
    00173-0904-xxNucala 40 mg/0.4 mL single-dose prefilled syringe (cartons of 1)
    Covered Diagnosis CodesICD-10Covered
    D72.110Idiopathic hypereosinophilic syndrome [IHES]
    D72.111Lymphocytic Variant Hypereosinophilic Syndrome [LHES]
    D72.119Hypereosinophilic syndrome [HES], unspecified
    J33.0Polyp of nasal cavity
    J33.1Polypoid sinus degeneration
    J33.8Other polyp of sinus
    J33.9Nasal polyp, unspecified
    J40Bronchitis, not specified as acute or chronic
    J41.0Simple chronic bronchitis
    J41.1Mucopurulent chronic bronchitis
    1–10 of 22
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    Nucala dose: COPD, CRSwNP, and severe eosinophilic asthma
    Applicable indicationsCOPD, chronic rhinosinusitis with nasal polyps (CRSwNP), and severe eosinophilic asthma
    Billable units100 HCPCS units per dose
    Administration intervalEvery 28 days
    Nucala dose: EGPA and HES
    Applicable indicationsEosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES)
    Billable units300 HCPCS units per dose

    Authorization, Documentation, and Denial Risks

    Prior Authorization

    12-Month Authorization Period

    Initial and renewal prior authorization are valid for 12 months (365 days). Renewal may be requested every 12 months thereafter.

    • Initial authorization: 12 months (365 days).
    • Renewal authorization: 12 months (365 days).
    Step Therapy

    Continuation Therapy Pathway

    For continuation therapy, document recent use of the requested agent or a prescriber attestation that the member used it within the past 90 days and is at risk if therapy is changed. Sample use does not qualify as treatment for this pathway.

    • Member treated with the requested agent within the past 90 days; or
    • Prescriber attests to treatment within the past 90 days and risk from changing therapy.
    • Starting therapy with samples is not approvable.

    Therapy and Policy Context

    Nucala (mepolizumab) is a subcutaneous biologic used for eosinophil-driven respiratory and inflammatory diseases. This policy addresses treatment for severe eosinophilic asthma, eosinophilic COPD, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), chronic rhinosinusitis with nasal polyps (CRSwNP), and other FDA-labeled or compendia-supported indications. Coverage depends on objective diagnostic evidence, clinically significant disease or relevant prior-treatment history, and continuation of appropriate background therapy when applicable.

    Clinical and Evidence Definitions

    COPD diagnostic confirmation
    Diagnostic methodSpirometry
    Required findingPostbronchodilator FEV1/FVC ratio less than 0.7
    DefinitionThis finding confirms the COPD diagnosis
    COPD eosinophilic phenotype
    PhenotypeEosinophilic COPD
    Baseline measurementBlood eosinophil count before therapy with the requested agent
    Definition thresholdAt least 300 cells/microliter
    Policy Summary
    PayerSecurity Health Plan of Wisconsin, Inc.
    PolicyNucala (mepolizumab) Subcutaneous Therapy
    Policy CodePolicy SHP-P0260
    Change TypeNo material change
    Effective DateN/A
    Last ReviewMar 3, 2026
    Next Review DateN/A
    Key ActionDocument the requested indication and supporting clinical evidence, including relevant laboratory results, diagnostic testing, treatment history, and adherence.
    SourceLink
    On This Page
    Medical Necessity and Coverage CriteriaBilling Codes and Clinical ThresholdsAuthorization, Documentation, and Denial RisksTherapy and Policy ContextClinical and Evidence Definitions
    3 months therapy; 90 adherent days in past 120 days
    Maintenance therapy:
    The member is currently treated with and will continue standard nasal polyp maintenance therapy, such as nasal saline irrigation or intranasal corticosteroids.
    Administration intervalEvery 28 days
    Severe eosinophilic asthma: baseline blood eosinophils
    TestBaseline blood eosinophil count before therapy with the requested agent
    Required threshold150 cells/microliter or higher
    Role in approvalOne option for objective confirmation of severe eosinophilic asthma
    Severe eosinophilic asthma: FeNO
    TestFraction of exhaled nitric oxide (FeNO)
    Required threshold20 parts per billion or higher
    Treatment contextMust be measured while on high-dose inhaled corticosteroids or daily oral corticosteroids
    Severe eosinophilic asthma: sputum eosinophils
    TestSputum eosinophils
    Required threshold2% or higher
    Treatment contextMust be measured while on high-dose inhaled corticosteroids or daily oral corticosteroids
    Severe asthma: lung function
    MeasurementBaseline Forced Expiratory Volume (FEV1) before therapy with the requested agent
    Required thresholdLess than 80% of predicted
    Approval contextQualifies as evidence of uncontrolled asthma while on asthma control therapy
    COPD: spirometric confirmation
    TestSpirometry after bronchodilator administration
    Required thresholdFEV1/FVC ratio less than 0.7
    PurposeConfirms the COPD diagnosis
    COPD: eosinophilic phenotype
    PhenotypeEosinophilic COPD
    MeasurementBaseline blood eosinophil count before therapy with the requested agent
    Required threshold300 cells/microliter or higher
    EGPA: eosinophil count
    ConditionEosinophilic granulomatosis with polyangiitis (EGPA)
    MeasurementBaseline blood eosinophil count before therapy for the requested indication
    Required threshold1000 cells/microliter or higher
    EGPA: eosinophil percentage
    MeasurementEosinophils on the white blood cell differential count
    Required threshold10% or higher
    UseAlternative EGPA eosinophil criterion to the baseline count threshold
    EGPA: oral corticosteroid exposure
    TherapyOral corticosteroid (OCS) therapy
    Required durationAt least 4 weeks
    Lookback periodCurrently treated within the past 90 days, when OCS will be continued with Nucala
    HES: diagnosis duration
    ConditionHypereosinophilic syndrome (HES)
    Minimum diagnosis durationAt least 6 months
    Approval contextThe diagnosis must meet the policy's additional confirmation and organ-involvement requirements
    HES: peripheral blood eosinophils
    MeasurementPeripheral blood eosinophil count
    Required threshold1000 cells/microliter or greater
    Diagnostic roleOne qualifying option for HES confirmation
    HES: bone marrow eosinophils
    MeasurementEosinophils in a bone marrow section
    Required thresholdMore than 20% of all nucleated cells
    Diagnostic roleOne qualifying option for HES confirmation
    HES: disease activity
    Disease activityHES flares, defined as worsening clinical symptoms and/or blood eosinophil counts requiring escalation in therapy
    Required numberAt least 2 flares
    Lookback periodWithin the past 12 months
    CRSwNP: symptom duration
    ConditionSymptoms consistent with chronic rhinosinusitis
    Required symptom countAt least 2 qualifying symptoms
    Required durationAt least 12 consecutive weeks
    Background-therapy adherence
    Minimum therapy durationAt least 3 months of the applicable background therapy
    Adherence windowAdherent for 90 days within the past 120 days
    When it appliesWhen specified for the relevant indication; permitted intolerance, hypersensitivity, or FDA-labeled contraindication exceptions may apply

    Unsupported block type: documentation

    Step Therapy

    Required Prior and Concomitant Therapy

    Document all required prior and concomitant therapy for the applicable indication, including treatment duration, adherence, intolerance or hypersensitivity, contraindication, and planned continuation with Nucala.

    • Severe eosinophilic asthma: maximally tolerated or adequately dosed ICS, plus asthma-control therapy such as LABA, LAMA, LTRA, or theophylline; required duration is generally at least 3 months with adherence for 90 days within the past 120 days. Continue asthma-control therapy with Nucala.
    • COPD: ICS for at least 3 months with adherence for 90 days within the past 120 days, and LAMA/LABA dual therapy for at least 3 months with adherence for 90 days within the past 120 days; continue COPD maintenance therapy, including triple or dual therapy.
    • EGPA: OCS for at least 4 weeks within the past 90 days and continued with Nucala, unless there is intolerance, hypersensitivity, or an FDA-labeled contraindication to the required corticosteroids.
    • HES: inadequate response to, or intolerance/hypersensitivity or contraindication to, OCS, hydroxyurea, interferon-alpha, or another immunosuppressive agent; continue existing HES therapy with Nucala.
    • CRSwNP: inadequate response to an intranasal corticosteroid after at least 4 weeks, or intolerance, hypersensitivity, or contraindication; continue standard nasal-polyp maintenance therapy with Nucala.
    Documentation Required

    Indication and Clinical-Support Documentation

    Submit diagnosis-specific clinical and laboratory evidence supporting the requested indication, along with treatment history and severity documentation.

    • Severe eosinophilic asthma: baseline eosinophils ≥150 cells/microliter, FeNO ≥20 ppb on high-dose ICS or daily OCS, sputum eosinophils ≥2% on high-dose ICS or daily OCS, or systemic-corticosteroid dependence; also document uncontrolled disease, severe exacerbations, steroid worsening, FEV1 <80%, or qualifying biologic history.
    • COPD: spirometry-confirmed postbronchodilator FEV1/FVC <0.7, baseline eosinophils ≥300 cells/microliter, and qualifying exacerbation history or biologic treatment history.
    • EGPA: eosinophils ≥1000 cells/microliter or ≥10% on differential, asthma history, absence of severe organ- or life-threatening disease, and qualifying OCS treatment or exception.
    • HES: diagnosis for at least 6 months; qualifying eosinophil, bone-marrow, granule-protein, or tissue-infiltration findings; evaluation for organ involvement; no secondary reactive cause; no FIP1L1-PDGFRA-positive disease; at least 2 flares in the prior 12 months; and qualifying prior-treatment failure or exception.
    • CRSwNP: at least 2 characteristic symptoms for at least 12 consecutive weeks, confirmed by anterior rhinoscopy, nasal endoscopy, or sinus CT; document intranasal corticosteroid treatment or exception.
    • For another FDA-labeled or compendia-supported indication, document the diagnosis, route, age-labeling or evidence support, and applicable clinical rationale.
    Documentation Required

    EGPA Documentation Requirements

    EGPA requests require disease-specific laboratory, clinical, severity, and treatment documentation. The record must support non-severe disease appropriate for the requested therapy and a qualifying corticosteroid pathway.

    • Baseline eosinophils ≥1000 cells/microliter or ≥10% of the white blood cell differential.
    • History or presence of asthma.
    • No severe disease with organ- or life-threatening manifestations, such as alveolar hemorrhage, glomerulonephritis, CNS vasculitis, mononeuritis multiplex, cardiac involvement, mesenteric ischemia, or limb/digit ischemia.
    • Relapsing or refractory disease, or maintenance of remission.
    • OCS treatment for at least 4 weeks within the past 90 days with planned continuation, unless intolerance, hypersensitivity, or an FDA-labeled contraindication is documented.
    Documentation Required

    HES Documentation Requirements

    HES requests require documentation of disease duration, diagnostic confirmation, organ-involvement evaluation, exclusion of secondary causes and FIP1L1-PDGFRA-positive disease, flare history, and prior-treatment response or exceptions.

    • HES diagnosis for at least 6 months.
    • At least one qualifying eosinophil, bone-marrow, granule-protein, or tissue-infiltration finding, plus evaluation of hypereosinophilia-related organ involvement.
    • No identifiable nonhematologic secondary cause, including infection, allergy or atopy, medication reaction, collagen vascular disease, adrenal insufficiency, or nonhematologic malignancy.
    • No FIP1L1-PDGFRA-positive disease and at least 2 HES flares in the prior 12 months.
    • Inadequate response, intolerance/hypersensitivity, or qualifying contraindication to OCS, hydroxyurea, interferon-alpha, or an immunosuppressive agent.
    Documentation Required

    Specialist and Combination-Use Documentation

    Document the specialist’s identity or consultation and disclose all proposed immunomodulatory combination therapy. Combination use requires that the prescribing information does not limit the combination and that supporting clinical evidence or guidelines are submitted.

    • Identify the prescribing specialist or consulting specialist appropriate to the diagnosis.
    • If Nucala will be combined with another immunomodulatory agent, submit clinical trials, phase III studies, or guideline support.
    • Combination therapy is not acceptable when the Nucala prescribing information limits the combination.
    Prior Authorization

    Renewal Response Documentation

    Renewal requests must show prior plan approval, clinical benefit, recent treatment and compliance with indication-specific maintenance therapy, as applicable.

    • Member was previously approved through the plan’s prior authorization process; otherwise, initial evaluation is required.
    • Document clinical benefit with Nucala.
    • For severe eosinophilic asthma or COPD, document treatment within the past 90 days and compliance with required control or maintenance therapy.
    • For HES, document continuation of existing HES therapy with Nucala.
    • For CRSwNP, document continuation of standard nasal-polyp maintenance therapy with Nucala.
    Denial Risk

    Contraindications, Specialist, and Combination-Therapy Failures

    Approval may be denied when required specialist involvement, combination-use support, or contraindication review is absent or unfavorable.

    • No qualifying specialist prescriber or specialist consultation.
    • Requested combination with another immunomodulatory agent is limited by prescribing information or lacks submitted clinical-trial, phase III, or guideline support.
    • Any FDA-labeled contraindication to Nucala is present.
    • Required documentation is missing or does not establish the applicable clinical criteria.
    Billing Rule

    Restricted Concomitant Immunomodulators

    Nucala must not be used concomitantly with the plan’s restricted immunomodulatory agents unless the policy’s combination-use requirements are satisfied and the agent is not prohibited by prescribing information.

    • Restricted agents include Abrilada, Actemra, Adalimumab, Adbry, Amjevita, Arcalyst, Avsola, Avtozma, Benlysta, Bimzelx, Cibinqo, Cimzia, Cinqair, Cosentyx, Cyltezo, Dupixent, Ebglyss, Enbrel, Entyvio, Exdensur, Fasenra, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Ilaris, Ilumya, Imuldosa, Inflectra, Infliximab, Kevzara, Kineret, Leqselvi, Litfulo, Nemluvio, Nucala, Olumiant, Omlyclo, Omvoh, Opzelura, Orencia, Otezla, Otezla XR, Otulfi, Pyzchiva, Remicade, Renflexis, Rhapsido, Riabni, Rinvoq, Rituxan, Rituxan Hycela, Ruxience, Saphnelo, Selarsdi, Siliq, Simlandi, Simponi, Simponi ARIA, Skyrizi, Sotyktu, Spevigo, Starjemza, Stelara, Steqeyma, Taltz, Tezspire, Tofacitinib, Tofidence, Tremfya, Truxima, Tyenne, Tyruko, Tysabri, Ustekinumab, Velsipity, Wezlana, Xeljanz, Xeljanz XR, Xolair, Yesintek, Yuflyma, Yusimry, Zeposia, and Zymfentra.
    Denial Risk

    Failure of Initial Criteria

    Initial approval may be denied when the member does not meet the diagnosis-specific clinical, laboratory, severity, treatment-history, age, or route-of-administration requirements.

    • No qualifying diagnosis or FDA-labeled/compendia-supported indication and route.
    • Missing required eosinophil, FeNO, sputum, spirometry, imaging, pathology, symptom-duration, flare, or exacerbation evidence.
    • Failure to document required prior therapy, inadequate response, intolerance, hypersensitivity, or FDA-labeled contraindication exception.
    • Failure to document required concomitant therapy or continuation plan.
    • For EGPA or HES, presence of an exclusion such as severe organ-threatening EGPA, a secondary HES cause, or FIP1L1-PDGFRA-positive disease.
    • For CRSwNP, failure to document at least two qualifying symptoms for 12 consecutive weeks and objective diagnostic confirmation.
    Denial Risk

    Failure of Renewal Criteria

    Renewal may be denied when prior plan approval, clinical benefit, recent treatment, compliance, or required concomitant maintenance therapy is not documented.

    • No prior approval through the plan’s prior authorization process.
    • No documented clinical benefit with Nucala.
    • For asthma or COPD, treatment or compliance with required control or maintenance therapy is not documented within the past 90 days.
    • Required HES or CRSwNP maintenance therapy is not continued with Nucala.
    • Specialist, combination-use, or FDA-labeled contraindication requirements are not satisfied.
    Denial Risk

    Avoid Contraindicated Concomitant Therapy

    Do not submit Nucala for concomitant use with a prohibited biologic, immunomodulator, or targeted therapy. Such combinations may result in denial unless the policy’s documented combination exception applies and the agent is not specifically restricted by prescribing information.

    • Prohibited categories include TNF inhibitors, JAK inhibitors, IL-4 inhibitors, other biologic immunomodulators, immunosuppressive agents, and targeted therapies listed in the policy’s Agents NOT to be used Concomitantly table.
    • The restricted table specifically includes Nucala with agents such as Dupixent, Fasenra, Tezspire, Xolair, Cinqair, and other listed biologic or targeted therapies.
    • Submit the proposed full medication regimen and supporting evidence whenever combination therapy is requested.
    Chronic rhinosinusitis symptom definition
    Qualifying symptomsNasal discharge; nasal obstruction or congestion; loss or decreased sense of smell; or facial pressure or pain
    Required symptom countAt least 2 symptoms
    Required durationAt least 12 consecutive weeks
    Compendia support
    AHFSQualifying compendia support
    DrugDexLevel 1 or 2a evidence
    NCCNLevel 1 or 2a recommended use