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    v1.0.28
    OpenPayerPolicy UpdatesPulmonologyallcareadvantage Mepolizumab Coverage & Prior Auth…
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    CurrentallcareadvantagePolicy 011.3

    Approval Criteria for Mepolizumab (Anti-IL5) — Coverage & Prior Authorization

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    Defines AllCare Advantage coverage, prior authorization, approval lengths, quantity limits, and clinical criteria for mepolizumab (and benralizumab) for severe eosinophilic asthma and mepolizumab for eosinophilic granulomatosis with polyangiitis (EGPA). Affects providers requesting PA for these agents.

    Policy Summary
    Payerallcareadvantage
    PolicyApproval Criteria for Mepolizumab (Anti-IL5)
    Policy CodePolicy 011.3
    Change TypeNo material change
    Effective DateJun 14, 2022
    Last ReviewJun 13, 2024
    Next Review DateJun 13, 2024
    Key ActionSubmit prior authorization with diagnosis, patient age, current and prior-year eosinophil levels, documentation of exacerbations or OCS use, controller therapy and compliance, and for EGPA trials/contraindications plus FFS score.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥12Min age (severe asthma)
    1 yrApproval length
    J2182Mepolizumab J-code
    100 mg q4w

    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.

    Qty limit (severe asthma)
    >150/µLEosinophil threshold

    Coverage and Medical Necessity Criteria

    Initial Therapy

    Covered when ALL of the following are met (distinct pathways for Severe Asthma and EGPA):

    Eligible diagnosis: Member has one of the following diagnoses: Severe asthma (eosinophilic phenotype) OR eosinophilic granulomatosis with polyangiitis (EGPA).

    If not met: Deny

    Age: Member meets the policy age requirement: for severe asthma pathway the policy references age criteria (document workflow uses ≥6 years; background notes FDA age ≥12 years).>=6 yrs (policy workflow); FDA ≥12 yrs noted in background

    Document age in request; if age criterion not met: Deny

    Eosinophilia: Documentation of a current peripheral blood eosinophil >150/µL OR a peripheral blood eosinophil level >300/µL at any time in the past year.>150/µL current OR >300/µL past year

    If not met: Deny

    Exacerbation or OCS requirement (severe asthma): Either: an exacerbation in the last 12 months requiring hospitalization or ED visit OR documentation of at least two courses of oral corticosteroids (OCS) for asthma control in the last 12 months.12 months timeframe

    If neither documented: Deny

    Controller therapy and compliance (severe asthma): Member is currently on maximum inhaled controller therapy: maximum dose inhaled corticosteroid plus a second long-acting anti-asthma agent (e.g., LAMA, montelukast, LABA/LAMA) and demonstrates good compliance defined as <45 days between two or more fills over the last 12 months.<45 days between fills over last 12 months

    If not on maximum therapy or poor compliance: Deny

    EGPA-specific requirements: For EGPA: Member is ≥18 years old; has had a trial of or documented contraindication to daily glucocorticoid therapy; has had a trial of or documented contraindication to cyclophosphamide, azathioprine, or methotrexate; and has vasculitis disease activity (Five-Factor Score, FFS) <2.FFS <2

    If any EGPA-specific requirement not met: Deny

    Renewal

    Renewal criteria — Covered when ANY listed clinical improvements are documented:

    Asthma renewal response: Documentation of ANY of the following: decreased hospitalizations or ED visits for asthma; decreased need for inhaled corticosteroid (ICS) or combination ICS agents; OR decreased serum eosinophil levels.

    If none documented: case reviewed with MD; may require peer-to-peer

    EGPA renewal response: Documentation of ANY of the following: disease remission; decreased Five-Factor Score (FFS); OR decreased dose of oral glucocorticoid.

    If none documented: case reviewed with MD; may require peer-to-peer

    Treatment with mepolizumab is covered only for the indications specified in this policy: severe eosinophilic asthma (eosinophilic phenotype) and eosinophilic granulomatosis with polyangiitis (EGPA). Requests for mepolizumab for other diagnoses or clinical indications are not covered. The policy also specifies covered age ranges for the asthma indication; AllCare covers injectable mepolizumab for members aged ≥12 years with severe eosinophilic asthma per the policy statement.

    Requests are considered not medically necessary and should be denied when required clinical criteria are not met. Denial conditions include: lack of documentation of a current serum eosinophil > 150/µL or a level > 300/µL at any time in the past year; absence of the required exacerbation history (an exacerbation requiring hospitalization or ED visit in the prior 12 months) or fewer than two courses of oral corticosteroids for asthma control in the prior 12 months; failure to document that the member is on maximum inhaled controller therapy (maximum combination regimen) when indicated; or the member does not meet the policy age requirement. For EGPA, denial applies when EGPA-specific step requirements (such as trials of or contraindications to glucocorticoids and required immunosuppressive agents) or the required Five-Factor Score threshold are not documented.

    Billing and Coding

    Covered HCPCS/J codesHCPCSCovered
    J2182Mepolizumab injection (billing J-code) as stated in policy
    Peripheral blood eosinophil
    ThresholdCurrent peripheral blood eosinophil >150/µL OR a level >300/µL at any time in the past year
    PurposeRequired laboratory criterion to qualify for mepolizumab under the severe eosinophilic asthma pathway
    DocumentationProvider must supply current serum eosinophil level and prior-year levels if applicable

    Provider Requirements, Prior Authorization, and Denials

    Prior Authorization

    Prior authorization required (use J2182)

    Prior authorization is required for all requests for mepolizumab; bill using HCPCS J2182.

    • All requests require PA approval.
    • J2182 is the J-code for mepolizumab.
    Step Therapy

    EGPA step therapy: document glucocorticoid and immunosuppressive trials

    For EGPA, document a trial of or contraindication to daily glucocorticoid therapy and a trial of or contraindication to cyclophosphamide, azathioprine, or methotrexate before approval.

    • Member must be ≥18 years old for EGPA pathway.
    • Trials or documented contraindications to the listed immunosuppressive agents are required.

    Definitions and Clinical Scores

    Five-Factor Score (FFS)
    DefinitionFive-Factor Score (FFS): a vasculitis disease activity score used in EGPA to assess severity
    Policy requirementFFS must be <2 for approval of mepolizumab for EGPA
    ContextMepolizumab is added for EGPA patients not controlled on glucocorticoids and who do not meet criteria for cyclophosphamide; FFS helps determine severity

    Background

    Mepolizumab is a monoclonal antibody targeting interleukin-5 (anti-IL5) used as add-on maintenance therapy for patients with severe eosinophilic asthma and is also indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA). The policy notes that EGPA primary therapy is systemic glucocorticoids and that mepolizumab may be used for patients not controlled on glucocorticoids after consideration of other immunosuppressive agents. The document further clarifies that all requests require prior authorization and that the billed J-code for mepolizumab is J2182.

    Policy Summary
    Payerallcareadvantage
    PolicyApproval Criteria for Mepolizumab (Anti-IL5)
    Policy CodePolicy 011.3
    Change TypeNo material change
    Effective DateJun 14, 2022
    Last ReviewJun 13, 2024
    Next Review DateJun 13, 2024
    Key ActionSubmit prior authorization with diagnosis, patient age, current and prior-year eosinophil levels, documentation of exacerbations or OCS use, controller therapy and compliance, and for EGPA trials/contraindications plus FFS score.
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaBilling and CodingProvider Requirements, Prior Authorization, and DenialsDefinitions and Clinical ScoresBackground
    Step Therapy

    Severe asthma step requirements: max controller therapy, compliance, exacerbation history

    For severe eosinophilic asthma, show the member is on maximum inhaled controller therapy (ICS plus a second anti‑asthma agent) and has documented good compliance; prior exacerbation or repeated OCS courses in the last 12 months are required.

    • Maximum therapy = ICS plus a second agent (e.g., LAMA, montelukast, LABA/LAMA).
    • Good compliance defined as <45 days between two or more fills over the last 12 months.
    • Either an exacerbation requiring hospitalization/ED visit in last 12 months or ≥2 courses of oral corticosteroids in last 12 months is required.
    Documentation Required

    Required documentation to support PA request

    Include diagnosis, patient age, current serum eosinophil level (and prior-year levels if applicable), documentation of exacerbations or oral corticosteroid use in the past 12 months, current controller therapy and compliance, and for EGPA evidence of trials/contraindications to glucocorticoids and other immunosuppressants plus the FFS score.

    • Current eosinophil >150/µL or a level >300/µL at any time in the past year when applicable.
    • Documentation of controller therapy and compliance (see compliance definition).
    • For EGPA, supply trial/contraindication documentation for glucocorticoids and cyclophosphamide/azathioprine/methotrexate and the Five‑Factor Score (FFS).
    Denial Risk

    Common denial triggers: diagnosis, age, labs, treatment trials

    Common denial reasons include lack of an eligible diagnosis (severe asthma or EGPA), member age below the policy threshold, missing required eosinophil laboratory values, or failure to document required treatment trials/compliance.

    • Policy requires an eligible diagnosis (severe asthma with eosinophilic phenotype or EGPA).
    • Age criteria: policy references minimum ages (see policy; severe asthma pathway assesses age).
    • Eosinophil labs required: current >150/µL or >300/µL at any time in past year.
    Denial Risk

    EGPA denial triggers: FFS ≥2 or missing immunosuppressive trials

    For EGPA requests, denials occur if the Five‑Factor Score (FFS) is ≥2 or if trials/contraindications to required immunosuppressive agents (cyclophosphamide, azathioprine, methotrexate) and daily glucocorticoid therapy are not documented.

    • Policy requires FFS <2 for approval.
    • Document trials of or contraindications to the listed immunosuppressive agents and daily glucocorticoids.