CurrentAvMedPolicy N/A

Nucala (mepolizumab) subcutaneous for Eosinophilic Granulomatosis with Polyangiitis (EGPA)

This document governs prior authorization and step-edit requirements for outpatient pharmacy coverage of Nucala (mepolizumab) for treatment of EGPA for AvMed members; it affects prescribers, specialty pharmacies, and prior authorization reviewers.

Policy Summary

PayerAvMed

PolicyNucala (mepolizumab) subcutaneous for EGPA

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign the prior authorization form and submit supporting clinical documentation including baseline eosinophil count and diagnostic evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial authorization duration

12 monthsReauthorization duration

300 mgRecommended dose

>10% or >1000Baseline eosinophil

Coverage Criteria for Nucala (mepolizumab)

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Prescriber and age: Medication must be prescribed by an allergist, immunologist, pulmonologist, or rheumatologist; member must be 18 years of age or older.

Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) (Churg-Strauss) based on history or presence of asthma.

Baseline eosinophilia: Baseline blood eosinophil level >10% of total white blood cells OR absolute eosinophil count >1000 cells/mm3; provide eosinophil count and date.>10% OR >1000 cells/mm3

Supportive diagnostic criteria: Documentation of TWO of the following: biopsy with histopathologic evidence of eosinophilic vasculitis/perivascular eosinophilic infiltration/eosinophil-rich granulomatous inflammation; mono- or polyneuropathy; pulmonary infiltrates non-fixed on chest x-ray; sino-nasal abnormality; MRI or echocardiography evidence of cardiomyopathy; glomerulonephritis; alveolar hemorrhage by bronchoalveolar lavage; palpable purpura; ANCA positive (MPO or PR3); OR physician-assessed baseline disease severity using an objective tool (e.g., BVAS).two items

Disease activity status

Relapsing disease: History of at least one confirmed EGPA relapse requiring an increase in oral corticosteroids, initiation/increase of immunosuppressive therapy, or hospitalization that occurred within the past 2 years while receiving prednisone (or equivalent) >7.5 mg/day for at least 90 consecutive days.
Refractory disease defined as failure to attain remission (BVAS = 0 and OCS <7.5 mg/day for ≥90 days) after induction therapy OR recurrence of symptoms while tapering OCS within 6 months prior to initiation.

Stable corticosteroid therapy: Member has been on a stable dose of oral corticosteroid therapy for at least 4 weeks prior to starting treatment (e.g., prednisone or equivalent >7.5 mg/day).4 weeks

Continuation / Reauthorization — Covered for continuation when ONE of the following is met

Covered for continuation when ONE of the following is met

Disease control: Documentation of remission or improvement in BVAS = 0 (no active vasculitis) plus prednisone/prednisolone daily dose of < 7.5 mg/day or equivalent.

Improved relapse frequency/duration: Documentation of improvement in duration of remission or decreased frequency of relapses.

Corticosteroid sparing: Documentation of decrease in maintenance dose of systemic corticosteroids.

Improvement on disease activity tool: Documentation of improvement on a disease activity scoring tool (e.g., VDI, BVAS, FVC, FEV1, ACQ-6).

Use of concomitant biologic therapy with Cinqair, Dupixent, Fasenra, Tezspire, or Xolair in members considered for Nucala is experimental and investigational. The safety and efficacy of combining these agents with Nucala have not been established, and such combinations will not be permitted. If a member has an active authorization for Cinqair, Dupixent, Fasenra, Tezspire, or Xolair on file, subsequent requests for Nucala will not be approved. Prior authorization requests should document whether the previously prescribed biologic will be discontinued and, if so, the effective date and the new medication to be initiated.

Medication samples provided to initiate therapy do not satisfy step-edit or prior authorization requirements and therefore do not meet medical necessity criteria for approval. Prior therapies and step-edit requirements will be verified through pharmacy paid claims or submitted chart notes, and documentation of prior treatment history must be included with the authorization request.

Coding and Dosing

Drug descriptionNDC|description

Nucala (mepolizumab)

300 mg/mL SubQ once every 4 weeks administered as 3 separate 100-mg injections; single-dose prefilled auto-injector/single-dose prefilled syringe

Baseline eosinophil requirement

Baseline eosinophil requirement>10% of total WBCs OR absolute eosinophil count >1000 cells/mm3

Documentation requiredProvide baseline eosinophil count and date on the prior authorization form

ApplicabilityRequirement applies at baseline prior to initiation of Nucala for EGPA

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization form and submission: The prescribing physician must sign and clearly print their name on the prior authorization (PA) request (preprinted stamps are not valid). Office staff may complete other fields. Fax the completed form to 1-305-671-0200. Incomplete, incorrect, or illegible information (including missing phone/fax) may delay or result in denial of the authorization.

Prescriber signature and printed name required (stamps not valid)
Fax to 1-305-671-0200
Ensure phone and fax numbers are provided and legible to avoid delays

Step Therapy

Step-Edit Verification

Step-edit verification: Prior therapies and step requirements will be verified through pharmacy paid claims or submitted chart notes. Provide documentation of prior treatments when indicated.

Pharmacy paid claims may be checked to confirm prior therapy
Chart notes may be required if claims are not available

Documentation Required

Documentation Required to Support Clinical Criteria

Required clinical documentation: All clinical criteria checked on the form must be supported by documentation. Submit relevant lab results, imaging, biopsies, diagnostic reports, and chart notes with dates to substantiate each criterion. Examples include baseline eosinophil count with date, biopsy pathology reports, ANCA results, imaging reports, objective disease severity scores (e.g., BVAS, VDI, FVC/FEV1, ACQ-6), and records of relapses, hospitalizations, corticosteroid dosing and duration, or immunosuppressive therapy use.

Baseline eosinophil count and date (e.g., >10% or absolute >1000 cells/mm3)
Biopsy reports showing histopathologic eosinophilic vasculitis or related findings
Documentation of relapses, hospitalizations, OCS dosing and duration, and immunosuppressive therapy
Objective disease activity scores (BVAS, VDI, FVC/FEV1, ACQ-6) with dates

Note

Formulary / Specialty Pharmacy Notes

Formulary and specialty pharmacy notes: If the drug is non-formulary for the member’s plan, documentation of medical necessity is required. Specialty pharmacy dispensing (e.g., Proprium Rx) may be used per plan rules. Use of drug samples to initiate therapy does not satisfy step-edit or prior authorization requirements.

If non-formulary, submit medical necessity documentation
Samples do not meet step-edit/prior authorization criteria
Medication may be dispensed by specialty pharmacy per plan guidance

Denial Risk

Concomitant Biologic Prohibition

Concomitant biologic prohibition and discontinuation documentation: The Health Plan will not permit concomitant use of listed biologics (Cinqair, Dupixent, Fasenra, Nucala, Tezspire, Xolair). Requests will be denied if the member has an active authorization for any of these agents. If the member will discontinue a previously prescribed biologic prior to initiation of the requested agent, indicate whether the biologic will be discontinued and provide the name(s) and effective discontinuation/initiation dates.

Concomitant use of Cinqair, Dupixent, Fasenra, Nucala, Tezspire, or Xolair is not permitted
If discontinuing a previously authorized biologic, document the medication to be discontinued, effective date, medication to be initiated, and effective date

Background

Eosinophilic Granulomatosis with Polyangiitis (EGPA, also known as Churg–Strauss syndrome) is a small-vessel vasculitis commonly associated with asthma and peripheral eosinophilia. Clinical management aims to control vasculitic manifestations, reduce relapses, and minimize systemic corticosteroid exposure. Mepolizumab (Nucala), an anti–IL-5 monoclonal antibody, is indicated for appropriate patients with EGPA as an adjunct to standard therapy when criteria such as baseline eosinophilia, supportive diagnostic findings, and relapsing or refractory disease are present.

Definitions

Baseline eosinophilia definition

DefinitionBlood eosinophil level >10% of total white blood cells or absolute eosinophil count >1000 cells/mm3

When measuredBaseline value required and must be provided with date

Use in criteriaPart of initial authorization criteria for Nucala in EGPA

Relapsing disease (EGPA)

Definition of relapsing diseaseHistory of at least one confirmed EGPA relapse requiring increase in oral corticosteroids, initiation/increased immunosuppressive therapy, or hospitalization

Timeframe and steroid exposureRelapse must have occurred within the past 2 years while receiving >7.5 mg/day prednisone (or equivalent) for ≥90 consecutive days

Examples of escalationIncrease in OCS dose; initiation or increased dose of azathioprine, cyclophosphamide, methotrexate, or mycophenolate mofetil; or hospitalization

Refractory disease (EGPA)

Definition of refractory diseaseFailure to attain remission (BVAS = 0 and OCS <7.5 mg/day) for ≥90 consecutive days after induction therapy OR recurrence of symptoms while tapering OCS within 6 months prior to initiation

Induction therapy examplesStandard regimens include azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, high-dose corticosteroids, or rituximab administered for ≥3 months

Tapering relapse criterionRecurrence while tapering OCS at any dose level ≥7.5 mg/day taken for ≥90 consecutive days within 6 months prior to initiation

Initial Authorization Criteria

Initial Authorization — Initial authorization criteria; ALL must be met

Initial authorization — ALL of the following must be met

Prescriber specialty: Medication must be prescribed by an allergist, immunologist, pulmonologist, or rheumatologist.

Age requirement: Member must be 18 years of age or older.

Diagnosis of EGPA: Member must have a diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) based on history or presence of asthma.

Baseline eosinophils: Baseline blood eosinophil level >10% of total WBCs OR absolute eosinophil count >1000 cells/mm3; include eosinophil count and date.>10% OR >1000 cells/mm3

Supportive diagnostic findings: Documentation of TWO supportive findings from the list (biopsy with eosinophilic vasculitis/perivascular eosinophilic infiltration/eosinophil-rich granulomatous inflammation; mono- or polyneuropathy; pulmonary infiltrates non-fixed on chest x-ray; sino-nasal abnormality; MRI or echocardiography evidence of cardiomyopathy; glomerulonephritis; alveolar hemorrhage by BAL; palpable purpura; ANCA positive [MPO or PR3]; or physician-assessed baseline disease severity using an objective measure such as BVAS).2

Relapsing, refractory, or active non-severe disease

Relapsing disease: History of at least ONE confirmed EGPA relapse requiring an increase in oral corticosteroids, initiation/increase of immunosuppressive therapy, or hospitalization within the past 2 years while on prednisone (or equivalent) >7.5 mg/day for ≥90 consecutive days.
Refractory disease: Failure to attain remission (BVAS = 0 and OCS <7.5 mg/day for ≥90 days) after induction therapy OR recurrence of symptoms while tapering OCS within 6 months prior to initiation.

Stable corticosteroid use prior to initiation: Member has been on a stable dose of oral corticosteroid therapy for at least 4 weeks prior to starting treatment (e.g., prednisone or equivalent >7.5 mg/day).4 weeks

Reauthorization / Continuation Criteria

Reauthorization — at least one of the listed criteria must be met for continuation

Reauthorization — at least one of the following must be met for continuation

Remission or BVAS = 0 with prednisone <7.5 mg/day (or equivalent).

Improved clinical course: Documentation of improvement in duration of remission or decreased frequency of relapses.

Corticosteroid-sparing effect: Documentation of decrease in maintenance dose of systemic corticosteroids.

Objective improvement on disease activity measures: Documentation of improvement on a disease activity scoring tool (e.g., VDI, BVAS, FVC, FEV1, ACQ-6).

Step	Requirement
1	Use of medication samples to initiate therapy does not meet step-edit/prior authorization criteria and will not satisfy step requirements; prior therapies will be verified through pharmacy paid claims or submitted chart notes.

Site of Care / Dispensing

Billing Rule

Specialty pharmacy dispensing and non‑formulary documentation

Dispensing is via specialty pharmacy (Proprium Rx). Not all drugs are covered under every plan; if the drug is non‑formulary for the member's plan, include medical necessity documentation. Provider should note that samples do not satisfy prior authorization requirements.

Specialty Pharmacy indicated: Proprium Rx.
If non‑formulary, submit medical necessity documentation.
Samples do not meet step-edit/preauthorization criteria.