CurrentCignaPolicy v080125

Nucala (mepolizumab) prior authorization and clinical criteria

This document governs prior authorization, clinical documentation, and coverage criteria for Nucala (mepolizumab) across multiple eosinophil-associated indications (asthma, COPD, CRSwNP, EGPA, etc.) for Cigna members requesting specialty pharmacy or infusion settings.

Policy Summary

PayerCigna

PolicyNucala (mepolizumab) prior authorization and clinical criteria

Policy CodePolicy v080125

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit a completed Cigna prior authorization form with indication-specific checklist items (treatment status, eosinophil counts, prior therapy history, and specialty prescriber information).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multiplecovered indications listed on the form

thresholdseosinophil thresholds vary

setting noteadministration site guidance

Accredopreferred specialty pharmacy

6EGPA checklist items

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Coverage Criteria for Nucala (mepolizumab)

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Is the requested use for Eosinophilic Granulomatosis with Polyangiitis (EGPA)? Covered when the following criteria are met:

EGPA - Initial and Ongoing Therapy

Therapy status
- Initial therapy
- Currently receiving Nucala for at least 6 months
- Restarting therapy with Nucala
Response (if currently receiving)
- Has the patient responded to therapy according to the prescriber? Examples include reduced rate of relapse, corticosteroid dose reduction, and reduced eosinophil levels.
  Required for continuation requests; if No, provide supporting documentation for continued use.
Initial therapy specific criteria
- Active, non-severe disease (vasculitis without life- or organ-threatening manifestations). Examples include rhinosinusitis, asthma, mild systemic symptoms, uncomplicated cutaneous disease, mild inflammatory arthritis.non-severe
- Blood eosinophil level ≥ 150 cells/μL within the previous 4 weeks, OR a blood eosinophil level ≥ 150 cells/μL prior to treatment with Nucala or another monoclonal antibody therapy that may alter blood eosinophil levels.>= 150 cells/μL
  List of monoclonal antibody therapies that may alter eosinophil levels includes, but is not limited to, Nucala, Adbry, Cinqair, Dupixent, Ebglyss, Fasenra, Nemluvio, Tezspire, Xolair.
- For initial therapy: patient is receiving a systemic corticosteroid (for example, prednisone) for a minimum of 4 weeks.
  If not, provide clinical rationale.
- Requested medication is prescribed by, or in consultation with, an allergist, immunologist, pulmonologist, or rheumatologist.
Prescriber and documentation requirements
- Prescriber attestation that information is accurate and provision of supporting documentation (labs showing eosinophil counts, treatment history, steroid use, and notes documenting disease severity).
Notes
- If continuation: documentation of clinical benefit (examples above) and ongoing use of systemic corticosteroid as indicated.
- If restarting: provide reason for discontinuation and evidence to support re-initiation and expected benefit.

Billing Codes, Formulations, and Clinical Thresholds

Covered HCPCS/J-codeHCPCSCovered

J3490	Unclassified drugs (use for billing if no specific J-code assigned)
J3590	Unclassified biologics (if applicable)

Product-specific NDCs (examples)NDC

00074-4345-02	Nucala (mepolizumab) 100 mg/1 mL single-dose vial
00074-4345-03	Nucala (mepolizumab) 100 mg/0.5 mL prefilled syringe / autoinjector (example NDC - verify current NDC)

Administration CPT CodesCPT

96372	Therapeutic, prophylactic, or diagnostic injection (SC)
96413	Chemotherapy administration, intravenous infusion technique (if IV administration is used) - verify appropriate code for biologic infusion

Revenue Codes / Miscmixed

0360	IV therapy - general revenue code (facility billing)

Formulations - Nucala (mepolizumab)mixedCovered

Vial	100 mg/1 mL single-dose vial for subcutaneous injection (provider-administered)
Prefilled syringe	100 mg/0.5 mL or 100 mg/1 mL prefilled syringe for subcutaneous injection (patient or provider use)
Autoinjector	Prefilled autoinjector presentation for subcutaneous self-administration (device-specific NDCs vary)

Billing notesmixed

Note	When billing, include appropriate NDC for product dispensed; use correct administration CPT/HCPCS for SC injection. Verify specific Nucala NDCs and J-code mapping per payer formulary prior to billing.

Relevant ICD-10 Codes (examples)ICD-10

J45.909	Unspecified asthma, uncomplicated
J44.9	COPD, unspecified
J33.9	Nasal polyp, unspecified (CRSwNP)
D72.828	Eosinophilia, other
M30.1	Polyarteritis nodosa (for vasculitis differential)
D72.1	Eosinophilia
D47.Z	Hypereosinophilic syndrome - use appropriate HES code/description

EGPA specificICD-10

M30.1

Polyarteritis nodosa (consider M30.1 or other vasculitis codes for EGPA documentation)

Hypereosinophilic SyndromeICD-10

D72.1

Eosinophilia (use specific HES coding as applicable)

Blood eosinophil thresholds and related clinical requirements

COPD eosinophil threshold>= 300 cells/µL within previous 6 weeks or prior to eosinophil-altering therapy

Asthma eosinophil threshold>= 150 cells/µL within previous 6 weeks or prior to eosinophil-altering therapy

EGPA eosinophil threshold>= 150 cells/µL within previous 4 weeks or prior to eosinophil-altering therapy

HES eosinophil threshold>= 1,000 cells/µL prior to monoclonal antibody therapy

EGPA corticosteroid requirementCurrently receiving systemic corticosteroid therapy for >= 4 weeks (for initial therapy)

HES prior therapy requirementTried at least one other HES treatment for minimum 4 weeks (for initial therapy)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization required using Cigna PA form (include J‑code and formulation); Accredo preferred

Submit a completed Cigna prior authorization form for Nucala that includes the J‑code and the selected medication formulation (vial, auto‑injector, or syringe). Use Accredo Specialty Pharmacy when indicated — Accredo is listed as Cigna’s nationally preferred specialty pharmacy for dispensing.

Include J‑Code on the form.
Select the specific Nucala formulation (vial, auto‑injector, or syringe).
Order through Accredo when appropriate (Accredo contact information provided).

Documentation Required

Complete condition‑specific PA checklist (treatment status, eosinophils, other fields)

Complete the condition‑specific checklist fields on the PA form for the requested indication, including whether the request is for initial therapy, restarting therapy, or the patient is currently receiving Nucala for the specified duration.

Background on Mepolizumab (Nucala)

Mepolizumab (Nucala) is a monoclonal antibody that targets eosinophilic inflammation and is used to treat multiple eosinophil-associated conditions. The prior authorization form collects indication-specific objective measures — including peripheral blood eosinophil counts, prior controller or alternative therapies, disease duration, and evidence of clinical response — and requires that the medication be prescribed by or in consultation with an appropriate specialist (allergist, immunologist, pulmonologist, or rheumatologist) for many indications.

Definitions and Key Terms

Blood eosinophil threshold definition — required counts by indication

COPDPeripheral blood eosinophil ≥ 300 cells/µL (measurement within previous 6 weeks or pre‑biologic), required for initial COPD therapy with Nucala.

AsthmaPeripheral blood eosinophil ≥ 150 cells/µL (measurement within previous 6 weeks or pre‑biologic), required for initial asthma therapy with Nucala.

EGPAPeripheral blood eosinophil ≥ 150 cells/µL within the previous 4 weeks or pre‑biologic, required for initial EGPA therapy.

HESPeripheral blood eosinophil ≥ 1,000 cells/µL prior to any monoclonal antibody therapy that may alter eosinophil levels, required for initial HES therapy.

Non-severe disease (EGPA) — definition and examples

Definition of non‑severe EGPA

Policy Summary

PayerCigna

PolicyNucala (mepolizumab) prior authorization and clinical criteria

Policy CodePolicy v080125

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

Indicate treatment status: Initial, Currently receiving (6 months for asthma/COPD/CRSwNP/EGPA; 8 months for HES), or Restarting.
Provide blood eosinophil level and timing per indication.
Complete indication‑specific checklist items (e.g., symptom duration, prior surgeries, specialist prescribing).

Step Therapy

Document required prior inhaled controller therapy (COPD and asthma)

For initial COPD and asthma requests, document a trial of the required inhaled controller regimens for at least three consecutive months prior to Nucala initiation.

COPD initial: ≥3 months of LABA + LAMA + ICS, or ≥3 months of LABA + LAMA if ICS contraindicated.
Asthma initial: ≥3 months of medium‑ or high‑dose inhaled corticosteroid plus at least one additional asthma controller (or an equivalent combination inhaler).

Step Therapy

Document prior HES treatment(s) tried for ≥4 weeks (list agents)

For HES initial therapy, document that the patient has tried at least one other HES treatment for a minimum of 4 weeks; provide the specific agent(s) and duration.

Examples to document: systemic corticosteroids, hydroxyurea, cyclosporine, imatinib, or pegylated‑interferon.
Indicate duration of each prior treatment (minimum 4 weeks required).

Documentation Required

Include required prescriber and patient identifiers and medication administrative fields on PA form

Ensure the PA form includes prescriber identifiers and patient administrative information required for processing.

Prescriber DEA, NPI, or TIN and prescriber specialty.
Patient identifiers: Cigna ID, date of birth, patient and office addresses and contact information.
Medication specifics: product form, dose, quantity, duration, ICD‑10 diagnosis, and J‑code.

Documentation Required

Provide indication‑specific clinical evidence (eosinophils, prior therapy, exacerbations, response)

Attach clinical evidence on the PA form relevant to the indication: recent blood eosinophil counts with timing, documentation of prior controller therapy or other prior HES treatments, exacerbation history, and prescriber‑reported response when applicable.

Blood eosinophil level with date (e.g., COPD ≥300 within 6 weeks; asthma ≥150 within 6 weeks; EGPA ≥150 within 4 weeks; HES ≥1,000 prior to biologic).
History of prior inhaled controller regimens or other treatments tried and durations.
Exacerbation history or objective measures (FEV1 criteria for asthma when applicable) and documentation of clinical response if currently receiving Nucala.

Documentation Required

Document treatment intent (initial/restarting/ongoing) and clinical response with duration

Document the treatment intent and, if applicable, the patient’s response and duration of current therapy: indicate whether therapy is initial, restarting, or ongoing and the length of time receiving Nucala.

For ongoing therapy, attest to clinical response (examples: reduced exacerbations, reduced steroid use, improved symptoms or lung function).
For EGPA and HES, document systemic corticosteroid use duration (EGPA ≥4 weeks) and duration of disease (HES ≥6 months) as applicable.

Billing Rule

Justify infusion site if not in least intensive medically appropriate setting

If the drug will be given by infusion, justify why the infusion cannot occur in the least intensive medically appropriate setting and indicate whether redirection to a lower‑intensity setting was considered.

Per some Cigna plans, infusion MUST occur in the least intensive, medically appropriate setting.
If requesting a higher‑intensity site, provide medical necessity rationale and indicate if Specialty Care Options Case Manager assistance was considered for redirection.

Denial Risk

Denial risk if treatment status or required clinical criteria are undocumented

Requests may be denied when the PA form does not indicate whether therapy is initial, restarting, or ongoing (with required duration), or when required clinical criteria (eosinophil thresholds, steroid use for EGPA, specialist prescribing) are not documented.

Lack of documentation of treatment status (initial/restarting/current) risks denial.
Failure to provide required eosinophil counts/timing, required steroid duration for EGPA, or specialist prescribing/consultation may result in denial.

Vasculitis without life‑ or organ‑threatening manifestations (examples include rhinosinusitis, asthma, mild systemic symptoms, uncomplicated cutaneous disease, mild inflammatory arthritis).

Clinical implicationNon‑severe disease status is required for initial EGPA therapy with Nucala; prescriber must indicate this on the PA form.

Specialist prescriberMedication must be prescribed by or in consultation with an allergist, immunologist, pulmonologist, or rheumatologist for EGPA.

Non-hematologic secondary causes (HES) — examples to exclude before diagnosing primary HES

Examples of non‑hematologic secondary causesDrug hypersensitivity, parasitic helminth infection, human immunodeficiency virus (HIV) infection, non‑hematologic malignancy.

Assessment requirementPresence of an identifiable non‑hematologic secondary cause must be documented on the PA form and may preclude meeting HES initial therapy criteria.

FIP1L1‑PDGFR alpha statusInitial HES criteria require FIP1L1‑PDGFR alpha‑negative disease in addition to exclusion of non‑hematologic secondary causes.