CurrentCignaPolicy N/A

Immunologicals - Nucala Prior Authorization Policy

Cigna pharmacy prior authorization policy for Nucala (mepolizumab subcutaneous injection) detailing coverage criteria for FDA‑approved indications (asthma, COPD, CRSwNP, EGPA, HES), not‑covered uses, prescriber requirements, approval durations, and prior therapy/eosinophil thresholds.

Policy Summary

PayerCigna

PolicyImmunologicals - Nucala Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMultiple substantive revisions (added COPD; revised asthma, CRSwNP, EGPA, HES criteria)

Effective Date

Next Review DateJun 4, 2025

Key ActionPrior authorization is recommended; submit required eosinophil lab results and documentation of prior therapies/exacerbations and ensure prescription is by/consults with the specified specialist.

SourceLink

POLICY UPDATE CHANGES

Chronic Obstructive Pulmonary Disease (COPD) indication and approval criteria were added to the policy.

CRSwNP criteria updated to require symptoms for at least 8 weeks and diagnosis duration of at least 6 months; intranasal corticosteroid trial changed to 4 weeks and prior systemic corticosteroid requirement limited to previous year.

EGPA initial approval duration and eosinophil timing clarified.

Asthma eosinophil timing clarified to require ≥ 150 cells/µL within the previous 6 weeks or prior to treatment with a monoclonal antibody that may alter eosinophil levels.

Hypereosinophilic Syndrome (HES) eosinophil timing clarified and initial approval duration set to 8 months.

Examples of monoclonal antibody therapies that may alter blood eosinophil levels were expanded to include Ebglyss and Nemluvio.

5FDA‑approved indications covered

6Eosinophil thresholds specified

6-9Initial approval durations (months)

1 yearContinuation approval duration

Coverage Summary

This is Cigna's pharmacy prior authorization policy for Nucala (mepolizumab subcutaneous injection). It details coverage criteria for the FDA‑approved indications—severe eosinophilic asthma, chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES)—and reflects an overall coverage stance of covered_with_criteria. Prior authorization is required, initial approvals require prescription by or in consultation with an appropriate specialist for the treated condition, and documentation of prior therapies, exacerbation history, and eosinophil laboratory values per indication timing is expected.

Key thresholds and approval durations

Asthma eosinophil threshold≥ 150 cells/µL within the previous 6 weeks or ≥ 150 cells/µL prior to treatment with a monoclonal antibody that may alter eosinophil levels

COPD eosinophil threshold≥ 300 cells/µL within the previous 6 weeks or ≥ 300 cells/µL prior to treatment with a monoclonal antibody that may alter eosinophil levels

EGPA eosinophil threshold≥ 150 cells/µL within the previous 4 weeks or ≥ 150 cells/µL prior to treatment with a monoclonal antibody that may alter eosinophil levels

HES eosinophil threshold≥ 1,000 cells/µL prior to treatment with any monoclonal antibody therapy that may alter blood eosinophil levels

Initial approval durations (quick ref)Asthma: 6 months; COPD: 6 months; CRSwNP: 6 months; EGPA: 9 months; HES: 8 months

Continuation approval durationPatients already receiving Nucala who meet continuation criteria: 1 year