Nucala® (mepolizumab)

Coverage is limited to Nucala’s FDA‑approved indications—add‑on treatment for severe eosinophilic asthma (≥6 years), EGPA (≥18 years), HES (≥12 years, ≥6 months duration, FIP1L1‑PDGFRA negative) and CRSwNP (≥18 years)—and excludes uses outside these indications (including certain HES subtypes and secondary eosinophilia). Approval requires indication‑specific criteria including blood eosinophil thresholds (asthma/EGPA ≥150 cells/µL; HES ≥1,000 cells/µL), prior therapy trials (e.g., ICS+controller ≥3 months for asthma; ≥4 weeks corticosteroids for EGPA; prior HES therapy ≥4 weeks; ≥3 months intranasal steroids for CRSwNP), specialist prescribing/consultation, and documented clinical response after 6 months of therapy (8 months for HES) for reauthorization.

"Add-on maintenance treatment of adults and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype."