Mepolizumab (Nucala®)

Nucala (mepolizumab) is covered only for its FDA‑approved indications — add‑on treatment for severe eosinophilic asthma (age ≥6), EGPA (adults), HES (age ≥12 with ≥6 months disease, FIP1L1‑PDGFRα‑negative and no secondary cause), and chronic rhinosinusitis with nasal polyps (adults) — and is excluded for non‑FDA uses. Approvals require indication‑specific documentation including blood eosinophil thresholds (≥150 cells/µL for asthma/EGPA; ≥1,000 cells/µL for HES), specified prior therapy trials/failures (e.g., ≥3 months ICS‑based controller for asthma; ≥4 weeks corticosteroids for EGPA; prior HES therapy), appropriate age and specialist prescriber/consultation, and evidence of clinical response and minimum therapy duration for reauthorization.

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

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