Nucala® (mepolizumab)

Nucala (mepolizumab) is covered for its FDA‑approved indications — add‑on maintenance for severe eosinophilic asthma (≥6 years), EGPA (adults), HES (≥12 years), chronic rhinosinusitis with nasal polyps (adults), and eosinophilic COPD (adults) — only when strict, indication‑specific clinical, laboratory, prior‑therapy, age, and specialist‑prescribing criteria are met. Key requirements include indication‑specific blood eosinophil thresholds (asthma ≥150 cells/µL within 6 weeks, COPD ≥300 cells/µL within 6 weeks, EGPA ≥150 within 4 weeks, HES ≥1,000 prior to mAb), specified prior therapy trials/durations (e.g., ≥3 months ICS+controller for asthma, ≥3 months LABA+LAMA±ICS for COPD, ≥4 weeks of alternate HES therapy), prescription by or in consultation with an allergist/immunologist/pulmonologist, initial authorization limits (generally 6 months; HES 8 months; EGPA 9 months) and reauthorization up to 12 months only with documented clinical benefit.

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