Mepolizumab (Nucala®)

Covered only for FDA‑approved indications—add‑on maintenance for severe eosinophilic asthma (age ≥6), eosinophilic granulomatosis with polyangiitis (EGPA, age ≥18), and hypereosinophilic syndrome (HES, age ≥12, disease ≥6 months, FIP1L1‑PDGFRα‑negative, no non‑hematologic secondary cause); requests outside these indications are excluded. Approvals require specific eosinophil thresholds (asthma/EGPA ≥150 cells/µL within 6 weeks; HES ≥1,000 cells/µL before anti‑IL‑5), documented prior therapy trials (≥3 months specified combination therapy for asthma; ≥4 weeks corticosteroids for EGPA; ≥4 weeks of another HES therapy), prescribing by/consultation with a specialist, age verification, dosing documentation, and demonstrated clinical response after ≥6 months (asthma/EGPA) or ≥8 months (HES) for reauthorization.

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