Mepolizumab (Nucala)

Nucala (mepolizumab) is covered as add‑on maintenance therapy for severe eosinophilic asthma and for EGPA in patients ≥12 years (patients <12 and off‑label compendial uses are excluded), with approvals limited to 12 months. Approval requires documented diagnosis and prior controller therapy (asthma: high‑dose ICS+LABA OR leukotriene modifier/theophylline prior year OR systemic steroids ≥50% of prior year), eosinophil thresholds (asthma: ≥150 cells/mcL at screening or ≥300 cells/mcL in the prior year; EGPA: ≥10% or >1,000 cells/mm3 plus ≥2 EGPA features), current non‑smoker status for asthma, adherence to dosing (asthma 100 mg SC q4 weeks; EGPA 300 mg SC q4 weeks as three 100‑mg injections), and reauthorization requires documented reduction in relapses and/or glucocorticoid use.

"Add-on maintenance treatment of individuals with severe asthma having an eosinophilic phenotype."