Canakinumab (Ilaris)

Ilaris (canakinumab) is covered only for FDA‑approved indications (CAPS — ≥4 years, TRAPS, HIDS/MKD, FMF, active sJIA ≥2 years, and adult‑onset Still’s disease ≥18) and is not covered for off‑label use. Coverage requires prescribing by or consultation with specified specialists, indication‑specific baseline CRP ≥10 mg/L (or ≥2× ULN) and disease‑activity/prior‑therapy criteria (e.g., colchicine trial and concurrent use for FMF unless contraindicated; specified flare‑frequency thresholds for FMF/HIDS/TRAPS; sJIA/Still’s require trials of ≥2 other biologics or specified alternatives), weight‑based dosing, initial approval typically 6 months (renewal 12 months), and reauthorization requires ≥6 months on therapy plus documented clinical improvement.

"Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, and Neonatal Onset Multisystem Inflammatory Disease (NOMID)/Chr..."