Rilonacept (Arcalyst®)

Arcalyst (rilonacept) is covered only for FDA‑approved uses — CAPS in patients ≥12 years, DIRA in patients ≥10 kg with a confirmed IL1RN mutation and prior clinical benefit on Kineret (anakinra), and recurrent pericarditis in patients ≥12 years with ≥3 prior episodes — and must be prescribed or authorized in consultation with an appropriate specialist. Coverage requires meeting indication‑specific initial and renewal criteria (initial approvals typically 6 months for CAPS and DIRA; renewals 12 months; pericarditis re‑authorization after ≥3 months), documentation of genetic testing for DIRA and prior therapy/history for pericarditis, and demonstration of objective or symptomatic improvement for re‑authorization.

"Cryopyrin-Associated Periodic Syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS), and Neonatal Onset Multisystem Inflammatory Disease (NOMID)/chr..."