Rilonacept (Arcalyst®)

Arcalyst (rilonacept) is covered only for FDA‑approved indications—CAPS (FCAS, MWS, NOMID/CINCA) in patients ≥12 years, DIRA maintenance in patients ≥10 kg with a confirmed IL1RN mutation, and recurrent pericarditis in patients ≥12 years with ≥3 prior episodes—non‑FDA uses are excluded. Coverage requires documentation of diagnosis/age/weight/genetic test/prior episodes as applicable, specified prescriber specialty or consultation, prior clinical benefit with Kineret for DIRA, adherence to dosing, minimum therapy duration before reauthorization (≥6 months for CAPS/ DIRA; ≥3 months for RP), and demonstrated objective or symptomatic improvement for renewals.

"Arcalyst is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and pe..."

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