Rilonacept (Arcalyst®)

Policy covers rilonacept (Arcalyst) only for FDA‑approved indications—CAPS in patients ≥12 years, DIRA in patients ≥10 kg with a confirmed IL1RN mutation and prior clinical benefit on anakinra (Kineret), and recurrent pericarditis in patients ≥12 years with ≥3 episodes in the past year—and excludes non‑FDA uses. Approvals require appropriate specialist prescribing/consultation, specific diagnostic documentation (eg, genetic test for DIRA, episode history for pericarditis), adherence to initial approval durations (CAPS and pericarditis: 3 months; DIRA: 6 months), renewal every 12 months with documented clinical response/sustained remission, and dosing/weight limits.

"Pericarditis: Initial approval duration is 3 months; renewal approval duration is 12 months and requires evidence the individual is responding to Arcalyst therapy (e."

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