Rilonacept (Arcalyst)

Arcalyst (rilonacept) is covered only for the FDA‑approved indication—treatment of CAPS (Familial Cold Auto‑inflammatory Syndrome and Muckle‑Wells Syndrome) in patients aged ≥12 years—and not for off‑label uses. Coverage requires documentation of diagnosis and age, absence of active/chronic infection, confirmation it will not be given with TNF‑inhibitors, and approvals are issued for up to 12 months with clinical records for renewal.

"Documentation that Arcalyst will not be given in combination with a TNF-inhibitor (e."

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