Rilonacept (Arcalyst)

Arcalyst (rilonacept) is covered only for FDA‑approved CAPS indications (FCAS and Muckle‑Wells) in patients aged ≥12 years and is not authorized for children <12 or for off‑label uses. Initial approval (3 months) and 12‑month renewals require prescription by or consultation with a rheumatologist/geneticist/allergist/immunologist/dermatologist, adherence to specified adult or weight‑based pediatric dosing limits, documentation of diagnosis/age/prescriber/weight and applicable safety criteria, and documented clinical response for reauthorization.

"Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)"

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