C1 Esterase Inhibitor (Ruconest)

Ruconest is covered only for treatment of acute hereditary angioedema (HAE) attacks due to C1‑INH deficiency (HAE Type I or II); off‑label uses, routine prophylaxis, and other angioedema types are excluded. Coverage requires baseline labs showing functional C1‑INH <50% and low serum C4, prescription by or in consultation with an allergist/immunologist or HAE specialist, dosing limited to 50 IU/kg (max 4,200 IU) with no more than two doses per 24 hours, initial and reauthorization approvals for 12 months, and reauthorization requires prior Ruconest use with documented favorable clinical response.

"Treatment of acute attacks of Hereditary Angioedema (HAE) (FDA-approved indication)."

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