Ecallantide (Kalbitor)

Kalbitor (ecallantide) is covered only for acute HAE attacks due to C1‑INH deficiency (type I or II) and not for prophylaxis, HAE with normal C1‑INH, or other non‑FDA‑approved uses; approvals are for up to 12 months with a maximum dose of 30 mg SC no more than twice daily. Coverage requires baseline labs showing functional C1‑INH <50% of normal and low serum C4, prescription by or in consultation with an allergist/immunologist or HAE specialist, and reauthorization requires prior Kalbitor use with documented clinical benefit.

"Must have documented HAE type I or II with baseline laboratory confirmation (functional C1-INH <50% of normal and low serum C4) — absence of these diagnostic findings would not meet coverage criteria."

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