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Kalbitor

Drug - Kalbitor® (ecallantide) [Dyax Corp]

May 2014

Therapeutic area - Hereditary Angioedema

Approval criteria

Patient is being treated for acute abdominal and/or laryngeal/facial attack of hereditary angioedema (HAE).

*Two 30 mg doses allowed per PA.

Payment

Kalbitor should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Kalbitor may be administered by a home infusion nurse at the patient’s home. KALBITOR Home Infusion is not appropriate for treating laryngeal attacks.

Kalbitor doses, regardless of location, must be billed on a professional claim using J1290 (buy-and-bill).

Dosing and administration

One dose of Kalbitor is 30 mg (3 mL) administered subcutaneously in three 10 mg (1 mL) injections. If an attack persists, an additional dose of 30 mg may be administered within a 24 hour period. 

If Kalbitor does not work for a patient’s attack, the prescriber will have to demonstrate that the patient does not have antibodies to Kalbitor before additional authorizations. In the Kalbitor HAE program, patients developed antibodies to Kalbitor. Rates of seroconversion increased with exposure to Kalbitor over time. Overall, 20.2% of patients seroconverted to anti-ecallantide antibodies. Neutralizing antibodies to ecallantide were determined in vitro to be present in 8.8% of patients within the time frame of the clinical trial. 

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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