Kalbitor (ecallantide) — Medica

Initial criteria

• Patient has HAE type I or type II as confirmed by BOTH of the following diagnostic criteria:
• • Low levels of functional C1-INH protein (< 50% of normal) at baseline, as defined by the laboratory reference values [documentation required]
• • Lower than normal serum C4 levels at baseline, as defined by the laboratory reference values [documentation required]
• A diagnosis of HAE with normal C1-INH (also known as HAE type III) does NOT satisfy this requirement
• Medication is prescribed by or in consultation with an allergist/immunologist or a physician that specializes in the treatment of HAE or related disorders

Reauthorization criteria

• Patient has a diagnosis of HAE type I or type II [documentation required]
• A diagnosis of HAE with normal C1-INH (also known as HAE type III) does NOT satisfy this requirement
• According to the prescriber, the patient has had a favorable clinical response with Kalbitor treatment (e.g., decrease in duration or severity of attacks, rapid symptom relief, complete resolution of symptoms, or decreased frequency of acute attacks)
• Medication is prescribed by or in consultation with an allergist/immunologist or a physician that specializes in the treatment of HAE or related disorders

Approval duration

1 year