Kalbitor (ecallantide) — CareFirst (Caremark)

Initial criteria

• Medication will not be used in combination with any other medication used for the treatment of acute HAE attacks
• Member meets either of the following:
• 1) Member has C1 inhibitor deficiency or dysfunction as confirmed by laboratory testing AND meets one of the following:
• • C1 inhibitor (C1-INH) antigenic level below the lower limit of normal as defined by the laboratory performing the test, OR
• • Normal C1-INH antigenic level and low C1-INH functional level (functional C1-INH < 50% or below the lower limit of normal as defined by the laboratory)
• OR 2) Member has normal C1 inhibitor as confirmed by laboratory testing AND meets one of the following:
• • Member has an F12, angiopoietin-1, plasminogen, kininogen-1 (KNG1), heparan sulfate-glucosamine 3-O-sulfotransferase 6 (HS3ST6), or myoferlin (MYOF) pathogenic variant as confirmed by genetic testing, OR
• • Member has a documented family history of angioedema and the member’s angioedema was refractory to a trial of high-dose antihistamine therapy (e.g., cetirizine at 40 mg/day or the equivalent) for at least one month
• Other causes of angioedema (e.g., ACE-inhibitor induced, estrogen-related, allergic angioedema) have been ruled out
• Medication prescribed by or in consultation with a prescriber who specializes in management of hereditary angioedema (HAE)

Reauthorization criteria

• Member continues to meet all initial coverage criteria
• Member has experienced a reduction in severity and/or duration of acute attacks
• Prophylaxis should be considered based on attack frequency, severity, comorbid conditions, and member’s quality of life

Approval duration

12 months