Kalbitor (ecallantide) — Medical Mutual

Initial criteria

• Patient is at least age ≥ 12 years; AND
• Must be prescribed by, or in consultation with, a specialist in allergy, immunology, hematology, pulmonology, or medical genetics; AND
• Confirmation the patient is avoiding the following possible triggers for HAE attacks: estrogen-containing oral contraceptive agents AND hormone replacement therapy; AND antihypertensive agents containing ACE inhibitors or angiotensin II receptor blockers (ARBs); AND dipeptidyl peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin); AND neprilysin inhibitors (e.g., sacubitril); AND
• Patient has a history of moderate to severe cutaneous attacks (without concomitant hives) OR abdominal attacks OR mild to severe airway swelling attacks of HAE (i.e., debilitating cutaneous/gastrointestinal symptoms OR laryngeal/pharyngeal/tongue swelling); AND
• Patient has one of the following clinical presentations consistent with a HAE subtype, confirmed by repeat blood testing:
• HAE I (C1-Inhibitor deficiency): Low C1 inhibitor (C1-INH) antigenic level below lab-defined lower limit of normal; AND Low C4 level below lab-defined lower limit of normal; AND Low C1-INH functional level below lab-defined lower limit of normal; AND patient has family history of HAE OR acquired angioedema ruled out (onset before 30 years, normal C1q, no underlying disease such as lymphoma or MGUS); OR
• HAE II (C1-Inhibitor dysfunction): Normal to elevated C1-INH antigenic level; AND Low C4 below normal; AND Low C1-INH functional level below normal; OR
• HAE with normal C1INH (formerly HAE III): Normal/near normal C1-INH antigenic, C4, and functional levels; AND repeat blood test during attack confirms not abnormal values of HAE I or II; AND either known HAE-causing mutation (e.g., factor XII, angiopoietin-1, plasminogen, kininogen 1, myoferlin, or heparan sulfate 3-O-sulfotransferase 6 mutations) OR family history of HAE with documented lack of efficacy of chronic high-dose antihistamine therapy (≥1 month or ≥3 attacks) AND corticosteroids with/without omalizumab

Reauthorization criteria

• Patient must continue to meet the universal and indication-specific criteria as in section III; AND
• Significant improvement in severity and duration of attacks have been achieved and sustained; AND
• Absence of unacceptable toxicity from the drug (e.g., no serious hypersensitivity or anaphylaxis); AND
• Cumulative amount of HAE medication(s) on-hand must not exceed the policy allowance (sufficient to treat up to 4 acute attacks per 4 weeks during authorization duration)

Approval duration

12 weeks