Andembry (garadacimab-gxii) — CareFirst (Caremark)

Initial criteria

• Requested medication will not be used in combination with any other medication used for the prophylaxis of HAE attacks
• Member meets either of the following criteria:
• • 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 a low C1-INH functional level (functional C1-INH less than 50% or below the lower limit of normal as defined by the laboratory performing the test)
• • OR 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 (cetirizine at 40 mg per day or equivalent) for at least one month
• Other causes of angioedema have been ruled out (e.g., angiotensin-converting enzyme inhibitor induced angioedema, angioedema related to an estrogen-containing drug, allergic angioedema)
• Prescriber is a specialist in the management of hereditary angioedema or is consulting with such a specialist

Reauthorization criteria

• Member meets all initial coverage criteria
• Member has experienced a significant reduction in frequency of attacks (e.g., ≥ 50%) since starting prophylactic treatment
• Member has reduced the use of medications to treat acute attacks since starting prophylactic treatment

Approval duration

12 months