Takhzyro (lanadelumab-flyo) — CareFirst (Caremark)

Initial criteria

• Medication will not be used in combination with any other medication used for the prophylaxis of HAE attacks
• Member has C1 inhibitor deficiency or dysfunction as confirmed by laboratory testing AND either 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 C1-INH functional level 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 either (a) 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 (b) Member has a documented family history of angioedema and the member’s angioedema was refractory to a trial of high-dose antihistamine therapy (i.e., cetirizine at 40 mg per day or the 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 must specialize in the management of hereditary angioedema (HAE)

Reauthorization criteria

• Member meets all requirements in the coverage criteria section
• 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
• Requested drug is being dosed every 4 weeks or dosing every 4 weeks has been considered if the member is well-controlled on therapy for more than 6 months

Approval duration

12 months