For the routine prevention of attacks of confirmed HAE Type I or II in patients 12 years of age or older who have had at least three HAE attacks that required the use of an acute injectable treatment within any four-week period in the three months before initiating lanadelumab therapy.

This medication must be prescribed by, or in consultation with, a physician experienced in the treatment of HAE. A record of the baseline total of HAE attacks requiring use of an acute injectable treatment in the three months prior to initiating lanadelumab is required.

Initial coverage may be approved for 3 months. The patient must be assessed after the initial three months to determine response. Patients who have a response to initial treatment* may receive continued coverage with lanadelumab for six months, and should be assessed for continued response** every six months.

Coverage cannot be provided for lanadelumab when used in combination with other medications used for long-term prophylactic treatment of angioedema (e.g., C1 esterase inhibitor).

Coverage may be approved for a dosage of up to 300 mg every two weeks. Patients will be limited to receiving a one-month supply per prescription at their pharmacy.

All requests for lanadelumab must be completed using the Icatibant/Lanadelumab for HAE Type I or II Special Authorization Request Form (ABC 60083).

*Response to initial lanadelumab treatment is defined as at least a 50% reduction in the number of HAE attacks requiring use of an acute injectable treatment compared to the three month baseline number of attacks prior to initiation of lanadelumab.

**Continued response is defined as maintenance of a minimum improvement of a 50% reduction in the number of HAE attacks requiring use of an acute injectable treatment compared to the baseline number of attacks observed before initiating treatment with lanadelumab.