emicizumab

Generic Name: emicizumab

Brand Name: Hemlibra

Manufacturer: Hoffmann-La Roche Ltd.

Therapeutic Area: Bleeding prevention, hemophilia A

Indications: Indicated for hemophilia A (congenital factor VIII deficiency) patients with or without factor VIII inhibitors as routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes. There is limited clinical experience of Hemlibra use in patients with mild or moderate hemophilia A.

Manufacturer Requested Reimbursement Criteria¹: For hemophilia A (congenital factor VIII deficiency) severe patients without factor VIII inhibitors as per the HAVEN 3 trial patient eligibility, and including: · Patients who have limited ability to receive regular intravenous (IV) therapy due to other underlying factors such as venous access challenges or geographical treatment access restrictions despite being candidates for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes with factor VIII. · Patients who are at a significant risk for increased bleeding rates due to factors that lead to poor adherence or persistence despite being candidates for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes with factor VIII.

Submission Type: Initial

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule A

1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.