Generic Name: emicizumab
Brand Name: Hemlibra
Manufacturer: Hoffmann-La Roche Ltd.
Indications: Bleeding prevention, 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: New
Project Status: Active
Companion Diagnostics: No
Fee Schedule: Schedule A
- 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.
|Call for patient input open||June 02, 2020|
|Call for patient input closed||July 22, 2020|
- Patient input submission received from Canadian Hemophilia Society (CHS)
|Submission received||June 30, 2020|
|Submission accepted||July 15, 2020|
|Review initiated||July 16, 2020|
|Draft CADTH review report(s) provided to sponsor for comment||September 30, 2020|
|Deadline for sponsors comments||October 09, 2020|
|CADTH responses on draft review report(s) provided to sponsor||November 06, 2020|
|Expert committee meeting (initial)||November 18, 2020|
|Draft recommendation issued||November 30, 2020
December 02, 2020