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
NOC Status at Filing: Post NOC
Project Status: Complete
Companion Diagnostics: No
Date Recommendation Issued: December 21, 2020
Recommendation Type: Reimburse with clinical criteria and/or conditions
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 to sponsor||November 30, 2020|
|End of embargo period||December 14, 2020|
|Final recommendation issued to sponsor and drug plans||December 21, 2020|
|Final recommendation posted||December 23, 2020|
|Deadline for sponsor to submit redaction requests on draft CADTH review report(s)||January 12, 2021|
|CADTH review report(s) posted||February 19, 2021|