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emicizumab

Last Updated: July 29, 2020
Result type: Reports
Project Number: ST0651-000
Product Line: Common Drug Review

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

  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.

Key Milestones2

Call for patient input open June 02, 2020
Call for patient input closed July 22, 2020
Clarification:

- 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
To
December 02, 2020