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emicizumab

Last Updated: December 1, 2020
Result type: Reports
Project Number: ST0651-000
Product Line: Reimbursement Review

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.

Key Milestones2

Call for patient input openJune 02, 2020
Call for patient input closedJuly 22, 2020
Clarification:

- Patient input submission received from Canadian Hemophilia Society (CHS)

Submission receivedJune 30, 2020
Submission acceptedJuly 15, 2020
Review initiatedJuly 16, 2020
Draft CADTH review report(s) provided to sponsor for commentSeptember 30, 2020
Deadline for sponsors commentsOctober 09, 2020
CADTH responses on draft review report(s) provided to sponsorNovember 06, 2020
Expert committee meeting (initial)November 18, 2020
Draft recommendation issued to sponsorNovember 30, 2020
End of embargo periodDecember 14, 2020
Final recommendation issued to sponsor and drug plansDecember 21, 2020
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)January 12, 2021
CADTH review report(s) posted-