emicizumab

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Generic Name:
emicizumab
Project Status:
Complete
Therapeutic Area:
Bleeding prevention, hemophilia A
Manufacturer:
Hoffmann-La Roche Ltd.
Call for patient/clinician input open:
Brand Name:
Hemlibra
Project Line:
Reimbursement Review
Project Number:
ST0651-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
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
Fee Schedule:
Schedule 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.
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 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