CDA | Evidence Driven
CDA | Evidence Driven

zanubrutinib

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Generic Name:
zanubrutinib
Project Status:
Complete
Therapeutic Area:
Chronic lymphocytic leukemia /small lymphocytic lymphoma.
Manufacturer:
BeiGene Canada ULC
Call for patient/clinician input open:
Brand Name:
Brukinsa
Project Line:
Reimbursement Review
Project Number:
PC0310-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with chronic lymphocytic leukemia (CLL).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with chronic lymphocytic leukemia (CLL).
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/clinician input open15-Dec-22
Call for patient/clinician input closed13-Feb-23
Clarification:

- Patient input submission received from Lymphoma Canada.

Submission received20-Jan-23
Submission accepted06-Feb-23
Review initiated07-Feb-23
Draft CADTH review report(s) provided to sponsor for comment25-Apr-23
Deadline for sponsors comments05-May-23
CADTH review report(s) and responses to comments provided to sponsor29-Jun-23
Expert committee meeting (initial)12-Jul-23
Draft recommendation issued to sponsor24-Jul-23
Draft recommendation posted for stakeholder feedback03-Aug-23
End of feedback period18-Aug-23
Final recommendation issued to sponsor and drug plans01-Sep-23
Final recommendation posted20-Sep-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)18-Sep-23
CADTH review report(s) posted29-Nov-23

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : November 29, 2023