zanubrutinib


( Last Updated : February 7, 2022)
Generic Name:
zanubrutinib
Project Status:
Complete
Therapeutic Area:
Waldenström’s macroglobulinemia
Manufacturer:
BeiGene, Ltd.
Brand Name:
Brukinsa
Project Line:
Reimbursement Review
Project Number:
PC0248-000
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients with Waldenström’s macroglobulinemia (WM)
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of patients with Waldenström’s macroglobulinemia (WM)
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open23-Mar-21
Call for patient/clinician input closed14-May-21
Clarification:

- Patient input submission received from CanCertainty and Lymphoma Canada (LC), Canadian Organization for Rare Disorders (CORD), Waldenstrom Macroglobulinemia Foundation of Canada (WMFC)

Submission received21-May-21
Submission accepted07-Jun-21
Review initiated08-Jun-21
Draft CADTH review report(s) provided to sponsor for comment27-Aug-21
Deadline for sponsors comments08-Sep-21
CADTH responses on draft review report(s) provided to sponsor29-Sep-21
Expert committee meeting (initial)13-Oct-21
Draft recommendation issued to sponsor26-Oct-21
Draft recommendation posted for stakeholder feedback04-Nov-21
End of feedback period18-Nov-21
Final recommendation issued to sponsor and drug plans01-Dec-21
Final recommendation posted17-Dec-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)15-Dec-21
CADTH review report(s) posted07-Feb-22