zanubrutinib

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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

Performance Metric:

Achieved

Biosimilar:

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:

December 21, 2021

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 open	23-Mar-21
Call for patient/clinician input closed	14-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 received	21-May-21
Submission accepted	07-Jun-21
Review initiated	08-Jun-21
Draft CADTH review report(s) provided to sponsor for comment	27-Aug-21
Deadline for sponsors comments	08-Sep-21
CADTH responses on draft review report(s) provided to sponsor	29-Sep-21
Expert committee meeting (initial)	13-Oct-21
Draft recommendation issued to sponsor	26-Oct-21
Draft recommendation posted for stakeholder feedback	04-Nov-21
End of feedback period	18-Nov-21
Final recommendation issued to sponsor and drug plans	01-Dec-21
Final recommendation posted	17-Dec-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	15-Dec-21
CADTH review report(s) posted	07-Feb-22