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Last Updated: June 9, 2021
Result type: Reports
Project Number: PC0248-000
Product Line: Reimbursement Review

Generic Name: zanubrutinib

Brand Name: Brukinsa

Manufacturer: BeiGene, Ltd.

Therapeutic Area: Waldenström’s macroglobulinemia

Indications: For the treatment of patients with Waldenström’s macroglobulinemia (WM)

Manufacturer Requested Reimbursement Criteria1: For the treatment of patients with Waldenström’s macroglobulinemia (WM)

Submission Type: Initial

Tumour Type: Lymphoma

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule1: 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/clinician input openMarch 23, 2021
Call for patient/clinician input closedMay 14, 2021

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

Submission receivedMay 21, 2021
Submission acceptedJune 07, 2021
Review initiatedJune 08, 2021
Draft CADTH review report(s) provided to sponsor for commentAugust 23, 2021
Deadline for sponsors commentsSeptember 01, 2021
CADTH responses on draft review report(s) provided to sponsorSeptember 30, 2021
Expert committee meeting (initial)October 13, 2021
Draft recommendation issued to sponsorOctober 25, 2021
October 27, 2021