CDA | Evidence Driven
CDA | Evidence Driven

zanubrutinib

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Generic Name:
zanubrutinib
Project Status:
Complete
Therapeutic Area:
Mantle cell lymphoma (MCL)
Manufacturer:
BeiGene Canada ULC
Call for patient/clinician input open:
Brand Name:
Brukinsa
Project Line:
Reimbursement Review
Project Number:
PC0267-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Recommendation Type:
Do not reimburse
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 open21-Sep-21
Call for patient/clinician input closed12-Nov-21
Clarification:

- Patient input submission received from Lymphoma Canada

Submission received30-Sep-21
Submission accepted15-Oct-21
Review initiated21-Oct-21
Draft CADTH review report(s) provided to sponsor for comment11-Jan-22
Deadline for sponsors comments20-Jan-22
CADTH review report(s) and responses to comments provided to sponsor25-Feb-22
Expert committee meeting (initial)09-Mar-22
Draft recommendation issued to sponsor23-Mar-22
Draft recommendation posted for stakeholder feedback31-Mar-22
End of feedback period14-Apr-22
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting13-Jul-22
Final recommendation issued to sponsor and drug plans27-Jul-22
Final recommendation posted15-Aug-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)11-Aug-22
CADTH review report(s) posted21-Sep-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : September 23, 2022