Canada’s Drug Agency | Drugs, Health Technologies and Systems.

ibrutinib

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Generic Name:
ibrutinib
Project Status:
Complete
Therapeutic Area:
Waldenström’s Macroglobulinemia
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Imbruvica
Project Line:
Reimbursement Review
Project Number:
PC0328-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Imbruvica, as a single agent or in combination with rituximab, for previously treated, relapsed/refractory (RR) Waldenström’s Macroglobulinemia (WM).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Imbruvica, as a single agent or in combination with rituximab, for previously treated, relapsed/refractory (RR) Waldenström’s Macroglobulinemia (WM).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation/Report:
  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 openMay 09, 2023
Call for patient/clinician input closedJune 30, 2023
Clarification:

- Patient input submission received from Lymphoma Canada and Waldenstrom’s Macroglobulinemia Foundation of Canada (WMFC)

Submission receivedJune 20, 2023
Submission acceptedJuly 05, 2023
Review initiatedJuly 06, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentSeptember 20, 2023
Deadline for sponsors commentsSeptember 29, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorOctober 27, 2023
Expert committee meeting (initial)November 08, 2023
Draft recommendation issued to sponsorNovember 22, 2023
Draft recommendation posted for stakeholder feedbackNovember 30, 2023
End of feedback periodDecember 14, 2023
Final recommendation issued to sponsor and drug plansJanuary 05, 2024
Final recommendation postedJanuary 23, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)January 19, 2024
Canada's Drug Agency review report(s) postedApril 02, 2024

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : April 2, 2024