Last Updated : April 2, 2024
Details
FilesGeneric 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:
- 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.
| Call for patient/clinician input open | May 09, 2023 |
|---|---|
| Call for patient/clinician input closed | June 30, 2023 |
| Clarification: - Patient input submission received from Lymphoma Canada and Waldenstromâs Macroglobulinemia Foundation of Canada (WMFC) | |
| Submission received | June 20, 2023 |
| Submission accepted | July 05, 2023 |
| Review initiated | July 06, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | September 20, 2023 |
| Deadline for sponsors comments | September 29, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | October 27, 2023 |
| Expert committee meeting (initial) | November 08, 2023 |
| Draft recommendation issued to sponsor | November 22, 2023 |
| Draft recommendation posted for stakeholder feedback | November 30, 2023 |
| End of feedback period | December 14, 2023 |
| Final recommendation issued to sponsor and drug plans | January 05, 2024 |
| Final recommendation posted | January 23, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 19, 2024 |
| CADTH review report(s) posted | April 02, 2024 |
Files
Last Updated : April 2, 2024