Last Updated : February 9, 2024
Details
FilesGeneric Name:
ibrutinib
Project Status:
Complete
Therapeutic Area:
Chronic lymphocytic leukemia (CLL)
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Imbruvica
Project Line:
Reimbursement Review
Project Number:
PC0317-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Imbruvica with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL), including those with 17p deletion.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Imbruvica with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL), including those with 17p deletion.
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 | March 09, 2023 |
|---|---|
| Call for patient/clinician input closed | May 09, 2023 |
| Clarification: - Patient input submission received from Lymphoma Canada | |
| Submission received | April 21, 2023 |
| Submission accepted | May 08, 2023 |
| Review initiated | May 09, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | July 24, 2023 |
| Deadline for sponsors comments | August 02, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | August 31, 2023 |
| Expert committee meeting (initial) | September 13, 2023 |
| Draft recommendation issued to sponsor | September 26, 2023 |
| Draft recommendation posted for stakeholder feedback | October 05, 2023 |
| End of feedback period | October 20, 2023 |
| Final recommendation issued to sponsor and drug plans | November 02, 2023 |
| Final recommendation posted | November 22, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 17, 2023 |
| CADTH review report(s) posted | February 09, 2024 |
Files
Last Updated : February 9, 2024