ibrutinib

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Generic 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:
  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 openMarch 09, 2023
Call for patient/clinician input closedMay 09, 2023
Clarification:

- Patient input submission received from Lymphoma Canada

Submission receivedApril 21, 2023
Submission acceptedMay 08, 2023
Review initiatedMay 09, 2023
Draft CADTH review report(s) provided to sponsor for commentJuly 24, 2023
Deadline for sponsors commentsAugust 02, 2023
CADTH review report(s) and responses to comments provided to sponsorAugust 31, 2023
Expert committee meeting (initial)September 13, 2023
Draft recommendation issued to sponsorSeptember 26, 2023
Draft recommendation posted for stakeholder feedbackOctober 05, 2023
End of feedback periodOctober 20, 2023
Final recommendation issued to sponsor and drug plansNovember 02, 2023
Final recommendation postedNovember 22, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 17, 2023
CADTH review report(s) postedFebruary 09, 2024