ibrutinib

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Generic Name:
ibrutinib
Project Status:
Active
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
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:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open09-May-23
Call for patient/clinician input closed30-Jun-23
Clarification:

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

Submission received20-Jun-23
Submission accepted05-Jul-23
Review initiated06-Jul-23
Draft CADTH review report(s) provided to sponsor for comment20-Sep-23
Deadline for sponsors comments29-Sep-23
CADTH review report(s) and responses to comments provided to sponsor27-Oct-23
Expert committee meeting (initial)08-Nov-23
Draft recommendation issued to sponsor22-Nov-23
Draft recommendation posted for stakeholder feedback30-Nov-23
End of feedback period14-Dec-23
Final recommendation issued to sponsor and drug plans05-Jan-24
Final recommendation posted23-Jan-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)19-Jan-24
CADTH review report(s) posted-