Generic Name:
Bendamustine hydrochloride
Project Status:
Complete
Therapeutic Area:
Chronic Lymphocytic Leukemia (first-line)
Manufacturer:
Lundbeck Canada Inc.
Brand Name:
Treanda
Project Line:
Reimbursement Review
Project Number:
PC0011-000
NOC Date:
Details
Strength:
25mg/vial and 100mg/vial
Tumour Type:
Leukemia
Indications:
Chronic lymphocytic leukemia (First Line)
Funding Request:
Patients with Chronic Lymphocytic Leukemia (first line) for whom fludarabine-based therapy is not appropriate
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
Lundbeck Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Clarification:
Time required for the submitter to provide additional information has impacted the review timeline.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Clarification:
Time required for the submitter to provide additional information has impacted the review timeline.
pERC Meeting:
Final Recommendation Issued:
As per pCODR Procedures B5.4, the pERC deliberations for Bendamustine (Treanda) First Line treatment of patients with CLL were deferred to the January 17, 2013 pERC meeting date, once the submitter provided the requested additional economic information. pERC issued a final recommendation for Bendamustine (Treanda) for Relapsed/Refractory CLL separately to the First Line indication. Please see the Bendamustine (Treanda) for Chronic Lymphocytic Leukemia (Relapsed/Refractory) Details page for more information.