CADTH | Evidence Driven
CADTH | Evidence Driven

Treanda for Chronic Lymphocytic Leukemia (First Line)

Details

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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
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.

Files

Provincial Funding Summary View PDF
Bendamustine (Treanda) for CLL (Firstline)- pERC Final Recommendation Final Recommendation February 19, 2013 View PDF
Bendamustine (Treanda) for CLL (First Line) - Final Clinical Guidance Report Guidance Report February 19, 2013 View PDF
Bendamustine (Treanda) for CLL (First Line) - Final Economic Guidance Report Guidance Report February 19, 2013 View PDF
Bendamustine (Treanda) for CLL (First Line) - pERC Initial Recommendation Initial Recommendation January 31, 2013 View PDF
Bendamustine (Treanda) for CLL (First Line) - PAG Feedback on Initial Recommendation Feedback February 19, 2013 View PDF
Bendamustine (Treanda) for CLL (First Line) - Manufacturer (Lundbeck Canada) Feedback on Initial Recommendation Feedback February 19, 2013 View PDF
Bendamustine (Treanda) for CLL (First Line) - Patient Advocacy Group (CLL PAG) COI Declarations Feedback February 19, 2013 View PDF
Bendamustine (Treanda) for CLL (First Line) - Patient Advocacy Group (LLSC) COI Declarations Feedback February 19, 2013 View PDF

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : March 6, 2013