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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.
|Generic Name||Bendamustine hydrochloride|
|Strength||25mg/vial and 100mg/vial|
|Indication||Chronic lymphocytic leukemia (First Line)|
|Funding Request||Patients with Chronic Lymphocytic Leukemia (first line) for whom fludarabine-based therapy is not appropriate|
|Pre Noc Submission||Yes|
|NOC Date||August 24, 2012|
|Manufacturer||Lundbeck Canada Inc.|
|Sponsor||Lundbeck Canada Inc.|
|Submission Date||April 24, 2012|
|Submission Deemed Complete||May 1, 2012|
|Prioritization Requested||Not Requested|
|Stakeholder Input Deadline ‡||May 8, 2012|
|Check-point meeting||June 27, 2012|
|pERC Meeting||January 17, 2013|
|Initial Recommendation Issued||January 31, 2013|
|Feedback Deadline ‡||February 14, 2013|
|Final Recommendation Issued||February 19, 2013|
|Notification to Implement Issued||March 6, 2013|
|Clarification||Time required for the submitter to provide additional information has impacted the review timeline.|
|Therapeutic Area||Chronic Lymphocytic Leukemia (first-line)|
|Recommendation Type||Reimburse with clinical criteria and/or conditions|
‡ 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.