pCODR Reimbursement Decision
|Generic Name||Bendamustine Hydrochloride|
|Manufacturer||Lundbeck Canada Inc.|
|pCODR Indication||Chronic Lymphocytic Leukemia|
|pCODR Tumour Type||Leukemia|
|Funding Request||For the treatment of patients with chronic lymphocytic leukemia (relapsed/refractory) for whom fludarabine-based therapy is not appropriate.|
|Submission Type||New Drug|
|Review Status||Notification to Implement Issued|
|Notification to Implement Date||2012-12-14|
|RD Interpretation of pERC Recommendation||Not recommended - clinical benefit insufficient/unclear.|
In the relapsed/refractory setting, the pCODR Expert Review Committee (pERC) does not recommend funding bendamustine (Treanda) for the treatment of patients with chronic lymphocytic leukemia. pERC made this recommendation because the Committee was not confident of the net clinical benefit of bendamustine for relapsed/refractory disease. This was due to the limited information available from a small unpublished randomized controlled trial, which pERC considered to be inadequate to assess whether a benefit relative to a alternative treatments exists. In the first-line setting, pERC acknowledged that based on the current evidence available, bendamustine appears to have a net clinical benefit and align with patient values. However, pERC lacked confidence in the information on cost-effectiveness, and a full deliberation on bendamustine in the first-line setting could not be completed in accordance with the pERC Deliberative Framework.
Patients with chronic lymphocytic leukemia (relapsed/refractory).
|RD Interpretation of Patient Population Requested vs Actual||
First-line: Same Relapsed/refractory: Same
|Summary of pERC Deliberations - Clinical||
pERC primarily deliberated upon the results of the Medgenberg 2009 study. It was noted that this was a relatively small study (N =96) and that there was insufficient information available to assess the quality of this randomized controlled trial. Although Medgenberg 2009 reported results on progression-free survival and response rate, pERC considered that the level of detail provided on the clinical trial design and results was not adequate to assess the effectiveness of bendamustine relative to treatments already being used in this patient population. pERC also considered that the five small non-randomized studies evaluating bendamustine in the relapsed /refractory setting provided inadequate evidence of a clinical benefit. pERC discussed that there is a need for new treatments in patients with relapsed or refractory CLL, given that CLL is a common leukemia and has a long natural history and that the burden of illness may be substantial in a prevalent population with limited treatment options. However, because of the limited information available from the Medgenberg 2009 study, pERC could not be certain that there is a net clinical benefit relative to other available treatments. Upon reconsideration of the pERC Initial Recommendation, the Committee discussed feedback from the manufacturer and a patient advocacy group suggesting that single-arm studies evaluating bendamustine in the relapse/refractory setting should have been deliberated upon in more depth. pERC considered these studies but, similar to the pCODR Clinical Guidance Panel, did not consider that they were sufficient to support decision-making regarding net clinical benefit in this context. pERC also discussed that when assessing the net clinical benefit, it is important to have comparative information to assess effectiveness relative to other treatments, and this information was not available in the single-arm studies evaluating bendamustine.
|Summary of pERC Deliberations - Safety||
The safety of bendamustine in patients with relapsed/refractory CLL was discussed but minimal safety data were reported from the Medgenberg 2009 study, and pERC did not consider the reported results sufficient for assessing the safety of bendamustine in these patients.
|Summary of pERC Deliberations - Cost-effectiveness||
pERC discussed the cost-effectiveness of bendamustine in the relapsed/refractory setting. pERC considered the pCODR Economic Guidance Panel's (EGP) assessment that the economic model submitted by the manufacturer for the relapsed/refractory setting had fundamental flaws and lacked face validity. This decreased the EGP's confidence in the cost-effectiveness estimates produced by the manufacturer's model and prevented the EGP from providing a best estimate of the cost-effectiveness of bendamustine in the relapsed/refractory setting. pERC accepted the EGP's assessment that it was not possible to determine the cost-effectiveness of bendamustine in the relapsed/refractory setting based on the submitted model. Regardless of cost-effectiveness, however, pERC considered that in the absence of a net clinical benefit for bendamustine in this setting, it could not recommend funding bendamustine.
|Provincial Funding Report:||
pCODR Provincial Funding Summary report
|Final Recommendation Report:||
pCODR-pERC Final Recommendation report
|Final Clinical Guidance Report:||
pCODR Final Clinical Guidance report
|Final Economic Guidance Report:||
pCODR Final Economic Guidance report
†The information referenced on this page is compiled from publicly available documents published by pCODR and is available through the embedded links.