pCODR Reimbursement Decision
|Generic Name||Bendamustine Hydrochloride|
|Manufacturer||Lundbeck Canada Inc.|
|pCODR Indication||Non-Hodgkin Lymphoma|
|pCODR Tumour Type||Lymphoma & Myeloma|
|Funding Request||For the treatment of patients with indolent non-Hodgkin lymphoma (iNHL) and mantle cell lymphoma (MCL) (first-line).|
|Submission Type||New Drug|
|Review Status||Notification to Implement Issued|
|Notification to Implement Date||2012-12-14|
|RD Interpretation of pERC Recommendation||Recommended - without criteria/conditions.|
The pCODR Expert Review Committee (pERC) recommends funding bendamustine (Treanda) as a first-line therapy in patients with indolent CD20 positive Non-Hodgkin Lymphoma (iNHL) and Mantle Cell Lymphoma (MCL) with an ECOG performance status of less than or equal to 2, when used in combination with rituximab. pERC made this recommendation because it considered that there is a net clinical benefit of bendamustine in this setting and that it is likely to be cost-effective.
First-line: Patients with indolent CD20 positive Non-Hodgkin Lymphoma (iNHL) and Mantle Cell Lymphoma (MCL) with an ECOG performance status of less than or equal to 2, when used in combination with rituximab.
|RD Interpretation of Patient Population Requested vs Actual||
|Summary of pERC Deliberations - Clinical||
One randomized controlled trial evaluating bendamustine plus rituximab (B-R) compared with R-CHOP in the first-line setting (STiL NHL1, Rummel 2009) and one randomized controlled trial evaluating B-R compared with fludarabine plus rituximab (F-R) in the relapsed/refractory setting (STiL NHL2, Rummel 2010) were included in the pCODR systematic review. Both of these studies are currently only available in abstract-form and have not been published as full journal articles. However, considering the available details on study design and the type of information included in these abstracts, pERC accepted that abstract data were sufficient in the review of bendamustine for indolent Non-Hodgkin Lymphoma (iNHL) and Mantle Cell Lymphoma (MCL). pERC deliberated upon the results of the STiL NHL1 study, which was conducted in the first-line setting. pERC considered that the magnitude of the progression-free survival benefit for B-R compared with R-CHOP was substantial and statistically significant (54.8 months versus 34.8 months, respectively). Therefore, pERC determined that there is a net clinical benefit of bendamustine in combination with rituximab in the first-line setting. In both studies, pERC considered that the impact of rituximab maintenance therapy on the apparent effectiveness of bendamustine was unclear given that it was not used in STiL NHL1 and given that the proportion of patients in STiL NHL2 who had previously received rituximab maintenance therapy was not reported . Upon reconsideration of the pERC Initial Recommendation, pERC noted that rituximab maintenance therapy is an accepted standard of care and therefore would be expected to be used after almost any combination first-line therapy in the treatment of iNHL.
|Summary of pERC Deliberations - Safety||
First-line: pERC also considered reports of grade 3 and grade 4 adverse events and noted that, in most cases, adverse events were similar or greater in the R-CHOP group compared with the B-R group. pERC discussed that comparing B-R with R-CHOP, which has known toxicities, may bias the results in favour of bendamustine and it is not certain how B-R compares with R-CVP. However, overall, pERC considered that the adverse event profile of bendamustine appeared tolerable in this setting and that the ongoing BRIGHT study would provide more details on B-R versus R-CVP.
|Summary of pERC Deliberations - Cost-effectiveness||
pERC deliberated upon the cost-effectiveness of bendamustine in patients with iNHL and MCL. In both of the submitted analyses, one for the first-line setting and the other in the relapsed-refractory setting, pERC acknowledged that there were serious limitations in the economic evaluations that were submitted and that there was considerable uncertainty in the cost-effectiveness estimates provided by pCODR’s Economic Guidance Panel (EGP). However, pERC noted that the face validity of the economic models was not questioned by the EGP. Despite the uncertainty, pERC considered that in both the first-line setting and the relapsed/refractory setting, the incremental cost-effectiveness ratio is likely acceptable. However, pERC acknowledged that these estimates should be interpreted with caution.
|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.