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pCODR Reimbursement Decision

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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) (relapsed/refractory).
Submission Date 2012-04-24
Submission Type New Drug
Review Status Notification to Implement Issued
Recommendation Date 2012-11-29
Notification to Implement Date 2012-12-14
RD Interpretation of pERC Recommendation Recommended - with criteria/conditions.
pERC Recommendation

The pCODR Expert Review Committee (pERC) recommends funding bendamustine (Treanda) in the relapsed/refractory setting in patients with iNHL and MCL when used in combination with rituximab, where the combination of fludarabine-rituximab could previously have been a therapeutic option. 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. pERC was unable to make an informed recommendation on funding bendamustine monotherapy in the broader patient population with relapsed or refractory disease, including those with rituximab refractory disease.

Patient Population

Relapsed/refractory: Patients with iNHL and MCL when used in combination with rituximab, where the combination of fludarabine-rituximab could previously have been a therapeutic option.

RD Interpretation of Patient Population Requested vs Actual

Relapsed/refractory: Limited

Summary of pERC Deliberations - Clinical

pERC also deliberated upon the results of the STiL NHL2 study, which was conducted in the relapsed/refractory setting. pERC considered that the magnitude of the progression-free survival benefit for B-R compared with F-R was substantial and statistically significant (30 months versus 11 months, respectively). pERC discussed whether F-R was the most appropriate comparator and noted that although this is one possible comparator, there are other treatments used in the relapsed/refractory setting and it is not clear how B-R would compare with those other therapies. 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 also discussed the patient population that was included in STiL NHL2 and considered that, although there is sufficient evidence to suggest a net clinical benefit, it would be important to limit the use of bendamustine to the patients in whom it had been studied. pERC further noted that rituximab-refractory patients were specifically excluded from the STiL NHL2 study, and therefore the clinical benefit of bendamustine in this population is unknown. pERC noted and accepted that based on standards of clinical practice, patients whose disease progressed while undergoing or within six months of completing a rituximab containing treament would be considered to have rituximab-refractory disease. pERC considered that the ongoing ROBIN study would likely provide more evidence on the effectiveness of bendamustine in rituximab-refractory NHL.

Summary of pERC Deliberations - Safety

Relapsed/refractory: pERC also noted that serious adverse events were similar between B-R and F-R, which satisfied pERC that bendamustine was no more toxic than fludarabine in this patient population and setting.

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  pCODR Provincial Funding Summary report
Final Recommendation Report: pCODR-pERC Final Recommendation report  pCODR-pERC Final Recommendation report
Final Clinical Guidance Report: pCODR Final Clinical Guidance Report  pCODR Final Clinical Guidance report
Final Economic Guidance Report: pCODR 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.

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