OBJECTIVES: Mantle cell lymphoma (MCL) is an aggressive sub-type of non-Hodgkin’s lymphoma (NHL) with a poor prognosis.  Approximately 6% of incident NHL cases are MCL.  Following initial treatment, relapsed MCL cases have an 18-month median survival.  In 2008, Health Canada approved bortezomib for relapsed MCL patients.       Although there is no standard treatment for relapsed MCL, a Canadian physician survey indicated FCM (fludarabine, cyclophosphamide, mitoxantrone) was a commonly used regimen.  Rituximab-containing regimens were excluded as comparators because rituximab re-treatment was not uniformly accessible.  However, the FCM regimen was accessible across Canada.  The objective was to evaluate the cost-effectiveness of bortezomib versus FCM.       METHODS:   The PINNACLE single-arm study evaluated bortezomib in relapsed MCL patients.  Most of these patients had received rituximab previously, and therefore provided rationale to support using a non-rituximab regimen as a comparator.  Published literature identified one relevant FCM study.   A five-year time horizon was selected as most patients were at this point deceased.  Costs and benefits were discounted by 5% and a provincial Ministry of Health perspective was taken.  The overall survival for bortezomib was projected based on the PINNACLE study.  Health utilities were obtained from a published study on aggressive NHL.  Resource use included costs of drugs, intravenous administration and managing key adverse events.  The survival of relapsed MCL patients treated with standard chemotherapy, including fludarabine regimens, was validated from a cohort of patients from the British Columbia Cancer Agency.  This ensured the FCM data in the analysis was not an underestimation of actual practice results.       RESULTS:   The discounted QALYs were 1.47 (Bortezomib) and 0.86 (FCM).  The total cost was CAN $27,886 (bortezomib) and $5,059 (FCM).  The ICER was $37,253 per QALY.  Results were most sensitive to the amount of bortezomib used and the survival of these patients.       CONCLUSIONS:   Bortezomib is an approved and cost-effective option in these difficult to treat patients.