WHAT IS THE REIMBURSEMENT RECOMMENDATION FOR EPKINLY?: We recommend that Epkinly be reimbursed by public drug plans for the treatment of adults with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL transformed from indolent lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, or follicular lymphoma grade 3B after 2 or more lines of systemic therapy and who have previously received or are unable to receive chimeric antigen receptor (CAR) T-cell therapy for a time-limited period while additional evidence is generated if certain conditions are met. Please note that time-limited reimbursement refers to temporary reimbursement by the drug programs while additional evidence is generated and submitted for reassessment (i.e., this does not refer to the length of treatment or number of cycles administered). WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Epkinly should only be covered to treat adults who have DLBCL, not otherwise specified, DLBCL transformed from indolent lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, or follicular lymphoma grade 3B that has come back or that did not respond to 2 or more previous treatments for their cancer, and who have also previously received CAR T-cell therapy, declined CAR T-cell therapy, or cannot receive CAR T-cell therapy. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Epkinly should only be reimbursed if not given in combination with other anticancer drugs. Reimbursement of Epkinly should be discontinued if a patient’s cancer grows or spreads or if the treatment is unacceptably toxic to the patient. Epkinly should only be reimbursed when prescribed by specialists with experience managing large B-cell lymphoma (LBCL), and if its cost is reduced. WHY IS REIMBURSEMENT RECOMMENDED IN A TIME-LIMITED MANNER? A time-limited recommendation is a recommendation to publicly fund a drug or drug regimen for a certain period of time on the condition the sponsor will generate additional data that addresses uncertainty in the evidence. Health Canada requires the sponsor to complete a phase III study and confirm that Epkinly improves survival in patients with DLBCL compared to bendamustine and rituximab (BR) or rituximab, gemcitabine, and oxaliplatin (R-GemOx). Given that there is uncertainty in the magnitude of clinical benefit with Epkinly, reimbursement has recommended in a time-limited manner and is contingent on a reassessment of the comparative efficacy and cost-effectiveness when the results of the phase III study are available from the sponsor. WHY DID WE MAKE THIS RECOMMENDATION? Evidence from 1 clinical trial suggested that treatment with Epkinly may improve survival and increase the time until the cancer grows or spreads. Additionally, 40% of patients treated with Epkinly experienced a disappearance of all signs and symptoms of cancer (i.e., completely responded to treatment). Epkinly may meet some important patient needs by providing another treatment option that delays disease progression and has manageable side effects. Based on an assessment of the health economic evidence, Epkinly does not represent good value to the health care system at the public list price. A price reduction is therefore required. Based on public list prices, Epkinly is estimated to cost the public drug plans approximately $44 million over the next 3 years.

ADDITIONAL INFORMATION

WHAT IS R/R DLBCL? Non-Hodgkin lymphoma (NHL) is a type of cancer that forms in the lymphatic system. DLBCL is an aggressive type of NHL that accounts for 30% to 40% of NHL cases in Canada. DLBCL occurs when a type of white blood cell, called a B-cell, grows or divides abnormally, which causes tumours in the lymph nodes or other organs, including the spleen, liver, or bone marrow. r/r DLBCL is cancer that has come back after treatment (relapsed) or has not responded to certain treatments (refractory). UNMET NEEDS IN R/R DLBCL: Not all patients with DLBCL respond to or are cured by first-line treatment with the combination chemotherapy treatment of rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulphate, and prednisone (R-CHOP). Approximately 30% to 50% of patients will experience disease progression or relapse within the first 2 years following R-CHOP therapy and will require additional treatments for their disease. There is also a need for accessible treatments for patients who progress after CAR T-cell therapy or for those who cannot receive CAR T-cell therapy. HOW MUCH DOES EPKINLY COST? Treatment with Epkinly is expected to cost approximately $14,320 in cycle 1, $26,436 in each of cycles 2 and 3, $13,218 in each of cycles 4 to 9, and $6,609 in each of cycles 10 and beyond. Costs are reported per patient.