What Is the CADTH Reimbursement Recommendation for Columvi?: CADTH recommends that Columvi be reimbursed by public drug plans for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received 2 or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T-cell therapy or have previously received CAR-T-cell therapy if certain conditions are met.
Which Patients Are Eligible for Coverage?: Columvi should only be covered to treat adult patients who have DLBCL not otherwise specified, trFL, or PMBCL 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?: Columvi should only be reimbursed for a maximum of 12 treatment cycles, after a single dose of obinutuzumab to reduce the risk of cytokine release syndrome (CRS) and should not be given in combination with other anticancer drugs. Reimbursement of Columvi should be discontinued if a patient’s cancer grows or spreads or if treatment is unacceptably toxic to the patient. Columvi should only be reimbursed when prescribed by specialists with experience managing DLBCL, and if its cost is reduced.
Why Did CADTH Make This Recommendation?:
Evidence from 1 clinical trial suggested that treatment with Columvi may improve survival and increase the time until the cancer grows or spreads. Additionally, 40% of patients treated with Columvi experienced a disappearance of all signs and symptoms of cancer (i.e., completely responded to treatment).
Columvi may meet some important patient needs by providing another treatment option that delays disease progression and has manageable side effects.
Based on CADTH’s assessment of the health economic evidence, Columvi 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, Columvi is estimated to cost the public drug plans approximately $3 million over the next 3 years, but it may cost $18 million or more, depending upon whether Columvi displaces a comparator treatment and which comparator treatment Columvi displaces.
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, causing 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 R-CHOP, which is a combination of chemotherapy treatments. Approximately 30% to 50% of patients will experience disease progression or relapse within the first 2 years 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 those who cannot or cannot receive CAR-T-cell therapy.
How Much Does Columvi Cost?: Treatment with Columvi is expected to cost $5,200 per patient for the first 21-day cycle and $12,480 per patient for each subsequent 21-day cycle. The cost of pretreatment before the first dose of Columvi is $5,479 per patient.