Talquetamab (Talvey): Indication: For the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on or after the last therapy: Reimbursement Recommendation

What is the reimbursement recommendation for talvey?Canada’s Drug Agency (CDA-AMC) recommends that Talvey not be reimbursed by public drug plans for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (mAb), and who have demonstrated disease progression on or after the last therapy. WHY DID CDA-AMC MAKE THIS RECOMMENDATION? • Evidence from 1 clinical study showed that Talvey may improve treatment response rates in adults with RRMM who have received at least 3 prior lines of therapy. However, no causal conclusions could be drawn about the effect of Talvey on the outcomes important to patients and clinicians (e.g., progression-free survival [PFS] and overall survival [OS]) based on the weak evidence from 1 noncomparative clinical trial. • The evidence is insufficient to determine whether Talvey meets patient needs for effective, accessible, and portable treatment options that can extend life, delay worsening or spreading of disease, improve quality of life, and reduce side effects. • Talvey’s adverse effect profile may not align with patient values regarding side effects. Notably, dysgeusia — an unfavourable side effect from the patient perspective — was 1 of the most frequently reported adverse events (AEs) with Talvey in the submitted clinical trial. Other frequently reported side effects may be considered unfavourable by patients, as the patient group input reported infections and nail, skin, and oral issues as the least bearable side effects.Additional informationWHAT IS MULTIPLE MYELOMA? Multiple myeloma (MM) is a cancer of plasma cells (i.e., white blood cells that make immunoglobulins) in the bone marrow (i.e., the soft matter inside bones where blood cells are produced). In 2023, an estimated 3,900 individuals were diagnosed with MM and about 1,700 deaths occurred due to MM in Canada. UNMET NEEDS IN MM: MM is an incurable disease with a low chance of recovery. MM often does not respond to initial treatments and will relapse, so the patient will need to try many different treatments. There is a need for additional treatment options that allow patients to live longer, delay the worsening or spread of cancer, improve quality of life, and reduce side effects. HOW MUCH DOES TALVEY COST? Treatment with Talvey on a weekly dosing schedule is estimated to cost approximately $31,154 per patient for the first 28 days, followed by $29,129 every 28 days thereafter. For the biweekly dosing schedule, the estimated cost is approximately $36,878 for the first 28 days and $27,184 every 28 days thereafter, per patient.