WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR KIMMTRAK?: CADTH recommends that Kimmtrak be reimbursed by public drug plans for the treatment of unresectable or metastatic uveal melanoma (mUM) if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Kimmtrak should only be covered to treat adults with uveal melanoma whose cancer cannot be removed by surgery or has spread and who have tested positive for the HLA-A02:01 gene. Patients receiving Kimmtrak should be in relatively good health (i.e., have a good performance status, as determined by a specialist). Cancer in central nervous system should either be controlled or that there be no spread of cancer to the brain at all. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Kimmtrak should only be reimbursed if prescribed by a specialist with expertise in managing uveal melanoma and cytokine release syndrome, and the cost of Kimmtrak is reduced. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial demonstrated that Kimmtrak improved survival compared with dacarbazine, pembrolizumab, or ipilimumab in HLA-A02:01-positive patients with mUM in the first-line setting, which meets an unmet need expressed by patients. Based on CADTH’s assessment of the health economic evidence, Kimmtrak 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, Kimmtrak is estimated to cost the public drug plans approximately $54 million over the next 3 years. However, the estimated budget impact is uncertain.

ADDITIONAL INFORMATION

WHAT IS UNRESECTABLE OR METASTATIC UVEAL MELANOMA? Uveal melanoma is a rare form of cancer involving the pigment cells of the uvea in the eye. Unresectable means the cancer cannot be removed by surgery and metastatic means the cancer has spread to other parts of the body. Metastatic disease is associated with poor survival, with about 1 in 2 patients dying from the disease within 1 year of diagnosis despite first-line treatments. It is estimated that 3.75 new cases arose per million Canadians each year between 1992 and 2010, with an increase of 0.074 new cases per million individuals every year. UNMET NEEDS IN UNRESECTABLE OR METASTATIC UVEAL MELANOMA? Metastatic uveal melanoma is an aggressive disease associated with poor survival and there are no current available therapies that predictably improve outcomes. HOW MUCH DOES KIMMTRAK COST? Treatment with Kimmtrak is expected to cost approximately $74,260 per 28-day cycle.