WHAT IS THE REIMBURSEMENT RECOMMENDATION FOR CARVYKTI?: Canada’s Drug Agency (CDA-AMC) recommends that Carvykti should be reimbursed by public drug plans for the treatment of adult patients with multiple myeloma (MM), who have received 1 to 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, and whose disease is refractory to lenalidomide if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Carvykti should only be covered to treat patients aged 18 years or older with documented diagnosis of MM, who have received 1 to 3 prior lines of therapy, and have a good performance status, as determined by a specialist. Carvykti should not be reimbursed for the treatment of patients whose MM is affecting their central nervous system. It should also not be reimbursed for patients who have previously received any treatment that targets B-cell maturation antigen (BCMA). WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Carvykti should only be reimbursed if it is prescribed and administered by clinicians with expertise in the treatment of MM at specialized centres with adequate infrastructure, resources, and expertise to facilitate treatment with chimeric antigen receptor (CAR) T-cell therapy, and the cost of Carvykti is reduced. WHY DID CDA-AMC MAKE THIS RECOMMENDATION? • Evidence from a clinical trial demonstrated that Carvykti prolonged the time until disease progression or death and was associated with an improved response to treatment. • Based on our assessment of the health economic evidence, Carvykti does not represent good value to the health care system at the public list price. A price reduction is therefore required. • Carvykti met some patient needs because it is a one-time treatment that offers an alternative option, delays disease progression, and may help reduce MM symptoms without worsening the patient’s overall quality of life. • The implementation of Carvykti, including in earlier lines of therapy, may raise several ethical and equity considerations related to access and resource allocation because of the resource-intensive nature of CAR T-cell therapy and the currently limited number of CAR T-cell centres in Canada. • Based on public list prices, Carvykti is estimated to cost public drug plans approximately $477 million over the next 3 years.
WHAT IS MM? MM is a cancer of plasma cells (the white blood cells that make immunoglobulins) in the bone marrow. In 2023, approximately 3,900 people in Canada were diagnosed with MM. UNMET NEEDS IN MM: MM is a disease with poor prognosis and many patients do not respond to initial treatments and their disease will relapse. This prognosis leaves patients trying many different treatments. There is a need for additional effective treatment options that can delay disease progression, prolong survival, reduce side effects, and improve the quality of life for both patients and their caregivers. HOW MUCH DOES CARVYKTI COST? Treatment with Carvykti is associated with a one-time infusion cost of $632,455.
