Daratumumab (Darzalex SC): Indication: Daratumumab in combination with bortezomib, lenalidomide, and dexamethasone, followed by maintenance treatment in combination with lenalidomide, for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant: Reimbursement Recommendation

What is the reimbursement recommendation for darzalex sc?Canada’s Drug Agency (CDA-AMC) recommends that Darzalex SC in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) followed by maintenance treatment in combination with lenalidomide be reimbursed by public drug plans for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant (ASCT), if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Darzalex SC should only be covered to treat patients aged 18 years or older with NDMM who are eligible to receive ASCT and have a good performance status. Patients must not have received prior systemic therapy (other than corticosteroids) for multiple myeloma (MM), and there must not be signs that the cancer has spread to the protective layers of the brain and spinal cord (known as the meninges). WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Darzalex SC should only be reimbursed if prescribed in combination with bortezomib, lenalidomide, and dexamethasone, followed by maintenance treatment in combination with lenalidomide, by clinicians with expertise in the diagnosis and management of MM, and if the cost of Darzalex SC is reduced. WHY DID CDA-AMC MAKE THIS RECOMMENDATION? ▪. Evidence from a clinical trial demonstrated that Darzalex SC prolonged the time until disease progression or death and was associated with an improved response to treatment in patients with NDMM who are eligible to receive ASCT. ▪. Darzalex SC met patient needs for an additional treatment option that delays disease progression and likely helps improve response to treatment without worsening the patient’s overall quality of life (QoL). ▪. Based on the CDA-AMC assessment of the health economic evidence, Darzalex SC 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, Darzalex SC is estimated to cost the public drug plans approximately $933.5 million over the next 3 years.Additional informationWHAT IS NEWLY DIAGNOSED MM? MM is a cancer of plasma cells (the white blood cells that make immunoglobulins) in the bone marrow. In 2024, approximately 4,100 people in Canada were newly diagnosed with MM and 1,895 patients with transplant-eligible NDMM. UNMET NEEDS IN NDMM: MM is a disease with a poor prognosis; many patients do not respond to current first-line 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, deepen response, reduce side effects, and improve QoL. HOW MUCH DOES DARZALEX SC COST? Treatment with Darzalex SC is expected to cost approximately $37,004 for each 28-day cycle in cycles 1 and 2; $20,943 per cycle in cycles 3 to 6; and $10,555 per cycle in cycles 10 onward, per patient.