Daratumumab (Darzalex SC): CADTH Reimbursement Recommendation: Indication: In combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis

What Is the CADTH Reimbursement Recommendation for Darzalex? CADTH recommends that Darzalex (daratumumab) in combination with cyclophosphamide, bortezomib, and dexamethasone (DCyBorD) should be reimbursed by public drug plans for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis if certain conditions are met. Which Patients Are Eligible for Coverage? Darzalex should only be covered to treat adult patients with newly diagnosed AL amyloidosis who have good performance status. Patients eligible for reimbursement of Darzalex must not have had prior therapy for AL amyloidosis or multiple myeloma, a previous or current diagnosis of multiple myeloma, or be planning to have a stem cell transplant during the first 6 cycles of treatment with DCyBorD. What Are the Conditions for Reimbursement? Darzalex should only be reimbursed if prescribed in combination with cyclophosphamide, bortezomib, and dexamethasone for 6 months, followed by daratumumab alone until the disease progresses or for a maximum of 2 years (whichever comes first), and if the cost of Darzalex is reduced. Why Did CADTH Make This Recommendation? Evidence from a clinical trial demonstrated that DCyBorD was more effective than CyBorD alone in terms of hematologic and organ response outcomes in patients with newly diagnosed AL amyloidosis. Darzalex met patient needs for an effective treatment to maintain quality of life without debilitating side effects. DCyBorD is the only approved treatment option for AL amyloidosis in Canada. Based on public list prices, DCyBorD would not be considered cost-effective at a willingness to pay of $50,000 per quality-adjusted life-year (QALY). A price reduction of at least 21% is needed to ensure DCyBorD is cost-effective at a $50,000 per QALY threshold. Based on public list prices, the cost to participating drug plans is expected to be $94,917,168 over 3 years.Additional Information What Is AL Amyloidosis? AL amyloidosis is a disease that occurs when an abnormal protein (amyloid) builds up in the organs, most commonly the heart and kidneys, and interferes with their normal function. AL amyloidosis is rare; in Canada, the annual incidence is 10 per million. Unmet Needs in Darzalex No treatments are currently publicly funded in Canada for patients with AL amyloidosis, and patients do not generally respond to those that are used. Therapies that can prevent, delay, or improve organ damage and are better tolerated by patients are needed. How Much Does Darzalex Cost? DCyBorD is given over a 28-day cycle. Treatment with DCyBorD is expected to cost public drug plans $31,892 per cycle in cycle 1 and cycle 2, $17,272 per cycle in cycle 3 to cycle 6, and $7,310 per cycle in subsequent cycles.