Difelikefalin (Korsuva)

Key Messages

• CADTH recommends that difelikefalin should not be reimbursed by public drug plans for the treatment of moderate to severe pruritus associated with chronic kidney disease (CKD-aP) in adult patients on hemodialysis (HD).
• The CADTH Canadian Drug Expert Committee could not conclude whether treatment with difelikefalin resulted in clinically meaningful improvements. Evidence from 2 randomized controlled trials (KALM-1 and KALM-2) demonstrated that treatment with difelikefalin was associated with statistically significant improvements in itch; however, whether the improvement is clinically meaningful to patients is unclear due to a high placebo response and the trials measuring itch in a way that is inconsistent with clinical practice. As such, it is difficult to determine the actual treatment effect of difelikefalin.
• Patients living with moderate to severe CKD-aP on HD expressed a need for treatments that improve quality of life (QoL). Based on the available evidence, it is unclear if difelikefalin is associated with an improvement in QoL.
• There is a lack of evidence to show that difelikefalin would meet the needs identified by patients, such as reducing hospital visits and the amount of overall medication required, improving sleep quality and reducing sleep disturbance, and reducing side effects.