PBAC's latest decision on Difelikefalin: Recommended with restriction (2023). Considered for Treatment of moderate to severe pruritus associated with chronic kidney disease in adult patients on haemodialysis who have inadequate response to best supportive care.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2023
Submissions
2
2023 → 2023
Eligible population
Adult patients on haemodialysis (in-centre or at-home) with chronic kidney disease and moderate to severe pruritus (WI-NRS score > 4) who have inadequate response to best supportive care.
Therapy area
Nephrology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
QoL
Comparator
best supportive care
Economic model
CUA
ICER note
ICER values are redacted in the public summary document. The document indicates ranges ('$45,000 to < $55,000' and '$55,000 to < $75,000') but the specific numeric ICER is marked as redacted (shown as '$___1' and '$___2').
Risk sharing
Risk-sharing arrangement in place — Risk sharing arrangement (RSA) proposed by the sponsor based on predicted financial estimates and a rebate percentage (redacted). PBAC advised that an RSA would be required to address uncertainty regarding use outside the proposed restriction.
Submission history
Mar 2023: Recommended with restriction · Authority Required
Nov 2023: Recommended with restriction · Authority Required