PBAC's latest decision on Idelalisib: Recommended with restriction (2016). Considered for Refractory follicular B-cell non-Hodgkin's lymphoma in patients refractory to both rituximab and an alkylating agent, as monotherapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
8
first 2015
Submissions
8
2015 → 2016
Eligible population
Patients with follicular B-cell non-Hodgkin's lymphoma that is refractory to both rituximab and an alkylating agent, as monotherapy.
Therapy area
Haematology
Line of therapy
Later-line
Evidence base
Single-arm
Primary endpoint
PFS
Comparator
best supportive care
Economic model
CUA
ICER note
ICER value not stated in public summary document; document notes PBAC 'maintained that the ICER remained high' but no numeric value provided.
ICER (historical)
$45k/QALY–$75k/QALY across 2 submissions (2016) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Risk sharing arrangement with financial cap recommended; cap based on utilisation estimates in March 2016 submission; utilisation to be reviewed 3 years after listing.
Submission history
Mar 2015: Recommended with restriction · Authority Required
Mar 2015: Deferred · Authority Required
Nov 2015: Not recommended · Authority Required
Nov 2015: Recommended with restriction · Authority Required
Mar 2016: Deferred · Authority Required — ICER $75k/QALY
Mar 2016: Deferred · Authority Required — ICER $75k/QALY
Jul 2016: Recommended · Authority Required
Jul 2016: Recommended with restriction · Authority Required