PBAC's latest decision on Vorinostat: Recommended with restriction (2017). Considered for Cutaneous T-cell lymphoma (CTCL) in patients with relapsed or chemotherapy-refractory disease who are ineligible for stem cell transplantation and have received prior systemic chemotherapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
3
first 2011
Submissions
3
2011 → 2017
Eligible population
Patients with cutaneous T-cell lymphoma with relapsed or chemotherapy-refractory disease, who have received prior systemic chemotherapy and are ineligible for stem cell transplantation, intended for curative treatment.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
Other
Primary endpoint
ORR
Economic model
Cost-minimisation
ICER note
ICER values redacted throughout the document (indicated by '''''''''). Cost per responder calculated at prior pricing ($'''''''''''''''), but not in ICER format per QALY or LY.
ICER (historical)
$75k/QALY–$105k/QALY in an earlier submission (2011) — 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 — Patient number cap with rebate mechanism: less than 10,000 patients in Year 1 (including grandfathered MSD EAP patients only in Year 1), with a 70% rebate for expenditure above the cap to address risk of use beyond progression or in other indications.
Submission history
Mar 2011: Not recommended — ICER $105k/QALY
Nov 2016: Recommended with restriction · Authority Required
Mar 2017: Recommended with restriction · Authority Required