PBAC's latest decision on Ipilimumab: Recommended with restriction (2016). Considered for Treatment of unresectable stage III or stage IV malignant melanoma as monotherapy or as the sole PBS-subsidised therapy for this condition.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
5
first 2011
PBS spend
$307M
15,198 scripts · 2024
Eligible population
Patients with unresectable stage III or stage IV malignant melanoma for induction, re-induction, or completion of treatment, with no prior ipilimumab treatment for induction cases.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
Other
Economic model
Not modelled
ICER note
Not applicable; minor submission requesting amendment to restriction wording only. No economic evaluation was undertaken.
ICER (historical)
$45k/QALY–$75k/QALY across 3 submissions (2011–2012) — 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 — The submission mentioned that nivolumab would be provided free-of-charge by the sponsor to enable a commitment to the TGA for a safety study of the combination. Additionally, the original positive recommendation in November 2012 included an 'Australian Outcomes Program' requiring the sponsor to rebate the cost of difference in performance between observed versus predicted benefits of ipilimumab.
PBS expenditure
The Australian government paid $307M in PBS benefits for Ipilimumab in 2024 across 15,198 scripts, at $20,185 per script.
Submission history
2011: Not recommended — ICER $200k/QALY
Mar 2012: Not recommended — ICER $75k/QALY
Nov 2012: Recommended with restriction · Authority Required (Streamlined) — ICER $75k/QALY
Jul 2015: Noted
Jul 2016: Recommended with restriction · Authority Required