PBAC's latest decision on Nivolumab + ipilimumab: Recommended with restriction (2022). Considered for Treatment of unresectable Stage III or IV malignant melanoma in patients who experience melanoma recurrence while receiving or within 6 months of completing adjuvant anti-PD-1 inhibitor monotherapy.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
4
first 2015
Submissions
4
2015 → 2022
Eligible population
Adults with unresectable Stage III or IV malignant melanoma who have experienced disease recurrence while receiving adjuvant PD-1 inhibitor monotherapy or within 6 months of completing adjuvant PD-1 inhibitor treatment, with ECOG performance status 0 or 1.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
Single-arm
Primary endpoint
OS
Pivotal trial size
355 patients
Key trials
da Silva et al (2021), Owen et al (2020), CheckMate 067
Comparator
Ipilimumab (IPI) monotherapy
Economic model
Cost-minimisation
ICER note
No economic analysis was provided; the submission relied on CheckMate 067 as a basis for the proposed price in lieu of an economic analysis.
ICER (historical)
$200k/QALY in an earlier submission (2017) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Nov 2015: Not recommended · Authority Required
Mar 2017: Not recommended · Authority Required — ICER $200k/QALY
Jul 2018: Recommended with restriction · Restricted
Nov 2022: Recommended with restriction · Restricted