PBAC's latest decision on Denosumab: Recommended (2025). Considered for Stoboclo for osteoporosis and established osteoporosis; Osenvelt for giant cell tumour of bone and bone metastases.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
14
first 2010
PBS spend
$291M
1,154,845 scripts · 2024
Eligible population
Patients eligible for denosumab under the same conditions and indications as the reference biologics Prolia and Xgeva.
Therapy area
Endocrinology
Line of therapy
Not applicable
Evidence base
Cost-minimisation
Primary endpoint
Cost-minimisation
Comparator
Prolia (for Stoboclo); Xgeva (for Osenvelt)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as biosimilars are not expected to provide substantial clinical improvement over reference biologics.
ICER (historical)
$100k/QALY–$200k/QALY in an earlier submission (2011) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
PBS expenditure
The Australian government paid $291M in PBS benefits for Denosumab in 2024 across 1,154,845 scripts, at $252 per script.
Submission history
Jul 2010: Recommended with restriction · Authority Required