PBAC's latest decision on Romosozumab: Recommended with restriction (2024). Considered for Treatment of severe osteoporosis in the first-line setting in patients at very high risk of fracture defined as those with a BMD T-score of ≤-2.5 and either a recent hip or symptomatic vertebral fracture, or multiple fractures.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$45k/QALY
$35k/QALY–$45k/QALY · across 2 submissions
Submissions
6
first 2018
Submissions
6
2018 → 2024
Eligible population
Patients with severe established osteoporosis at very high risk of fracture (BMD T-score ≤-2.5) who have had either at least one hip or symptomatic vertebral fracture in the previous 24 months, or at least two fractures including one symptomatic new fracture in the previous 24 months, and who have not received prior PBS-subsidised treatment with anti-resorptive therapy, teriparatide, or romosozumab.
Therapy area
Endocrinology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Fracture prevention
Key trials
ARCH
Comparator
alendronate
Economic model
CUA
ICER note
ICER range of $35,000 to <$45,000 per QALY was advised by PBAC in March 2023 as the threshold for cost-effectiveness. The submission proposed revised scenarios to achieve this ICER range at the sponsor's proposed price.
ICER basis
Range aggregates 2 submissions (2023–2024) — not a single base case.
Risk sharing
Risk-sharing arrangement in place — Risk Sharing Arrangement with percentage rebate for expenditure above specified caps.
Submission history
Nov 2018: Recommended with restriction · Authority Required
Jul 2019: Recommended with restriction · Authority Required
Mar 2020: Recommended with restriction · Authority Required
Jul 2022: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required — ICER $55k/QALY
Mar 2024: Recommended with restriction · Authority Required — ICER $45k/QALY