PBAC's latest decision on Abaloparatide: Recommended with restriction (2025). Considered for First-line treatment for patients with severe established osteoporosis and very high risk of fracture. Approved TGA indication is for osteoporosis in postmenopausal women at increased risk of fracture.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Adults aged ≥18 years with severe established osteoporosis and very high risk of fracture (BMD T-score ≤-2.5, prior symptomatic fracture(s) within 24 months), who have not received prior PBS-subsidised anabolic or anti-resorptive therapy, or who have developed severe intolerance to prior therapy within 6 months.
Therapy area
Endocrinology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Incidence of new vertebral fractures
Key trials
ACTIVE, ATOM
Comparator
romosozumab
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis (CMA) approach used; no traditional ICER calculated. Abaloparatide price set to be cost-equivalent to romosozumab over one complete treatment course (18 months of abaloparatide vs 12 months of romosozumab).