AbaloparatideEladynos
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.
Decision on record
- Meeting Jul 2025 Recommended Severe established osteoporosis, very high fracture risk
Access path
- TGA registered · Eladynos
TGA label narrower than the PBS population
- Jul 2025Recommended · restricted
vs romosozumab
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the General Schedule Authority Required listing of abaloparatide for the treatment of patients with severe established osteoporosis and very high risk of fracture. The PBAC considered that it would be appropriate for the PBS listings for abaloparatide to allow use in either the first or second-line settings, consistent with the listings for the main comparator, romosozumab.PSD · Jul 2025
7.2 The PBAC considered that a cost-minimisation approach (CMA) to romosozumab in the 1L setting, and to the least costly alternative of romosozumab or teriparatide in 42 OFFICIALPSD · Jul 2025
6.43 The submission presented a CMA to support the listing of abaloparatide for the first- line treatment of severe osteoporosis. This was based on the claim of non-inferior effectiveness and superior safety compared to romosozumab based on the indirect comparison of the ACTIVE and FRAME trials.PSD · Jul 2025
6.44 The key components of the approach are summarised in Table 9.PSD · Jul 2025
PBS population. Abaloparatide has a superior safety profile compared with romosozumab. Source: Table 1-2, p11 of the submission. BMD = bone mineral density; SC = subcutaneousPSD · Jul 2025
6.37 The submission described abaloparatide as non-inferior in terms of efficacy compared to romosozumab.PSD · Jul 2025
6.4 The HCPs commented that abaloparatide is an effective treatment for patients with severe osteoporosis as described by the following points: it is a potent anabolic agent which allows for bone formation and improvement of bone density and quality; it has demonstrated clinical trial evidence for efficacy improving bone density and strength, and reducing fracture risk; and it is easily administered as a daily injection without requirement to refrigerate.PSD · Jul 2025
6.70 The submission did not propose a risk-sharing arrangement (RSA). However, there is a RSA that covers use of romosozumab in the first- and second-line settings. Given the proposed substitution of romosozumab by abaloparatide, the evaluation noted that it may be appropriate for abaloparatide to join this RSA. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Jul 2025
Cost-effectiveness
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).
Listing was requested based on a cost-minimisation approach (CMA) to derive the proposed price of abaloparatide, such that the total cost of treatment over one complete treatment course (based on a maximum 18 months of treatment) is equivalent to a duration of treatment with romosozumab (the comparator, consisting of up to 12 months of treatment). PSD · 2025
Decision context
PopulationAdults 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | romosozumab | — | RCT · Incidence of new vertebral fractures |
Clinical evidence
Consumer voice
Healthy Bones Australia and eight healthcare professionals supported abaloparatide as a first-line treatment, emphasizing anabolic agents' role in building new bone followed by antiresorptive therapy, and noting the clinical trial evidence and absence of adverse cardiovascular events.
Healthy Bones Australia indicated its support for the application for abaloparatide as a first-line treatment in Australia. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe osteoporosis (T-score ≤-2.5), prior fracture within 24 months, treatment-naive or intolerant patients, and first-line use only.