RomosozumabEvenity
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.
Decisions on record
- Meeting Mar 2024 Recommended Osteoporosis
- Meeting Mar 2023 Recommended Osteoporosis; severe established osteoporosis
- Meeting Jul 2022 Not recommended Severe osteoporosis first-line treatment
- Meeting Sep 2021 Recommended Osteoporosis no PSD
- Meeting Mar 2020 Recommended Osteoporosis
- Meeting Jul 2019 Not recommended The treatment of osteoporosis in
- Meeting Nov 2018 Not recommended Osteoporosis
Access path
- TGA registered · Evenity
TGA label narrower than the PBS population
- Nov 2018Not recommended
vs teriparatide (later-line population); alendronate…
- Jul 2019Not recommended
Comparator changed: teriparatide (later-line population); alendronate (additional…
- ↻ resubmittedMar 2020Recommended · restricted
Comparator changed: teriparatide → teriparatide (cost-minimisation); alendronate…
- Jul 2022Not recommended
Comparator changed: teriparatide (cost-minimisation); alendronate (cost-effectiveness…
- ↻ resubmittedMar 2023Recommended · restricted
- Mar 2024Recommended · restricted
ICER dropped $55,000 → $45,000 (-18%)
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Authority Required (Telephone/electronic) listing of romosozumab for the treatment of severe osteoporosis in the first-line setting. The PBAC considered that romosozumab provides, for some patients, a significant improvement in efficacy over alendronate.PSD · Mar 2024
The PBAC reiterated its July 2022 advice that there is likely a clinical need for earlier use of romosozumab in patients at very high risk of fracture (para 7.2, romosozumab Public Summary Document (PSD), July 2022 PBAC meeting) and noted the consumer comments outlining the benefits of romosozumab as a first-line treatment, rather than after anti-resorptive therapy.PSD · Mar 2024
The submission presented a cost-utility analysis of romosozumab versus alendronate in patients with severe osteoporosis. Compared with the inputs that the PBAC advised would be reasonable in its March 2023 consideration, the submission proposed changes to two parameters: baseline fracture risk; and the proportion of patients in the alendronate arm who are assumed to use romosozumab in the second-line setting. Baseline fracture risk:PSD · Mar 2024
In the previous economic model (March 2023), the baseline fracture risk (annual risk of a clinical fracture) was 5.02% per year, based on the alendronate arm of the ARCH trial. The submission claimed that the PBS restriction defines a population with a higher average fracture risk than the ARCH trial population, as outlined in Table 3.PSD · Mar 2024
At its March 2023 meeting, the PBAC noted that the comparative effectiveness evidence presented was unchanged from the July 2022 resubmission. Hence, the resubmission was based on a direct comparison of romosozumab versus alendronate in the ARCH trial which was conducted in patients predominantly naïve to anti- 7PSD · Mar 2024
The PBAC reiterated its March 2023 advice that the claim of superior comparative effectiveness was reasonable in the first-line setting, however the magnitude of effect was uncertain due to poor transition to and persistence with anti-resorptive therapy post romosozumab.PSD · Mar 2024
The PBAC noted and welcomed the input from an individual, a health care professional and from an organisation via the Consumer Comments facility on the PBS website. The comments emphasised the efficacy of romosozumab in the first-line setting in terms of improving outcomes and preventing fractures.PSD · Mar 2024
The PBAC noted the advice received from Healthy Bones Australia which outlined the need for treatment options with both an anabolic and anti-resorptive effect, the efficacy in terms of fracture reduction and the advantages of romosozumab in terms of being administered monthly for 12 months (while teriparatide requires a daily injection over 18 months).PSD · Mar 2024
Cost-effectiveness
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.
The revised incremental cost per QALY gained is $45,000 to < $55,000. PSD · 2023
Decision context
PopulationPatients 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.
Risk sharingRisk Sharing Arrangement with percentage rebate for expenditure above specified caps.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | alendronate | $35k–45k | RCT · Fracture prevention |
| Mar 2023 | Recommended · restricted | alendronate | $45k–55k | RCT · Fracture prevention |
| Jul 2022 | Not recommended | alendronate | — | RCT · Prevention of osteoporosis-related fractures |
| Mar 2020 | Recommended · restricted | teriparatide (cost-minimisation); alendronate (cost-effectiveness analysis) | — | RCT · Fracture prevention |
| Jul 2019 | Not recommended | teriparatide | — | RCT · Surrogate |
| Nov 2018 | Not recommended | teriparatide (later-line population); alendronate (additional population) | — | RCT · Fracture prevention; bone mineral density |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ARCH | Ph 3 | 4,093 | Percentage of Participants With New Vertebral Fractures Through Month 24 | completed |
| STRUCTURE | Ph 3 | 436 | Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) | completed |
| FRAME | Ph 3 | 7,180 | Percentage of Participants With New Vertebral Fracture Through Month 12 | completed |
| BRIDGE | Ph 3 | 245 | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12 | completed |
Consumer voice
Consumer input emphasized romosozumab's efficacy in preventing fractures and addressing unmet need in first-line treatment, with benefits including reduced fractures leading to greater independence and less reliance on family carers. Healthy Bones Australia highlighted the advantages of monthly administration over daily injections and noted that prescribers are aware of cardiovascular contraindica
The comments emphasised the efficacy of romosozumab in the first-line setting in terms of improving outcomes and preventing fractures. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe osteoporosis (BMD T-score ≤-2.5) with recent fractures, first-line only, versus broader TGA label.