Zoledronic AcidACLASTA
Adjuvant management of breast cancer in post-menopausal women. Treatment duration of up to 3 years at a dose of 4 mg IV every six months.
Decisions on record
- Meeting Sep 2023 Noted Adjuvant management of breast cancer in post-menopausal women no PSD
- Meeting Jul 2023 Recommended Adjuvant treatment of breast cancer
- Meeting Jul 2018 Recommended Multiple myeloma
- Meeting Nov 2012 Recommended Osteoporosis
- Meeting Jul 2012 Recommended Bone metastases from prostate cancer or breast cancer, multiple myeloma, hypercalcaemia of malignancy no PSD
- Meeting Jul 2011 Recommended Osteoporosis no PSD
- Meeting Nov 2009 Recommended Bone conditions eg osteoporosis and Paget disease of bone.
- Meeting Nov 2009 Recommended Bone conditions eg osteoporosis and Paget disease of bone.
6 earlier decisions
- Nov 2009 Recommended Bone conditions eg osteoporosis and Paget disease of bone.
- Nov 2008 Recommended Reduces risk of fracture in patients with osteoporosis
- Jul 2008 Recommended Osteoporosis
- Sep 2002 Recommended Normalises bone re-modelling no PSD
- Sep 2002 Recommended Normalises bone re-modelling no PSD
- Dec 2001 Recommended Bisphosphonate used to treat hypercalcaemia. no PSD
Access path
- TGA registered · ACLASTA
- Jul 2008Recommended · restricted
vs alendronate sodium
- Nov 2008Recommended · restricted
Comparator changed: alendronate sodium → alendronate
- Nov 2009Recommended · restricted
Comparator changed: alendronate → risedronate
- Nov 2009Recommended · restricted
Comparator changed: alendronate → risedronate
- Nov 2009Recommended · restricted
Comparator changed: alendronate → risedronate
- Nov 2012Recommended · restricted
Comparator changed: disodium pamidronate → alendronate
- Nov 2012Recommended · restricted
Comparator changed: disodium pamidronate → alendronate
- Jul 2018Recommended · restricted
Evidence: RCT → Cost-minimisation
- Jul 2023Recommended · restricted
Evidence: Cost-minimisation → Meta-analysis
- PBS listing · Authority Required
From the public summary
6.1 The PBAC deferred making a recommendation to amend the circumstances under which zoledronic acid, injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL, is available on the PBS to include the adjuvant management of breast cancer in post-menopausal women as the TGA Delegate’s Overview was not available at the time of PBAC consideration.PSD · Jul 2023
6.2 The PBAC noted the financial estimates presented were intended to provide an upper estimate of the potential financial impact. Outcome: Deferred 11PSD · Jul 2023
5.19 An economic analysis, that adjusted the NICE analysis to the Australian context, was conducted. There have been no major new studies published since the 2018 NICE analysis that would materially change the efficacy and safety inputs into the economic analysis.PSD · Jul 2023
7 O'Carrigan B, Wong MH, Willson ML, Stockler MR, Pavlakis N, Goodwin A. Bisphosphonates and other bone agents for breast cancer. Cochrane database of systematic reviews. 2017(10) 8PSD · Jul 2023
Cost-effectiveness
ICER range calculated from NICE QALYs applied to Australian drug costs. Node-positive group: $690/QALY; all-comers: $5444/QALY; post-menopausal: $2722/QALY. Actual ICER for restricted post-menopausal population likely lower due to excluded fracture reductions and cost offsets.
The temporary listing will likely result in net saving to the Government, as the sponsor proposed an AEMP of $'''''''''''''' for a pack of five vials, which is a lower price than the currently listed zoledronic acid (AEMP $173.89 for a pack of 1). PSD · 2018
Decision context
PopulationPost-menopausal women with early breast cancer (adjuvant setting). The population includes all-comers, node-positive, and specifically post-menopausal subgroups. Treatment duration up to 3 years.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Recommended · restricted | no treatment | $1k–5k | Meta-analysis · OS |
| Jul 2018 | Recommended · restricted | — | — | Cost-minimisation |
| Nov 2012 | Recommended · restricted | alendronate | — | RCT · Other (fracture outcomes) |
| Nov 2012 | Recommended · restricted | alendronate | — | RCT · morphometric vertebral fractures |
| Nov 2009 | Recommended · restricted | risedronate | — | RCT · BMD |
| Nov 2009 | Recommended · restricted | alendronate sodium | — | RCT · BMD |
| Nov 2009 | Recommended · restricted | disodium pamidronate | — | RCT · SAP |
| Nov 2008 | Recommended · restricted | alendronate | — | RCT · Fracture incidence |
| Jul 2008 | Recommended · restricted | alendronate sodium | — | RCT, Indirect comparison · Clinical fractures, vertebral fractures, non-vertebral fractures, hip fractures |