Ibandronic Acid
Treatment of bone metastases from breast cancer. Oral formulation providing a more convenient dosing option compared to intravenous administration.
Decisions on record
- Meeting Nov 2008 Recommended Reduce bone pain and risk of fracture
- Meeting Mar 2008 Not recommended Bone pain in cancer patients.
- Meeting Mar 2007 Recommended Osteoporosis
Access path
- Jul 2006Not recommended
Inadequate evidence of demonstrating no difference between ibandronic acid and alendronate, doubts about acceptability…
- Jul 2006Not recommended
inadequate evidence of demonstrating no difference between ibandronic acid and alendronate, two-step indirect…
- Jul 2006Not recommended
Inadequate evidence of demonstrating no difference between ibandronic acid and alendronate, doubts about acceptability…
- Jul 2006Not recommended
Inadequate evidence of demonstrating no difference between ibandronic acid and alendronate based on two-step indirect…
- ↻ resubmittedMar 2007Recommended
Comparator changed: alendronate 70 mg once weekly → alendronate 70 mg/week once weekly
- Mar 2007Recommended · restricted
Comparator changed: alendronate 70 mg once weekly → alendronate 70 mg/week once weekly
- Mar 2008Not recommended
inadequate evidence that it is not inferior to the comparator clodronate, variability of evidence presented, errors in…
- ↻ resubmittedNov 2008Recommended · restricted
Comparator changed: oral sodium clodronate → oral clodronate
- PBS listing · Restricted
From the public summary
The PBAC considered it difficult to describe ibandronic acid as non-inferior in terms of comparative effectiveness due to the variability of the evidence presented and errors in the analysis of results.PSD · Mar 2008
For further details of PBAC’s view see Recommendation and Reasons. 10. Economic Analysis The submission presented a cost minimisation analysis. The equi-effective doses in terms of cost-minimisation were claimed by the submission to be ibandronic acid 50 mg daily and clodronate 1600 mg daily, both for long-term administration. These are the TGA approved doses for bone metastases from breast cancer. 11.PSD · Mar 2008
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
The submission presented a cost minimisation analysis. PSD · 2008
Decision context
PopulationPatients with bone metastases from breast cancer, eligible for oral bisphosphonate therapy
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2008 | Recommended · restricted | oral clodronate | — | RCT · Surrogate |
| Mar 2008 | Not recommended | oral sodium clodronate | — | RCT · Skeletal-related events |
| Mar 2007 | Recommended | alendronate 70 mg/week once weekly | — | RCT · null |
| Mar 2007 | Recommended · restricted | alendronate 70 mg/week once weekly | — | Meta-analysis |
| Jul 2006 | Not recommended | alendronate 70 mg once weekly | — | RCT · new or worsening vertebral fractures; new clinical vertebral fractures |
| Jul 2006 | Not recommended | alendronate 70 mg once weekly | — | RCT |
| Jul 2006 | Not recommended | alendronate 70 mg once weekly | — | RCT |
| Jul 2006 | Not recommended | alendronate 70 mg once weekly | — | RCT |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both indicate treatment of bone metastases from breast cancer; PBAC adds administrative detail (oral formulation, eligibility criteria) but does not restrict the clinical population.