Lanthanum Carbonate HydrateFosrenol Chewable Tablets
Management of hyperphosphataemia in patients with chronic kidney disease on dialysis whose serum phosphate is not controlled on other products and where serum phosphate is greater than 1.6 mmol per L or the serum calcium times phosphate product is greater than 4.0.
Decision on record
- Meeting Jul 2010 Recommended Binds phosphate in patients with end stage kidney disease. no PSD
Access path
- TGA registered · Fosrenol Chewable Tablets
TGA label narrower than the PBS population
- Mar 2007Not recommended
uncertain efficacy of lanthanum versus calcium carbonate in phosphate control, lack of data linking treatment effects…
- ↻ resubmittedNov 2008Recommended
Comparator changed: calcium carbonate → sevelamer hydrochloride
- PBS listing · Restricted
Cost-effectiveness
Cost-minimisation analysis presented; no ICER calculated by design
The meta-analysis on which the dose relativity is based uses trials that are widely variable clinically, which made the calculation of equi-effective doses somewhat uncertain. PBAC · 2008
Decision context
PopulationPatients with chronic kidney disease on dialysis whose serum phosphate is not controlled on other products and where serum phosphate is greater than 1.6 mmol per L or the serum calcium times phosphate product is greater than 4.0
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2008 | Recommended | sevelamer hydrochloride | — | RCT · Phosphate control |
| Mar 2007 | Not recommended | calcium carbonate | $45k–75k | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with inadequate phosphate control on other products and specific biochemical thresholds (phosphate >1.6 mmol/L or calcium-phosphate product >4.0).