Lanthanum Carbonate
Recommended Renal disease
Treatment of hyperphosphataemia in adult patients with chronic renal failure on dialysis whose serum calcium levels are at least 2.60 mmol/L.
1
Submissions
2007–07
On the record
$45k–75k
ICER range
1 sourced ICER · 2007
ICER stated
Cost basis
Decisions on record
- Meeting Nov 2008 Recommended Phosphate-binder
- Meeting Mar 2007 Not recommended Management of phosphate levels in renal disease
Cost-effectiveness
ICER uncertainICER / price too high
Decision context
Populationadult patients with chronic renal failure on dialysis whose serum calcium levels are at least 2.60 mmol/L
Why it was knocked back
- High and uncertain cost-effectiveness ratio, lack of data conclusively linking treatment effects to patient-relevant outcomes such as reduction in mortality, unproven equi-efficacy with calcium carbonate in reducing phosphate levels, trial population not representative of PBS target population, uncertainty about clinical significance of hypercalcaemic events, flawed trial design
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2007 | Not recommended | calcium carbonate | $45k–75k | RCT, Registry · PO controlled patients (PO ≤ 1.80mmol/L) |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| LAM-IV-301 | Ph 3 | 93 | Treatment emergent adverse events | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with serum calcium ≥2.60 mmol/L; TGA label has no calcium threshold.