Sevelamer HydrochlorideRenagel
Treatment of hyperphosphataemia in adult patients with chronic kidney disease on dialysis whose serum phosphate is not controlled on other products.
Decisions on record
- Meeting Jul 2010 Recommended Binds phosphate in patients with end stage kidney disease no PSD
- Meeting Jul 2009 Not recommended Hyperphosphataemia no PSD
- Meeting Jul 2008 Recommended Chronic kidney disease no PSD
- Meeting Mar 2008 Recommended Chronic kidney disease no PSD
- Meeting Nov 2007 Recommended Kidney disease no PSD
- Meeting Jul 2007 Recommended Hyperphosphataemia
Access path
- TGA registered · Renagel
TGA label narrower than the PBS population
- Mar 2006Recommended
Comparator changed: calcium-based phosphate binders → calcium-based phosphate binders…
- Mar 2006Recommended
Comparator changed: calcium-based phosphate binders → calcium-based phosphate binders…
- Nov 2006Not recommended
uncertain clinical benefit (mortality results relied on pre-specified subgroup analysis with non-significant primary…
- Nov 2006Not recommended
uncertain clinical benefit due to doubts about validity of mortality results in DCOR (reliance on pre-specified…
- ↻ resubmittedJul 2007Recommended · restricted
- Jul 2007Recommended · restricted
- PBS listing · Authority Required
Cost-effectiveness
The estimated incremental cost-effectiveness ratios per life year gained are in the range $15,000 – $45,000 based on the DCOR trial 65 and older population and RIND trials. PBAC · 2007
Decision context
PopulationAdults with chronic kidney disease on dialysis whose serum phosphate is not controlled on other products, with serum phosphate >1.6 mmol/L or serum calcium times phosphate product >4.0.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2007 | Recommended · restricted | calcium carbonate | $15k–45k | RCT |
| Jul 2007 | Recommended · restricted | calcium carbonate | $15k–45k | RCT |
| Nov 2006 | Not recommended | calcium carbonate | $15k–75k | RCT | Other · Other |
| Nov 2006 | Not recommended | calcium carbonate | $15k–45k | RCT · CAC |
| Mar 2006 | Recommended | calcium-based phosphate binders | $45k–105k | RCT |
| Mar 2006 | Recommended | calcium-based phosphate binders (calcium carbonate and calcium citrate) | $45k–105k | RCT · OS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to dialysis patients with uncontrolled phosphate despite other products; TGA label includes all stage 4–5 CKD patients.