Sevelamer CarbonateARX-Sevelamer
Management of hyperphosphataemia in patients with chronic kidney disease that require dialysis.
Decisions on record
- Meeting Jul 2022 Noted Hyperphosphataemia in dialysis patients with chronic kidney disease no PSD
- Meeting Mar 2019 Recommended Hyperphosphataemia
- Meeting Nov 2017 Recommended Hyperphosphataemia in patients with chronic kidney disease
- Meeting Nov 2006 Not recommended Management of hyperphosphatemia in adult patients with stage 4 and 5 chronic kidney disease.
Access path
- TGA registered · ARX-Sevelamer
TGA label narrower than the PBS population
- Mar 2019Recommended
vs sevelamer hydrochloride (Renagel)
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the listing of a new form of sevelamer (Sevelamer Dr Reddy’s) for the treatment of hyperphosphataemia. The PBAC’s recommendation for listing was based, among other matters, on its assessment that on a per gram basis Sevelamer Dr Reddy’s is equi-effective to Renagel.PSD · Mar 2019
6.2 The PBAC considered the claim that Sevelamer Dr Reddy’s is therapeutically equivalent (and bioequivalent) to Renagel was reasonable based on the studies presented in the submission.PSD · Mar 2019
Cost-effectiveness
This was a minor submission with no economic evaluation. The submission expected no financial implications to the PBS as sevelamer carbonate would only substitute for sevelamer hydrochloride at the same price.
Decision context
PopulationAdult patients with chronic kidney disease stage 4 and 5 undergoing dialysis with hyperphosphataemia inadequately controlled by calcium, and serum phosphate greater than 1.6 mmol per L or serum calcium times phosphate product greater than 4 at commencement of therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Recommended | sevelamer hydrochloride (Renagel) | — | Single-arm · Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to dialysis patients with inadequate control and specific phosphate/calcium thresholds; TGA label includes all stage 4-5 CKD patients.