Sucroferric OxyhydroxideVELPHORO
Recommended EndocrinologyRestrictedNot applicable line 💬 consumer voice
Treatment of hyperphosphataemia in patients undergoing dialysis for chronic kidney disease.
2
Submissions
1 resub
2014–15
On the record
—
ICER range
Not modelled
Cost basis
Decisions on record
- Meeting Jul 2015 Recommended Hyperphosphataemia
- Meeting Nov 2014 Recommended Iron (as sucroferric oxyhydroxide) 500 mg tablet: chewable, 90; Velphoro® Vifor Pharma Pty Ltd. New listing (Major submission) Hyperphosphataemia General schedule listing (maintenance therapy) and Section 100 Authority Required (initiation of therapy) listing for the management of hyperphosphataemia
Access path
- TGA registered · VELPHORO
TGA label narrower than the PBS population
- Nov 2014Recommended · restricted
vs sevelamer hydrochloride
- Jul 2015Noted
Listing: Authority Required → Restricted
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of sucroferric oxyhydroxide under Section 100 and Section 85 for the treatment of hyperphosphataemia in patients with chronic kidney disease undergoing dialysis. The recommendation was made on a cost minimisation basis with sevelamer.PSD · Nov 2014
7.2 The PBAC recommended that the restriction should be modelled on that currently applying to the main comparator sevelamer. The PBAC also agreed with the ESC that the restriction should specify that sucroferric oxyhydroxide should not be used in combination with sevelamer or lanthanum, but requested this be extended further to include any other phosphate binder. This restriction should also apply to sevelamer and lanthanum.PSD · Nov 2014
Economic analysis
6.32 The equi-effective doses were estimated as: 1.8mg of sucroferric oxyhydroxide is equivalent to 7mg sevelamer hydrochloride based on the maintenance phase (Week 12 to Week 24) of the PA-CL-05A trial and the assumption that sevelamer carbonate is equivalent to sevelamer hydrochloride.PSD · Nov 2014
6.33 The estimated equi-effective doses in the clinical trials may not be applicable to clinical practice due to differences between the trial population (stabilised on phosphate binders) and the requested PBS population (uncontrolled by calcium- based phosphate binders); and the lower sucroferric oxyhydroxide starting dose (1000mg) compared to the draft Product Information document (1500mg).PSD · Nov 2014
Clinical claim
6.30 The submission describes sucroferric oxyhydroxide as non-inferior in terms of efficacy and safety compared to sevelamer hydrochloride. This claim may not be reasonable: The results of the pivotal trial PA-CL-05A/PA-CL-05B may not be generalisable to the requested PBS population, given the differences in patient populations (patients stabilised on phosphate binders versus patients uncontrolled on calcium- based phosphate binders), comparator …PSD · Nov 2014
However, the formulation of sevelamer available in Australia (sevelamer hydrochloride) may have a poorer gastrointestinal tolerability profile compared to sevelamer carbonate.PSD · Nov 2014
Consumer comments
6.2 The PBAC noted and welcomed the input from one health care professional via the Consumer Comments facility on the PBS website. The comment described a range of benefits of treatment with sucroferric oxyhydroxide including reduced pill burden, increased compliance and reduced need for intravenous iron supplementation.PSD · Nov 2014
Cost-effectiveness
Not applicable; this is a minor submission regarding restriction clarification, not a full economic evaluation.
The submission was based on one sucroferric oxyhydroxide dose ranging study with a comparative sevelamer hydrochloride arm (PA-CL-03A) and one Phase 3 clinical trial with extension (PA-CL-05A/PA-CL-05B) comparing sucroferric oxyhydroxide to sevelamer carbonate. PSD · 2014
Decision context
PopulationPatients with hyperphosphataemia undergoing dialysis for chronic kidney disease, with serum phosphate >1.6 mmol/L or calcium-phosphate product >4, where condition is not adequately controlled by calcium alone.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Noted | — | — | — |
| Nov 2014 | Recommended · restricted | sevelamer hydrochloride | — | RCT · Surrogate |
Consumer voice
One health care professional provided input highlighting benefits of sucroferric oxyhydroxide treatment, including reduced pill burden, improved compliance, and decreased need for intravenous iron supplementation.
The comment described a range of benefits of treatment with sucroferric oxyhydroxide including reduced pill burden, increased compliance and reduced need for intravenous iron supplementation. Consumer comments · PSD
treatment burdencompliancereduced medication load
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to dialysis patients with uncontrolled hyperphosphataemia despite calcium-based binders; TGA label covers all ESRD phosphorus control.