Iron (As Sucrose)
Recommended HaematologyRestrictedSecond-line line
Iron deficiency anaemia in patients undergoing chronic haemodialysis receiving supplemental erythropoietin therapy.
1
Submissions
1 resub
2014–14
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2014 Recommended iron (as sucrose) 100 mg/5 mL injection, 5 x 5 mL ampoules, Venofer® Aspen Pharmacare Australia Pty Ltd Change to listing (Minor submission) Iron deficiency anaemia To amend the current Authority required listing to be consistent with the current restriction for iron polymaltose. no PSD
- Meeting Nov 2007 Not recommended Iron deficiency in patients on chronic haemodialysis no PSD
Access path
- Nov 2014Recommended
vs iron polymaltose
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended amending the current listing of iron sucrose to be identical to iron polymaltose, on a cost-minimisation basis with iron polymaltose. The PBAC considered that iron sucrose and iron polymaltose are equi-effective on a per mg elemental iron basis.PSD · Nov 2014
7.2 The PBAC accepted the nominated comparator of iron polymaltose.PSD · Nov 2014
Economic analysis
6.9 Although the minor submission did not present a formal economic comparison, the clinical claim was consistent with a cost-minimisation analysis and an equi-effective dose of 1:1 elemental iron content was proposed.PSD · Nov 2014
6.10 The PBAC had previously agreed that iron sucrose and iron polymaltose are equi-effective on a per mg elemental iron basis (November 2004 PBAC minutes, para 5.10.6).PSD · Nov 2014
Clinical claim
6.8 The minor submission claimed that all available intravenous iron formulations are roughly equi-effective at a ratio of 1:1 per mg basis albeit with contrasting safety profiles.PSD · Nov 2014
For more detail on PBAC’s view, see section 7 “PBAC outcome”PSD · Nov 2014
Cost-effectiveness
Cost-minimisation analysis; no numeric ICER calculated.
The PBAC considered that iron sucrose and iron polymaltose are equi-effective on a per mg elemental iron basis. PBAC · 2014
Decision context
PopulationPatients undergoing chronic haemodialysis receiving erythropoiesis stimulating agent therapy, with documented hypersensitivity reaction to iron polymaltose (restricted benefit) or any patient meeting the unrestricted benefit criteria.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2014 | Recommended | iron polymaltose | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use and adds hypersensitivity criteria absent from the TGA label.