Hydroxyethyl Starch 130/0.4Voluven 6%
Recommended · restricted OtherUnrestrictedNot applicable line
Plasma volume expander for the treatment and prophylaxis of hypovolaemia, as an alternative to succinylated gelatin (Gelofusine)
1
Submissions
2009–09
On the record
—
ICER range
Cost-min
Cost basis
Access path
- TGA registered · Voluven 6%
TGA label narrower than the PBS population
- Jul 2009Recommended · restricted
vs succinylated gelatin (Gelofusine) I.V. infusion
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost minimisation analysis performed; no ICER calculated
The PBAC considered the evidence indicated that the safety profile of HES is different to succinylated gelatin however, overall non-inferior to succinylated gelatin. PBAC · 2009
Decision context
Populationpatients undergoing cardiac (three trials), abdominal (three trials), major orthopaedic (one trial) or paediatric (one trial) surgery
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2009 | Recommended · restricted | succinylated gelatin (Gelofusine) I.V. infusion | — | RCT · Surrogate | Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to specific surgical populations (cardiac, abdominal, orthopaedic, paediatric) as alternative to succinylated gelatin; TGA label covers all hypovolaemia indications.