Ferric CarboxymaltoseFerric Carboxymaltose-Teva
Recommended OtherUnrestrictedNot applicable line
Treatment of iron deficiency anaemia (IDA).
3
Submissions
2 resub
2013–18
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2018 Recommended Iron deficiency anaemia
- Meeting Nov 2013 Recommended 500 mg/10 mL, injection, vial Ferinject® Vifor Pharma Pty Ltd Major submission Iron deficiency anaemia Resubmission to request PBS listing as an Unrestricted Benefit for the treatment of iron deficiency anaemia. s calculated cost saving in treatment costs.
Access path
- TGA registered · Ferric Carboxymaltose-Teva
TGA label equal than the PBS population
- Mar 2013Recommended
vs iron polymaltose
- Nov 2013Recommended
Comparator changed: iron polymaltose → intravenous iron polymaltose
- Nov 2018Recommended
Evidence: Single-arm → Cost-minimisation
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the listing of ferric carboxymaltose 1,000mg/20 mL in addition to the existing 500 mg/10 mL presentation, on the General Schedule as an unrestricted benefit for the treatment of iron deficiency anaemia (IDA).PSD · Nov 2018
5.2 The PBAC noted that the sponsor had proposed an equivalent price per milligram for the 1,000 mg/20 mL vial relative to the 500 mg/10 mL vial, and that the new presentation would provide a substitute for prescribing 2 x 500 mg/10 mL vials. The PBAC noted that there was expected to be no financial impact associated with the new listing. Outcome: RecommendedPSD · Nov 2018
Cost-effectiveness
This is a minor submission for an additional strength presentation; no economic evaluation conducted.
The PBAC noted that the sponsor had proposed an equivalent price per milligram for the 1,000 mg/20 mL vial relative to the 500 mg/10 mL vial, and that the new presentation would provide a substitute for prescribing 2 x 500 mg/10 mL vials. PBAC · 2018
Economic model disputedCost-effectiveness accepted
Decision context
PopulationPatients requiring intravenous iron treatment for iron deficiency anaemia, particularly those who would typically receive a 1,000 mg dose.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2018 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2013 | Recommended | intravenous iron polymaltose | — | Single-arm · Other |
| Mar 2013 | Recommended | iron polymaltose | — | RCT · Haemoglobin level change and response rates |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both describe IV iron treatment for iron deficiency anaemia; PBAC specifies typical 1,000 mg dosing without excluding any patient subgroup.