Ferric DerisomaltoseMonofer
Treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used, or where there is a clinical need to deliver iron rapidly.
Decisions on record
- Meeting Aug 2019 Recommended Iron deficiency anaemia no PSD
- Meeting Jul 2019 Deferred Iron deficiency anaemia
- Meeting Jul 2018 Recommended Iron deficiency anaemia (IDA)
Access path
- TGA registered · Monofer
TGA label equal than the PBS population
- Jul 2018Recommended
vs ferric carboxymaltose
- Jul 2019Recommended
Evidence: RCT → Cost-minimisation
- Jul 2019Deferred
Evidence: RCT → Cost-minimisation
From the public summary
5.1 The PBAC deferred making a recommendation on the unrestricted Section 85 listing for ferric derisomaltose 1000 mg/10 mL and the change to maximum quantity and repeats for ferric derisomaltose 500 mg/10 mL.PSD · Jul 2019
5.2 The PBAC maintained its view that the clinical place for ferric derisomaltose would remain as an alternative IV iron formulation for the treatment of iron deficiency anaemia when treatment with oral iron is ineffective or not tolerated (paragraph 7.2, ferric derisomaltose PSD, July 2018).PSD · Jul 2019
4.4 As a minor submission, no economic comparison was presented in the submission.PSD · Jul 2019
Ferric derisomaltose vs ferric carboxymaltose (indirect comparison)PSD · Jul 2018
6.27 The submission described ferric derisomaltose as non-inferior in terms of efficacy compared with ferric carboxymaltose and non-inferior in terms of safety compared to ferric carboxymaltose for the treatment of iron deficiency anaemia.PSD · Jul 2018
6.46 The submission acknowledged that the main comparator, ferric carboxymaltose, is subject to an SPA and was willing to adopt an equivalent SPA to ensure the cost- minimisation framework was maintained.PSD · Jul 2018
6.47 The submission and the PSCR also acknowledged that a risk sharing arrangement (RSA) in the form of subsidisation caps is in place for ferric carboxymaltose. The PBAC considered it appropriate for ferric derisomaltose to be included in the same RSA. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Jul 2018
Cost-effectiveness
Minor submission; cost-minimisation basis with no ICER calculated.
The PBAC accepted an equivalent price per milligram for the 1000 mg/10 mL vial relative to the 500 mg/5 mL vial, which was consistent with the July 2018 consideration of ferric derisomaltose where ferric derisomaltose was recommended to have the same overall cost of treatment as ferric carboxymaltose. PBAC · 2019
Decision context
PopulationAdults with iron deficiency requiring intravenous iron when oral iron is ineffective or cannot be used, or where rapid iron delivery is clinically needed.
Risk sharingRisk Sharing Arrangement (RSA) for iron deficiency anaemia; renegotiation of Deed of Agreement pending. New RSA to be implemented based on forward estimates projections and similar derivation of RSA Caps as original arrangement.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2019 | Recommended | ferric carboxymaltose | — | Cost-minimisation · Cost-minimisation |
| Jul 2019 | Deferred | ferric carboxymaltose | — | Cost-minimisation |
| Jul 2018 | Recommended | ferric carboxymaltose | — | RCT · ORR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| REPAIR-IDA | Ph 4 | 120 | Impact of iron deficiency anemia on regional cerebrovascular oxygen delivery (ml O2/100g/m… | recruiting |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify identical conditions: oral iron ineffective/cannot be used, or clinical need for rapid delivery in adults.