FilgrastimNivestim
Chemotherapy-induced neutropenia, mobilisation of peripheral blood progenitor cells, bone marrow transplantation, autologous peripheral blood progenitor cell transplantation, severe congenital neutropenia, severe chronic neutropenia, and chronic cyclical neutropenia.
Decisions on record
- Meeting Apr 2018 Recommended Chemotherapy- induced neutropenia; Mobilisation of peripheral blood progenitor cells; Assisting bone marrow transplantation; Assisting autologous peripheral blood progenitor cell transplantation; Severe congenital neutropenia; Severe chronic neutropenia; Chronic cyclical neutropenia no PSD
- Meeting Mar 2018 Deferred Chemotherapy-induced neutropenia; Mobilisation of peripheral blood progenitor cells; Assisting bone marrow transplantation; Assisting autologous peripheral blood progenitor cell transplantation; Severe congenital neutropenia; Severe chronic neutropenia; Chronic cyclical neutropenia
- Meeting Nov 2011 Recommended Bone marrow cell stimulator no PSD
- Meeting Nov 2010 Recommended Prevention of neutropenia
- Meeting Mar 2009 Recommended Immunostimulant no PSD
- Meeting Nov 2008 Recommended Immunostimulant
- Meeting Mar 2008 Recommended Prevention of neutropenia
- Meeting Nov 2007 Recommended Neutropenia no PSD
Access path
- TGA registered · Nivestim
TGA label equal than the PBS population
- Nov 2010Recommended · restricted
vs Neupogen (filgrastim)
- Mar 2018Recommended
Listing: Restricted → Authority Required
- PBS listing · Authority Required
From the public summary
6.1 The PBAC deferred making a recommendation on this submission due to seeking further information regarding whether the four filgrastim brands currently PBS listed could be marked as equivalent in the Schedule of Pharmaceutical Benefits (‘a’ flagged), for the purposes of substitution by the pharmacist at the point of dispensing for all circumstances filgrastim is listed for.PSD · Mar 2018
6.2 The PBAC, in principle, considered that filgrastim is suitable for the application of biosimilar uptake drivers for all biosimilar brands, as outlined in strategic agreements with relevant organisations. However, the PBAC decided to defer making a recommendation regarding application of the biosimilar uptake drivers at this time. ***** Committee in Confidence*****PSD · Mar 2018
Cost-effectiveness
Not applicable — this is a minor submission for restriction level amendment and brand equivalence determination; no economic evaluation conducted.
The PBAC noted that the evidence in nearly all studies presented concluded similar efficacy and safety with the reference biologic. PBAC · 2018
Decision context
PopulationPatients requiring filgrastim for chemotherapy-induced neutropenia, mobilisation of peripheral blood progenitor cells, bone marrow transplantation, autologous peripheral blood progenitor cell transplantation, severe congenital neutropenia, severe chronic neutropenia, and chronic cyclical neutropenia.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Recommended | — | — | Registry · Surrogate |
| Nov 2010 | Recommended · restricted | Neupogen (filgrastim) | — | — |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both texts list identical indications with no meaningful population restrictions or clinical criteria differentiating them.