PlerixaforMozobil
In combination with G-CSF, for mobilisation of haematopoietic stem cells in patients with multiple myeloma or lymphoma requiring autologous stem cell transplantation, specifically in failed mobilisers or those undergoing rescue of failing mobilisation.
Decisions on record
- Meeting Nov 2013 Recommended 24 mg/2 mL, injection, vial Mozobil® Sanofi-Aventis Australia Pty Ltd Major submission Multiple myeloma or lymphoma Resubmission for a Section 100 (Highly Specialised Drugs Program) Authority Required (+/-STREAMLINED) listing for use in combination with G-CSF, patients with multiple myeloma or lymph
- Meeting Jul 2012 Not recommended Use in combination with granulocyte-colony stimulating factor (GCSF) to mobilise haematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma.
- Meeting Nov 2011 Not recommended Use in combination with G-CSF to mobilise haematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma.
- Meeting Nov 2010 Not recommended Anti-cancer drug
Access path
- TGA registered · Mozobil
TGA label narrower than the PBS population
- Nov 2010Not recommended
vs G-CSF in combination with chemotherapy (ifosfamide plus…
- Nov 2011Not recommended
clinical management algorithm did not adequately represent current Australian clinical practice, minimal data presented…
- Nov 2011Not recommended
Clinical management algorithm did not adequately represent current Australian clinical practice, minimal data on…
- Jul 2012Not recommended
Uncertain clinical benefit relating to lack of comparative data, uncertainty regarding the economic model…
- ↻ resubmittedJul 2012Noted
Comparator changed: G-CSF in combination with chemotherapy (ifosfamide + carboplatin +…
- Nov 2013Recommended · restricted
Comparator changed: granulocyte-colony stimulating factor (G-CSF) in combination with…
- PBS listing · Authority Required
From the public summary
11. Estimated PBS Usage and Financial Implications The financial costs per year to the PBS (inclusive of patient co-payments) for the requested listings were all estimated in the submission to be less than $10 million.PSD · Nov 2010
The PBAC considered the submission’s estimates uncertain. 12. Recommendation and Reasons The PBAC noted that the submission nominated G-CSF alone as the comparator in treating patients with NHL and MM, who have not failed previous stem cell collections or collection attempts.PSD · Nov 2010
Cost-effectiveness
The PBAC considered there to be a considerable risk of leakage beyond the proposed PBS population into a lower risk population where cost-effectiveness of plerixafor has not been established. PBAC · 2013
Decision context
PopulationAdult patients with multiple myeloma or lymphoma who require autologous stem cell transplantation and are either failed mobilisers (stem cell yield <2.0 × 10⁶ CD34+ cells/kg at previous attempt) or undergoing rescue of failing mobilisation (peripheral CD34+ cell count ≤10 cells/µL or Day 1 yield <1.0 × 10⁶ CD34+ cells/kg).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2013 | Recommended · restricted | G-CSF in combination with chemotherapy (ifosfamide + carboplatin + etoposide for lymphoma; cyclophosphamide for multiple | $15k–200k | Single-arm · Surrogate |
| Jul 2012 | Not recommended | Granulocyte-colony stimulating factor (G-CSF) 10µg/kg in combination with chemotherapy (ifosfamide + carboplatin + etopo | — | RCT, Single-arm, Registry · OS | PFS | DFS | ORR | QoL | Surrogate |
| Jul 2012 | Noted | granulocyte-colony stimulating factor (G-CSF) in combination with chemotherapy | — | Single-arm |
| Nov 2011 | Not recommended | G-CSF in combination with chemotherapy (ifosfamide + carboplatin + etoposide for lymphoma; cyclophosphamide for multiple | $15k–75k | Other |
| Nov 2011 | Not recommended | G-CSF in combination with chemotherapy (ifosfamide + carboplatin + etoposide for lymphoma; cyclophosphamide for multiple | $15k–75k | Registry |
| Nov 2010 | Not recommended | G-CSF in combination with chemotherapy (ifosfamide plus carboplatin plus etoposide for NHL; cyclophosphamide for MM) | — | RCT | Single-arm · OS | PFS | DFS | ORR | QoL | Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| comparative trial of AMD3100 (240 μg/kg) plus G-CSF (10 μg/kg) versus G-CSF (10 μg/kg) plus placebo to mobilise and collect ≥5 x 106 CD34+ cells/kg in non-Hodgkin’s lymphoma patients for autologous transplantation – final 12-month clinical study report. Micallef I | Ph 2 | 22 | Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Pl… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to failed mobilisers or rescue of failing mobilisation; TGA label includes all patients requiring mobilisation without these criteria.