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MOZOBIL (plérixafor)
Reason for request
- Key points
Favourable opinion for reimbursement in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:
- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilisation with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or
- who previously failed to collect sufficient haematopoietic stem cells.
- What therapeutic improvement?
Therapeutic improvement in the strategy to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours.
- Role in the care pathway?
The mobilisation of haematopoietic stem cells (HSC) is performed using granulocyte-colony stimulating growth factors (G-CSF) administered alone or following chemotherapy on exit from aplasia. HSC harvesting is performed until a minimum number of CD34+ progenitor cells to be collected is obtained. It is considered that a suitable transplant contains more than 5x106 CD34+ cells/kg.
If mobilisation failure is observed, either before cytapheresis (inadequate number of circulating stem cells < 20 CD34+ cells/µL +/- combined with factors predictive of poor mobilisation) or during collection of the graft following cytapheresis (graft ≤ 2x106 CD34+ cells/kg after mobilisation), remobilisation a period of time after the initial mobilisation using the abovementioned strategies (G-CSF) may be envisaged in certain patients. Autologous transplantation of bone marrow haematopoietic stem cells may also be proposed in some cases.
Plerixafor (MOZOBIL) in combination with G-CSF has been available for several years as a second-intention treatment to enhance mobilisation of haematopoietic stem cells for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly.
Role of the medicinal product in the care pathway:
MOZOBIL (plerixafor) is a second-intention treatment, in combination with G-CSF, to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours in the following situations:
- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilisation with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or
- who previously failed to collect sufficient haematopoietic stem cells.
Clinical Benefit
| Substantial |
The clinical benefit of MOZOBIL (plerixafor) is substantial in the paediatric indication extension in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:
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Clinical Added Value
| minor |
MOZOBIL (plerixafor) in combination with G-CSF provides a minor clinical added value (CAV IV) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:
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