Introduction
Guidelines are available to help clinicians decide when transfusion of blood from a donor (known as allogenic blood transfusion) is appropriate and to help minimise the avoidable risks of transfusion.
- scope of the HTA
- clinical and cost-effectiveness questions
- issues affecting patient care
- indicative timelines for the project
- background information on the HTA process and methodology.
Scope of the HTA
The scope of the HTA is limited to the following aspect of the licensed indication for epoetinum alfa:
Epoetinum alfa can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thrombo-embolic events. Treatment should only be given to patients with moderate anaemia (Hb 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males.
Epoetinum alfa can be used to reduce exposure to allogeneic blood transfusions in adult non-iron-deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (eg Hb 10-13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1800 ml) (Summary of Product Characteristics Eprex ).
Literature searches indicated that there are small trials using epoetinum alfa in other surgery, particularly in cardiac surgery. However, the safety of such use has not been demonstrated by the manufacturer so these potential applications will not be considered further.
Expected Date of Publication
Consultation report: April 2006
Final report: September 2006
