595
Objectives This study reports an economic evaluation undertaken alongside a multicentre international phase III trial. The objectives of the study were to assess the within trial resource usage and hence evaluate the cost implications of using basiliximab (Simulect®, Novartis AG); to explore the differential resource use between countries and how this relates to differences in clinical results, published recently (Nashan B. Lancet, Vol 350, pp1193-1198, 1997).
Methods 380 adult recipients of a primary cadaveric kidney transplant were recruited in seven countries throughout Europe and Canada. Patients were randomly allocated, in this double-blind trial, to receive a 20mg infusion of basiliximab on the day of surgery and on day 4, to provide IL-2 receptor suppression for 4-6 weeks (n=193), or to receive placebo (n=187). Secondary outcome measures included occurrence of acute rejection and resource usage across several dimensions over the 12 months following transplantation. Local unit costs were obtained for each dimension, global trial analysis was facilitated by the use of health sector Purchasing Power Parity rates.
Results 376 patients were eligible for intention to treat analysis (basiliximab n=190; placebo n=186). No statistically significant differences were found in any of the economically important categories of resource use or in the mean cost of treatment per patient, either across the whole trial or for any country. The mean cost of treatment (PPP $US), excluding the cost of Simulect, was $48,270 for Simulect patients and $48,340 for placebo patients with a standard deviation of approximately $30,000 in both groups. Country level analysis indicated large differences between countries in resource usage and mean cost per patient. This suggests that there are very different treatment protocols and methods of working in operation within different countries. Furthermore, analysis of clinical results at country level reveals a common treatment effect but apparent difference in overall clinical effectiveness between countries.
Conclusion - This international trial identified no statististically significant results in terms of resource use and costs between basiliximab and placebo, despite the clinical differences observed. This contrasts with a similar phase III trial undertaken in the United States, where a similar clinical advantage resulted in a statistically significant difference in cost of treatment in favour of basiliximab. This result may be explained by the relative homogeneity and efficiency of the care process in the United States relative to Europe and Canada.