BACKGROUND: International phase III studies (CHIB 201 and 352) showed that basiliximab, a high affinity chimeric monoclonal antibody interleukin-2 receptor antagonist, is highly effective in preventing acute rejection when used as immunoprophylaxis in patients receiving cyclosporin (Neoral). We conducted a cost evaluation by applying international clinical results to standard Japanese medical practice. OBJECTIVE: To evaluate the impact of basiliximab in renal transplant patients receiving conventional immunosuppressive therapy using cyclosporin and corticosteroids from the perspective of the healthcare payer in Japan. STUDY DESIGN: A decision tree model was developed, comprising seven pathways with key clinical events identified after the transplantation. The average first-year treatment costs after transplantation for patients treated with and without basiliximab were calculated using the model. A sensitivity analysis was done to measure the degree of influence of several criteria including the incidences of rejection, and rejection responding to steroid pulse therapy and antibody therapy. METHODS: Estimates of key clinical events were derived from the international studies. Calculation of direct medical costs were made from the payers' perspective, based on the Social Insurance Medical Fee Table in Japan. The cost of basiliximab was assumed as zero. MAIN OUTCOME MEASURES AND RESULTS:Basiliximab use produced an estimated saving of 315,807 yen (2000 values) during the first year after transplantation. Reduced acute rejection treatment and dialysis most influenced the cost saving. The sensitivity analysis showed that the average cost for a patient was lower in the basiliximab group and that the model was effective within the plausible range of each criterion that would reflect renal transplantation in Japan. CONCLUSIONS: If the cost of basiliximab is less than 315,807 yen, the clinical and economic benefits of basiliximab in the first year after transplantation support the routine use of basiliximab in renal transplantation in Japan.
RCT Entities:
BACKGROUND: International phase III studies (CHIB 201 and 352) showed that basiliximab, a high affinity chimeric monoclonal antibody interleukin-2 receptor antagonist, is highly effective in preventing acute rejection when used as immunoprophylaxis in patients receiving cyclosporin (Neoral). We conducted a cost evaluation by applying international clinical results to standard Japanese medical practice. OBJECTIVE: To evaluate the impact of basiliximab in renal transplant patients receiving conventional immunosuppressive therapy using cyclosporin and corticosteroids from the perspective of the healthcare payer in Japan. STUDY DESIGN: A decision tree model was developed, comprising seven pathways with key clinical events identified after the transplantation. The average first-year treatment costs after transplantation for patients treated with and without basiliximab were calculated using the model. A sensitivity analysis was done to measure the degree of influence of several criteria including the incidences of rejection, and rejection responding to steroid pulse therapy and antibody therapy. METHODS: Estimates of key clinical events were derived from the international studies. Calculation of direct medical costs were made from the payers' perspective, based on the Social Insurance Medical Fee Table in Japan. The cost of basiliximab was assumed as zero. MAIN OUTCOME MEASURES AND RESULTS:Basiliximab use produced an estimated saving of 315,807 yen (2000 values) during the first year after transplantation. Reduced acute rejection treatment and dialysis most influenced the cost saving. The sensitivity analysis showed that the average cost for a patient was lower in the basiliximab group and that the model was effective within the plausible range of each criterion that would reflect renal transplantation in Japan. CONCLUSIONS: If the cost of basiliximab is less than 315,807 yen, the clinical and economic benefits of basiliximab in the first year after transplantation support the routine use of basiliximab in renal transplantation in Japan.
Authors: J M Kovarik; E Rawlings; P Sweny; O Fernando; R Moore; P J Griffin; P Fauchald; D Albrechtsen; G Sodal; K Nordal; P L Amlot Journal: Transpl Int Date: 1996 Impact factor: 3.782
Authors: P S Almond; A Matas; K Gillingham; D L Dunn; W D Payne; P Gores; R Gruessner; J S Najarian Journal: Transplantation Date: 1993-04 Impact factor: 4.939
Authors: K R Brinker; R M Dickerman; T A Gonwa; A R Hull; J W Langley; D L Long; D A Nesser; G Trevino; R L Velez; P J Vergne-Marini Journal: Transplantation Date: 1990-07 Impact factor: 4.939