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Economic relevance of cyclosporine microemulsion in kidney transplanted patients
Economic Relevance of Cyclosporine Microemulsion in Kidney Transplanted Patients Fl. Cogny-Van weydevelt, C. Ngohou, K. Bacquaert-Dufour, D. Touzard, N. Kerkeni, E. Maksour, P. Riberi
M
ICROEMULSION Cyclosporine (ME) formulation has been reported to be as safe as conventional Cyclosporine (CsA) in all transplanted patients. In order to analyse the economic impact of the conversion from conventional CsA to ME we performed a 6 months prospective study in 181 kidney transplanted patients.
PATIENTS AND METHODS The conversion was realized on the basis of 1:1. We collected clinical, biological, and economic data before the switch and at day 10, month 1, 3, and 6. For each patient we identified the monthly cost of the concerned formulation of CsA at different points of the study. Statistical analysis used the t test for paired series (significant value for P , .05). CsA trough levels was kept within 80 to 150 ng/mL (Monoclonal Sorin RIA). Pharmaco-economical parameters consisted on actual galenic CsA formulation costs collected for each patient (hospital dispensary prices, in 1997 FF) reported on the basis of 30 days treatment (1 month).
RESULTS
One hundred eighty-one patients have been enrolled in the study including 69 females, medium age at the time of transplantation was 42 6 13 years, 148 first, 30 second, and 3 third kidney graft. At the time of the switch the mean duration of the transplantation was 63.2 6 38.2 months. With conventional CsA, HTA occured in 80% of patients, adverse effects had been noted in 72 patients, 11 patients presented 2 or more adverse effects. Previous acute rejection episode was noted in 25.4% of patients, and 40 patients presented a chronic rejection. During the first few days of the conversion we noted 17 patients who suffered from an increase in previous adverse effects, and 34 patients presented de novo adverse effects. At the end of the study patients who had experienced conventional CsA adverse effects reported an improvement with the use of ME. All the patients who presented an adverse effect at the beginning of ME prescription had been cured with a reduction of the dose.
31 ng/mL. At day 10 of the switch, we observed a significant raise of CsA trough level (140 6 39 ng/mL 2P 5 .0001) with a significant raise of serum creatinine concentration (P 5 .04). At month 1 a significant lowering of CsA dose (251 6 71 mg/d, P 5 .0001) resulted in serum creatinine concentrations tapered back to the preswitch values. Three months after the switch the situation was stable with mean creatininemia at 150 6 54 mmol/L, CsA dose at 243 6 69 mg/d, and mean CsA trough level at 122 6 34 ng/mL. At month 6 we observed a significant decrease in serum creatinine (P 5 .006), allowed by a significant decrease in ME daily dose (P 5 .0002), while CsA trough levels were lower than those observed at any time of the study (P 5 .002 to .03). Compared with the day before conversion, the use of ME Cyclosporine lead to a reduction in CsA dosage in 56.9% of the patients at month 3, and in 62.5% of them at month 6. At the end of the study mean reduction of CsA dosage was of 11.9% of the initial value (range from 6.2% to 46%). Cost analysis
Analysis of direct costs reported to the CsA formulation showed a significantly lower cost of the medicine with the ME. Mean thirty days conventional CsA cost was 432.8 6 120 US$ (2,478FF), at month 3 mean ME cost was 392 6 111US$ (2,240FF), P 5 .0001, and at month 6 this cost was 380.3 6 110US$ (2177FF). The mean monthly cost benefit observed 6 months after the conversion was of 52US$ per patient. Thus, 6 months after the switch from conventional to ME Cyclosporin in 181 patients we observed a benefit of 91412US$ (53,837FF) per month in our center. DISCUSSION AND CONCLUSION
Conversion to ME Cyclosporine in kidney transplanted patients lead to a substantial dose reduction (about 12% in 62% of patients) as yet described in literature.1– 4 A raise in Cyclosporine trough levels and adverse effects was imposed
Pharmacological and Biological Parameters
Before conversion mean serum creatinine was 154 6 53 mmol/L, mean conventional CsA dose was 270 6 75 mg/d (4 6 1.4 mg/kg per day), mean CsA trough level was 121 6
From the Service de ne´phrologie, C.H.U., Angers, and Service de ne´phrologie, C.H. Laval, France. Address reprint requests to Dr Cogny-Van Weydevelt, Service de Ne´phrologie CHU, 49033 Angers Cedex, France.
0041-1345/98/$19.00 PII S0041-1345(98)00815-X
© 1998 by Elsevier Science Inc. 655 Avenue of the Americas, New York, NY 10010
2802
Transplantation Proceedings, 30, 2802–2803 (1998)
ECONOMIC RELEVANCE OF CYCLOSPORINE
to lower the dosage on the first month of the switch. Secondarily, patients’ clinical and biological evolution authorized to reduce, furthermore, the CsA dosage on the following months. This is observed without deleterious effect on the renal function, even if the patient presented a chronic rejection before the switch. Concerning Cyclosporine adverse effects, we observed an increase in their expression with the 1:1 conversion. But after CsA dose adaptation all the concerned patients were improved. The economic impact of the switch has been analyzed in each patient for the two drugs formulations, and we showed a mean monthly benefit of 52US$ per patient with the ME. Considering the mean kidney transplantation cost in our center5 that has been measured at 4006US$ after the first year, this difference represents a reduction of about 15% of the transplan-
2803
tation cost. Our results concerning the economic interest of ME Cyclosporin confirm the preliminary information published by Keown et al.6 REFERENCES 1. Taesh S, Niese D: Transpl Int 7(suppl 1):263, 1994 2. Svendsen U, Larsen K, Allemand H, Thayssen P, Jensen S, Petterson G: Transplant Proc 27:3477, 1995 3. Heroux AL, LeBlanc MH, Beaudoin D, et al: Transplant Pro 28:3145, 1996 4. Neumayer HH, Budde K, Fa¨rber L, et al: Clin Nephrol 45(5):326, 1996 5. Cogny–Van Weydevelt F, Ngohou C, Pontefract R, Bacquaert–Dufour K, Riberi P: Transplant Proc 28:2838, 1996 6. Keown PA: Transplant Proc 28:2147, 1996
M
ICROEMULSION Cyclosporine (ME) formulation has been reported to be as safe as conventional Cyclosporine (CsA) in all transplanted patients. In order to analyse the economic impact of the conversion from conventional CsA to ME we performed a 6 months prospective study in 181 kidney transplanted patients.
PATIENTS AND METHODS The conversion was realized on the basis of 1:1. We collected clinical, biological, and economic data before the switch and at day 10, month 1, 3, and 6. For each patient we identified the monthly cost of the concerned formulation of CsA at different points of the study. Statistical analysis used the t test for paired series (significant value for P , .05). CsA trough levels was kept within 80 to 150 ng/mL (Monoclonal Sorin RIA). Pharmaco-economical parameters consisted on actual galenic CsA formulation costs collected for each patient (hospital dispensary prices, in 1997 FF) reported on the basis of 30 days treatment (1 month).
RESULTS
One hundred eighty-one patients have been enrolled in the study including 69 females, medium age at the time of transplantation was 42 6 13 years, 148 first, 30 second, and 3 third kidney graft. At the time of the switch the mean duration of the transplantation was 63.2 6 38.2 months. With conventional CsA, HTA occured in 80% of patients, adverse effects had been noted in 72 patients, 11 patients presented 2 or more adverse effects. Previous acute rejection episode was noted in 25.4% of patients, and 40 patients presented a chronic rejection. During the first few days of the conversion we noted 17 patients who suffered from an increase in previous adverse effects, and 34 patients presented de novo adverse effects. At the end of the study patients who had experienced conventional CsA adverse effects reported an improvement with the use of ME. All the patients who presented an adverse effect at the beginning of ME prescription had been cured with a reduction of the dose.
31 ng/mL. At day 10 of the switch, we observed a significant raise of CsA trough level (140 6 39 ng/mL 2P 5 .0001) with a significant raise of serum creatinine concentration (P 5 .04). At month 1 a significant lowering of CsA dose (251 6 71 mg/d, P 5 .0001) resulted in serum creatinine concentrations tapered back to the preswitch values. Three months after the switch the situation was stable with mean creatininemia at 150 6 54 mmol/L, CsA dose at 243 6 69 mg/d, and mean CsA trough level at 122 6 34 ng/mL. At month 6 we observed a significant decrease in serum creatinine (P 5 .006), allowed by a significant decrease in ME daily dose (P 5 .0002), while CsA trough levels were lower than those observed at any time of the study (P 5 .002 to .03). Compared with the day before conversion, the use of ME Cyclosporine lead to a reduction in CsA dosage in 56.9% of the patients at month 3, and in 62.5% of them at month 6. At the end of the study mean reduction of CsA dosage was of 11.9% of the initial value (range from 6.2% to 46%). Cost analysis
Analysis of direct costs reported to the CsA formulation showed a significantly lower cost of the medicine with the ME. Mean thirty days conventional CsA cost was 432.8 6 120 US$ (2,478FF), at month 3 mean ME cost was 392 6 111US$ (2,240FF), P 5 .0001, and at month 6 this cost was 380.3 6 110US$ (2177FF). The mean monthly cost benefit observed 6 months after the conversion was of 52US$ per patient. Thus, 6 months after the switch from conventional to ME Cyclosporin in 181 patients we observed a benefit of 91412US$ (53,837FF) per month in our center. DISCUSSION AND CONCLUSION
Conversion to ME Cyclosporine in kidney transplanted patients lead to a substantial dose reduction (about 12% in 62% of patients) as yet described in literature.1– 4 A raise in Cyclosporine trough levels and adverse effects was imposed
Pharmacological and Biological Parameters
Before conversion mean serum creatinine was 154 6 53 mmol/L, mean conventional CsA dose was 270 6 75 mg/d (4 6 1.4 mg/kg per day), mean CsA trough level was 121 6
From the Service de ne´phrologie, C.H.U., Angers, and Service de ne´phrologie, C.H. Laval, France. Address reprint requests to Dr Cogny-Van Weydevelt, Service de Ne´phrologie CHU, 49033 Angers Cedex, France.
0041-1345/98/$19.00 PII S0041-1345(98)00815-X
© 1998 by Elsevier Science Inc. 655 Avenue of the Americas, New York, NY 10010
2802
Transplantation Proceedings, 30, 2802–2803 (1998)
ECONOMIC RELEVANCE OF CYCLOSPORINE
to lower the dosage on the first month of the switch. Secondarily, patients’ clinical and biological evolution authorized to reduce, furthermore, the CsA dosage on the following months. This is observed without deleterious effect on the renal function, even if the patient presented a chronic rejection before the switch. Concerning Cyclosporine adverse effects, we observed an increase in their expression with the 1:1 conversion. But after CsA dose adaptation all the concerned patients were improved. The economic impact of the switch has been analyzed in each patient for the two drugs formulations, and we showed a mean monthly benefit of 52US$ per patient with the ME. Considering the mean kidney transplantation cost in our center5 that has been measured at 4006US$ after the first year, this difference represents a reduction of about 15% of the transplan-
2803
tation cost. Our results concerning the economic interest of ME Cyclosporin confirm the preliminary information published by Keown et al.6 REFERENCES 1. Taesh S, Niese D: Transpl Int 7(suppl 1):263, 1994 2. Svendsen U, Larsen K, Allemand H, Thayssen P, Jensen S, Petterson G: Transplant Proc 27:3477, 1995 3. Heroux AL, LeBlanc MH, Beaudoin D, et al: Transplant Pro 28:3145, 1996 4. Neumayer HH, Budde K, Fa¨rber L, et al: Clin Nephrol 45(5):326, 1996 5. Cogny–Van Weydevelt F, Ngohou C, Pontefract R, Bacquaert–Dufour K, Riberi P: Transplant Proc 28:2838, 1996 6. Keown PA: Transplant Proc 28:2147, 1996