RESUMEN
OBJECTIVES: To evaluate cost-effective pharmacological treatment in adult kidney transplant recipients from the perspective of the Colombian health system. METHODS: A decision tree model for the induction phase and a Markov model for the maintenance phase were built. A review of the clinical literature was conducted to extract probabilities, and the life-years were used as the outcome. Costs were calculated using the administrative databases. The evaluating treatment schemes are organized by groups of evidence with direct comparisons. RESULTS: In the induction phase, anti-thymocyte immunoglobulin+ methylprednisolone is dominant, more effective, and less expensive, compared with basiliximab+methylprednisolone. In the maintenance phase, azathioprine (AZA) is dominant in contrast to mycophenolate mofetil (MFM) both with cyclosporine (CIC)+ corticosteroids (CE); CIC is dominant relative to sirolimus (SIR) and tacrolimus (TAC) (both with MFM+CE or AZA+CE), and TAC is dominant compared with SIR (in addition with MFM+CE or mycophenolate sodium [MFS]+CE); MFM is dominant in relation to MFS and everolimus, and SIR is more effective MFM but it does not exceed the threshold (in sum with TAC+CE); MFS and MFM are dominant relative to everolimus, and SIR is more effective than MFM, but it does not exceed the threshold (in addiction with CIC+CE); MFM is dominant in relation to TAC (in sum with SIR+CE), and CIC+AZA+CE is dominant in relation to TAC+MFM+CE. CONCLUSIONS: The base-case results for all evidence groups are consistent with the different sensitivity analyses.
Asunto(s)
Inmunosupresores , Trasplante de Riñón , Adulto , Humanos , Corticoesteroides/uso terapéutico , Corticoesteroides/economía , Azatioprina/uso terapéutico , Azatioprina/economía , Colombia , Análisis de Costo-Efectividad , Ciclosporina/uso terapéutico , Ciclosporina/economía , Árboles de Decisión , Rechazo de Injerto/prevención & control , Rechazo de Injerto/economía , Inmunosupresores/economía , Inmunosupresores/uso terapéutico , Trasplante de Riñón/economía , Cadenas de Markov , Ácido Micofenólico/uso terapéutico , Ácido Micofenólico/economía , Sirolimus/uso terapéutico , Sirolimus/economía , Tacrolimus/economía , Tacrolimus/uso terapéutico , Receptores de Trasplantes/estadística & datos numéricosRESUMEN
OBJECTIVE To analyze the cost-effectiveness of treatment regimens with cyclosporine or tacrolimus, five years after renal transplantation. METHODS This cost-effectiveness analysis was based on historical cohort data obtained between 2000 and 2004 and involved 2,022 patients treated with cyclosporine or tacrolimus, matched 1:1 for gender, age, and type and year of transplantation. Graft survival and the direct costs of medical care obtained from the National Health System (SUS) databases were used as outcome results. RESULTS Most of the patients were women, with a mean age of 36.6 years. The most frequent diagnosis of chronic renal failure was glomerulonephritis/nephritis (27.7%). In five years, the tacrolimus group had an average life expectancy gain of 3.96 years at an annual cost of R$78,360.57 compared with the cyclosporine group with a gain of 4.05 years and an annual cost of R$61,350.44. CONCLUSIONS After matching, the study indicated better survival of patients treated with regimens using tacrolimus. Moreover, regimens containing cyclosporine were more cost-effective [corrected].
Asunto(s)
Análisis Costo-Beneficio/economía , Ciclosporina/economía , Inmunosupresores/economía , Fallo Renal Crónico/cirugía , Trasplante de Riñón/economía , Tacrolimus/economía , Adulto , Estudios de Cohortes , Ahorro de Costo , Ciclosporina/uso terapéutico , Esquema de Medicación , Femenino , Supervivencia de Injerto , Humanos , Inmunosupresores/uso terapéutico , Fallo Renal Crónico/tratamiento farmacológico , Fallo Renal Crónico/economía , Masculino , Años de Vida Ajustados por Calidad de Vida , Tacrolimus/uso terapéuticoRESUMEN
OBJECTIVE To analyze the cost-effectiveness of treatment regimens with cyclosporine or tacrolimus, five years after renal transplantation. METHODS This cost-effectiveness analysis was based on historical cohort data obtained between 2000 and 2004 and involved 2,022 patients treated with cyclosporine or tacrolimus, matched 1:1 for gender, age, and type and year of transplantation. Graft survival and the direct costs of medical care obtained from the National Health System (SUS) databases were used as outcome results. RESULTS Most of the patients were women, with a mean age of 36.6 years. The most frequent diagnosis of chronic renal failure was glomerulonephritis/nephritis (27.7%). In five years, the tacrolimus group had an average life expectancy gain of 3.96 years at an annual cost of R$78,360.57 compared with the cyclosporine group with a gain of 4.05 years and an annual cost of R$61,350.44. CONCLUSIONS After matching, the study indicated better survival of patients treated with regimens using tacrolimus. However, regimens containing cyclosporine were more cost-effective. .
OBJETIVO Analisar custo-efetividade de regimes terapêuticos com ciclosporina ou tacrolimo cinco anos após transplante renal. MÉTODOS Análise de custo-efetividade com base em dados de coorte histórica 2000-2004, com 2.022 pacientes tratados com ciclosporina ou tacrolimo e pareados 1:1 segundo sexo, idade, tipo e ano de transplante. A sobrevida do enxerto e os custos diretos de cuidados médicos a partir das bases de dados do Sistema Único de Saúde foram utilizados como medida de resultado. RESULTADOS A maioria dos pacientes era do sexo feminino e média de idade de 36,6 anos. O diagnóstico mais frequente de insuficiência renal crônica foi a glomerulonefrite/nefrite (27,7%). Em cinco anos, o grupo tacrolimo obteve uma expectativa de vida média de 3,96 anos de vida ganhos ao custo anual de R$78.360,57 ante 4,05 anos de vida ganhos e de R$61.350,44 para ciclosporina. CONCLUSÕES Após o pareamento, o estudo não mostrou melhor sobrevida dos pacientes com regimes que usam tacrolimo. Além disso, regimes contendo ciclosporina foram mais custo-efetivos. .
Asunto(s)
Humanos , Masculino , Femenino , Adulto , Trasplante de Riñón/economía , Tacrolimus/economía , Ciclosporina/economía , Análisis Costo-Beneficio/economía , Inmunosupresores/economía , Fallo Renal Crónico/cirugía , Esquema de Medicación , Estudios de Cohortes , Tacrolimus/uso terapéutico , Ciclosporina/uso terapéutico , Ahorro de Costo , Años de Vida Ajustados por Calidad de Vida , Supervivencia de Injerto , Inmunosupresores/uso terapéutico , Fallo Renal Crónico/economía , Fallo Renal Crónico/tratamiento farmacológicoRESUMEN
In Brazil, the Unified National Health System (SUS) is responsible for the majority of kidney transplants. To maintain these interventions, the guidelines recommend the use of cyclosporine or tacrolimus, associated with corticosteroids and azathioprine or mycophenolate. Taking the perspective of the National Health System, an economic analysis was performed on the outpatient and hospital resources and medicines used by patient and therapeutic group. A cohort was constructed from 2000 to 2004, with 5,174 kidney transplant patients in use of cyclosporine or tacrolimus, identified by probabilistic record linkage from the National Health System. The cohort included 4,015 patients in use of cyclosporine and 1,159 using tacrolimus. The majority were males, age < 38 years, with nephritis, cardiovascular diseases, and indeterminate causes as the most frequent primary diagnoses. After 48 months of follow-up, the expenditures were higher for kidney transplants in hospitals in the Northeast, cadaver donors, patients in dialysis > 24 months before the transplant, and in the tacrolimus group. Total hospital and outpatient costs and expenditure on medication were higher in patients on tacrolimus as compared to the cyclosporine group.
Asunto(s)
Ciclosporina/economía , Rechazo de Injerto/prevención & control , Inmunosupresores/economía , Trasplante de Riñón/economía , Tacrolimus/economía , Adulto , Estudios de Cohortes , Ciclosporina/uso terapéutico , Rechazo de Injerto/economía , Costos de la Atención en Salud , Humanos , Inmunosupresores/uso terapéutico , Masculino , Tacrolimus/uso terapéuticoRESUMEN
No Brasil, o Sistema Único de Saúde (SUS) é responsável maioria dos transplantes renais. Para a manutenção dessas intervenções, os protocolos recomendam uso da ciclosporina ou tacrolimus, associado com corticosteróides e azatioprina ou micofenolato. Na perspectiva do SUS, realizou-se análise econômica sobre recursos ambulatoriais, hospitalares e medicamentos utilizados por paciente e grupo terapêutico. Foi construída coorte de 2000 a 2004, com 5.174 pacientes em transplantes renais e em uso de ciclosporina ou tacrolimus, identificados por relacionamento probabilístico em registros do SUS. A coorte continha 4.015 pacientes em uso de ciclosporina e 1.159 com tacrolimus. A maioria era do sexo masculino, idade < 38 anos, cujos diagnósticos primários mais freqüentes eram nefrites, doenças cardiovasculares e causas indeterminadas. Após 48 meses, observou-se gasto superior para transplantes renais em hospitais do Nordeste, doador cadáver, naqueles em diálises > 24 meses antes do transplantes renais e no grupo do tacrolimus. Constatou-se maior gasto total com recursos hospitalares, ambulatoriais e medicamentos para os transplantes renais em pacientes com esquemas com tacrolimus, quando comparados com o grupo da ciclosporina.
In Brazil, the Unified National Health System (SUS) is responsible for the majority of kidney transplants. To maintain these interventions, the guidelines recommend the use of cyclosporine or tacrolimus, associated with corticosteroids and azathioprine or mycophenolate. Taking the perspective of the National Health System, an economic analysis was performed on the outpatient and hospital resources and medicines used by patient and therapeutic group. A cohort was constructed from 2000 to 2004, with 5,174 kidney transplant patients in use of cyclosporine or tacrolimus, identified by probabilistic record linkage from the National Health System. The cohort included 4,015 patients in use of cyclosporine and 1,159 using tacrolimus. The majority were males, age < 38 years, with nephritis, cardiovascular diseases, and indeterminate causes as the most frequent primary diagnoses. After 48 months of follow-up, the expenditures were higher for kidney transplants in hospitals in the Northeast, cadaver donors, patients in dialysis > 24 months before the transplant, and in the tacrolimus group. Total hospital and outpatient costs and expenditure on medication were higher in patients on tacrolimus as compared to the cyclosporine group.
Asunto(s)
Adulto , Humanos , Masculino , Ciclosporina/economía , Rechazo de Injerto/prevención & control , Inmunosupresores/economía , Trasplante de Riñón/economía , Tacrolimus/economía , Estudios de Cohortes , Ciclosporina/uso terapéutico , Rechazo de Injerto/economía , Costos de la Atención en Salud , Inmunosupresores/uso terapéutico , Tacrolimus/uso terapéuticoRESUMEN
BACKGROUND: The high cost of tacrolimus is a major problem in Mexico. Ketoconazole increases tacrolimus bioavailability by inhibiting cytochrome P450 3A4 and glycoprotein-p. OBJECTIVE: To demonstrate that the coadministration of tacrolimus and ketoconazole allows a significant dose and cost reduction. PATIENTS AND METHODS: This prospective study administered tacrolimus and ketoconazole to renal transplant recipients with dose adjustment according to tacrolimus blood levels. At 0-1, 1-6, 6-12, and 12-24 months posttransplant demographic, transplant type, immunosuppression, and clinical data were reviewed. The cost of tacrolimus treatment was calculated based on the dose used as compared to the recommended dose (0.15-0.20 mg/kg/d). RESULTS: Eleven patients with an age of 40 years (range, 13-71) were studied from May 2000 to August 2002. Follow-up was 15 +/- 10 months. Graft source was living donor in six patients and cadaveric in five. All patients received tacrolimus + mycophenolate mofetil + prednisone. The mean ketoconazole dose was 87 mg/d. Since the dose of tacrolimus was 0.04 mg/kg/d versus the recommended dose of 0.15-0.20 mg/kg/d, there was a 78% cost reduction (P =.000). Tacrolimus blood levels remained in the therapeutic range. There were no drug-related side effects. CONCLUSIONS: The co-administration of tacrolimus and ketoconazole results in a substantial dose and cost reduction while maintaining therapeutic levels. No adverse metabolic consequences were seen with this combination.