Cost-effectiveness analysis of diagnostic-therapeutic strategies for visceral leishmaniasis in Brazil

Submitted by Nuzia Santos ([email protected]) on 2019-09-03T12:37:34Z No. of bitstreams: 1 Cost-effectiveness analysis.pdf: 3912324 bytes, checksum: 22baa609ea909687962f980d59e4970d (MD5)Approved for entry into archive by Nuzia Santos ([email protected]) on 2019-09-03T12:42:27Z (GMT) No. of bitstreams: 1 Cost-effectiveness analysis.pdf: 3912324 bytes, checksum: 22baa609ea909687962f980d59e4970d (MD5)Made available in DSpace on 2019-09-03T12:42:27Z (GMT). No. of bitstreams: 1 Cost-effectiveness analysis.pdf: 3912324 bytes, checksum: 22baa609ea909687962f980d59e4970d (MD5) Previous issue date: 2019Fundação Oswaldo Cruz. Instituto Rene Rachou. Grupo de Pesquisa Clínica e Políticas Públicas sobre Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, BrasilFundação Oswaldo Cruz. Instituto Rene Rachou. Grupo de Pesquisa Clínica e Políticas Públicas sobre Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, BrasilFundação Oswaldo Cruz. Instituto Rene Rachou. Grupo de Pesquisa Clínica e Políticas Públicas sobre Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, BrasilUniversidade do Estado do Rio de Janeiro. Instituto de Medicina Social. Departamento de Epidemiologia. Rio de Janeiro, RJ, Brasil.Instituto de Avaliação de Tecnologia em Saúde. Porto Alegre, RS, Brasil/Universidade Federal do Rio Grande do Sul. Porto Alegre, RS, BrasilIntroduction: Visceral leishmaniasis (VL) is fatal if not diagnosed and treated. This study aimed to estimate the cost–effectiveness of diagnostic–therapeutic alternatives for VL in Brazil. Methods: A decision model estimated the life expectancy and costs of six diagnostic–therapeutic strategies. Results: IT LEISH + liposomal amphotericin B emerged the best option, presenting lower costs and higher effectiveness. DAT-LPC + liposomal amphotericin B showed an incremental cost–effectiveness ratio of US$ 326.31 per life year. Conclusions: These findings indicate the feasibility of incorporating DAT and designating liposomal amphotericin B as the first-line drug for VL in Brazil

Impacto presupuestario de las pruebas diagnósticas para la leishmaniosis visceral en Brasil

Submitted by Nuzia Santos ([email protected]) on 2018-03-05T19:15:43Z No. of bitstreams: 1 Budgetary impact of diagnostic tests for visceral leishmaniasis in Brazil.pdf: 163713 bytes, checksum: 71da31d1e3ff77b8509b57bd7e232888 (MD5)Approved for entry into archive by Nuzia Santos ([email protected]) on 2018-03-05T19:27:28Z (GMT) No. of bitstreams: 1 Budgetary impact of diagnostic tests for visceral leishmaniasis in Brazil.pdf: 163713 bytes, checksum: 71da31d1e3ff77b8509b57bd7e232888 (MD5)Made available in DSpace on 2018-03-05T19:27:28Z (GMT). No. of bitstreams: 1 Budgetary impact of diagnostic tests for visceral leishmaniasis in Brazil.pdf: 163713 bytes, checksum: 71da31d1e3ff77b8509b57bd7e232888 (MD5) Previous issue date: 2017Centro Federal de Educação Tecnológica de Minas Gerais. Contagem, MG, Brasil / Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Instituto para Avaliação de Tecnologias em Saúde. Porto Alegre, RS, Brasil / Universidade Federal do Rio Grande do Sul. Porto Alegre, RS, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Universidade do Estado do Rio de Janeiro. Instituto de Medicina Social. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.O estudo teve como objetivo estimar os custos financeiros da incorporação e/ou substituição dos testes diagnósticos para a leishmaniose visceral (LV) humana no Brasil. A análise foi realizada na perspectiva do Sistema Único de Saúde (SUS) ao longo de três anos. Foram avaliados seis testes diagnósticos: reação de imunofluorescência indireta (RIFI), teste rápido IT LEISH, exame parasitológico de aspirado de medula óssea, teste de aglutinação direta DAT-LPC padronizado pelo Laboratório de Pesquisas Clínicas do Instituto René Rachou, Fundação Oswaldo Cruz, teste rápido Kalazar Detect e reação em cadeia da polimerase (PCR). Os parâmetros utilizados foram o número de casos suspeitos de LV notificados ao Ministério da Saúde em 2014 e o custo direto dos testes diagnósticos. Os custos do diagnóstico de casos suspeitos de LV ao longo de três anos usando o RIFI e DAT-LPC foram estimados em USD 280.979,91 e USD 121.371,48, respectivamente. De acordo com a análise, comparado ao uso do RIFI, a incorporação do DAT-LPC pelo SUS resultaria numa economia de USD 159.608,43. Com relação ao impacto dos testes rápidos, o uso do IT LEISH resultou em economia de USD 21.708,72 ao longo de três anos. Comparado ao exame parasitológico, o diagnóstico com PCR resultou em economia de USD 3.125.068,92 ao longo de três anos. Neste estudo, a substituição do RIFI pelo DAT-LPC mostrou ser financeiramente vantajosa. Além disso, a substituição do teste rápido Kalazar Detect com o IT LEISH em 2015 foi economicamente apropriada, e a substituição do exame parasitológico pela PCR está economicamente indicada.The aim of the present study was to estimate the financial costs of the incorporation and/or replacement of diagnostic tests for human visceral leishmaniasis (VL) in Brazil. The analysis was conducted from the perspective of the Brazilian Unified National Health System (SUS) over a period of three years. Six diagnostic tests were evaluated: the indirect immunofluorescence antibody test (IFAT), the IT LEISH rapid test, the parasitological examination of bone marrow aspirate, the direct agglutination test (DAT-LPC) standardized in the Clinical Research Laboratory, René Rachou Institute of the Oswaldo Cruz Foundation, the Kalazar Detect rapid test, and polymerase chain reaction (PCR). The assumptions used were the number of suspected cases of VL reported to the Brazilian Ministry of Health in 2014 and the direct cost of diagnostic tests. The costs to diagnose suspected cases of VL over three years using the IFAT and the DAT-LPC were estimated at USD 280,979.91 and USD 121,371.48, respectively. The analysis indicated that compared with the use of the IFAT, the incorporation of the DAT-LPC into the SUS would result in savings of USD 159,608.43. With regard to the budgetary impact of rapid tests, the use of IT LEISH resulted in savings of USD 21.708,72 over three years. Compared with a parasitological examination, diagnosis using PCR resulted in savings of USD 3,125,068.92 over three years. In this study, the replacement of the IFAT with the DAT-LPC proved financially advantageous. In addition, the replacement of the Kalazar Detect rapid test with the IT LEISH in 2015 was economically valuable, and the replacement of parasitological examination with PCR was indicated.El objetivo del estudio fue estimar los costes financieros de la incorporación y/o sustitución de las pruebas diagnósticas para la leishmaniasis visceral (LV) humana en Brasil. El análisis se realizó desde la perspectiva del Sistema Único de Salud (SUS) a lo largo de tres años. Se evaluaron seis pruebas diagnósticas: reacción de inmunofluorescencia indirecta (RIFI), test rápido IT LEISH, examen parasitológico de aspirado de medula ósea, test de aglutinación directa DAT-LPC, estandarizado por el Laboratorio de Investigación Clínica del Centro de Investigación René Rachou, Fundación Oswaldo Cruz, test rápido Kalazar Detect y la reacción en cadena de la polimerasa (PCR). Los parámetros utilizados fueron el número de casos sospechosos de LV notificados al Ministerio de Salud en 2014 y el coste directo de los test diagnósticos. Los costes del diagnóstico de casos sospechosos de LV a lo largo de tres años, usando el RIFI y DAT-LPC, se estimaron en USD 280.979,91 y USD 121.371,48, respectivamente. De acuerdo con el análisis, comparado con el uso del RIFI, la incorporación del DAT-LPC por el SUS resultaría en un ahorro de USD 159.608,43. En relación con el impacto de los test rápidos, el uso del IT LEISH aportaba un ahorro de USD 21.708,72 a lo largo de tres años. Comparado con el examen parasitológico, el diagnóstico con PCR suponía un ahorro de USD 3.125.068,92 a lo largo de tres años. De acuerdo con el estudio, la sustitución del RIFI con el DAT-LPC mostró ser financieramente ventajosa. Asimismo, la sustitución del test rápido Kalazar Detect con el IT LEISH en 2015 representó un ahorro económico, y los resultados favorecieron la sustitución del examen parasitológico con PCR

The direct costs of treating human visceral leishmaniasis in Brazil

Abstract INTRODUCTION: The drugs available for visceral leishmaniasis (VL) treatment in Brazil have specific characteristics in terms of operability, effectiveness, toxicity, and cost. The aim of this study was to estimate the direct costs of therapies recommended by the Ministry of Health (MH) for VL treatment in Brazil. METHODS: The analytical perspective used was that adopted by the Brazilian Public Health System. Three drugs and four regimens were included: 1) N-methyl glucamine antimoniate intramuscularly at 20mg per kg per day for 30 days; 2) N-methyl glucamine antimoniate intravenously at 20mg per kg per day for 30 days; 3) amphotericin B deoxycholate at 1mg per kg per day for 21 days; and 4) liposomal amphotericin B at 3mg per kg per day for a 7 days treatment. RESULTS: The estimated direct costs of treatment for an adult patient using N-methylglucamine antimoniate administered via the intramuscular and intravenous routes were USD 418.52 and USD 669.40, respectively. The estimated cost of treatment with amphotericin B deoxycholate was USD 1,522.70. Finally, the estimated costs of treatment with liposomal amphotericin B were USD 659.79, and USD 11,559.15 using the price adopted by the WHO and the Drug Regulation Board, respectively. CONCLUSIONS: This analysis indicates the economic feasibility of replacing N-methyl glucamine antimoniate with liposomal amphotericin B, which allows a shorter treatment period with less toxicity compared with other treatments, provided that the purchase value used by the WHO and transferred to the MH is maintained

Use of HAS-BLED Score in an Anticoagulation Outpatient Clinic of a Tertiary Hospital

<div><p>Abstract Background: HAS-BLED score was developed to assess 1-year major bleeding risk in patients anticoagulated with vitamin K antagonists (VKA) due to atrial fibrillation (AF). Objective: Of this study was to assess the ability of HAS-BLED score and its components to predict major bleeding in patients treated in an anticoagulation outpatient clinic of a tertiary hospital. Methods: A retrospective cohort study on AF patients treated with VKA was conducted. Logistic regression analysis was performed to evaluate the ability of individual score components to predict major bleeding. The significance level adopted in all tests was 5%. Results: We studied 263 patients with a mean age of 71.1 ± 10.5 years over a period of 237.6 patients-year. Median HAS-BLED score was 2 (1-3). The overall incidence of major bleeding was 5.7%, and it was higher among high-risk HAS-BLED score patients than in low risk patients (9.6 vs. 3.1%; p = 0.052). Area under the ROC curve was 0.70 (p = 0.01). Cut-off point ≥ 3 showed sensibility of 66.7%, specificity of 62.1%, positive predictive value of 9.6% and negative predictive value of 96.9%. Major bleeding-free survival was lower in high-risk group (p = 0.017). In multivariate analysis, concurrent antiplatelet use was the only independent predictor of major bleeding among score components (OR 5.13, 95%CI: 1.55-17.0; p = 0.007). Conclusion: HAS-BLED score was able to predict major bleeding in this cohort of AF patients. Among score components, special attention should be given for concomitant antiplatelet use, which was independently associated to this outcome. Antiplatelets in AF patients under VKA anticoagulation should be used in selected patients with favorable risk-benefit assessment.</p></div

The direct costs of treating human visceral leishmaniasis in Brazil

Submitted by Nuzia Santos ([email protected]) on 2018-10-03T16:50:35Z No. of bitstreams: 1 The direct costs of treating human visceral.pdf: 380634 bytes, checksum: 70e43e776f164ae3ba77aa88ecd076c4 (MD5)Approved for entry into archive by Nuzia Santos ([email protected]) on 2018-10-03T16:59:08Z (GMT) No. of bitstreams: 1 The direct costs of treating human visceral.pdf: 380634 bytes, checksum: 70e43e776f164ae3ba77aa88ecd076c4 (MD5)Made available in DSpace on 2018-10-03T16:59:08Z (GMT). No. of bitstreams: 1 The direct costs of treating human visceral.pdf: 380634 bytes, checksum: 70e43e776f164ae3ba77aa88ecd076c4 (MD5) Previous issue date: 2017Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brasil/Centro Federal de Educação Tecnológica de Minas Gerais. Contagem, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, BrasilFundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, BrasilFundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, BrasilInstituto de Avaliação de Tecnologia em Saúde. Porto Alegre, RS, Brasil/Universidade Federal do Rio Grande do Sul. Porto Alegre, RS, Brasil.Universidade do Estado do Rio de Janeiro. Instituto de Medicina Social. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brasil.INTRODUCTION: The drugs available for visceral leishmaniasis (VL) treatment in Brazil have specific characteristics in terms of operability, effectiveness, toxicity, and cost. The aim of this study was to estimate the direct costs of therapies recommended by the Ministry of Health (MH) for VL treatment in Brazil. METHODS: The analytical perspective used was that adopted by the Brazilian Public Health System. Three drugs and four regimens were included: 1) N-methyl glucamine antimoniate intramuscularly at 20mg per kg per day for 30 days; 2) N-methyl glucamine antimoniate intravenously at 20mg per kg per day for 30 days; 3) amphotericin B deoxycholate at 1mg per kg per day for 21 days; and 4) liposomal amphotericin B at 3mg per kg per day for a 7 days treatment. RESULTS: The estimated direct costs of treatment for an adult patient using N-methylglucamine antimoniate administered via the intramuscular and intravenous routes were USD 418.52 and USD 669.40, respectively. The estimated cost of treatment with amphotericin B deoxycholate was USD 1,522.70. Finally, the estimated costs of treatment with liposomal amphotericin B were USD 659.79, and USD 11,559.15 using the price adopted by the WHO and the Drug Regulation Board, respectively. CONCLUSIONS: This analysis indicates the economic feasibility of replacing N-methyl glucamine antimoniate with liposomal amphotericin B, which allows a shorter treatment period with less toxicity compared with other treatments, provided that the purchase value used by the WHO and transferred to the MH is maintained

Use of HAS-BLED Score in an Anticoagulation Outpatient Clinic of a Tertiary Hospital

<div><p>Abstract Background: HAS-BLED score was developed to assess 1-year major bleeding risk in patients anticoagulated with vitamin K antagonists (VKA) due to atrial fibrillation (AF). Objective: Of this study was to assess the ability of HAS-BLED score and its components to predict major bleeding in patients treated in an anticoagulation outpatient clinic of a tertiary hospital. Methods: A retrospective cohort study on AF patients treated with VKA was conducted. Logistic regression analysis was performed to evaluate the ability of individual score components to predict major bleeding. The significance level adopted in all tests was 5%. Results: We studied 263 patients with a mean age of 71.1 ± 10.5 years over a period of 237.6 patients-year. Median HAS-BLED score was 2 (1-3). The overall incidence of major bleeding was 5.7%, and it was higher among high-risk HAS-BLED score patients than in low risk patients (9.6 vs. 3.1%; p = 0.052). Area under the ROC curve was 0.70 (p = 0.01). Cut-off point ≥ 3 showed sensibility of 66.7%, specificity of 62.1%, positive predictive value of 9.6% and negative predictive value of 96.9%. Major bleeding-free survival was lower in high-risk group (p = 0.017). In multivariate analysis, concurrent antiplatelet use was the only independent predictor of major bleeding among score components (OR 5.13, 95%CI: 1.55-17.0; p = 0.007). Conclusion: HAS-BLED score was able to predict major bleeding in this cohort of AF patients. Among score components, special attention should be given for concomitant antiplatelet use, which was independently associated to this outcome. Antiplatelets in AF patients under VKA anticoagulation should be used in selected patients with favorable risk-benefit assessment.</p></div

SAMe-TT2R2 Score: A Useful Tool in Oral Anticoagulation Decision-Making for Venous Thromboembolism Patients?

<div><p>Abstract Background: The SAMe-TT2R2 score was introduced to identify atrial fibrillation patients with a high risk of not achieving a good time in therapeutic range (TTR) during vitamin K antagonists (VKA) therapy. Objective: The aim of this study was to evaluate this score in venous thromboembolism (VTE) patients. Patients and methods: A retrospective cohort study of patients receiving care at the outpatient anticoagulation clinic of a tertiary care teaching hospital. Patients were classified as having low (score 0-1) or high risk (score ≥ 2) of not achieving a good TTR. The area under the ROC curve was calculated to assess the ability of the score to predict a TTR ≥ 65%. Adverse event-free survival curves according to the SAMe-TT2R2 score were calculated by the Kaplan-Meier method and compared by the log-rank test. A p-value < 0.05 was considered statistically significant. Results: We investigated 111 patients during a median follow-up of 2.3 (0.7-6.4) years. Mean age was 54.1 ± 15.7 years and 71 (64.0%) were women. Low- and high-risk groups had similar mean TTR (51.9 vs. 49.6%; p = 0.593). The two groups did not differ significantly in the percentage of patients achieving a TTR ≥ 65% (35.6 vs. 25.8%; p = 0.370). The c-statistic was 0.595 (p = 0.113) for TTR ≥ 65%. Adverse event-free survival during anticoagulation was also similar in both groups (p = 0.136). Conclusions: The SAMe-TT2R2 score does not seem to be a useful tool in oral anticoagulation decision-making for patients with VTE and should not be used in this setting.</p></div