Multi-Criteria Model for Evaluating Drugs to Prevent Deep Venous Thrombosis Associated With Orthopedic Surgery: A Hospital-Based Case Study.

BACKGROUND: It's estimated that 40% to 60% of patients undergoing major orthopedic surgery of the hip or knee who do not receive thromboprophylaxis will develop deep venous thrombosis Instituto Nacional de Traumatologia e Ortopedia has established a guideline to prevent DVT with the administration of the Enoxaparin. Recently, institute stakeholders have been questioning this guideline as new oral anticoagulants that offer more comfort and efficacy, but present higher risk of bleeding, have been appearing in the market for treating deep venous thrombosis. OBJECTIVE: This study aims to validate the application of a multicriteria decision analysis in a real-world problem, the use of rivaroxaban and enoxaparin to prevent deep venous thrombosis. METHODS: The multicriteria method MACBETH (Measuring Attractiveness by a Categorical Based Evaluation Technique) was used in a decision conferencing process to develop an evaluation model for measuring the relative value of the drugs on each evaluation criterion, separately and globally. The model-building process was informed by a literature review and meta-analysis of randomized clinical trials with a critical appraisal of the evidence. RESULTS: We report a model-structure with eight criteria, each one associated with a weighting coefficient and value function. Following a simple additive aggregation process, the model-outputs showed that Rivaroxaban was considered a robust option for DVT. Sensitivity analysis and robustness analysis were performed and testify the consistency of the results. CONCLUSION: This article contributes to literature by showing how MACBETH method can be combined with scientific evidence and participatory group processes, for health technology assessment in hospitals.

Análise de Custo-efetividade e Impacto Orçamentário de Anticoagulantes no Tratamento da Trombose Venosa Profunda em Pacientes Oncológicos / Analysis of Cost-effectiveness and Budget Impact of Anticoagulants in the Treatment of Deep Venous Thrombosis in Oncology Patients / Análisis de Costo-efectividad e Impacto Presupuestal de Anticoagulantes en el Tratamiento de la Trombosis Venosa Profunda en Pacientes Oncológicos

Introdução: A trombose venosa profunda é uma complicação comum e intimamente relacionada às neoplasias. Novos anticoagulantes orais foram lançados nos últimos anos, entre eles, a rivaroxabana. Objetivo: O estudo analisou o custo-efetividade e o impacto orçamentário da rivaroxabana versus enoxaparina. Método: Trata-se de uma coorte retrospectiva, realizada com população oncológica sob a perspectiva do Sistema Único de Saúde. Por meio do modelo de árvore de decisão, foram comparados desfechos de sangramento e retrombose, e custos do tratamento da trombose venosa profunda com rivaroxabana ou enoxaparina, em um horizonte temporal de sete meses. Custos diretos foram extraídos do Sistema de Gerenciamento da Sistema de Gerenciamento da Tabela de Procedimentos, Medicamentos, Órteses, Próteses e Materiais e Medicamentos Especiais do SUS (SIGTAP-SUS), e empregou-se a Planilha Brasileira de Impacto Orçamentário de tecnologias da saúde para avaliação do impacto orçamentário com base na população brasileira de 2017, em cinco anos. A análise de sensibilidade simulou cenários tanto na avaliação de custo-efetividade quanto na de impacto orçamentário. Resultados: Cento e cinquenta e três pacientes foram incluídos na análise de custo-efetividade com diversas neoplasias. A rivaroxabana demonstrou não inferioridade terapêutica comparada à enoxaparina. A razão de custo-efetividade incremental foi de R$ 5.521,71 por unidade de benefício ganho com a nova alternativa, rivaroxabana. Na análise de sensibilidade, a rivaroxabana manteve-se dominante. Foi demonstrada uma economia no impacto orçamentário incremental de R$ 85.950.791.129,21 com a utilização de rivaroxabana ao longo de cinco anos em comparação ao cenário de referência, e esta se manteve como opção mais econômica perante as análises de sensibilidade. Conclusão: A rivaroxabana, nesse contexto, apresentou-se como uma importante alternativa terapêutica.

Introduction: Deep vein thrombosis is a common complication and closely related to neoplasms. New oral anticoagulants have been launched in recent years, among them rivaroxaban. Objective: The study analyzed the cost-effectiveness and budget impact of rivaroxaban versus enoxaparin. Method: This is a retrospective cohort, performed with oncological population from the perspective of Sistema Único de Saúde (National Health System). The decision tree model compared outcomes of bleeding and rethrombosis, and costs of treatment of deep venous thrombosis with rivaroxaban or enoxaparin in a time horizon of seven months. Direct costs were extracted from the SIGTAP-SUS, and the Brazilian Spreadsheet for Budgetary Impact of Health Technologies was used to evaluate the budgetary impact based in the Brazilian population of 2017 over a five-year period. The sensitivity analysis simulated scenarios for both cost-effectiveness and budget impact assessments. Results: One hundred and fifty-three patients were included in the cost-effectiveness analysis with several neoplasms. Rivaroxaban demonstrated no therapeutic inferiority compared to enoxaparin. The incremental cost-effectiveness ratio was R$ 5,521.71 per benefit unit spared with the new alternative, rivaroxaban. In the sensitivity analysis, rivaroxaban remained dominant. An economy in incremental budget impact of R$ 85,950,791,129.21 was demonstrated with the use of rivaroxaban over five years in comparison to the reference scenario, and this continued as the most economic option in relation to sensitivity analyzes. Conclusion: In this context rivaroxaban was an important therapeutic alternative.

Introducción: La trombosis venosa profunda es una complicación común e íntimamente relacionada a las neoplasias. Los nuevos anticoagulantes orales. Objetivo: El estudio analizó el Costo-Efectividad y el Impacto Presupuestario de la rivaroxabana versus enoxaparina. Método: En el modelo de árbol de decisión se compararon los resultados de la hemorragia y la retrombosis, y los costos del tratamiento de la trombosis venosa profunda con rivaroxabana o enoxaparina, con una cohorte retrospectiva, realizada con población oncológica bajo la perspectiva del Sistema Único de Salud en un horizonte temporal de siete meses. Los costos directos fueron extraídos del SIGTAP-SUS, y se empleó la Planilla Brasileña de Impacto Presupuestario de Tecnologías de la Salud para evaluación del Impacto Presupuestario con base en la población brasileña de 2017 en un horizonte temporal de cinco años. El análisis de sensibilidad simuló escenarios tanto en la evaluación de Costo-Efectividad y en la de Impacto Presupuestario. Resultados: Ciento cincuenta y tres pacientes fueron incluidos en el análisis de Costo-Efectividad con diversas neoplasias. La rivaroxabana demostró no inferioridad terapéutica comparada a la enoxaparina. La razón de costo-efectividad incremental fue de R $ 5.521,71 por unidad de beneficio ganada con la nueva alternativa, rivaroxabana. En el análisis de sensibilidad, la rivaroxabana se mantuvo dominante. Se demostró una economía em el Impacto Presupuestario incremental de R$ 85.950.791.129,21 con la utilización de rivaroxabana a lo largo de 5 años en comparación al escenario de referencia, y ésta se mantuvo como opción más económica ante los análisis de sensibilidad. Conclusión: La rivaroxabana, en este contexto, se presentó como una importante alternativa terapéutica.

Benefit, risk and cost of new oral anticoagulants and warfarin in atrial fibrillation; A multicriteria decision analysis.

INTRODUCTION: Warfarin and new oral anticoagulants are effective in reducing stroke in atrial fibrillation; however, the benefits and risks rates in clinical trials show heterogeneity for each anticoagulant, and is unknown the cost influence on a model considering most of the treatment consequences. We designed a benefit-risk and cost assessment of oral anticoagulants. DESIGN: We followed the roadmap proposed by IMI-PROTECT and the considerations of emerged good practice to perform Multi-Criteria Decision Analysis (MCDA). The roadmap defines the following steps: (1) planning, (2) evidence gathering and data preparation, (3) analyses, (4) explorations, and (5) conclusions. We defined two reference points (0-100) to allocate numerical values for scores and weights, and used an analogue numeric scale to assess physicians' preferences. As benefits of the anticoagulant therapy, we included reductions in stroke and all-cause mortality; intracranial haemorrhage, gastrointestinal haemorrhage, minor bleeding and myocardial infarction were considered risks. We also made an estimation of the annual drug cost per person. MAIN RESULTS: The scores were: Apixaban 33, Dabigatrán 25, warfarin 18 and Rivaroxaban 14 this score reveals the most preferred up to the less preferred option, considering the benefit-risk ratio and drug costs altogether. The relative model weights were: 51.1% for risks, 40.4% for benefits and 8.5% for cost. The sensitivity analysis confirms the model robustness. CONCLUSIONS: From this analysis, apixaban should be considered as the preferred anticoagulant option -due to a better benefit-risk balance and a minor cost influence- followed by dabigatran, warfarin and rivaroxaban.

Economic evaluation of the new oral anticoagulants for the prevention of thromboembolic events: a cost-minimization analysis.

CONTEXT AND OBJECTIVE: Randomized clinical trials have shown that the new oral anticoagulants have at least similar impact regarding reduction of thromboembolic events, compared with warfarin, with similar or improved safety profiles. There is little data on real costs within clinical practice. Our aim here was to perform economic analysis on these strategies from the perspective of Brazilian society and the public healthcare system. DESIGN AND SETTING: Cost-minimization analysis; anticoagulation clinic of Hospital Municipal Odilon Behrens, Belo Horizonte, MG, Brazil. METHODS: Patients at the anticoagulation clinic were recruited between August and October 2011, with minimum follow-up of four weeks. Operational and non-operational costs were calculated and corrected to 2015. RESULTS: This study included 633 patients (59% women) of median age 62 years (interquartile range -49-73). The mean length of follow-up was 64 ± 28 days. The average cost per patient per month was $ 54.26 (US dollars). Direct costs accounted for 32.5% of the total cost. Of these, 69.5% were related to healthcare professionals. With regards to indirect costs, 52.4% were related to absence from work and 47.6% to transportation. Apixaban, dabigatran and rivaroxaban were being sold to Brazilian public institutions, on average, for $ 49.87, $ 51.40 and $ 52.16 per patient per month, respectively, which was lower than the costs relating to warfarin treatment. CONCLUSION: In the Brazilian context, from the perspective of society and the public healthcare system, the cumulative costs per patient using warfarin with follow-up in anticoagulation clinics is currently higher than the strategy of prescribing the new oral anticoagulants.