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1.
Rev. bras. cancerol ; 65(3)19/09/2019.
Artículo en Portugués | LILACS | ID: biblio-1048431

RESUMEN

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.


Asunto(s)
Humanos , Enoxaparina/economía , Trombosis de la Vena/tratamiento farmacológico , Rivaroxabán/economía , Neoplasias/complicaciones , Sistema Único de Salud , Análisis Costo-Beneficio , Economía Farmacéutica , Anticoagulantes/economía
2.
Clin Drug Investig ; 37(9): 833-844, 2017 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-28608312

RESUMEN

BACKGROUND AND OBJECTIVE: Venous thromboembolism (VTE), comprising deep-vein thrombosis (DVT) and pulmonary embolism (PE), is a major healthcare concern that results in substantial morbidity and mortality with great economic burden for healthcare systems. Hence, the need for effective and efficient treatment of patients with VTE is important for both clinical and economic reasons. The objective of this study was to evaluate the cost effectiveness of rivaroxaban compared to standard of care (SoC) with enoxaparin followed by dose-adjusted vitamin-K antagonists for the treatment of DVT and PE in Greece. METHODS: An existing Markov model was locally adapted from a third-party payer perspective to reflect the management and complications of DVT and PE in the course of 3-month cycles, up to death. The clinical inputs and utility values were extracted from published studies. Direct medical costs, obtained from local resources, were incorporated in the model and refer to year 2017. Both costs and outcomes were discounted at 3.5%. The incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained was calculated. Probabilistic sensitivity analysis (PSA) was carried out to deal with uncertainty. RESULTS: The base-case analysis showed that rivaroxaban in 3- and 6-month treatment duration for DVT and PE, respectively, as this is the common clinical practice in Greece, was associated with a 0.02 and 0.01 increment in QALYs compared to SoC, respectively. Rivaroxaban was associated with a reduced total cost in DVT (€85) but with an additional total cost in PE (€2) compared to SoC. Therefore, rivaroxaban was a dominant (less costly, more effective) and cost-effective (ICER: €177) alternative over SoC for the management of DVT and PE, respectively. PSA revealed that the probability of rivaroxaban being cost effective at a threshold of €34,000 per QALY gained was 99% and 81% for DVT and PE, respectively. CONCLUSION: Rivaroxaban may represent a cost-effective option relative to SoC for the management of DVT and PE in Greece.


Asunto(s)
Enoxaparina/uso terapéutico , Embolia Pulmonar/tratamiento farmacológico , Rivaroxabán/uso terapéutico , Trombosis de la Vena/tratamiento farmacológico , Anciano , Anticoagulantes/economía , Anticoagulantes/uso terapéutico , Análisis Costo-Beneficio , Enoxaparina/economía , Fibrinolíticos/uso terapéutico , Grecia , Humanos , Persona de Mediana Edad , Embolia Pulmonar/economía , Años de Vida Ajustados por Calidad de Vida , Rivaroxabán/economía , Trombosis de la Vena/economía
3.
J Med Econ ; 18(5): 323-32, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25557176

RESUMEN

OBJECTIVE: Venous thromboembolism (VTE) impacts ∼900,000 individuals annually in the US, causing up to 100,000 deaths. Patients experiencing VTE have heightened risk of recurrence. Initial parenteral anti-coagulation is standard therapy for acute VTE followed by ≥3 months of warfarin, which introduces the risk of major bleeding. Balancing increased risks of bleeding and recurrent VTE remains challenging. Recent clinical trials suggest that rivaroxaban, an oral direct inhibitor of factor Xa, provides an effective, safe, simplified approach to treatment. This study considers the economic implications of these data. METHODS: This study modeled inpatient, acute, and 1-year VTE costs for a hypothetical commercial plan with 1 million members. At baseline, all VTE patients receive standard therapy. Alternatively, 25% are instead treated with rivaroxaban. Model inputs are trial- and literature-based. RESULTS: Standard therapy for VTE consumes 9474 inpatient days ($31.6 million). Added to that is treatment for 74 recurrences ($1.4 million); major and non-major bleed events ($1 million); and direct costs of anti-coagulation ($5.3 million). Alternatively, a 25% shift to oral anti-coagulation with rivaroxaban reduces inpatient days (by 5%); associated acute-care costs (by 2%); recurrences and costs (by 6%). Four major bleeding events are prevented, at the cost of one additional non-major bleeding event, which, taken together, reduce net utilization by 9%. Direct costs of anti-coagulation increase by 5%. CONCLUSION: The reduction in inpatient utilization, recurrences, and major bleeding resulting from a 25% shift from standard therapy to rivaroxaban following acute VTE would conserve ∼$860,475 for every 1 million commercial health plan enrollees.


Asunto(s)
Enoxaparina/economía , Enoxaparina/uso terapéutico , Embolia Pulmonar/tratamiento farmacológico , Rivaroxabán/economía , Rivaroxabán/uso terapéutico , Tromboembolia Venosa/tratamiento farmacológico , Anticoagulantes/uso terapéutico , Simulación por Computador , Análisis Costo-Beneficio , Quimioterapia Combinada , Hemorragia/economía , Hospitalización/economía , Humanos , Modelos Econométricos , Embolia Pulmonar/prevención & control , Recurrencia , Estados Unidos , Tromboembolia Venosa/prevención & control , Vitamina K/antagonistas & inhibidores
4.
J Med Econ ; 17(1): 52-64, 2014 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-24156243

RESUMEN

BACKGROUND: Venous thromboembolism (VTE), comprised of deep vein thrombosis (DVT) and pulmonary embolism (PE), is commonly treated with a low-molecular-weight heparin such as enoxaparin plus a vitamin K antagonist (VKA) to prevent recurrence. Administration of enoxaparin + VKA is hampered by complexities of laboratory monitoring and frequent dose adjustments. Rivaroxaban, an orally administered anticoagulant, has been compared with enoxaparin + VKA in the EINSTEIN trials. The objective was to evaluate the cost-effectiveness of rivaroxaban compared with enoxaparin + VKA as anticoagulation treatment for acute, symptomatic, objectively-confirmed DVT or PE. METHODS: A Markov model was built to evaluate the costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios associated with rivaroxaban compared to enoxaparin + VKA in adult patients treated for acute DVT or PE. All patients entered the model in the 'on-treatment' state upon commencement of oral rivaroxaban or enoxaparin + VKA for 3, 6, or 12 months. Transition probabilities were obtained from the EINSTEIN trials during treatment and published literature after treatment. A 3-month cycle length, US payer perspective ($2012), 5-year time horizon and a 3% annual discount rate were used. RESULTS: Treatment with rivaroxaban cost $2,448 per-patient less and was associated with 0.0058 more QALYs compared with enoxaparin + VKA, making it a dominant economic strategy. Upon one-way sensitivity analysis, the model's results were sensitive to the reduction in index VTE hospitalization length-of-stay associated with rivaroxaban compared with enoxaparin + VKA. At a willingness-to-pay threshold of $50,000/QALY, probabilistic sensitivity analysis showed rivaroxaban to be cost-effective compared with enoxaparin + VKA approximately 76% of the time. LIMITATIONS: The model did not account for the benefits associated with an oral and minimally invasive administration of rivaroxaban. 'Real-world' applicability is limited because data from the EINSTEIN trials were used in the model. Also, resource utilization and costs were based on the US healthcare system. CONCLUSION: Rivaroxaban is a cost-effective option for anticoagulation treatment of acute VTE patients.


Asunto(s)
Anticoagulantes/economía , Enoxaparina/economía , Morfolinas/economía , Tiofenos/economía , Trombosis de la Vena/prevención & control , Vitamina K/economía , Anticoagulantes/uso terapéutico , Análisis Costo-Beneficio , Quimioterapia Combinada/economía , Enoxaparina/uso terapéutico , Humanos , Cadenas de Markov , Persona de Mediana Edad , Morfolinas/uso terapéutico , Años de Vida Ajustados por Calidad de Vida , Rivaroxabán , Tiofenos/uso terapéutico , Estados Unidos/epidemiología , Trombosis de la Vena/mortalidad , Vitamina K/uso terapéutico
5.
BMC Health Serv Res ; 12: 192, 2012 Jul 09.
Artículo en Inglés | MEDLINE | ID: mdl-22776616

RESUMEN

BACKGROUND: Patients undergoing major orthopaedic surgery (MOS), such as total hip (THR) or total knee replacement (TKR), are at high risk of developing venous thromboembolism (VTE). For thromboembolism prophylaxis, the oral anticoagulant rivaroxaban has recently been included in the German diagnosis related group (DRG) system. However, the cost-effectiveness of rivaroxaban is still unclear from both the German statutory health insurance (SHI) and the German hospital perspective. OBJECTIVES: To assess the cost-effectiveness of rivaroxaban from the German statutory health insurance (SHI) perspective and to analyse financial incentives from the German hospital perspective. METHODS: Based on data from the RECORD trials and German cost data, a decision tree was built. The model was run for two settings (THR and TKR) and two perspectives (SHI and hospital) per setting. RESULTS: Prophylaxis with rivaroxaban reduces VTE events (0.02 events per person treated after TKR; 0.007 after THR) compared with enoxaparin. From the SHI perspective, prophylaxis with rivaroxaban after TKR is cost saving (€27.3 saving per patient treated). However, the cost-effectiveness after THR (€17.8 cost per person) remains unclear because of stochastic uncertainty. From the hospital perspective, for given DRGs, the hospital profit will decrease through the use of rivaroxaban by €20.6 (TKR) and €31.8 (THR) per case respectively. CONCLUSIONS: Based on our findings, including rivaroxaban for reimbursement in the German DRG system seems reasonable. Yet, adequate incentives for German hospitals to use rivaroxaban are still lacking.


Asunto(s)
Anticoagulantes/economía , Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Enoxaparina/economía , Morfolinas/economía , Complicaciones Posoperatorias/prevención & control , Tiofenos/economía , Tromboembolia Venosa/prevención & control , Anticoagulantes/uso terapéutico , Análisis Costo-Beneficio , Bases de Datos Factuales , Árboles de Decisión , Enoxaparina/uso terapéutico , Alemania , Humanos , Morfolinas/uso terapéutico , Estudios Multicéntricos como Asunto , Programas Nacionales de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Rivaroxabán , Tiofenos/uso terapéutico
6.
Postgrad Med ; 124(1): 41-9, 2012 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-22314113

RESUMEN

UNLABELLED: This study assesses the use of new anticoagulants for the prevention of venous thromboembolism (VTE) in patients undergoing elective orthopedic surgery using traditional cost-effectiveness analysis and efficiency frontier methodology. RATIONALE: Efficiency frontier methodology has the potential to systematically improve the information used in policy and decision making, though it is still relatively uncommon in health economics. Anticoagulation in elective orthopedic surgery provides a fitting and timely case study for examining the influence of choosing one methodology over another. METHODS: An economic model was developed to capture the relative benefits and consequences of choosing one anticoagulation strategy over another in the context of orthopedic surgery. Three novel oral anticoagulants (apixaban, rivaroxaban, dabigatran) are compared with enoxaparin 40 mg daily from the UK National Health Service perspective using traditional cost-effectiveness estimates (cost/quality-adjusted life years, cost/life years gained) and the efficiency frontier. The latter explicitly includes embolic and bleeding events as outcomes. A 5-year time horizon was adopted. RESULTS: Total discounted costs ranged from about £200 000 to £431 000 over 5 years per 1000 patients undergoing elective total hip arthroplasty, and from £243 000 to £463 000 per 1000 patients for elective total knee arthroplasty. Analysis of the efficiency frontier demonstrates that apixaban and rivaroxaban are the preferred choices, depending on the outcome examined and the type of surgery. In terms of safety, apixaban is associated with more bleeding events avoided; yet, rivaroxaban demonstrated better VTE outcomes. CONCLUSION: Traditional cost-effectiveness analysis systematically excludes information related to the safety profiles of these anticoagulants. The efficiency frontier approach presented in this study provides critical information, without substantial effort, to permit a fully informed decision by taking into account all relevant outcomes as they relate to the costs associated with treatment choice.


Asunto(s)
Anticoagulantes/uso terapéutico , Artroplastia de Reemplazo , Modelos Económicos , Complicaciones Posoperatorias/prevención & control , Tromboembolia Venosa/prevención & control , Anciano , Anticoagulantes/economía , Bencimidazoles/economía , Bencimidazoles/uso terapéutico , Análisis Costo-Beneficio , Dabigatrán , Árboles de Decisión , Costos de los Medicamentos , Procedimientos Quirúrgicos Electivos , Enoxaparina/economía , Enoxaparina/uso terapéutico , Femenino , Humanos , Masculino , Cadenas de Markov , Morfolinas/economía , Morfolinas/uso terapéutico , Pirazoles/economía , Pirazoles/uso terapéutico , Piridonas/economía , Piridonas/uso terapéutico , Años de Vida Ajustados por Calidad de Vida , Rivaroxabán , Medicina Estatal , Tiofenos/economía , Tiofenos/uso terapéutico , Reino Unido , beta-Alanina/análogos & derivados , beta-Alanina/economía , beta-Alanina/uso terapéutico
7.
Pharmacoeconomics ; 30(2): 87-101, 2012 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-22187932

RESUMEN

BACKGROUND: Major orthopaedic surgery, such as total hip replacement (THR) and total knee replacement (TKR), is associated with an increased risk of venous thromboembolism (VTE). OBJECTIVE: Clinical trials have demonstrated the efficacy of rivaroxaban, a once-daily, orally administered Factor Xa inhibitor, for the prevention of VTE in patients undergoing THR or TKR. This analysis evaluated the cost effectiveness of rivaroxaban compared with enoxaparin, from a U.S. payer's perspective. METHODS: A decision-analytic model was developed to compare the costs and outcomes associated with rivaroxaban and enoxaparin for the prevention of VTE. The model replicated short-term clinical outcomes from the phase III RECORD trials. RECORD1 and RECORD2 compared rivaroxaban 10 mg daily (qd), given for 35 days, with enoxaparin 40 mg qd, given for 35 days or 10 to 14 days, respectively, in patients undergoing THR. RECORD3 compared 10 mg of rivaroxaban qd for 10 to 14 days versus 40 mg of enoxaparin qd for 10 to 14 days in patients undergoing TKR. The decision-analytic model also included data on long-term complications and sequelae as captured in observational studies and databases. It also included direct year 2010 medical costs over 1-year and 5-year time horizons. A series of sensitivity analyses were performed to determine the impact of different factors on the results of the model. Results of the cost-effectiveness analysis were reported in terms of symptomatic VTE events avoided. RESULTS: Rivaroxaban was associated with cost savings of $US 511.93 per patient and prevented an average of 0.0145 symptomatic VTE events per patient in the THR population, compared with enoxaparin. For a TKR population, 10 to 14 days of rivaroxaban prophylaxis was associated with cost savings of $US 465.74 and prevented an average 0.0193 symptomatic VTE events per patient. Sensitivity analysis suggested that the results of the model were robust, with cost savings ranging from $US 133.96-629.57 in the THR population and $US 293.01-848.68 in the TKR population, depending on the variables used. Sensitivity analysis also suggested that the economic profile of rivaroxaban is improved when the time horizon of the model is extended from 1 year to 5 years. A probabilistic sensitivity analysis confirmed the findings of baseline results, showing that rivaroxaban was less costly and more effective in all model simulations for both populations. CONCLUSIONS: This decision-analytic model analysis, from the U.S. payer's perspective, concluded that rivaroxaban may be cost saving in both the THR and the TKR populations, when compared with enoxaparin in the U.S.


Asunto(s)
Artroplastia de Reemplazo/efectos adversos , Enoxaparina/economía , Enoxaparina/uso terapéutico , Morfolinas/economía , Morfolinas/uso terapéutico , Tiofenos/economía , Tiofenos/uso terapéutico , Tromboembolia Venosa/economía , Tromboembolia Venosa/prevención & control , Anciano , Anticoagulantes/efectos adversos , Anticoagulantes/economía , Anticoagulantes/uso terapéutico , Artroplastia de Reemplazo/economía , Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Cadera/economía , Artroplastia de Reemplazo de Rodilla/efectos adversos , Artroplastia de Reemplazo de Rodilla/economía , Ensayos Clínicos Fase III como Asunto , Análisis Costo-Beneficio , Enoxaparina/efectos adversos , Humanos , Persona de Mediana Edad , Modelos Económicos , Morfolinas/efectos adversos , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Rivaroxabán , Tiofenos/efectos adversos , Resultado del Tratamiento , Estados Unidos , Tromboembolia Venosa/etiología , Tromboembolia Venosa/terapia
8.
Rev Esp Salud Publica ; 86(6): 601-12, 2012 Dec.
Artículo en Español | MEDLINE | ID: mdl-23325135

RESUMEN

BACKGROUND: Due to high health care costs of venous thromboembolism (VTE), economic analyses are needed to determine the efficiency of different drug treatments. Consequently, a study was conducted to estimate the budgetary impact for the National Health System (NHS) with apixaban for prevention of venous thromboembolism (VTE) in total hip (THR) or knee (TKR) replacement. METHODS: Cost considered: the drugs for the prevention of VTE (apixaban, dabigatran, enoxaparin, fondaparinux, other heparins, rivaroxaban and warfarin) and the complications of VTE in the short term and in 5 years (deep vein thrombosis, pulmonary embolism, bleedings and the post-thrombotic syndrome). The effectiveness of prophylaxis was estimated using a meta-analysis. The VTE rates and death with apixaban are lower in THR and TKR than enoxaparin (-3.5% and -10.0%, respectively) with less bleeding events (-0.7% and -1.6%, respectively). Population data and unit costs were obtained from Spanish sources. TIME HORIZON: 5 years. All costs were discounted by 3.5% annually. Five years after commercialization, the use of apixaban was estimated to account for 23% of the prophylaxis of VTE and the use of enoxaparin decrease from the 60% to 33%. RESULTS: Apixaban´s introduction for the prophylaxis of VTE would have a significant impact for the NHS, resulting in a saving of 547,422 Euro over a period of 5 years. In the case of outpatient administration of heparin did not have a cost, the savings for the NHS five years amount to 270,068 Euro. CONCLUSIONS: According to this study, the introduction of apixaban may reduce the rate of VTE and bleeding compared with enoxaparin, decreasing the expenditure of NHS in VTE prophylaxis.


Asunto(s)
Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Fibrinolíticos/uso terapéutico , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Medicina Estatal/economía , Tromboembolia Venosa/prevención & control , Anciano , Anticoagulantes/economía , Anticoagulantes/uso terapéutico , Bencimidazoles/economía , Bencimidazoles/uso terapéutico , Presupuestos , Control de Costos/economía , Dabigatrán , Enoxaparina/economía , Enoxaparina/uso terapéutico , Femenino , Fibrinolíticos/economía , Fondaparinux , Hemorragia/tratamiento farmacológico , Hemorragia/economía , Humanos , Morfolinas/economía , Morfolinas/uso terapéutico , Polisacáridos/economía , Polisacáridos/uso terapéutico , Embolia Pulmonar/tratamiento farmacológico , Embolia Pulmonar/economía , Pirazoles/economía , Piridonas/economía , Rivaroxabán , España , Tiofenos/economía , Tiofenos/uso terapéutico , Tromboembolia Venosa/etiología , beta-Alanina/análogos & derivados , beta-Alanina/economía , beta-Alanina/uso terapéutico
9.
Am J Manag Care ; 17(1 Suppl): S22-6, 2011 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-21517652

RESUMEN

Venous thromboembolism (VTE) following joint replacement surgery represents an economic as well as a clinical burden; however, the risk of thromboembolic events is greatly reduced by appropriate anticoagulation. Rivaroxaban, a Factor Xa inhibitor currently in phase III development, was compared with the low molecular weight heparin enoxaparin in 4 clinical trials, collectively called the RECORD program (REgulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism). In a pooled analysis of data from the RECORD trials, rivaroxaban was superior to enoxaparin regimens in reducing the composite end point of symptomatic venous thromboembolism and all-cause mortality in patients following elective primary total hip or total knee arthroplasty (THA or TKA), with a comparable incidence of major bleeding events. In cost-effectiveness analyses, compared with enoxaparin, rivaroxaban showed the potential to reduce costs associated with the prophylaxis and treatment of thromboembolic events in a post-orthopedic surgery/arthroplasty population.


Asunto(s)
Anticoagulantes/uso terapéutico , Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Enoxaparina/uso terapéutico , Morfolinas/uso terapéutico , Tiofenos/uso terapéutico , Tromboembolia Venosa/prevención & control , Anticoagulantes/economía , Análisis Costo-Beneficio , Enoxaparina/economía , Inhibidores del Factor Xa , Humanos , Morfolinas/economía , Rivaroxabán , Tiofenos/economía , Estados Unidos , Tromboembolia Venosa/economía , Tromboembolia Venosa/etiología
10.
J Med Econ ; 14(2): 238-44, 2011.
Artículo en Inglés | MEDLINE | ID: mdl-21385145

RESUMEN

OBJECTIVE: To compare the efficacy, in the prevention of venous thromboembolism (VTE), and safety, of rivaroxaban and dabigatran relative to the common comparator enoxaparin. METHODS: Two randomized clinical trials of dabigatran, one after total hip replacement (THR), RE-NOVATE, and one after total knee replacement (TKR), RE-MODEL, were identified as using the same enoxaparin regimen (40 mg once daily given the evening before surgery) and being of comparable duration to two rivaroxaban trials, RECORD1 and RECORD3. Indirect comparisons were performed on both efficacy and safety endpoints. To enable comparisons, symptomatic VTE results were based on the total study duration period, i.e. including the follow-up period. Major bleeding included surgical-site bleeding events. RESULTS: After THR, rivaroxaban 10 mg once daily significantly reduced total VTE and symptomatic VTE relative to dabigatran 220 mg once daily (relative risk 0.34 and 0.19, respectively). After TKR, rivaroxaban significantly reduced total VTE versus dabigatran (relative risk 0.53); symptomatic VTE was not different between dabigatran and rivaroxaban. There was no significant difference in the rates of major bleeding for patients receiving rivaroxaban or dabigatran. CONCLUSIONS: Based on the indirect comparisons, rivaroxaban was estimated to be more efficacious than dabigatran in the prevention of total VTE after THR and TKR. Our analysis relied upon published data for dabigatran and did not have the advantages of more detailed comparative data obtained directly from a randomized trial, as was the case with rivaroxaban. Further comparative research may be of value, but until available our conclusions represent the best available evidence.


Asunto(s)
Anticoagulantes/uso terapéutico , Bencimidazoles/uso terapéutico , Enoxaparina/uso terapéutico , Morfolinas/uso terapéutico , Complicaciones Posoperatorias/prevención & control , Tiofenos/uso terapéutico , Tromboembolia Venosa/prevención & control , beta-Alanina/análogos & derivados , Anciano , Anticoagulantes/economía , Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Cadera/economía , Artroplastia de Reemplazo de Rodilla/efectos adversos , Artroplastia de Reemplazo de Rodilla/economía , Bencimidazoles/economía , Dabigatrán , Enoxaparina/economía , Femenino , Costos de la Atención en Salud , Humanos , Masculino , Persona de Mediana Edad , Morfolinas/economía , Complicaciones Posoperatorias/economía , Riesgo , Factores de Riesgo , Rivaroxabán , Tiofenos/economía , beta-Alanina/economía , beta-Alanina/uso terapéutico
11.
Clin Ther ; 31(1): 194-212, 2009 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-19243718

RESUMEN

OBJECTIVE: This was an evaluation of the cost-effectiveness of oral dabigatran etexilate compared with subcutaneous low-molecular-weight heparin (enoxaparin) for the prevention of venous thromboembolism (VTE) after total knee replacement (TKR) and total hip replacement (THR) surgery from the perspective of the UK National Health Service. METHODS: Dabigatran etexilate (220 mg once daily) was compared with enoxaparin (40 mg once daily) in patients undergoing TKR (duration of prophylaxis, 6-10 days) and THR (duration of prophylaxis, 28-35 days). The 10-week acute postsurgical phase was modeled using a decision tree. A Markov process (1-year cycle length) was used to model long-term events (recurrent VTE, postthrombotic syndrome, and consequences of intracranial hemorrhage) for patients' remaining lifetimes. Relative risks for VTE and bleeding events were derived from 2 Phase III studies that compared dabigatran etexilate with enoxaparin 40 mg once daily. The probabilities of long-term events were estimated using data from published longitudinal studies. RESULTS: Rates of VTE and bleeding events did not differ significantly between dabigatran etexilate and enoxaparin. Dabigatran etexilate was less costly than enoxaparin in TKR and substantially less costly in THR, primarily due to differences in administration costs. The cost of prophylaxis for THR patients, including drugs and administration costs, was estimated at pound 137 for dabigatran etexilate and pound 237 for enoxaparin ( pound 7 for nursing time during the hospital stay, pound 91 for nurse home visits for administration after hospital discharge, and an additional pound 2 in drug costs). At a willingness-to-pay threshold of pound 20,000 per quality-adjusted life-year, the probability of cost-effectiveness for dabigatran etexilate was 75% in TKR and 97% in THR. These results were robust across a range of sensitivity analyses. CONCLUSION: From the perspective of the UK National Health Service, thromboprophylaxis with dabigatran etexilate was cost-saving compared with enoxaparin 40 mg once daily, with comparable efficacy and safety profiles.


Asunto(s)
Anticoagulantes/economía , Bencimidazoles/economía , Piridinas/economía , Tromboembolia Venosa/prevención & control , Anciano , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Artroplastia de Reemplazo de Cadera/economía , Artroplastia de Reemplazo de Cadera/métodos , Artroplastia de Reemplazo de Rodilla/economía , Artroplastia de Reemplazo de Rodilla/métodos , Bencimidazoles/administración & dosificación , Bencimidazoles/efectos adversos , Ensayos Clínicos Fase III como Asunto , Análisis Costo-Beneficio , Dabigatrán , Árboles de Decisión , Costos de los Medicamentos , Enoxaparina/administración & dosificación , Enoxaparina/efectos adversos , Enoxaparina/economía , Femenino , Hemorragia/inducido químicamente , Humanos , Estudios Longitudinales , Masculino , Cadenas de Markov , Programas Nacionales de Salud/economía , Piridinas/administración & dosificación , Piridinas/efectos adversos , Reino Unido
12.
Pharmacotherapy ; 18(6): 1335-42, 1998.
Artículo en Inglés | MEDLINE | ID: mdl-9855335

RESUMEN

We attempted to determine health and economic outcomes from the perspective of an integrated health system of administering enoxaparin 30 mg twice/day versus heparin 5000 U twice/day for prophylaxis against venous thrombosis after major trauma. A decision-analytic model was developed from best literature evidence, institutional data, and expert opinion. We assumed that 40% of proximal deep vein thromboses (DVTs) and 5% of distal DVTs are diagnosed and confirmed with initial or repeat duplex scanning; 50% of undiagnosed proximal DVTs result in pulmonary embolism; 2% and 1% of undiagnosed proximal DVTs will lead to readmission for DVT and pulmonary embolism, respectively, and pulmonary embolism-related mortality rates range from 8-30%. Length of hospital stay data and 1996 institutional drug use and acquisition cost data were used to estimate the cost of enoxaparin and heparin therapy. Diagnosis and treatment costs for DVT and pulmonary embolism were derived from institutional charge data using cost:charge ratios. A second analysis of patients with lower extremity fractures was completed. One-way and multiway sensitivity analyses were performed. For 1000 mixed trauma patients receiving enoxaparin versus heparin, our model showed that 62.2 (95% CI -113 to -12) DVTs or pulmonary emboli would be avoided, resulting in 67.6 (8 to 130) life-years saved at a net cost increase of $104,764 (-$329,300 to $159,600). Enoxaparin versus heparin resulted in a cost of $1684 (-$3600 to $9800) for each DVT or pulmonary embolus avoided and a discounted cost/life-year saved of $2303 (-$8100 to $19,000). For 1000 patients with lower extremity fractures, enoxaparin versus heparin resulted in a cost of $751 (-$4200 to $3300) for each DVT or pulmonary embolus avoided and a discounted cost/life-year saved of $1017 (-$10,200 to $6300). Although enoxaparin increases overall health care costs, it is associated with a cost/additional life-year saved of only $2300, which is generally lower than the commonly used hurdle rate of $30,000/life-year saved. The cost-effectiveness ratio is more favorable in patients with lower extremity fractures than in the general mixed trauma population.


Asunto(s)
Anticoagulantes/uso terapéutico , Enoxaparina/uso terapéutico , Heparina/uso terapéutico , Trombosis de la Vena/prevención & control , Heridas y Lesiones/tratamiento farmacológico , Análisis Costo-Beneficio , Enoxaparina/economía , Costos de la Atención en Salud/estadística & datos numéricos , Heparina/administración & dosificación , Humanos , Trombosis de la Vena/economía
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