RESUMEN
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.
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Procedimientos Ortopédicos/economía , Preparaciones Farmacéuticas/normas , Complicaciones Posoperatorias/economía , Trombosis de la Vena/tratamiento farmacológico , Anticoagulantes/efectos adversos , Anticoagulantes/economía , Anticoagulantes/uso terapéutico , Brasil/epidemiología , Enoxaparina/efectos adversos , Enoxaparina/economía , Enoxaparina/uso terapéutico , Hemorragia/economía , Hemorragia/epidemiología , Hemorragia/etiología , Humanos , Procedimientos Ortopédicos/efectos adversos , Procedimientos Ortopédicos/métodos , Preparaciones Farmacéuticas/economía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Rivaroxabán/efectos adversos , Rivaroxabán/economía , Rivaroxabán/uso terapéutico , Trombosis de la Vena/epidemiología , Trombosis de la Vena/prevención & controlRESUMEN
BACKGROUND: In Colombia, hemophilia is considered a high-cost disease, and hemophilia A with high-titer inhibitors may be responsible for a significant economic pressure on the Colombian health system. OBJECTIVES: To estimate the direct cost of care for patients with hemophilia A with high-titer inhibitors in Colombia, from the perspective of the health system. METHODS: A cost-of-illness study was carried out using standard case methodology, which was designed based on literature review and validation by expert consensus. Scenarios were established for adults and children, including cases of prophylaxis, immune tolerance induction, bleeding, and surgery. The frequencies were taken from the official report for Colombia, issued by the High-Cost Account 2017 (reported 2018). The prices were obtained from the list of regulated medicines in the country. The cost estimate is presented with a range of values by weight (between 10 kg and 90 kg). RESULTS: The total estimated cost per year for Colombia was US $44 905 252 (between US $32 260 497 and US $58 202 393). The average cost per year calculated for a patient was US $498 947 (between US $358 450 and US $646 693). A total of 99.8% of the estimated cost was directly related to the cost of the coagulation factors and bypassing agents. CONCLUSIONS: Hemophilia A with high-titer inhibitors is a disease that generates significant pressure on the Colombian health system, mainly linked to the cost of factors and bypassing agents.
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Costos de la Atención en Salud/estadística & datos numéricos , Hemofilia A/economía , Adulto , Niño , Colombia/epidemiología , Hemofilia A/sangre , Hemofilia A/complicaciones , Hemorragia/economía , Hemorragia/prevención & control , HumanosRESUMEN
OBJECTIVES: To evaluate the direct costs of venous thromboembolism (VTE) treatment with unfractionated heparin (UFH) and low-molecular weight heparin, from the institutional perspective. METHODS: This is a real-world cohort study that included inpatients treated with UFH or enoxaparin for deep venous thromboembolism or pulmonary embolism in a tertiary public hospital. To estimate medical costs we computed the acquisition costs of drugs, supplies for administration, laboratory tests, and hospitalization cost according to the patient ward. RESULTS: One hundred sixty-seven patients aged 18 to 92 years were studied (50 treated with UFH and 117 with enoxaparin). The median of days in use of heparin was the same in both groups. Activated partial thromboplastin time was monitored in 98% of patients using UFH and 56.4% using enoxaparin. Nonstatistically significant differences were observed between groups in the number of bleeding events (10.0% and 9.4%; P = 1.00); blood transfusion (2.0% and 2.6%; P = 1.00); death (8.0% and 3.4%; P = 0.24); and recurrent VTE, bleeding, or death (20.0% and 14.5%; P = 0.38). Daily mean cost per patient was US$12.63 ± $4.01 for UFH and US$9.87 ± $2.44 for enoxaparin (P < 0.001). The total costs considering the mean time of use were US$88.39 and US$69.11. CONCLUSION: The treatment of VTE with enoxaparin provided cost savings in a large teaching hospital located in southern Brazil.
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Anticoagulantes/economía , Costos de los Medicamentos , Enoxaparina/economía , Recursos en Salud/economía , Heparina/economía , Costos de Hospital , Hospitalización/economía , Evaluación de Procesos y Resultados en Atención de Salud/economía , Tromboembolia Venosa/economía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Coagulación Sanguínea/efectos de los fármacos , Transfusión Sanguínea/economía , Brasil , Distribución de Chi-Cuadrado , Ahorro de Costo , Esquema de Medicación , Monitoreo de Drogas/economía , Enoxaparina/administración & dosificación , Enoxaparina/efectos adversos , Recursos en Salud/estadística & datos numéricos , Investigación sobre Servicios de Salud , Hemorragia/inducido químicamente , Hemorragia/economía , Hemorragia/terapia , Heparina/administración & dosificación , Heparina/efectos adversos , Hospitales de Enseñanza/economía , Humanos , Modelos Logísticos , Persona de Mediana Edad , Modelos Económicos , Estudios Prospectivos , Recurrencia , Factores de Tiempo , Resultado del Tratamiento , Tromboembolia Venosa/sangre , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/mortalidad , Adulto JovenRESUMEN
The first-line treatment for mild-to-moderate bleeding episodes in patients with haemophilia and inhibitors in Brazil is currently activated prothrombin complex concentrate (aPCC), with recombinant activated factor VII (rFVIIa) used as second-line therapy or as a last resort. The aim of this study was to determine the cost and effectiveness of these treatments from the perspective of the Brazilian National Health Service. A decision analysis model was constructed to assess total direct medical costs (including drug costs, costs of outpatient or inpatient care, ambulance transportation and cost of concomitant medications) of first-line treatment with aPCC or rFVIIa. Clinical outcome and resource utilization data were obtained both retrospectively and prospectively and validated by the consensus of an expert panel of Brazilian haematologists. A total of 103 bleeds in 25 patients were included in the analysis. rFVIIa resolved bleeds more quickly (4.4 h) than aPCC (62.6 h) and was more effective (100% vs. 56.7% respectively). Mean total direct medical costs (from initiation to cessation of bleed) were estimated to be US$13 500 (aPCC) and US$7590 (rFVIIa). Extensive sensitivity analyses confirmed the cost-effectiveness of rFVIIa. Compared with aPCC, rFVIIa was more effective and less expensive when used as first-line treatment for mild-to-moderate bleeding episodes in patients with haemophilia and inhibitors in Brazil. rFVIIa should be considered a first-line treatment for the management of these patients.
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Factor VII/uso terapéutico , Hemofilia A/tratamiento farmacológico , Hemorragia/prevención & control , Adolescente , Adulto , Brasil , Niño , Estudios de Cohortes , Costo de Enfermedad , Factor VII/economía , Factor VIIa , Femenino , Hemofilia A/economía , Hemorragia/economía , Humanos , Masculino , Estudios Prospectivos , Proteínas Recombinantes/economía , Proteínas Recombinantes/uso terapéutico , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: To assess the incremental cost-effectiveness of prophylactic compared with episodic care in boys with severe hemophilia A. SETTING: Eleven U.S. hemophilia treatment centers. METHODS: Charge data from a randomly selected cohort of 70 boys receiving episodic infusions for bleeding events and from all 27 boys receiving infusions prophylactically were collected from documents obtained from the hemophilia treatment centers during a period of approximately 2 years. Published and public sources were used for conversion to cost, lifetime earnings, and earnings losses from disability. A model was constructed for a hypothetical patient from ages 3 to 50 years by means of three infusion scenarios. RESULTS: The cohort receiving prophylactic treatment had fewer bleeding events each year (median, 3 vs 31) but used more concentrate (3323 vs 1015 units/kg per year). Factor VIII concentrate accounted for more than 93% of the cost of both episodic and prophylactic care. Compared with episodic infusion, prophylaxis from ages 3 to 20 years costs $1100 per bleeding event prevented, in comparison with $1380 for prophylaxis from ages 3 to 50 years. The total cost of prophylactic care from ages 3 to 50 years would equal the current total cost of episodic care if the price of the concentrate were decreased by 50%. CONCLUSION: Prophylactic care markedly reduces the number of bleeding events and should prevent joint function impairment, but at substantial cost.