Cost-utility analysis of dupilumab compared with endoscopic sinus surgery in patients with chronic rhinosinusitis with nasal polyps. Evaluation in Colombia, a developing country.

INTRODUCTION: Chronic rhinosinusitis with nasal polyps (CRSwNP) compromises respiratory function, sleep, concentration, work capacity, and quality of life, generating high costs for patients and health systems. The aim of the study was to analyze the cost utility of Dupilumab compared to endoscopic sinus surgery for patients with CRSwNP. RESEARCH DESIGN AND METHODS: We developed a model-based cost-utility analysis from the perspective of the Colombian health system to compare Dupilumab vs. endoscopic nasal surgery in patients with difficult-to-treat CRSwNP. Transition probabilities were extracted from the published literature about CRSwNP, and costing was based on local tariffs. We performed probabilistic sensitivity analysis for outcomes, probabilities, and costs (10.000 Monte Carlo simulations). RESULTS: The cost of dupilumab ($ 142.919) was 7.8 times higher than nasal endoscopic sinus surgery ($ 18.347). In terms of quality-adjusted life years (QALYs), surgery generates better results than Dupilumab: 11.78 vs. 9.05 QALYs. CONCLUSIONS: From the perspective of the health system, endoscopic sinus surgery for the management of CRSwNP is a dominant alternative in all the analyzed scenarios compared to the use of Dupilumab. From a cost-utility point of view, the use of dupilumab should be considered when the patient requires multiple surgeries or when there is a contraindication for surgery performance.

Challenges of Health Technology Assessment in Pluralistic Healthcare Systems: An ISPOR Council Report.

Health technology assessment (HTA) has been growing in use over the past 40 years, especially in its impact on decisions regarding the reimbursement, adoption, and use of new drugs, devices, and procedures. In countries or jurisdictions with "pluralistic" healthcare systems, there are multiple payers or sectors, each of which could potentially benefit from HTA. Nevertheless, a single HTA, conducted centrally, may not meet the needs of these different actors, who may have different budgets, current standards of care, populations to serve, or decision-making processes. This article reports on the research conducted by an ISPOR Health Technology Assessment Council Working Group established to examine the specific challenges of conducting and using HTA in countries with pluralistic healthcare systems. The Group used its own knowledge and expertise, supplemented by a narrative literature review and survey of US payers, to identify existing challenges and any initiatives taken to address them. We recommend that countries with pluralistic healthcare systems establish a national focus for HTA, develop a uniform set of HTA methods guidelines, ensure that HTAs are produced in a timely fashion, facilitate the use of HTA in the local setting, and develop a framework to encourage transparency in HTA. These efforts can be enhanced by the development of good practice guidance from ISPOR or similar groups and increased training to facilitate local use of HTA.

Analysis of the Cost-Effectiveness of Liquid Biopsy to Determine Treatment Change in Patients with Her2-Positive Advanced Breast Cancer in Colombia.

BACKGROUND: Breast cancer is highly prevalent worldwide and leads to high health-care costs. HER2-positive subtype represents 30% of all breast cancers and is associated with a poor prognosis. Patients treated with anti-HER2 therapies frequently develop resistance and require pharmacological treatment change. Liquid biopsy is a minimally invasive and an easily accessible technique, with high sensitivity and specificity, to detect molecular treatment resistance even before the onset of clinical manifestations and can thus be used to reduce unnecessary anti-HER2 treatment costs. OBJECTIVE: To evaluate the cost-effectiveness of using liquid biopsy (ctDNA detection) to determine treatment change in women with HER2-positive advanced breast cancer in Colombia. METHODOLOGY: We performed an economic evaluation using decision tree modeling and deterministic analyses based on literature search for first and second lines of treatment (trastuzumab, pertuzumab, docetaxel, and TDM1); resistance; outcomes; and sensitivity and specificity of tests detecting molecular resistance. The effectiveness was measured using quality-adjusted life year (QALY) score, and costs were obtained from databases with national validity, suppliers, the Colombian Drug Price Information System (SISMED), and local studies. RESULTS: The use of liquid biopsy (ctDNA detection) with conventional treatment was more expensive and less effective than conventional treatment without liquid biopsy (US $177,985.35 and 0.533889206 QALY, respectively). The incremental cost with liquid biopsy was US $7,333.17 and the incremental effectiveness was 0.00042256 QALY relative to the conventional method. CONCLUSION: Including liquid biopsy in the treatment of HER2-positive advanced breast cancer was considered currently inapplicable in Colombia because it was not cost effective. Our results open a window of opportunity to improve the development and implementation of ctDNA testing in Colombia, potentially reducing current costs. More evidence is required on the utility of this test, depending on the financial capacity of Colombia and other countries.

Implementing Health Technology Assessments in Latin America: Looking at the Past, Mirroring the Future. A Perspective from the ISPOR Health Technology Assessment Roundtable in Latin America.

OBJECTIVES: In the last two decades, several countries in Latin America (LA) have shown an interest in developing health technology assessments (HTAs), but the process has not been uniform and has often been challenged by the health systems characteristics and the political or economic idiosyncrasies of these countries. METHODS: This article summarizes the discussions held by the participants at the 40th ISPOR HTA Council Roundtable for LA. An additional literature review was carried out to support some of the concepts included. RESULTS: This article includes a brief description of the implementation of HTA over the last 30 years and then a conceptual analysis using examples of the broader use of HTA to support procurement decisions and risk-sharing agreements, which might play a future role in healthcare priority-setting in LA. CONCLUSIONS: Formerly, HTA processes and methods played important although mostly isolated roles (with drug licensing or reimbursement being examples of this). Nowadays, with more and more innovative technologies and the establishment of value frameworks to support the priority setting in healthcare, HTA features a promising panorama for the health systems sustainability.

Evaluating the centralized purchasing policy for the treatment of hepatitis C: The Colombian CASE.

The high cost of drugs for hepatitis C limits access and adherence to treatment. In 2017, the Colombian health care system decided to design a strategy. It consisted of centralized purchasing, regulations, clinical practice guidelines, and direct observation of the treatment and follow-up of patients. The main objective of this study was to assess the centralized purchasing strategy in Colombia. The study design was a policy implementation assessment. We analyzed the change in prices, the clinical outcomes, and the opinions of stakeholders using data from the Ministry of Health. Additional information about effectiveness came from the Colombian Fund for High-Cost Diseases and semi-structured interviews of the stakeholders. The follow-up was from October, 2017 to October, 2018. The total number of patients reported in the cohort period was 1069. The number that finished 12 weeks of treatment, completed the follow-up for the case closure, and were considered cured through the end of October, 2018 was 563 (53%). The remainder, 506 patients (47%), are currently in treatment. A total of 543 of these treated patients (96%) were cured. After implementing this strategy, the drug prices decreased by more than 90% overall. Before implementation, the total direct cost was $100 102 171.75 dollars. Afterward, the cost was $8 378 747 dollars.

Carga de enfermedad atribuible al uso de tabaco en Colombia y potenciales beneficios sanitarios y económicos del aumento del precio del cigarrillo mediante impuestos / Disease burden attributable to smoking in Colombia and potential economic and health benefits of price increase through taxes

Resumen Objetivo: estimar la carga de enfermedad asociada al consumo de tabaco en Colombia y evaluar el potencial efecto sanitario y económico del aumento de precio en los cigarrillos mediante impuestos. Materiales y métodos: se diseñó un modelo de simulación de Monte Cario de primer orden que incorporó la historia natural, los costos y la calidad de vida de enfermedades relacionadas con el consumo de tabaco en adultos. Se estimó el impacto en la prevalencia de tabaquismo y en la recaudación de diferentes escenarios de aumento de precio a través de impuestos. Resultados: en Colombia cada año mueren 32.088 personas como consecuencia del consumo de cigarrillo y pueden atribuírsele los siguientes porcentajes: el 16% de las muertes cardiovasculares, el 13% de las producidas por accidentes cerebrovasculares, el 77% de las muertes ocasionadas por enfermedad pulmonar obstructiva crónica y el 80% de las muertes por cáncer de pulmón. Las enfermedades relacionadas con el cigarrillo representan un costo directo anual al sistema de salud de más de 4,5 billones de pesos, mientras la recaudación impositiva por la venta de cigarrillos apenas logra cubrir un 10% de este gasto. Un aumento en el precio de los cigarrillos del 50% podría evitar, en un horizonte de 10 años, más de 45.000 muertes y generar recursos por 8 billones por ahorro en gastos sanitarios y aumento de recaudación. Conclusiones: la carga de enfermedad y el costo para el sistema de salud asociados al consumo de tabaco son muy elevados en Colombia. Un aumento del precio de los cigarrillos a través de los impuestos tendría importantes beneficios tanto sanitarios como económicos.

Abstract Objective: to estimate the burden of disease associated with tobacco consumption in Colombia and to evaluate the potential health and economic effect of the price increase in cigarettes through taxes. Materials and methods: to estimate the burden of disease, a first-order Monte Carlo simulation model was designed that incorporated the natural history, costs and quality of life of diseases related to tobacco consumption in adults. A tax model was designed to calculate the impact on the prevalence of smoking and on the collection of different price increase scenarios. Results: according to the proposed model, it can be estimated that in Colombia 26,464 people die every year as a result of cigarette smoking. 13% of cardiovascular deaths, 13% of those caused by strokes, 77% of deaths caused by chronic lung disease and 81 % of deaths from lung cancer can be attributed to their consumption. The diseases related to cigarettes in Colombia represent a direct annual cost of more than 4 billion pesos, while the tax collection from the sale of cigarettes barely covers 10% of this expense. An increase in the price of cigarettes of 50% could prevent more than 30,000 deaths in ten years and generate resources for 7.9 billion savings in health spending and increased collection. Conclusions: the burden of disease and the cost to the health system associated with tobacco use are very high in Colombia. An increase in the price of cigarettes through taxes would have important health and economic benefits for Colombia.

Costo-efectividad de la reanimación cardiopulmonar con el uso del desfibrilador externo automático, comparado con reanimación cardiopulmonar básica, para personas con pérdida de conciencia en espacios de afluencia masiva de público / Cost-effectiveness of cardiopulmonary resuscitation using an automated external defibrillator compared with a basic defibrillator in unconscious patients in crowded public spaces in Colombia

Resumen Objetivo: Estimar la razón de costo-efectividad de la reanimación cardiopulmonar con el uso del desfibrilador externo automático (DEA), comparado con la reanimación cardiopulmonar básica, para la reanimación de personas con pérdida de conciencia en espacios de afluencia masiva de público en Colombia. Métodos: Para estimar los costos y desenlaces de las dos alternativas de comparación, se diseñó un árbol de decisiones en el cual se reflejan los principales desenlaces posterior a la pérdida de conciencia y la reanimación con cualquiera de las dos alternativas. Se asumió la perspectiva del sistema de salud colombiano en un horizonte temporal comprendido entre el momento de la pérdida de conciencia de la persona hasta el ingreso al hospital. Las probabilidades de los eventos se obtuvieron de un meta-análisis de ensayos clínicos y la información de costos de fuentes oficiales y consulta directa a proveedores de DEA en Colombia. Los costos fueron expresados en pesos colombianos de 2016 y la efectividad en muertes evitadas. Se realizaron análisis de sensibilidad determinísticos y probabilísticos para estimar el impacto de la incertidumbre sobre las conclusiones. Resultados: La razón de costo-efectividad de la reanimación cardiopulmonar con DEA fue de $3.267.777 por muerte evitada. La probabilidad de que esta intervención sea costo-efectiva es superior al 90% para un umbral de costo-efectividad superior a 10 millones de pesos. Conclusión: Un programa de reanimación cardiopulmonar con desfibrilación temprana mediante el uso de DEA, en espacios de afluencia masiva de público, es una alternativa costo-efectiva para el sistema de salud colombiano.

Abstract Objective: To estimate the cost-effectiveness of cardiopulmonary resuscitation using an automated external defibrillator (AED) compared with basic cardiopulmonary resuscitation, for the resuscitation of unconscious patients in crowded public spaces in Colombia. Methods: A decision tree was designed in order to estimate the costs and outcomes of the two alternatives. This included the main outcomes after the loss of consciousness and resuscitation by any of the two alternatives. The perspective of the Colombian Health System was adopted in a time scale consisting of the time of loss of consciousness until hospital admission. The probabilities of the events were obtained from a meta-analysis of clinical trials, and the information on costs from official sources and direct consultations with AED providers in Colombia. The costs were expressed in Colombian pesos of 2016, and the effectiveness in deaths prevented. Deterministic and probabilistic sensitivity analyses were performed to estimate the impact of uncertainty on the conclusions. Results: The cost-effectiveness of cardiopulmonary resuscitation with AED was COP $3,267,777 per death avoided. The probability that this intervention would be cost-effective is greater than 90% for cost-effectiveness threshold greater than 10 million Colombian pesos. Conclusion: A cardiopulmonary resuscitation program with early defibrillation using an AED in crowded public spaces is a cost-effective alternative for the Colombian Health System.

Value-Based Pricing in Latin America: How Far Away Are We?

In February and September of 2017, the International Society for Pharmacoeconomics and Outcomes Research Health Technology Assessment Council held roundtables focused on Latin America to discuss health technology assessment best practices, collaboration opportunities, and regional experiences regarding health policies to improve the affordability of and access to healthcare technologies. The access to high-cost technologies, increased social pressure to achieve universal coverage, population aging, and the limits of traditional mechanisms to control costs create political pressure to begin considering other pricing alternatives, including value-based pricing, in Latin America. This article attempts to conceptualize key stakeholders' perceptions of their experiences, opportunities, and barriers to implementing value-based pricing in Latin America.

Opciones en Colombia para la regulación del uso de sistemas electrónicos con o sin dispensación de nicotina: un resumen de evidencias para política (policy brief) / Opciones en Colombia para la regulación del uso de sistemas electrónicos con o sin dispensación de nicotina: un resumen de evidencias para política (policy brief)

Objetivo: El propósito de este resumen de evidencias para política (policy brief) fue sintetizar en un formato amigable, la evidencia de investigación de mejor calidad disponible respecto al uso de sistemas electrónicos con o sin dispensación de nicotina y similares, y sobre los efectos de cuatro opciones de abordaje de regulación seleccionadas por el Ministerio de Salud y Protección Social. Estas intervenciones podrían mejorar lo que actualmente se está haciendo en materia de regulación de sistemas electrónicos con o sin dispensación de nicotina y similares en Colombia, especialmente para la protección de grupos vulnerables como son los niños y adolescentes quienes actualmente pueden acceder a estos dispositivos sin ninguna restricción, exponiéndose a temprana edad a sustancias como la nicotina y el propilenglicol, las cuales están asociadas con cáncer y otras enfermedades. El presente documento da cuenta de cuatro opciones de abordaje en términos de sus beneficios, daños y consideraciones acerca de la implementación, monitoreo, evaluación y equidad: • Opción 1: regulación de los SEAN, los SSSN y similares como productos sucedáneos del tabaco, en el marco de la legislación vigente; • Opción 2: regulación de los SEAN y similares como medicamentos para la cesación tabáquica; • Opción 3: regulación específica para los SEAN, los SSSN y similares como productos de consumo humano; • Opción 4: prohibición total para la fabricación, exportación, importación, comercialización, uso, consumo, publicidad, promoción y patrocinio de los SEAN, los SSSN y similares.

Mapping to Estimate Health-State Utility from Non-Preference-Based Outcome Measures: An ISPOR Good Practices for Outcomes Research Task Force Report.

Economic evaluation conducted in terms of cost per quality-adjusted life-year (QALY) provides information that decision makers find useful in many parts of the world. Ideally, clinical studies designed to assess the effectiveness of health technologies would include outcome measures that are directly linked to health utility to calculate QALYs. Often this does not happen, and even when it does, clinical studies may be insufficient for a cost-utility assessment. Mapping can solve this problem. It uses an additional data set to estimate the relationship between outcomes measured in clinical studies and health utility. This bridges the evidence gap between available evidence on the effect of a health technology in one metric and the requirement for decision makers to express it in a different one (QALYs). In 2014, ISPOR established a Good Practices for Outcome Research Task Force for mapping studies. This task force report provides recommendations to analysts undertaking mapping studies, those that use the results in cost-utility analysis, and those that need to critically review such studies. The recommendations cover all areas of mapping practice: the selection of data sets for the mapping estimation, model selection and performance assessment, reporting standards, and the use of results including the appropriate reflection of variability and uncertainty. This report is unique because it takes an international perspective, is comprehensive in its coverage of the aspects of mapping practice, and reflects the current state of the art.

Costos de la rehidratación oral y nasogástrica comparadas con la rehidratación endovenosa en niños con diarrea en Colombia / Costs of oral and nasogastric rehydration compared to intravenous rehydration in children under 5 years of age with diarrhea in Colombia

RESUMEN Objetivo Evaluar los costos de las terapias de rehidratación oral (TRO) y de rehidratación nasogástrica (TRN) comparadas con la terapia de rehidratación endovenosa (TRE) para corregir la deshidratación por diarrea en niños. Metodología Análisis de minimización de costos desde la perspectiva del Sistema de Salud colombiano comparando TRO (seguida de TRN ante falla de la TRO), con la TRE. El horizonte temporal fue la duración de la rehidratación. La medida de efectividad se extrajo de una revisión sistemática de literatura. Para determinar costos, se construyó un caso típico y un árbol de decisiones, a partir de revisión de guías e historias clínicas, validado con expertos. Los costos unitarios se obtuvieron de bases de datos colombianas. Costos fueron calculados en pesos colombianos (COP) y dólares americanos (USD). Se realizaron análisis de sensibilidad de una y dos vías. Resultados La TRO y la TRE son similares en efectividad para prevenir hospitalización y lograr rehidratación. En el caso base, el costo de la TRO fue $91,221COP (40.5 USD) y para TRE $112,944COP (50.14USD), es decir, un ahorro de $21,723 COP (9.64 USD). En los análisis de sensibilidad por regímenes de aseguramiento y complejidad del hospital, la TRO suele ser la estrategia menos costosa. Discusión Ambas intervenciones son similares en efectividad, pero la TRO, seguida de TRN ante falla de la primera resulta menos costosa que la TRE. La TRO es recomendable como primera opción para corregir la deshidratación. Deberían continuarse esfuerzos por implementar TRO y TRN en los servicios de salud en Colombia.(AU)

ABSTRACT Objective To evaluate the costs of oral rehydration therapy (ORT) and nasogastric rehydration therapy (NRT) compared with intravenous rehydration therapy (IRT) to treat dehydration in children under 5 years of age with diarrhea. Methodology Cost-minimization analysis from the perspective of the Colombian Health System, comparing ORT, (followed by NRT when ORT fails), with IRT. The time horizon was the duration of rehydration. The effectiveness measure was obtained from a systematic review of the literature. To determine costs, a typical case was created based on current guidelines and medical records; this case was validated by experts. Unit costs were obtained from Colombian databases and were provided in Colombian pesos (COP) and US dollars (USD) for 2010. One- and two-way sensitivity analyzes were performed. Results ORT and ERT are similarly effective to prevent hospitalization and to achieve rehydration. In the base case, the expected cost of ORT was $91,221 COP (40.5 USD) and for IRT was $112,944 COP ($50.14 USD), saving $21,723 COP ($9.64 USD) per case. In the sensitivity analyzes by health insurance and hospital level, ORT is often the least costly strategy. Discussion Both interventions are similarly effective, but ORT, followed by NRT when ORT fails, is less costly than IRT. ORT is recommended as the first option to treat dehydration since it is effective and less expensive. Efforts should be continued to implement TRO and NRT in the health services of Colombia.(AU)

[Costs of oral and nasogastric rehydration compared to intravenous rehydration in children under 5 years of age with diarrhea in Colombia]. / Costos de la rehidratación oral y nasogástrica comparadas con la rehidratación endovenosa en niños con diarrea en Colombia.

OBJECTIVE: To evaluate the costs of oral rehydration therapy (ORT) and nasogastric rehydration therapy (NRT) compared with intravenous rehydration therapy (IRT) to treat dehydration in children under 5 years of age with diarrhea. METHODOLOGY: Cost-minimization analysis from the perspective of the Colombian Health System, comparing ORT, (followed by NRT when ORT fails), with IRT. The time horizon was the duration of rehydration. The effectiveness measure was obtained from a systematic review of the literature. To determine costs, a typical case was created based on current guidelines and medical records; this case was validated by experts. Unit costs were obtained from Colombian databases and were provided in Colombian pesos (COP) and US dollars (USD) for 2010. One- and two-way sensitivity analyzes were performed. RESULTS: ORT and ERT are similarly effective to prevent hospitalization and to achieve rehydration. In the base case, the expected cost of ORT was $91,221 COP (40.5 USD) and for IRT was $112,944 COP ($50.14 USD), saving $21,723 COP ($9.64 USD) per case. In the sensitivity analyzes by health insurance and hospital level, ORT is often the least costly strategy. DISCUSSION: Both interventions are similarly effective, but ORT, followed by NRT when ORT fails, is less costly than IRT. ORT is recommended as the first option to treat dehydration since it is effective and less expensive. Efforts should be continued to implement TRO and NRT in the health services of Colombia.

OBJETIVO: Evaluar los costos de las terapias de rehidratación oral (TRO) y de rehidratación nasogástrica (TRN) comparadas con la terapia de rehidratación endovenosa (TRE) para corregir la deshidratación por diarrea en niños. METODOLOGÍA: Análisis de minimización de costos desde la perspectiva del Sistema de Salud colombiano comparando TRO (seguida de TRN ante falla de la TRO), con la TRE. El horizonte temporal fue la duración de la rehidratación. La medida de efectividad se extrajo de una revisión sistemática de literatura. Para determinar costos, se construyó un caso típico y un árbol de decisiones, a partir de revisión de guías e historias clínicas, validado con expertos. Los costos unitarios se obtuvieron de bases de datos colombianas. Costos fueron calculados en pesos colombianos (COP) y dólares americanos (USD). Se realizaron análisis de sensibilidad de una y dos vías. RESULTADOS: La TRO y la TRE son similares en efectividad para prevenir hospitalización y lograr rehidratación. En el caso base, el costo de la TRO fue $91,221COP (40.5 USD) y para TRE $112,944COP (50.14USD), es decir, un ahorro de $21,723 COP (9.64 USD). En los análisis de sensibilidad por regímenes de aseguramiento y complejidad del hospital, la TRO suele ser la estrategia menos costosa. DISCUSIÓN: Ambas intervenciones son similares en efectividad, pero la TRO, seguida de TRN ante falla de la primera resulta menos costosa que la TRE. La TRO es recomendable como primera opción para corregir la deshidratación. Deberían continuarse esfuerzos por implementar TRO y TRN en los servicios de salud en Colombia.

COST-UTILITY ANALYSIS OF PRIMARY PROPHYLAXIS, COMPARED WITH ON-DEMAND TREATMENT, FOR PATIENTS WITH SEVERE HEMOPHILIA TYPE A IN COLOMBIA.

OBJECTIVES: This article presents a cost-utility analysis from the Colombian health system perspective comparing primary prophylaxis to on-demand treatment using exogenous clotting factor VIII (FVIII) for patients with severe hemophilia type A. METHODS: We developed a Markov model to estimate expected costs and outcomes (measured as quality-adjusted life-years, QALYs) for each strategy. Transition probabilities were estimated using published studies; utility weights were obtained from a sample of Colombian patients with hemophilia and costs were gathered using local data. Both deterministic and probabilistic sensitivity analysis were performed to assess the robustness of results. RESULTS: The additional cost per QALY gained of primary prophylaxis compared with on-demand treatment was 105,081,022 Colombian pesos (COP) (55,204 USD), and thus not considered cost-effective according to a threshold of up to three times the current Colombian gross domestic product (GDP) per-capita. When primary prophylaxis was provided throughout life using recombinant FVIII (rFVIII), which is much costlier than FVIII, the additional cost per QALY gained reached 174,159,553 COP (91,494 USD). CONCLUSIONS: using a decision rule of up to three times the Colombian GDP per capita, primary prophylaxis (with either FVIII or rFVIII) would not be considered as cost-effective in this country. However, a final decision on providing or preventing patients from primary prophylaxis as a gold standard of care for severe hemophilia type A should also consider broader criteria than the incremental cost-effectiveness ratio results itself. Only a price reduction of exogenous FVIII of 50 percent or more would make primary prophylaxis cost-effective in this context.

Determinantes de los costos de la atención y la rehabilitación de personas lesionadas en accidentes de tránsito en Medellín, Colombia / Determinants of the Cost of Care and Rehabilitation of People Injured in Traffic Accidents in Medellin, Colombia / Determinantes dos custos de atendimento e reabilitação de pessoal lesado em acidentes de trânsito em Medellín, Colômbia

Resumen Objetivo: estimar los determinantes de los costos de atención y rehabilitación de personas lesionadas en accidentes de tránsito en Medellín, Colombia. Materiales y métodos: estudio de seguimiento a un año de 483 pacientes atendidos por lesiones moderadas y graves. Se incluyeron costos médicos, calculados a partir de los sistemas de facturación de los hospitales, y costos indirectos, asociados a la incapacidad para pacientes y cuidadores. Los determinantes del costo total se estimaron mediante un modelo lineal generalizado. Resultados: los costos de los pacientes graves fueron en promedio USD $2152 mayores que los de pacientes con lesiones moderadas. Quienes ingresaron a unidades de cuidados intensivos y especiales generaron costos adicionales de USD $29 362 y USD $5746 con respecto a quienes no lo hicieron. Los costos indirectos ascendieron al 3 % del costo total. Conclusiones: la gravedad de la lesión y el tipo de atención fueron los que más afectaron los costos de atención y rehabilitación.

Abstract Objective: estimating the determinants of the costs of care and rehabilitation of people injured in traffic accidents in Medellin, Colombia. Materials and Methods: follow-up study for a year on 483 patients treated due to moderate and severe injuries. We included medical costs calculated based on the hospital billing systems and indirect costs associated to the incapacity for patients and caregivers. The determinants of the total cost were estimated by means of a generalized linear model. Results: the costs for severely injured patients were, on average, higher by US $2,152 than those of patients with moderate injuries. Those who were interned in the intensive and special care units generated additional costs amounting to US $29,362 and US $5,746 in comparison to those who were not interned there. Indirect costs amounted to 3% of the total cost. Conclusions: the severity of the injuries and the type of care were the factors that influenced the most the cost of care and rehabilitation.

Resumo Objetivo: estimar as determinantes de custos de atendimento e reabilitação de pessoal leso em acidentes de trânsito em Medellín, Colômbia. Materiais e métodos: estudo de acompanhamento durante um ano de 483 pacientes atendidos por lesões moderadas e críticas. Incluíram-se custos médicos, calculados a partir dos sistemas de faturação dos hospitais e custos indiretos, associados à incapacidade para pacientes e cuidadores. As determinantes do custo total foram estimadas mediante modelo lineal generalizado. Resultados: os custos dos pacientes críticos foram USD $2152 em media, superiores aos de pacientes com lesões moderadas. Aqueles que ingressaram a unidades de tratamento intensivo e especial geraram custos adicionais de USD $29 362 e USD $5746 no que diz respeito de aqueles que não. Os custos indiretos ascenderam a 3% do custo total. Conclusões: a gravidade da lesão e o tipo de atendimento foram os que mais afetaram os custos de atendimento e reabilitação.

Análisis de costo-efectividad de dabigatran, rivaroxaban y apixaban comparado con warfarina para prevención de fenómenos tromboembólicos e isquémicos en pacientes adultos con fibrilación auricular no valvular en Colombia / Cost-effectiveness analysis of dabigatran, rivaroxaban, and apixaban compared to warfarin for prevention of thromboembolic and ischemic events in adult patients with non-valvular atrial fibrillation in Colombia

Problema de investigación: Calcular los costos y la efectividad esperada de dabigatran, rivaroxaban y apixaban, comparado con warfarina, para prevención de fenómenos tromboembólicos e isquémicos en pacientes adultos con fibrilación auricular no valvular en Colombia. Tipo de evaluación económica: Evaluación de costo-efectividad. Población objetivo: Pacientes adultos con fibrilación auricular no valvular en Colombia, análisis del subgrupo de pacientes en falla. Intervención y comparadores: Dabigatran 110 mg y 150 mg, rivaroxaban y apixaban, comparado con warfarina. Horizonte temporal: Tiempo trascurrido entre diagnóstico y expectativa de vida. Perspectivas: Sistema general de Seguridad\tSocial en salud de Colombia. Tasa de descuento: En el caso base se empleó una tasa de descuento común tanto a los costos como a los desenlaces en salud, equivalente al 5% anual. Adicionalmente, se realizaron análisis de sensibilidad de 0 %, 3,5 %, 7 % y 12 %. Estructura del modelo: Modelo de Markov. Fuentes de datos de efectividad y seguridad: \r\nRevisiones sistemáticas de literatura, de acuerdo a la población y tecnologías de la pregunta de investigación. Desenlaces y valoración: Años de Vida Ajustados por Calidad (AVAC). Costos incluidos: Costos directos del tratamiento de acuerdo a las alternativas evaluadas y seguimiento a los pacientes. Fuentes de datos de costos: Los medicamentos fueron costeados con la información del SISMED, el costo de los procedimientos fue estimado a partir de los valores contenidos en el Manual Tarifario ISS2001 + 30%. Resultados del caso base: Los nuevos anticoagulantes orales son más costosos pero más efectivos que el tratamiento con warfarina. La relación de costo-efectividad incremental oscila entre $ 74.462.000 para dabigatran 150 mg y $ 97.501.541 para apixaban y para dabigatran 110 mg es de 72.107.742. Es decir, a los precios actuales, estas no serían alternativas costo-efectivas para un umbral equivalente a 3 veces el PIB per cápita. Análisis de sensibilidad: Los resultados del caso base son sensibles a cambios en el precio de los nuevos anticoagulantes y las probabilidades de ACV isquémico y sangrado. A partir de los resultados del análisis de sensibilidad se concluye que para que los nuevos anticoagulantes orales sean costo ­ efectivos, es necesaria una reducción del precio de los nuevos anticoagulantes orales. Conclusiones y discusión: Los resultados de esta evaluación muestran que desde la perspectiva del Sistema General de Seguridad Social de Colombia, los nuevos anticoagulantes orales dabigatran, apixaban y rivaroxaban, son más efectivos que warfarina, en el esquema de prescripción habitual, para la prevención de eventos tromboembólicos e isquémicos en pacientes adultos iguales o mayores a 60 años con diagnóstico de fibrilación auricular no valvular sin falla renal y con falla renal, pero no son estrategias costo-efectivas, a los precios actuales.(AU)

Cost-effectiveness analysis of ticagrelor compared to clopidogrel for the treatment of patients with acute coronary syndrome in Colombia / Análisis de costo-efectividad del ticagrelor en comparación con el clopidogrel para el tratamiento de pacientes con síndrome coronario agudo en Colombia

Introduction: Acute coronary syndrome is one of the most frequent medical emergencies in developing countries. Objective: To determine, from the perspective of the Colombian health system, the cost-effectiveness of ticagrelor compared to clopidogrel for the treatment of patients with acute coronary syndrome. Materials and methods: We conducted a cost-effectiveness analysis from the perspective of the Colombian health system comparing ticagrelor and clopidogrel for the treatment of patients with acute coronary syndrome. To estimate the expected costs and outcomes, a Markov model was constructed in which patients could remain stable without experiencing new cardiovascular events, suffer from a new event, or die. For the baseline case, a 10-year time horizon and a discount ratio of 3% for costs and benefits were adopted. The transition probabilities were extracted from the PLATO (Platelet Inhibition and Patient Outcomes) clinical trial. Vital statistics were drawn from the Departmento Administrativo Nacional de Estadística (DANE) and additional information from Colombian patients included in the Access registry. To identify and measure resource use, a standard case was built by consulting guidelines and protocols. Unit costs were obtained from Colombian rate lists. A probabilistic sensitivity analysis was conducted in which costs were represented by a triangular distribution, and the effectiveness through a beta distribution. Results: In the base case, the additional cost per quality-adjusted life-year gained with ticagrelor was COP$ 28,411,503. The results were sensitive to changes in the time horizon and the unit cost of clopidogrel. For a willingness-to-pay equivalent to three times the Colombian per capita gross domestic product, the probability of ticagrelor being cost-effective was 75%. Conclusions: Ticagrelor is a cost-effective strategy for the treatment of patients with acute coronary syndrome in Colombia.

Introducción. El síndrome coronario agudo es una de las emergencias médicas más frecuentes en los países en desarrollo. Objetivo. Determinar, desde la perspectiva del sistema de salud colombiano, la relación de costo-efectividad del ticagrelor comparado con el clopidogrel para el tratamiento de pacientes con síndrome coronario agudo. Materiales y métodos. Se hizo un análisis de costo-efectividad desde la perspectiva del sistema de salud colombiano, comparando el ticagrelor y el clopidogrel para el tratamiento de pacientes con síndrome coronario agudo. Para estimar los costos y resultados esperados de las dos alternativas, se construyó un modelo de Markov en el cual los pacientes podían permanecer estables sin experimentar nuevos eventos cardiovasculares, sufrir de un nuevo evento coronario o morir. Para el caso de base, se adoptó un horizonte temporal de 10 años y una tasa de descuento de 3 % para los costos y beneficios. Las probabilidades de transición se extrajeron del estudio Platelet Inhibition and Patient Outcomes , PLATO. Las estadísticas vitales se consultaron en informes del Departamento Administrativo Nacional de Estadística (DANE) y los parámetros adicionales del modelo se basaron en la información de los pacientes colombianos incluidos en el registro en Access. Para identificar y medir el uso de recursos, se construyó un caso estándar a partir de guías y protocolos. Los costos unitarios se obtuvieron de manuales tarifarios colombianos. Se hizo un análisis de sensibilidad probabilístico en el que los costos se representaron por una distribución triangular y, las probabilidades de transición, mediante una distribución beta. Resultados. En el caso de base, el costo adicional por años de vida ajustados por calidad ganados con el ticagrelor fue de COP$ 28´411.503. Los resultados fueron sensibles a los cambios en el horizonte temporal y al costo unitario del clopidogrel. Para un umbral de costo-efectividad equivalente a tres veces el producto interno bruto per cápita de Colombia, la probabilidad de que el ticagrelor fuera costo-efectivo fue de 75 %. Conclusiones. El ticagrelor es una estrategia costo-efectiva para el tratamiento de los pacientes con síndrome coronario agudo en Colombia.

Análisis de costo efectividad de prasugrel, comparado con clopidogrel para pacientes con síndrome coronario agudo sometidos a intervención coronaria percutánea en Colombia / Analysis of cost effectiveness of prasugrel compared with clopidogrel for patients with acute coronary syndrome undergoing percutaneous coronary intervention in Colombia

Objetivo: determinar, desde la perspectiva del sistema de salud colombiano, la relación de costo-efectividad del prasugrel comparado con clopidogrel, para el tratamiento de pacientes adultos con síndrome coronario agudo. Material y métodos: se construyó un modelo de Markov con ciclos anuales en el cual los pacientes pueden permanecer sin experimentar nuevos eventos cardiovasculares, sufrir un nuevo evento o morir. En el caso base se adoptó un horizonte temporal de 10 años y una tasa de descuento de 3%. Las probabilidades de transición se extrajeron del ensayo clínico TRITON-TIMI 38, de las estadísticas vitales del Departamento Nacional de Estadística y de la información de los pacientes colombianos del registro ACCESS. Para identificar y medir el uso de recursos se diseñó un caso típico a partir de la revisión de guías y protocolos; para la valoración se emplearon manuales tarifarios colombianos. Se realizaron análisis de sensibilidad determinísticos y probabilísticos. Resultados: en el caso base, el costo por año de vida ajustado por calidad ganado con prasugrel es $79 987 695 pesos colombianos. Los resultados son sensibles a cambios en el horizonte temporal y al costo del clopidogrel. Bajo un umbral de disposición a pagar de tres veces el PIB per cápita colombiano, la probabilidad de que el prasugrel sea costo efectivo es 7%. Conclusiones: la decisión respecto a la inclusión del prasugrel en el tratamiento de pacientes con síndrome coronario agudo, sometidos a intervención coronaria percutánea depende fundamentalmente del costo del clopidogrel que el decisor considere relevante para realizar la comparación. (Acta Med Colomb 2015; 40: 310-317).

Objective: to determine the cost-effectiveness relation of prasugrel compared with clopidogrel for the treatment of adult patients with acute coronary syndrome from the perspective of Colombian health system. Material and methods: a Markov model with annual cycles in which patients can remain without experiencing new cardiovascular events, have a new event or die, was built. In the base case a time horizon of 10 years and a discount rate of 3% was adopted. Transition probabilities were taken from the clinical trial TRITON-TIMI 38, of vital statistics from the National Department of Statistics and from the information of Colombian patients in ACCESS registry. To identify and measure the use of resources, a typical case was designed from the review of guidelines and protocols; Colombian tariff manuals were used for assessment. Deterministic and probabilistic sensitivity analyzes were performed. Results: in the base case, the cost per year of quality-adjusted life gained with prasugrel is $ 79,987,695 Colombian pesos. The results are sensitive to changes in the timeframe and cost of clopidogrel. Under a threshold willingness to pay three times the per capita GDP of Colombia, the probability that prasugrel may be cost-effective, is 7%. Conclusions: the decision on the inclusion of prasugrel in the treatment of patients with acute coronary syndrome undergoing percutaneous coronary intervention depends mainly on the cost of clopidogrel that the decision maker considers relevant to perform the comparison. (Acta Med Colomb 2015; 40: 310-317).

Cost-effectiveness analysis of zinc supplementation for treatment of acute diarrhea in children younger than 5 years in Colombia.

OBJECTIVE: The objective of this study was to determine the cost-effectiveness of zinc supplementation for the treatment of acute diarrhea (AD) in children younger than 5 years in Colombia. METHODS: The cost-effectiveness analysis was performed from the perspective of the Colombian health system. The standard treatment with the addition of zinc was compared with the standard treatment without zinc in children younger than 5 years. The time horizon was 1 month. Effectiveness was extracted from a systematic review of literature. The specific data for Colombia were taken from local databases and observational studies. To determine the costs, a typical case was constructed by reviewing guidelines and medical records and validated by experts. To evaluate the resources consumed, Colombian tariff manuals were used. Costs were stated in Colombian pesos (COP) and US dollar (USD) for 2010. Deterministic sensitivity analysis was performed to evaluate the impact of changes in cost and effectiveness of the strategies on the results from the model. RESULTS: The results from the model indicate that zinc supplementation is a dominant strategy; it is less costly and more effective than standard treatment without zinc (reduction of $15,210 COP [8.14 USD] per child). The results are sensitive to changes in the probability of hospitalization and of persistent diarrhea. CONCLUSIONS: Zinc for the treatment of AD is a highly cost-effective strategy and is recommended for inclusion in the benefit plan of the Colombian health system. This intervention is more cost-effective in children with a higher risk of persistent diarrhea and hospitalization.

Cost-effectiveness analysis of ticagrelor compared to clopidogrel for the treatment of patients with acute coronary syndrome in Colombia.

INTRODUCTION: Acute coronary syndrome is one of the most frequent medical emergencies in developing countries. OBJECTIVE: To determine, from the perspective of the Colombian health system, the cost-effectiveness of ticagrelor compared to clopidogrel for the treatment of patients with acute coronary syndrome. MATERIALS AND METHODS: We conducted a cost-effectiveness analysis from the perspective of the Colombian health system comparing ticagrelor and clopidogrel for the treatment of patients with acute coronary syndrome. To estimate the expected costs and outcomes, a Markov model was constructed in which patients could remain stable without experiencing new cardiovascular events, suffer from a new event, or die. For the baseline case, a 10-year time horizon and a discount ratio of 3% for costs and benefits were adopted. The transition probabilities were extracted from the PLATO (Platelet Inhibition and Patient Outcomes) clinical trial. Vital statistics were drawn from the Departmento Administrativo Nacional de Estadística (DANE) and additional information from Colombian patients included in the Access registry. To identify and measure resource use, a standard case was built by consulting guidelines and protocols. Unit costs were obtained from Colombian rate lists. A probabilistic sensitivity analysis was conducted in which costs were represented by a triangular distribution, and the effectiveness through a beta distribution. RESULTS: In the base case, the additional cost per quality-adjusted life-year gained with ticagrelor was COP$ 28,411,503. The results were sensitive to changes in the time horizon and the unit cost of clopidogrel. For a willingness-to-pay equivalent to three times the Colombian per capita gross domestic product, the probability of ticagrelor being cost-effective was 75%. CONCLUSIONS: Ticagrelor is a cost-effective strategy for the treatment of patients with acute coronary syndrome in Colombia.

Análisis de costo efectividad de ondansetrón para el tratamiento del vómito en niños menores de cinco años con gastroenteritis en Colombia.

INTRODUCTION: Ondansetron reduces hospitalization rates for diarrhea and vomiting in children, but is not yet routinely used. OBJECTIVE: To estimate from a social perspective the relative cost-effectiveness of ondansetron for the treatment of vomiting in children with gastroenteritis and at risk of dehydration in Colombia. METHODS: Cost-effectiveness analysis from a social perspective, including direct medical costs and costs for caregivers. With a decision tree we compared costs and health outcomes of usual treatment without antiemetic to usual treatment plus ondansetron in children under 5 years with gastroenteritis and vomiting. Effectiveness of intervention was measured as reduction in hospitalization rates, and the time horizon of the model was the episode. Probabilities were obtained from clinical trials and systematic reviews, measurement of resources use was based on protocols and expert opinions, while unit costs were obtained from Colombian tariff manuals. We performed a survey to estimate indirect costs for caregivers (n=81) that included questions about wage loss, transportation, meals expenditures and other out-of-pocket payments. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Usual treatment plus ondansetron is a dominant strategy compared to usual treatment without antiemetic yielding fewer hospitalizations and saving $44.562 Colombian pesos (23,98USD) per episode. Ondansetron was dominant in 98,91% of simulations of the probabilistic analysis. CONCLUSIONS: Ondansetron is a dominant intervention that reduces hospitalization rates and costs for health system and caregivers. We recommend assessing the inclusion of this drug in the Colombian Health Benefit Plan for the treatment of gastroenteritis in children under 5 years.