[Cost-effectiveness analysis of a vaccine for Helicobacter pylori in southern Europe]. / Análisis coste-efectividad de una vacuna para Helicobacter pylori en el sur de Europa.

OBJECTIVE: There is sufficient evidence on the feasibility of a vaccine to prevent Helicobacter pylori infection. Modeling studies in low prevalence environments report a very probable long-term cost-effectiveness. The objective of this study was to quantify its efficiency in a local context. METHODS: The evolution of a cohort of newborns was simulated through a compartmental model representing a series of clinical situations regarding H. pylori infection and related diseases. The model was run under the assumption of both vaccination in the first year of life and no intervention. The time horizon was set as equivalent to the life expectancy and the perspective of the health system was taken into account. RESULTS: Vaccination against H. pylori would cost an average of €2,168/person more than no intervention. This would yield an average additional 0.32 quality-adjusted life years gained (QALY), which would entail an incremental cost-effectiveness ratio (ICER) of €7,196/QALY. For a willingness to pay of €24,506/QALY, 99.96% of the simulations were cost-effective at eighty-four years old. This threshold was crossed thirty years after vaccination. The variables that carried the most weight in explaining the variability of the ICER were, in this order, vaccine effectiveness, the incidence of infection in young children, and the price of the vaccine. Vaccination would cease to be cost-effective with a price greater than €3,634/dose or with effective population coverage less than 11%. CONCLUSIONS: When implemented in an environment with the epidemiological and economic characteristics of Southern Europe, a prophylactic vaccination against H. pylori would be cost-effective in the long run.

OBJECTIVE: Existen pruebas de la factibilidad de una vacuna para prevenir la infección por Helicobacter pylori. Modelizaciones en entornos de baja prevalencia informan de una muy probable coste-efectividad a largo plazo. El objetivo de este estudio fue cuantificar su eficiencia en un contexto local. METHODS: Se simuló la evolución de una cohorte de nacidos a través de un modelo compartimental representativo de varios estados clínicos en relación a la infección por H. pylori. Se ejecutó dicho modelo bajo las premisas de vacunación en el periodo de lactante y de no intervención. El horizonte temporal fue equivalente a la esperanza de vida y se tuvo en cuenta la perspectiva del sistema de salud. RESULTS: La vacunación frente a H. pylori costaría de media 2.168 €/persona más que la no intervención. Con ello se obtendrían 0,32 años de vida ganados ajustados por calidad (AVAC), lo que implicaría una razón de coste-efectividad incremental (RCEI) media de 7.196 €/AVAC. Para una disposición a pagar de 24.506 €/AVAC, el 99,96% de las simulaciones resultaron coste-efectivas al alcanzar el horizonte temporal y se cruzó dicho umbral a partir de los treinta años de la vacunación. Las variables que más peso tuvieron para explicar la variabilidad de la RCEI fueron, en este orden, la efectividad vacunal, la incidencia de la infección en la primera infancia y el precio de la vacuna. La vacunación dejaría de ser coste-efectiva con un precio mayor de 3.634€/vial o con una cobertura poblacional efectiva menor del 11%. CONCLUSIONS: Una vacunación frente a la infección por H. pylori administrada en la infancia sería coste-efectiva a largo plazo en un entorno con las características epidemiológicas y económicas del sur de Europa.

Análisis coste-efectividad de una vacuna para Helicobacter pylori en el sur de Europa / Cost-effectiveness analysis of a vaccine for Helicobacter pylori in southern Europe

Fundamentos: existen pruebas de la factibilidad de una vacuna para prevenir la infección por helicobacter pylori. Modelizacio-nes en entornos de baja prevalencia informan de una muy probable coste-efectividad a largo plazo. El objetivo de este estudio fue cuantificar su eficiencia en un contexto local.métodos: se simuló la evolución de una cohorte de nacidos a través de un modelo compartimental representativo de varios estados clínicos en relación a la infección por h. Pylori. Se ejecutó dicho modelo bajo las premisas de vacunación en el periodo de lactante y de no intervención. El horizonte temporal fue equivalente a la esperanza de vida y se tuvo en cuenta la perspectiva del sistema de salud.resultados: la vacunación frente a h. Pylori costaría de media 2.168 €/persona más que la no intervención. Con ello se obten-drían 0,32 años de vida ganados ajustados por calidad (avac), lo que implicaría una razón de coste-efectividad incremental (rcei) media de 7.196 €/avac. Para una disposición a pagar de 24.506 €/avac, el 99,96% de las simulaciones resultaron coste-efectivas al alcanzar el horizonte temporal y se cruzó dicho umbral a partir de los treinta años de la vacunación. Las variables que más peso tuvieron para explicar la variabilidad de la rcei fueron, en este orden, la efectividad vacunal, la incidencia de la infección en la primera infancia y el precio de la vacuna. La vacunación dejaría de ser coste-efectiva con un precio mayor de 3.634€/vial o con una cobertura poblacional efectiva menor del 11%.conclusiones: una vacunación frente a la infección por h. Pylori administrada en la infancia sería coste-efectiva a largo plazo en un entorno con las características epidemiológicas y económicas del sur de europa.(AU)

Background: there is sufficient evidence on the feasibility of a vaccine to prevent helicobacter pylori infection. Modeling studies in low prevalence environments report a very probable long-term cost-effectiveness. The objective of this study was to quantify its efficiency in a local context.methods: the evolution of a cohort of newborns was simulated through a compartmental model representing a series of clinical situations regarding h. Pylori infection and related diseases. The model was run under the assumption of both vaccination in the first year of life and no intervention. The time horizon was set as equivalent to the life expectancy and the perspective of the health system was taken into account.results: vaccination against h. Pylori would cost an average of €2,168/person more than no intervention. This would yield an average additional 0.32 quality-adjusted life years gained (qaly), which would entail an incremental cost-effectiveness ratio (icer) of €7,196/qaly. For a willingness to pay of €24,506/qaly, 99.96% of the simulations were cost-effective at eighty-four years old. This threshold was crossed thirty years after vaccination. The variables that carried the most weight in explaining the variability of the icer were, in this order, vaccine effectiveness, the incidence of infection in young children, and the price of the vaccine. Vaccination would cease to be cost-effective with a price greater than €3,634/dose or with effective population coverage less than 11%.(AU)

Evaluación de desenlaces percibidos por pacientes adultos con incontinencia que utilizan pañales desechables en Colombia

R E S U M E N Introducción: La incontinencia es un problema de salud frecuente que afecta la calidad de vida de las personas, limitando la autonomía y reduciendo la autoestima. Entre el 36-54% de las personas con incontinencia severa pueden presentar deterioro moderado a extremo en su cotidianidad y confianza. Objetivo: Evaluar la percepción de pacientes adultos con incontinencia urinaria y/o incontinencia fecal severa frente al uso de los pañales desechables. Metodología: Estudio observacional de cohorte, en pacientes afiliados a programas de atención domiciliaria usuarios de tres marcas comerciales de pañales. La percepción se evaluó con el instrumento ICIQ-PadPROM®. Resultados: Participaron I79 pacientes, 68% mujeres con edad promedio 7I,9 años. El dominio de diseño de pañal y efecto físico fue el que presentó mejor calificación, siendo el pañal Content Medical® el mejor calificado, con diferencias significativas principalmente frente al grupo de Rely®; en el ítem de filtraciones del dominio carga del pañal, Content Medical® presenta mejor percepción comparado contra los otros grupos (p<0.00I). Conclusiones: Los pacientes tienen adecuada percepción de las marcas de pañal; sin embargo, los que utilizaron Content Medical® refieren mayor percepción favorable.

Introduction: Incontinence is a frequent health problem that affects the quality of life of people, limiting autonomy and reducing self-esteem. Between 36-54% of people with severe incontinence may have moderate to extreme deterioration in their daily lives and confidence. Objective: To evaluate the perception of adult patients with urinary incontinence and/or severe fecal incontinence compared to the use of disposable diapers. Methodology: Observational cohort study in patients affiliated in home care programs using three commercial brands of diapers. Perception was assessed with the ICIQ-PadPROM® instrument. Results: I79 patients participated, 68% were women and an average age of 7I.9 years. The domain of diaper design and physical effect was the one that presented the best rating, with the Content Medical® diaper being the best qualified, with significant differences mainly compared to the Rely® group; in the leakage item of the diaper loading domain, Content Medical® presents better perception compared to the other groups (p<0.00I). Conclusions: Patients have adequate perception of diaper brands; however; those who used Content Medical® reported a higher favorable perception.

Introdução: A incontinência é um problema de saúde comum que afeta a qualidade de vida das pessoas, limitando a autonomia e reduzindo a auto-estima. Entre 36-54% das pessoas com incontinência severa podem ter uma deficiência moderada a extrema em sua vida diária e confiança. Objetivo: Avaliar a percepção de pacientes adultos com incontinência urinária e/ou incontinência fecal grave em relação ao uso de fraldas descartáveis. Metodologia: Estudo de coorte observacional em pacientes afiliados a programas de cuidados domiciliares utilizando três marcas comerciais de fraldas. A percepção foi avaliada com o instrumento ICIQ-PadPROM®. Resultados: I79 pacientes participaram, 68% mulheres com uma média de idade de 7I,9 anos. O domínio de design e efeito físico das fraldas foi o mais bem avaliado, sendo a fralda Content Medical® a mais bem avaliada, com diferenças significativas principalmente em relação ao grupo Rely®; no item vazamento do domínio de carga de fraldas, Content Medical® apresentou melhor percepção em comparação com os outros grupos (p<0,00I). Conclusões: Os pacientes têm uma percepção adequada das marcas de fraldas; entretanto, aqueles que usaram Content Medical® relatam uma percepção mais favorável.

Cost-effectiveness analysis of the human recombinant epidermal growth factor in the management of patients with diabetic foot ulcers.

Introduction: Diabetic foot ulcers are one of the most frequent complications of diabetes; such ulcers cause an increase in the costs of the health care of the diabetic patient and can even cause disability due to amputation in the patient. Although a proportion of patients achieve a spontaneous closure of ulcers, others require medical or surgical treatment. Objective: To determine the cost-effectiveness of the intra- and perilesional application of recombinant human epidermal growth factor (rhEGF), as opposed to conventional therapy for the management of patients diagnosed with Wagner's 3 or 4 diabetic foot ulcer in Colombia. Methodology: Using a Markov model, the process of care of a diabetic patient with diagnosis of Wagner's 3 or 4 ulcer receiving conventional treatment, or intra- and perilesional rhEGF, is configured. The evaluation cycles of the treatments are weekly over a 5-year horizon and the outcomes evaluated are quality-adjusted life years (QALYs) and the number of amputations avoided by each treatment scheme, in addition to the total costs for treatments. Results: For the analysed base case, in the outcome of amputations, it was found that the factor presents 39 fewer amputations, in a cohort of 100 patients, compared with conventional treatment. Likewise, QALYs are 0.65 more with the use of rhEGF in an average patient. The estimated cost-utility ratio for the base case would be below the threshold established for Colombia. Conclusions: The intra- and perilesional application of rhEGF is a more effective therapeutic option than conventional therapy in the treatment of patients with Wagner's 3 or 4 diabetic foot ulcers and is cost-effective, taking as an outcome the QALYs for Colombia from the perspective of the health system.

Public health impact and economic benefits of quadrivalent influenza vaccine in Latin America.

Annual trivalent influenza vaccines (TIV) containing 2 A strains and one B lineage have been recommended for the prevention of influenza in most of Latin American countries. However, the circulation of 2 B lineages (Victoria and Yamagata) and difficulties in predicting the predominating lineage have led to the development of quadrivalent influenza vaccines (QIV), including both B lineages. Thus, the objective was to estimate the public health impact and influenza-related costs if QIV would have been used instead of TIV in 3 Latin American countries. We used a static model over the seasons 2010-2014 in Brazil, 2007-2014 in Colombia and 2006-2014 in Panama, focusing on population groups targeted by local vaccination recommendations: young children, adults with risk factors and the elderly. In Brazil, between 2010 and 2014, using QIV instead of TIV would have avoided US$ 6,200 per 100,000 person-years in societal costs, based on 168 influenza cases, 89 consultations, 3.2 hospitalizations and 0.38 deaths per 100,000 person-years. In Colombia and Panama, these would have ranged from US$ 1,000 to 12,700 (based on 34 cases, 13-25 consultations, 0.6-8.9 hospitalizations and 0.04-1.74 deaths) and from US$ 3,000 to 33,700 (based on 113 cases, 55-82 consultations, 0.5-27.8 hospitalizations and 0.08-6.87 deaths) per 100,000 person-years, respectively. Overall, the broader protection offered by QIV would have reduced the influenza humanistic and economic burden in the 3 countries. Despite the lack of local data leading to several extrapolations, this study is the first to give quantitative estimates of the potential benefits of QIV in Latin America.

Análisis de costo-utilidad del uso de detemir en pacientes con diabetes tipo 2 / Cost-Utility Analysis of the Use of Detemir in Patients with Type 2 Diabetes / Análise custo-efetividade para o uso do detemir em pacientes com Diabetes tipo 2

Objetivo: realizar un análisis de costo-utilidad para evaluar el tratamiento con las diferentes opciones de insulina en pacientes diabéticos tipo 2. Metodología: partiendo del análisis realizado previamente por Romero et al., se actualizó la información y se incluyó un análisis específico para calidad de vida. El modelo de Markov simuló pacientes tratados con insulina NPH, detemir o glargina. Se consideraron los eventos de hipoglucemia más sus complicaciones. Los costos corresponden al precio máximo de regulación por dosis. Los costos de eventos son tomados de registros del sistema de información de transacciones de entidades prestadoras de salud al año 2014. Resultados: los avac con detemir se calculan en 2,604, en comparación con 2,545 con glargina y 2,533 con NPH. Los análisis de sensibilidad muestran dominancia de detemir. Conclusiones: detemir es una opción favorable por su seguridad, efectividad y costo, demostrando beneficios medidos en avac sobre sus comparadores.

Objective: Performing a cost-utility analysis to assess the treatment with different insulin options in patients with Type 2 Diabetes. Methodology: Based on the analysis previously performed by Romero et al., we updated the information and included an specific analysis for the quality of life. The Markov model simulated patients treated with NPH, determir, or glargine insulin. We considered the hypoglycemia events and their complications. The costs corresponded to the maximum regulated price per dose. The event costs were taken from the transaction information system records of health care providers in 2014. Results: The qaly with detemir are calculated as 2.604, compared to 2.545 with glargine, and 2.533 con NPH. The sensitivity analysis show determir dominance. Conclusions: Detemir is a favorable option due to its safety, effectiveness, and cost, with proven benefits measured in qaly over the other items being compared.

Objetivo: realizar análise de custo-efetividade para avaliar o tratamento com as diferentes opcoes de insulina em pacientes diabéticos tipo 2. Metodologia: partindo da análise realizada previamente por Romero et al., foi atualizada a informação e incluiu-se análise específica para qualidade de vida. O modelo de Markov simulou pacientes tratados com insulina NPH, detemir ou glargina. Eventos de hipoglicemia foram considerados além das complicares. Os custos correspondem ao preco máximo de regulamentação por dose. Os custos de eventos sao tirados de registos do sistema de informação de transações de entidades prestadoras de saúde no ano 2014. Resultados: os avac do detemir calculam-se em 2,604, em comparação com 2,545 da glargina e 2,533 do NPH. As análises de sensibilidade demostram dominancia de detemir. Conclusoes: detemir é uma opcao favorável por sua seguranca, efetividade e custo, demostrando beneficios medidos em avac sobre os comparadores.

Impacto en el acceso a medicamentos en la población colombiana después de la actualización del plan de beneficios en el 2012 / Impact on the Access to Medication in Colombian Population after the Benefit Plan Update in 2012 / Impacto no acesso a remédios na populagáo colombiana após a atualizagáo do plano de beneficios no 2012

Objetivo: evaluar los cambios en la demanda de servicios en salud, luego de la actualización del plan de beneficios de Colombia, entre los años 2010 y 2012. Métodos: estudio tipo descriptivo y explicativo, donde se evalúa el uso de tecnologías sanitarias antes y después de la actualización del Plan Obligatorio de Salud. Se tomaron las dispensaciones de medicamentos entre el 2010 y el 2012 del Sistema de Información de Precios de Medicamentos. Para valorar los cambios se construyó una escala de valoración de cambios porcentuales. Resultados: se evidenciaron cambios en el comportamiento de la demanda de servicios. Como se esperaba, la actualización del Plan de Beneficios representa para los pacientes mayor acceso a las nuevas tecnologías, medido a través del mayor uso de tecnologías nuevas. Conclusión: la actualización del plan de beneficios mejoró el acceso de los pacientes a una gran parte de los servicios de salud.

Objective: Assessing the changes in the demand of health services after the update of the benefit plan in Colombia, during 2010 and 2012. Methods: Descriptive and Explanatory type study, where the use of healthcare technologies before and after the update of the Compulsory Health Plan is assessed. We took the drug dispensations between 2010 and 2012 from the Drug Price Information System. To assess the changes, we made an evaluation scale of percentage changes. Results: We found evidence of changes in the behavior of the demand of services. As expected, the update of the Benefits Plan represents greater access to new technologies, measured through a greater use of new technologies. Conclusion: The update of the Benefits Plan improved access for patients to a large part of the health services.

Objetivo: avaliar as mudancas na demanda de servicos em saúde, após atualizacao do plano de beneficios da Colombia, entre os anos 2010 e 2012. Métodos: estudo tipo descritivo e explicativo, onde avalia-se o uso de tecnologias sanitarias antes e depois da atualizacao do Plano Obrigatório de Saúde. Tomaram-se as dispensares de medicamentos entre o 2010 e 2012 do Sistema de Informacao de Precos de Medicamentos. Para avaliar as mudancas foi construída uma escala de valoracao de mudancas porcentuais. Resultados: evidenciaram-se mudancas no comportamento da demanda de servicos. Como esperado, a atualizacao do Plano de Beneficios representa para os pacientes maior acesso as novas tecnologias, medido a través do maior uso de tecnologia nova. Conclusao: a atualizacao do plano de beneficios melhorou o acesso dos pacientes a uma grande parte dos servicos de saúde.

Análisis de costo-efectividad del uso de Detemir en pacientes con diabetes tipo 2 en riesgo de presentar eventos cardiovasculares y muerte en Colombia / Cost-effectiveness of using Detemir for patients with type 2 diabetes in risk of cardiovascular events and death in Colombia

Objetivo: Analizar la costo-efectividad del uso de Detemir frente a otras insulinas (Glargine e NPH) para tratamiento de diabetes tipo 2 en Colombia. Métodos: Mediante un modelo deMarkov se analizó la costo-efectividad desde la perspectiva del tercero pagador, en una cohorte de 10000 personas de 45 años, en un horizonte temporal de 5 años. Como desenlaces se evaluaron eventos cardiovasculares y muertes evitadas -medidas en Años de Vida Salvados (AVS)- relacionadas con eventos de hipoglicemia severa. Los costos se tomaron de bases de datos de prestadores de servicios de salud a precios 2013. Se utilizó una tasa de descuento del 3% para costos y resultados. Se aplicó un análisis de sensibilidad para comprobar la robustez del modelo. Resultados: Detemir presentó un menor número de eventos de hipoglicemia severa (730) frente a Glargine (1.910) y NPH (2.140), y un menor número de eventos macrovasculares (1.053) y microvasculares (1.019) frente a Glargine (1.116,1.037, respectivamente) y NPH (1.129 y 1.042, respectivamente). Detemir evitó 122 y 147 muertes frente a Glargine y NPH, respectivamente, equivalentes a 4.233 y 3.513 AVS, respectivamente. Tras el descuento el ICER por AVS con Detemir frente a Glargine fue de USD $ 998,39 y frente a NPH fue de USD $4.096,86. En el análisis de sensibilidad tipo Montecarlo, Detemir se mantiene costo-efectivo en el 100% de los casos, según el umbral propuesto por la OMS. Conclusiones: Detemir, desde la perspectiva del tercero pagador, es costo-efectivo frente a Glargine y NPH para tratamiento de diabetes tipo 2 en Colombia.

Objective: Analyze the cost-effectiveness of using Detemir versus using other insulins (Glargine and NPH insulin) for treatment of type 2 diabetes in Colombia. Methods: A Markov model was used to evaluate cost-effectiveness of Determir from a third-party payer's perspective in a hypothetical cohort of 10,000 patients, aged 45 years, with type 2 diabetes in risk of cardiovascular events and death in a 5-year time horizon. Both cardiovascular events and deaths avoided -expressed in Life-Year Saved- related to severe hypoglycemia events were considered as outcomes. Costs were obtained from health care providers databases at 2013 prices. A discount rate of 3% was applied to costs and outcomes. A sensitivity analysis was conducted to test the robustness of the model. Results: In the model, using Detemir has fewer numbers of severe hypoglycemic events (730) versus NPH insulin (1,910) and Glargine (2,140), and fewer number of macrovas-cular (1,053) and microvascular (1,019) events versus Glargine (1,116; 1,037) and NPH (1,129; 1,042). Using Detemir, 122 and 147 deaths were avoided compared to Glargine and NPH respectively; those figures are respectively equivalent to 4,233and 3,513 Life-Year Saved. As discount was applied the ICER per Life-Year Saved for Detemir versus Glargine was US$ 998.39 and USD 4,096.86 against NPHinsulin. In the Montecarlo sen-sitivity analysis Detemir remains cost effective in 100% of cases according to the WHO-proposed threshold. Conclusion: From a third-party payer's perspective,Detemir is cost-effective compared to Glargine and NPH insulin for treatment of type 2 diabetes in Colombia.

Descripción del estado de salud y calidad de vida en pacientes tratados con etanercept dentro de un programa de atención para artritis reumatoide en un centro especializado en Colombi / Description of health status and quality of life in rheumatoid arthritis patients treated with etanercept in a care program in a Colombian specialist center

Resumen Objetivo: Realizar un análisis descriptivo de la actividad de la enfermedad medida por DAS28, de la funcionalidad medida por HAQ (Health Assessment Questionnaire) y escala de depresión, tras un año de seguimiento en un programa de gerenciamiento de la enfermedad «Evaluación día¼, para pacientes colombianos con artritis reumatoide que iniciaron tratamiento con etanercept (Enbrel®). Materiales y métodos: Se diseñó un programa como parte del manejo integral de la enfermedad que comprendía cuatro visitas e incluía paraclínicos, evaluación por reumatólogo, psicólogo, terapeuta físico y ocupacional, y clinimetría. Resultados: Se incluyeron 91 sujetos. Al ingreso del programa, 42 pacientes (80.7%) fueron clasificados con actividad moderada y grave. Al año, la remisión fue alcanzada en 25%. El número de pacientes que presentaron una reducción mayor de 1.2 en el DAS28, respecto al inicio del tratamiento, fue de 19 (37.5%). La medida promedio de HAQ al inicio fue 1,07 y mejoró al disminuir a 0,96 en el último control, aunque en 11 de los individuos (13,5%) no se realizó la medición. Al ingreso del programa, 33.3% de los pacientes, tenía algún grado de depresión mayor de acuerdo con la escala de Zung y al año de la observación sólo la presentaba el 21.9%. Conclusiones: La descripción de estos programas de gerenciamiento es importante para contar con data propia de los pacientes colombianos con artritis reumatoide y brindar el manejo integral que se requiere en las enfermedades crónicas. Los resultados obtenidos parecen corresponder a los descritos en otras observaciones.

Abstract Objective: We conducted a descriptive analysis of rheumatoid arthritis activity according to DAS28, and functionality with HAQ (Health Assessment Questionnaire), and depression scales after one year of follow-up, in a disease management program «Evaluación día¼ for Colombian patients whom started treatment with etanercept. Methods: We designed a program as part of an integral disease management. It involved four visits, including: lab tests, questionnaires, and clinical evaluation by rheumatologist, psychologist, physical and occupational therapist. Results: 91 patients were included. At the beginning of the program, 80.7% of the individuals were classified in moderate and severe disease activity. At the end of follow-up, disease remission by DAS28 was reached in 25% of the patients. The number of patients who experienced DAS28 reduction more than 1.2 points was 19 (37.5%). HAQ average at baseline was 1.07 and improved to 0.96 at the end of the follow-up. At baseline, 33.3% of patients had a mayor depression according to Zung Score and, after one year, this score was present in 21.9% of the patients. Conclusions: The description of this disease management program is important for the understanding of rheumatoid arthritis in Colombia and it may offer an integral treatment, which is necessary in all chronic diseases. The results found in this analysis seem to be similar as described in other observations.