Criterios de financiación y reembolso de los medicamentos huérfanos

Dado su elevado precio, los medicamentos huérfanos no suelen ser coste-efectivos bajo los umbrales estándares de aceptación de la evaluación económica. Sin embargo, la sociedad puede considerar relevante tener en cuenta otros criterios adicionales en su decisión de financiación y reembolso público. Este trabajo pretende identificar los criterios que podrían ser relevantes, y aquéllos que efectivamente imperan en la práctica real de los países desarrollados.RESUMEN 1. INTRODUCCIÓN Y OBJETIVO 2. METODOLOGÍA 3. CRITERIOS DE FINANCIACIÓN DE LOS MEDICAMENTOS HUÉRFANOS DESDE UNA PERSPECTIVA TEÓRICA 4. CRITERIOS DE FINANCIACIÓN DE LOS MEDICAMENTOS HUÉRFANOS EN DISTINTOS PAÍSES DESARROLLADOS 5. DISCUSIÓN 6. CONCLUSIONES REFERENCIAS BIBLIOGRÁFICA

A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain

Introduction: Hereditary angioedema (HAE) is a rare genetic disease that impairs quality of life and could be life-threatening. The aim of this study was to apply a multicriteria decision analysis to assess the value of three long-term prophylactic (LIP) therapies for HAE in Spain. Methods: A multidisciplinary committee of 10 experts assessed the value of lanadelumab (subcutaneous use), C1-inhibitor (C1-INH; intravenous), and danazol (orally), using placebo as comparator. We followed the EVIDEM methodology that considers a set of 13 quantitative criteria. The overall estimated value of each intervention was obtained combining the weighting of each criterion with the scoring of each intervention in each criterion. We used two alternative weighting methods: hierarchical point allocation (HPA) and direct rating scale (DRS). A reevaluation of weightings and scores was performed. Results: Lanadelumab obtained higher mean scores than C1-INH and danazol in all criteria, except for the cost of the intervention and clinical practice guidelines. Under the HPA method, the estimated values were 0.51 (95% confidence interval [CI]: 0.44-0.58) for lanadelumab, 0.47 (95%CI: 0.41-0.53) for C1-INH, and 0.31 (95%CI: 0.240.39) for danazol. Similar results were obtained with the DRS method: 0.51 (95%CI: 0.42-0.60), 0.47 (95%CI: 0.40-0.54), and 0.27 (95%CI: 0.18-0.37), respectively. The comparative cost of the intervention was the only criterion that contributed negatively to the values of lanadelumab and C1-INH. For danazol, four criteria contributed negatively, mainly comparative safety. Conclusion: Lanadelumab was assessed as a high-value intervention, better than C1-INH and substantially better than danazol for LTP treatment of HAE

Evaluation of Antibody-based Preventive Alternatives for Respiratory Syncytial Virus: A Novel Multi-Criteria Decision Analysis Framework and Assessment of Nirsevimab in Spain

Respiratory syncytial virus (RSV) is a highly infectious disease that poses a significant clinical and medical burden, as well as social disruption and economic costs, recognized by the World Health Organization as a public health issue. After several failed attempts to find preventive candidates (compounds, products, including vaccines), new alternatives might be available, one being nirsevimab, the first and only option approved for RSV prevention in neonates and infants during their first RSV season. The objective of this study was to develop a novel multi-criteria decision analysis (MCDA) framework for RSV antibody-based preventive alternatives and to use it to assess the value of nirsevimab vs. placebo as a systematic immunization approach to prevent RSV in neonates and infants during their first RSV season in Spain.This project was funded by Sanofi and AstraZeneca.Medicin

Opposite poles: A comparison between two Spanish regions in health-related quality of life, with implications for health policy

<p>Abstract</p> <p>Background</p> <p>Although health is one of the main determinants of the welfare of societies, few studies have evaluated health related quality of life in representative samples of the population of a region or a country. Our aim is to describe the health-related quality of life of the inhabitants of two quite different Spanish regions (Canary Islands and Catalonia) and to compare the prevalence of health problems between age-sex groups.</p> <p>Methods</p> <p>We use data obtained from the 2006 Health Survey of Catalonia and the 2004 Canary Islands Health Survey. With an ordinal composite variable measuring HRQOL we identify the association of characteristics of individuals with self-reported quality of life and test for differences between the regions.</p> <p>Results</p> <p>The prevalence of problems in the five EQ-5 D dimensions increases with age and is generally higher for women than for men. The dimension with the highest prevalence of problems is "anxiety/depression", and there is noteworthy the extent of discomfort and pain among Canary Island women. Education, especially among the elderly, has an important effect on health-related quality of life.</p> <p>Conclusions</p> <p>There are substantial structural and compositional differences between the two regions. Regional context is a significant factor, independent of the compositional differences, and the effects of context are manifest above all in women. The findings show the importance of disease prevention and the need for improving the educational level of the population in order to reduce health inequalities.</p

Valoración y determinantes del stock de capital salud en la Comunidad Canaria y Cataluña

En los últimos años estamos asistiendo a cambios en la definición del concepto de salud aplicable a individuos y poblaciones. En el presente trabajo se propone la estimación del stock de capital salud de la población residente en la Comunidad Canaria. Para ello, en primer lugar, se estiman la Esperanza de Vida Ajustados por Calidad de dicha población (ajustada por edad y género), para a continuación proponer una valoración monetaria de los resultados obtenidos. En la segunda parte del trabajo se analiza los principales determinantes de la Calidad de Vida Relacionada con la Salud de la población estudiada, empleando la Encuesta Canaria de Salud. Con tal fin, se plantea un modelo probit ordenado, estimándose los efectos marginales de las variables explicativas utilizadas (sociodemográficas, salud “objetiva” y estilos de vida). La edad, el género, el nivel educativo y las enfermedades diagnosticadas son las principales variables significativas, siendo más complicado determinar el efecto de los hábitos y estilos de vida. En ambas fases de trabajo se compara los resultados obtenidos con los de un trabajo previo correspondientes a la población residente en Cataluña.

Measuring Changes in Health Capital

This study is aimed to estimate the value of the change in health observed in Catalonia, from 1994 to 2002. Quality-adjusted years of life (QALYs) and years of life (YOL) for genders and different ages were calculated and then transformed in monetary values. Our results shown that the health capital stock has diminished from 1994 to 2002 due to a worsening in the quality of life of the population. Different estimation procedures have been applied for revealing relevant variables that help to explain this negative result

Association between maternal and paternal employment and their children’s weight status and unhealthy behaviours: does it matter who the working parent is?

Abstract Background The growing number of employed women has been associated with an increase in the prevalence of overweight and obesity in children. We sought to determine whether childhood overweight/obesity in Spain is associated with labour participation of mothers and fathers, and whether the identity of the main caregiver has an influence on child’s weight and unhealthy behaviour. Methods We used microdata from the 2010 and 2014 Health Behaviour in School-Aged Children surveys performed in Spain (n = 32,694). Logistic and linear multi-level regression models were applied to assess the association between parental employment and children’s self-reported weight status, accounting for school effects and controlling for socioeconomic factors. Separated binary models were also fitted for consumption of fruit, sweets, screen viewing and sedentarism. Results In most cases, the significant associations between children’s weight and their parents’ work status disappeared once the models were adjusted for family wealth and education. However, we found persistent associations for some groups. Girls under 13 years-old living in households where the mother was the only employed parent were more likely to be affected by obesity and to report a higher body mass index value. Children in this type of household were more likely to show unhealthy lifestyles related to diet and leisure time activities. Conclusions Parents’ socioeconomic characteristics had a protective effect on their children’s risk of obesity. Unhealthy behaviours were observed in households with a non-working father and a working mother, although the link with obesity was limited to girls. Our results suggest the need for a more equally shared burden of caregiving

Estudios de coste de la diabetes tipo 2: una revisión de la literatura

La diabetes mellitus tipo 2 (DM2) es una enfermedad crónica, compleja y de alta prevalencia, relacionada con una elevada morbi-mortalidad. Según los estudios empíricos, la DM2 está asociada a importantes costes socioeconómicos. Sin embargo, la disparidad metodológica utilizada dificulta la extrapolación de resultados y conclusiones, lo que puede obstaculizar las decisiones a nivel de gestión. El objetivo de este trabajo es realizar una revisión narrativa de la literatura para identificar y analizar los principales estudios de coste asociados a la DM2, con el fin de comparar sus metodologías y determinar los principales factores que influyen en los costes de la DM2.RESUMEN 1. INTRODUCCIÓN 2. JUSTIFICACIÓN Y OBJETIVO 3. TIPOS DE COSTES ASOCIADOS A LA DIABETES 4. METODOLOGÍA DE LA REVISIÓN 5. RESULTADOS DE LA REVISIÓN 5.1 Aspectos metodológicos de los estudios incluidos . 5.2 Resultados de costes asociados a la diabetes 5.2.1 Tipos de costes incluidos 5.2.1.1 Costes directos sanitarios 5.2.1.2 Costes directos no sanitarios 5.2.1.3 Pérdidas de productividad laboral 5.2.2 Resultados para España 5.2.3 «Exceso de costes» atribuibles a la población con diabetes 5.2.4 Coste de las complicaciones de la diabetes 6. DISCUSIÓN Y CONCLUSIONES REFERENCIAS BIBLIOGRÁFICAS ANEX

The impact of obesity on health-related quality of life in Spain

Abstract Background It is well documented that obesity is strongly associated with mortality and morbidity, but less is known about its impact on functional status and health-related quality of life (HRQOL). The purpose of this study was to calculate the impact of the Body Mass Index (BMI) on the HRQOL of the Spanish adult population, with special emphasis on BMI ≥ 35. Methods We used the Spanish National Health Survey (SNHS) 2011–2012 to assess the statistical association between HRQOL, measured through the EuroQol-5D-5L questionnaire, and the BMI. We conducted linear regression analysis for the EuroQol-5D-5L Visual Analogue Scale (VAS) and probit regressions for each of the five dimensions of the EuroQol-5D-5L. Results Self-perceived problems in the five dimensions of the EuroQol-5D-5L increased along the BMI, especially in the mobility and pain/discomfort dimensions. Having a BMI ≥ 35 reduced HRQOL even in the absence of chronic diseases. After controlling for comorbidities, severe obesity decreased the VAS score by an average of 1.9 points and increased the probability of reporting any HRQOL problem in mobility (11.8%), self-care (2.2%), usual activities (4.3%) and pain/discomfort (7.4%). No association was found between obesity and mental problems. All the parameters analysed suggest that HRQOL in women and people aged 65 years and over was significantly worse than average. Conclusions BMI is an explanatory factor of self-perceived quality of life. Obesity is associated with a worse HRQOL, especially in women and people aged over 64 years. These results may be useful for designing prevention or treatment health policies to target obesity among the Spanish population