BackgroundIt 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.MethodsWe 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.ResultsSelf-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.ConclusionsBMI 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.

Background and ObjectiveMulti-criteria decision analysis (MCDA) is a tool that systematically considers multiple factors relevant to health decision-making. The aim of this study was to use an MCDA to assess the value of dupilumab for severe atopic dermatitis compared with secukinumab for moderate to severe plaque psoriasis in Spain.MethodFollowing the EVIDEM (Evidence and Value: Impact on DEcision Making) methodology, the estimated value of both interventions was obtained by means of an additive linear model that combined the individual weighting (between 1 and 5) of each criterion with the individual scoring of each intervention in each criterion. Dupilumab was evaluated against placebo, while secukinumab was evaluated against placebo, etanercept and ustekinumab. A retest was performed to assess the reproducibility of weights, scores and value estimates.ResultsThe overall MCDA value estimate for dupilumab versus placebo was 0.51 ± 0.14. This value was higher than those obtained for secukinumab: 0.48 ± 0.15 versus placebo, 0.45 ± 0.15 versus etanercept and 0.39 ± 0.18 versus ustekinumab. The highest-value contribution was reported by the patients’ group, followed by the clinical professionals and the decision makers. A fundamental element that explained the difference in the scoring between pathologies was the availability of therapeutic alternatives. The retest confirmed the consistency and replicability of the analysis.ConclusionsUnder this methodology, and assuming similar economic costs per patient for both treatments, the results indicated that the overall value estimated of dupilumab for severe atopic dermatitis was similar to, or slightly higher than, that of secukinumab for moderate to severe plaque psoriasis.Electronic supplementary materialThe online version of this article (10.1007/s40259-018-0284-3) contains supplementary material, which is available to authorized users.

DT nº 01/2017 »»» Tabla 1. Comparación de definiciones de biosimilares en el mundo Nomenclatura Regulador Definición Similar biological medicinal products UE / EMA (2006) Medicamentos biológico que se desarrolla para que sea similar a un medicamento biológico exixtente. Cuando se aprueba, se ha demostrado que su variabilidad y las duiferencias entre este y su medicamento de referencia no afectan la seguridad o eficiencia. Similar biotherapeutic products WHO (2009) Producto bioterapéutico que es similar en términos de calidad, seguridad y eficacia a un producto bioterapéutico de referencia autorizado previamente. Biothechnological drug products Japón / PMDA (2009) Producto farmacológico biotecnológico, desarrollado por una empresa difeente, que es comparable a un producto derivado de la biotecnología de una empresa innovadora (producto de referencia). Subsequent entry products Health Canada (2010) Es un fármaco biológico que entra en el mercado después de una versión previamente autorizada en Canada y con similaridad demostrada a un fármaco biológico de referencia. Follow-on products EEUU /FDA (2012) Producto biológico qye es muy similar a un produzcto biológico de referencia con autorización de EE.UU., independientemente de las diferencias menores entre el producto biológico y el producto de referencia en términos de seguridad, pureza y concentración del producto. Biosimilar medicines Australia / TGA (2013) Un medicamento biosimilar es una versión de una medicina biológica y aregistrada (el medicamento de referencia). Tanto el biosimilar como su medicamento de referencia tendrán las siguientes características similares (demostradas mediante estudios de comparabilidad completos): Físicoquímicas, biológicas, inmunológicas, eficacia y seguridad.