Expert-based collaborative analysis of the situation and prospects of biomarker test implementation in oncology in Spain.

PURPOSE: Biomarkers as screening for precision medicine is a fundamental step. The purpose of this article is twofold. First, to highlight the existing barriers in the implementation of Precision Medicine in Spain, with a special emphasis on barriers in access to the determination of biomarkers. Second, to provide a Roadmap that can help implement Precision Medicine equitably at the national level and optimize the use of biomarkers. METHODS: A systematic review of literature (SRL) and a focus group (FG) with multidisciplinary experts has been carried out in 2023. Participants were contacted individually, and discourse analysis was processed anonymously. RESULTS: We carried out a quantitative (SRL) and a qualitative approach (FG). The discourse analysis and roadmap were sent individually to each expert for approval. CONCLUSIONS: The potential of Precision Medicine has not been fulfilled in Spain. While several regional initiatives are in place, a national plan or strategy around Precision Medicine and use of biomarkers is lacking. In a general context of rapid progress at a global and European level, including the 2021 Europe's Beating Cancer Plan, it is time to define and implement a National Plan to make the promise come true. While some comparable countries within Europe - such as the UK or France - are mature enough to adopt such strategies, in Spain there is still a long way to go. We consider that the different strands of work outlined in the Roadmap can be used as basis for such purpose.

Los costes indirectos de la cefalea tensional. Una revisión sistemática de la literatura / The indirect costs of tension type headache. A systematic literature review

Objetivo: El objetivo de este trabajo fue revisar sistemáticamente la literatura publicada con relación a los costes indirectos estimados asociados al TTH.DiseñoEsta revisión sistemática siguió la declaración de elementos de informes preferidos para revisiones sistemáticas y metaanálisis (PRISMA).Fuentes de datosLa revisión se realizó en dos bases de datos principales, PubMed y EconLit, y fue completada con la búsqueda de literatura gris.Selección de estudiosEl criterio básico para la inclusión de estudios fue que presentaran al menos una medida de costes indirectos específicos del TTH.Extracción de datosSe seleccionaron finalmente 12 estudios para la extracción de la información. De todos los artículos seleccionados se sintetizaron las características del diseño del estudio, los tipos de coste incluidos, así como el instrumento de medida, y los resultados principales.ResultadosLa búsqueda arrojó en total 568 estudios. Se encontró heterogeneidad en los diseños y muestras/poblaciones de los estudios incluidos. Sólo dos estudios estimaron costes directos e indirectos para el TTH. Entre los resultados más destacables, encontramos un impacto moderado estimado de la discapacidad por TTH (entre 0,037 y 0,15 por persona, 0,06-0,09% para la población). Las pérdidas de productividad y eficiencia se observaron y fueron muy heterogéneas. La disposición a pagar por un tratamiento efectivo oscilaría entre $1,32 y $9,20 mensuales. La calidad de vida es baja, entre 28,2 y 28,4 puntos sobre 100, y la calidad de vida relacionada con la salud, parece mejorar significativamente con un tratamiento.ConclusionesA pesar de la elevada heterogeneidad de los resultados, podemos concluir que la cefalea tensional se caracteriza por un impacto moderado en la discapacidad, en la productividad y eficiencia en el trabajo o la escuela, y en la calidad de vida de quien la sufre.

Objective: The objective of this work was to systematically review the published literature in relation to the estimated indirect costs associated with TTH.DesignThis systematic review followed the Preferred Reporting Items Statement for Systematic Reviews and Meta-analyzes (PRISMA).Data sourcesThe review was performed in two main databases, PubMed and EconLit, and was completed with the gray literature search.Study selectionThe basic criterion for the inclusion of studies was that they present at least one measure of indirect costs specific to TTH.Data extraction12 studies were finally selected for information extraction. Of all the selected articles, the characteristics of the study design, the types of costs included, as well as the measurement instrument, and the main results were synthesized.ResultsThe search yielded a total of 568 studies. Heterogeneity was found in the designs and samples/populations of the included studies. Only two studies estimated direct and indirect costs for TTH. Among the most notable results, we find an estimated moderate impact of disability due to TTH (between 0.037 and 0.15 per person, 0.06–0.09% for the population). Productivity and efficiency losses were observed and were very heterogeneous. The willingness to pay for effective treatment would range from $1.32 to $9.20 per month. Quality of life is low, between 28.2 and 28.4 points out of 100, and health-related quality of life seems to improve significantly with treatment.ConclusionsDespite the high heterogeneity of the results, we can conclude that tension headache is characterized by a moderate impact on disability, on productivity and efficiency at work or school, and on the quality of life of those who suffer it.

[The indirect costs of tension type headache. A systematic literature review]. / Los costes indirectos de la cefalea tensional. Una revisión sistemática de la literatura.

OBJECTIVE: The objective of this work was to systematically review the published literature in relation to the estimated indirect costs associated with TTH. DESIGN: This systematic review followed the Preferred Reporting Items Statement for Systematic Reviews and Meta-analyzes (PRISMA). DATA SOURCES: The review was performed in two main databases, PubMed and EconLit, and was completed with the gray literature search. STUDY SELECTION: The basic criterion for the inclusion of studies was that they present at least one measure of indirect costs specific to TTH. DATA EXTRACTION: 12 studies were finally selected for information extraction. Of all the selected articles, the characteristics of the study design, the types of costs included, as well as the measurement instrument, and the main results were synthesized. RESULTS: The search yielded a total of 568 studies. Heterogeneity was found in the designs and samples/populations of the included studies. Only two studies estimated direct and indirect costs for TTH. Among the most notable results, we find an estimated moderate impact of disability due to TTH (between 0.037 and 0.15 per person, 0.06-0.09% for the population). Productivity and efficiency losses were observed and were very heterogeneous. The willingness to pay for effective treatment would range from $1.32 to $9.20 per month. Quality of life is low, between 28.2 and 28.4 points out of 100, and health-related quality of life seems to improve significantly with treatment. CONCLUSIONS: Despite the high heterogeneity of the results, we can conclude that tension headache is characterized by a moderate impact on disability, on productivity and efficiency at work or school, and on the quality of life of those who suffer it.

[Treatment of disease-related malnutrition: status of regulation in the Spanish National Health System. An exploratory study through focus groups]. / Tratamiento de la desnutrición relacionada con la enfermedad: situación de la regulación en el Sistema Nacional de Salud. Un estudio exploratorio mediante grupos focales.

INTRODUCTION: Background: the legislation currently regulating the inclusion of Food for Special Medical Purposes (FSMP) among the benefits of the National Health System (SNS) was made approximately 15 years ago. The evolution of the technical characteristics of the FSMP justifies an analysis of the current regulation and the consideration of possible regulatory modifications that would allow the incorporation of the progress achieved. Material and methods: four successive focus groups of experts, mostly doctors (91%), hospital specialists in disciplines related to nutrition (73%), from 8 different hospitals and 6 autonomous communities. Previously, 4 documents summarizing different technical aspects of the regulation on FSMP in Spain were sent to the participants. The audio of the meetings was transcribed anonymously and its content was codified. Results: the contents of the focus groups were grouped into 9 codes: 1) problems and regulation; 2) clinical benefits and evidence of efficacy or effectiveness; 3) clinical indications; 4) international context and comparisons with other countries; 5) budgetary impact; 6) cost-effectiveness; 7) risks and reasons for maintaining current regulation; 8) proposals for progress, feasibility and aspects that make implementation difficult; and 9) other issues. Conclusions: based on the technological development and clinical application of the FSMP carried out in recent years, an update of the regulation of these products can be proposed for financing by the National Health System in Spain. Most of these changes do not imply an increase in expenditure if current conditions regarding indications and maximum prices are maintained.

INTRODUCCIÓN: Antecedentes: la normativa que regula la inclusión de alimentos para usos médicos especiales (ADUME) entre las prestaciones del Sistema Nacional de Salud (SNS) fue elaborada hace unos 15 años, si bien la nutrición enteral domiciliaria se comenzó a regular en 1998. La evolución de las características técnicas de los ADUME justifica un análisis de la actual normativa y la consideración de posibles modificaciones que permitan la incorporación de avances tecnológicos. Material y métodos: reuniones estructuradas siguiendo la metodología del grupo focal, con expertos en su mayoría médicos (91 %), mujeres (55 %) y especialistas hospitalarios en disciplinas relacionadas con la nutrición (73 %) de 8 hospitales y 6 comunidades autónomas. Previamente, los participantes recibieron 4 documentos resumen de diferentes aspectos técnicos de la regulación sobre ADUME en España. Se transcribió de forma anonimizada el audio de las reuniones y se codificó su contenido en 9 códigos: 1) problemática y regulación; 2) beneficios clínicos y evidencia de eficacia o efectividad; 3) indicaciones clínicas; 4) contexto internacional y comparaciones con otros países; 5) impacto presupuestario; 6) coste-efectividad; 7) riesgos y motivos para mantener la regulación actual; 8) propuestas de avance, factibilidad y aspectos que dificultan la implementación; y 9) otros temas. Resultados: los grupos señalaron la necesidad de modificar aspectos regulatorios relacionados con la exclusión de financiación de las fórmulas de densidad calórica superior a 2,1 kcal/ml, exclusión de la financiación de los ADUME obtenidos total o parcialmente a partir de alimentos ordinarios, preferencia por la alimentación por sonda y exclusividad de la financiación de fórmulas completas para los ADUME que se empleen por vía oral como complemento de una ingesta insuficiente. Conclusiones: sobre la base del desarrollo tecnológico y la aplicación clínica de los ADUME en los últimos años, el SNS debería actualizar la regulación de la financiación de estos productos. La mayor parte de estos cambios no implican incremento del gasto si se mantienen las condiciones actuales en cuanto a indicaciones y precios máximos.