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BackgroundWorldwide, binge drinking (BD) today follows being a public health concern among adolescents. This study sought to assess the cost-effectiveness and cost-utility of a web-based computer-tailored intervention to prevent BD in adolescence.MethodsThe sample was drawn from a study evaluating the Alerta Alcohol programme. The population consisted of adolescents aged 15–19. Decision tree analysis was used to estimate costs and health outcomes, as measured by number of BD occasions and quality-adjusted life years (QALYs). Incremental Cost-Effectiveness and Cost-Utility Ratios were also calculated from National Health Service (NHS) and societal perspective and for a time horizon of four months. Multivariate deterministic sensitivity analysis of best/worst scenarios by subgroups was used to account for uncertainty.ResultsThe intervention was dominant from the societal perspective resulting in savings of €7,986.37 by one BD occasion averted per month. With regard to Incremental Cost-Utility Ratios, the intervention resulted in an incremental cost of €71.05 per QALY gained from NHS perspective and this was dominant, from societal perspective, resulting in savings of €34,126.64 per QALY gained in comparison with the control group. Subgroup analyses showed that the intervention resulted dominant for girls from both perspectives, and for those who were older (17 years or more) from NHS perspective.ConclusionComputer-tailored feedback is a cost-effective way to reduce BD and to increase QALYs among adolescents. However, long-term follow-up would probably be needed to capture major changes both in reduction of BD and in increasing of health-related quality of life.Trial registration(ClinicalTrials.gov): NCT03288896. Registration date: September 20, 2017. “Retrospectively registered”.

This study aimed at determining the cost-effectiveness of amyloid-positron emission tomography (PET) compared to Alzheimer's disease (AD) cerebrospinal fluid (CSF) biomarkers (amyloid-β

María Merino,1 Teresa Martín Lorenzo,1 Paulina Maravilla-Herrera,1 Julio Ancochea,2– 4 José Tomás Gómez Sáenz,5 Nicole Hass,6 Jesús Molina,7 Germán Peces-Barba,8 Marta Trapero-Bertran,9 Juan Antonio Trigueros Carrero,10 Álvaro Hidalgo-Vega11 1Health Outcomes Research, Weber, Madrid, Spain; 2Pulmonology Service, La Princesa University Hospital - IIS-Princesa, Madrid, Spain; 3Faculty of Medicine, Universidad Autónoma de Madrid, Madrid, Spain; 4Respiratory Diseases Networking Biomedical Research Centre - CIBERES, Carlos III Institute of Health - ISCIII, Madrid, Spain; 5Nájera Health Centre, Nájera, La Rioja, Spain; 6Chronic Obstructive Pulmonary Disease Patient and Family Association - APEPOC, Pontevedra, Spain; 7Francia Health Centre, Fuenlabrada, Madrid, Spain; 8Pulmonology Service, Fundación Jiménez Díaz University Hospital, Madrid, Spain; 9Basic Sciences Department, University Institute for Patient Care, Universitat Internacional de Catalunya, Barcelona, Spain; 10Menasalbas Health Centre, Mensalbas, Toledo, Spain; 11Department of Economic Analysis and Finances, Universidad de Castilla-La Mancha, Toledo, SpainCorrespondence: María Merino, Health Outcomes Research, Weber, Calle Moreto 17, 5° Dcha, Madrid, 28014, Spain, Tel +34 91 639 38 24, Fax +34 91 634 6643, Email maria.merino@weber.org.esPurpose: To define a set of proposals that would improve the current management of chronic obstructive pulmonary disease (COPD) within the Spanish National Healthcare System (SNHS) from a comprehensive multidisciplinary perspective and to assess the impact of its implementation from clinical, healthcare, economic, and social perspectives.Patients and Methods: A group of 20 stakeholders related to COPD (healthcare professionals, patients, and informal caregivers, among others) participated in an online Delphi process to agree on a set of 15 proposals that would improve the current management of COPD within the SNHS in four areas: diagnosis, risk stratification, management of exacerbations, and management of stable COPD. A one-year forecast-type social return on investment (SROI) analysis was used to estimate the impact that implementing the set of proposals would have in relation to the investment required. A sensitivity analysis was used to test the strength of the model when varying assumption-based data-points.Results: The hypothetical implementation of the complete set of 15 proposals would require a € 668 million investment and would generate a € 2079 million social impact concerning savings for the SNHS and quality of life improvements for patients and their informal caregivers, among others. Accordingly, for every euro invested in the set of proposals, a social return of € 3.11 would be generated (€ 2.71 in the worst-case scenario and € 3.62 in the best-case scenario) of both tangible (32.56%) and intangible nature (67.44%).Conclusion: Altogether, implementing this set of 15 proposals would generate a positive social impact, threefold the required investment. The results may inform decisions relative to healthcare policy and practice regarding COPD management within the SNHS, further contributing to reduce the large burden of COPD.Keywords: disease management, chronic disease, respiratory disease, economic evaluation, social impact, Spain

The new WHO air quality guidelines indicate that the air pollution disease burden is greater than previously reported. We aimed to estimate the air pollution disease burden and its economic cost in Barcelona to inform local action.We used a quantitative health impact assessment to estimate the non-accidental mortality and incidence of childhood asthma and lung cancer attributable to long-term air pollution exposure in the city of Barcelona (Spain) in 2018-2019. We used the population weighted mean of PMMean exposure was 17 μg/mAir pollution in Barcelona represents a huge disease and economic burden, which is greater than previous estimates. Much stronger measures to reduce PM

The main data on HIV in high-income countries from the standpoint of health economics are updated and discussed. Specifically, issues surrounding the economic impact of HIV are addressed for health care and occupational perspectives. We review the main epidemiological data on the prevalence of disease and foreseeable changes in patterns within the coming years. Recent research on health care costs of HIV/AIDS and the occupational situation of HIV+ people are discussed. In high-income countries, there is an incipient change in trends that indicate that an increasing percentage of the intermediate-age HIV+ population will age prematurely, presenting more frequently comorbidities and becoming more exposed to frailty situations. Accordingly, health-care systems should have to plan their resources to accommodate new determinants of healthcare costs in the HIV+ population. On the occupational side, the decreased life expectancy of HIV+ persons, coupled with more severe health issues, on average may prompt early -retirement of this population from the labor market.

Smoke-free policies are effective in preventing secondhand smoke (SHS) exposure, but their adoption at home remains largely voluntary. This study aimed to quantify SHS exposure in homes with residents who smoke in Europe according to households’ characteristics, tobacco consumption habits, and national contextual factors. Cross-sectional study (March 2017–September 2018) based on measurements of air nicotine inside 162 homes with residents who smoke from nine European countries. We installed passive samplers for seven consecutive days to monitor nicotine concentrations. Through self-administered questionnaires, we collected sociodemographic information and the number of individuals who smoke, smoking rules, frequency, location, and quantity of tobacco use in households. Country-level factors included the overall score in the Tobacco Control Scale 2016, the smoking prevalence, and self-reported SHS exposure prevalence. Nicotine concentrations were analyzed as continuous and dichotomous variables, categorized based on the limit of quantification of 0.02 μg/m3. Overall, median nicotine concentration was 0.85 μg/m3 (interquartile range (IQR):0.15–4.42), and there was nicotine presence in 93% of homes. Participants reported that smoking was not permitted in approximately 20% of households, 40% had two or more residents who smoked, and in 79% residents had smoked inside during the week of sampling. We found higher nicotine concentrations in homes: with smell of tobacco smoke inside (1.45 μg/m3 IQR: 0.32–6.34), where smoking was allowed (1.60 μg/m3 IQR: 0.68–7.63), with two or more residents who smoked (2.42 μg/m3 IQR: 0.58–11.0), with more than 40 cigarettes smoked (2.92 μg/m3 IQR: 0.97–10.61), and where two or more residents smoked inside (4.02 μg/m3 IQR: 1.58–11.74). Household nicotine concentrations were significantly higher in countries with higher national smoking prevalence and self-reported SHS exposure prevalence (p < 0.05). SHS concentrations in homes with individuals who smoke were approximately twenty times higher in homes that allowed smoking compared to those reporting smoke-free household rules. Evidence-based interventions promoting smoke-free homes should be implemented in combination with strengthening other MPOWER measures. This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 681040. The work of SG was partially supported by the Italian League Against Cancer (LILT, Milan). EF is partly supported by Ministry of Universities and Research, Government of Catalonia (2017SGR319) and by the Instituto Carlos III and co-funded by the European Regional Development Fund (FEDER) (INT16/00211 and INT17/00103), Government of Spain.

Assess cost-effectiveness and -utility associated with post-transplant HCC surveillance compared to standard follow-up.Despite lack of prospective clinical data, expert consensus recommends post-transplant surveillance to detect hepatocellular carcinoma (HCC) recurrence in a latent phase, while it might be amenable to curative-intent therapy.A Markov-based transition model was created to estimate life expectancy and quality-of-life among liver transplant patients undergoing HCC surveillance. Models were built for two cohorts: one undergoing HCC surveillance with contrast-enhanced CT of chest and abdomen and serum alpha-fetoprotein analysis and the other receiving standard post-transplant follow-up. Primary model outputs included life-year (LY) and quality-adjusted life-year (QALY) gains, incremental cost-effectiveness ratio (ICER), and incremental cost-utility ratio (ICUR). Willingness-to-pay (WTP) for a QALY gain (cost-effectiveness threshold) was used to estimate efficiency.Surveillance was marginally more effective versus no surveillance, resulting in means of 0.069 LYs and 0.026 QALYs gained. Costs for surveillance were increased by an average of 988.32[Euro sign], resulting in ICER 14,410.15[Euro sign]/LY and ICUR 37,547.97[Euro sign]/QALY. Surveillance did not appear cost-effective in our setting, considering WTP threshold of 25,000[Euro sign]/QALY. Probabilistic sensitivity analysis indicated surveillance might be cost-effective in 42% of cases, but degree of uncertainty in the analysis was high.Performing post-transplant HCC surveillance offers marginal clinical benefits and increases costs. While expert consensus supports surveillance, results of this decision analysis raise doubt regarding the utility of such recommendations and support ongoing need for prospective clinical trials.

Availability of data and materials: Not applicable for this opinion paper. Copyriight © The Author(s) 2022. WHO promotes the use of research in policy-making to drive improvements in health, including in achieving Sustainable Development Goals such as tobacco control. The European Union’s new €95 billion Horizon Europe research framework programme parallels these aims, and also includes commitments to fund economic evaluations. However, researchers often express frustration at the perceived lack of attention to scientific evidence during policy-making. For example, some researchers claim that evidence regarding the return on investment from optimal implementation of evidence-based policies is frequently overlooked. An increasingly large body of literature acknowledges inevitable barriers to research use, but also analyses facilitators encouraging such use. This opinion piece describes how some research is integrated into policy-making. It highlights two recent reviews. One examines impact assessments of 36 multi-project research programmes and identifies three characteristics of projects more likely to influence policy-making. These include a focus on healthcare system needs, engagement of stakeholders, and research conducted for organizations supported by structures to receive and use evidence. The second review suggests that such characteristics are likely to occur as part of a comprehensive national health research system strategy, especially one integrated into the healthcare system. We also describe two policy-informing economic evaluations conducted in Spain. These examined the most cost-effective package of evidence-based tobacco control interventions and the cost-effectiveness of different strategies to increase screening coverage for cervical cancer. Both projects focused on issues of healthcare concern and involved considerable stakeholder engagement. The Spanish examples reinforce some lessons from the global literature and, therefore, could help demonstrate to authorities in Spain the value of developing comprehensive health research systems, possibly following the interfaces and receptor model. The aim of this would be to integrate needs assessment and stakeholder engagement with structures spanning the research and health systems. In such structures, economic evaluation evidence could be collated, analysed by experts in relation to healthcare needs, and fed into both policy-making as appropriate, and future research calls. The increasingly large local and global evidence base on research utilization could inform detailed implementation of this approach once accepted as politically desirable. Given the COVID-19 pandemic, increasing the cost-effectiveness of healthcare systems and return on investment of public health interventions becomes even more important.

The aim of this systematic literature review is to identify economic evaluations of programmes or interventions aimed at the prevention, treatment and rehabilitation of alcohol use disorders, as well as to determine those types of programmes, treatments or interventions that are efficient. The systematic literature review was conducted by searching the following databases: National Health Service Economic Evaluation Database (NHS EED), Health Technology Assessment (HTA), MEDLINE Ovid and PubMed. The search terms used were in English. No time restriction was applied. A data extraction form was used to draw information. The systematic review follows the recommendations of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) on reporting systematic reviews. The interventions were classified into three categories: "A" treatments for people with alcohol use disorders (tertiary prevention); "B" treatments for people at risk for alcohol-related problems (secondary prevention); "C" policy legislation and enforcement interventions (primary prevention). Furthermore, the "A" interventions were subclassified into psychological, pharmacological and combined interventions. The review included 63 papers. In terms of treatments for people with alcohol use disorders, any psychosocial intervention compared to no intervention appeared to be a dominant strategy. In terms of treatments for people at risk of alcohol-related problems, brief intervention appears to be dominant or cost-effective when compared to no intervention. Advertising controls, tax increases, licensing, legal drinking age, and mass media campaigns seem to be dominant or cost-effective strategies compared to no intervention or random breath testing. Previous reviews have been extended by depicting alcohol programmes according to their efficiency. Despite this, the available studies in this regard have heterogeneous approaches and most do not adequately define the costs included in their analyses. Therefore, it is necessary to encourage the evaluation of the efficiency of these types of interventions to aid decision-making in public health.El objetivo de esta revisión sistemática de la literatura es identificar evaluaciones económicas de programas o intervenciones dirigidas a la prevención, tratamiento y rehabilitación de trastornos por consumo de alcohol, así como determinar aquellos tipos de programas, tratamientos o intervenciones que son eficientes. Se realizó una revisión sistemática de la literatura mediante la búsqueda en las siguientes bases de datos: National Health Service Economic Evaluation Database (NHS EED), Health Technology Assessment (HTA), MEDLINE Ovid and PubMed. Los términos de búsqueda utilizados fueron en inglés. No se aplicó ninguna restricción de tiempo. Se utilizó un formulario de extracción de datos para resumir la información. La revisión sistemática siguió las recomendaciones (PRISMA-P) sobre la presentación de informes de revisiones sistemáticas. Las intervenciones fueron clasificadas en tres categorías: «A» tratamientos para personas con trastornos por consumo de alcohol (prevención terciaria); «B» tratamientos para personas en riesgo de problemas relacionados con el alcohol (prevención secundaria); «C» legislación sobre políticas e intervenciones de aplicación (prevención terciaria). Además, las intervenciones «A» fueron subclasificadas en intervenciones psicológicas, farmacológicas y combinadas. Se incluyeron 63 documentos. En términos de tratamientos para personas con trastornos por uso de alcohol, cualquier intervención psicosocial en comparación con ninguna intervención parece ser una estrategia dominante. En términos de tratamientos para personas en riesgo de problemas relacionados con el alcohol, la intervención breve parece ser dominante o rentable en comparación con no hacer nada. Los controles publicitarios, las subidas de impuestos, las licencias, la edad legal para consumir alcohol y las campañas en los medios de comunicación parecen ser una estrategia dominante o rentable en comparación con ninguna intervención o prueba aleatoria de alcoholemia. Se han ampliado las revisiones anteriores al mostrar los programas de alcohol según criterios de eficiencia. A pesar de ello, los estudios disponibles al respecto tienen enfoques heterogéneos y la mayoría no define adecuadamente los costes incluidos en su análisis. Por tanto, es necesario continuar evaluando en términos de eficiencia este tipo de intervenciones para informar mejor la toma de decisiones en salud pública.

The aim of this systematic literature review is to identify economic evaluations of programmes or interventions aimed at the prevention, treatment and rehabilitation of alcohol use disorders, as well as to determine those types of programmes, treatments or interventions that are efficient. The systematic literature review was conducted by searching the following databases: National Health Service Economic Evaluation Database (NHS EED), Health Technology Assessment (HTA), MEDLINE Ovid and PubMed. The search terms used were in English. No time restriction was applied. A data extraction form was used to draw information. The systematic review follows the recommendations of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) on reporting systematic reviews. The interventions were classified into three categories: "A" treatments for people with alcohol use disorders (tertiary prevention); "B" treatments for people at risk for alcohol-related problems (secondary prevention); "C" policy legislation and enforcement interventions (primary prevention). Furthermore, the "A" interventions were subclassified into psychological, pharmacological and combined interventions. The review included 63 papers. In terms of treatments for people with alcohol use disorders, any psychosocial intervention compared to no intervention appeared to be a dominant strategy. In terms of treatments for people at risk of alcohol-related problems, brief intervention appears to be dominant or cost-effective when compared to no intervention. Advertising controls, tax increases, licensing, legal drinking age, and mass media campaigns seem to be dominant or cost-effective strategies compared to no intervention or random breath testing. Previous reviews have been extended by depicting alcohol programmes according to their efficiency. Despite this, the available studies in this regard have heterogeneous approaches and most do not adequately define the costs included in their analyses. Therefore, it is necessary to encourage the evaluation of the efficiency of these types of interventions to aid decision-making in public health.

Marketing of new and existing drugs with new indications used alone or in combination is increasing. To identify the advantages and disadvantages of indication-based pricing (IBP) systems for such drugs from the standpoint of economic theory, practical applications and international experiences. We conducted a systematic review of published articles and reports using six bibliographic databases: PubMed, ASCO, Scopus, DARE, HTA and NHS EED. We also conducted a search of gray literature in Google Scholar. The same search terms were used as in Towse et al. (The debate on indication-based pricing in the U.S. and five major European countries. OHE Consulting Report, London, 2018). Articles and reports published from 1 January 2000 to 30 September 2018 were included. A total of 26 studies met the inclusion criteria. There are three main types of IBP: different brands with different prices for each indication, an averaged single price for all indications and a single price with differential discounts. The studies indicate that IBP systems are premised on the idea that charging a different price for different indications reflects the differences in their value and in social willingness to pay for each one and for the investment in R&D based on the indication’s incremental clinical benefit. Some argue that a uniform price reduces access and increases the price for lower-value indications, while others contend that if IBP sets prices at the maximum threshold of social willingness to pay for each indication, all surplus is transferred to the producer and consumer surplus is reduced to zero. No practical applications of pure IBP were found. Single pricing for drugs is the most prevalent approach. The system that most closely approximates an IBP model consists of agreements that are generally confidential and linked to risk-sharing agreements. There are no applications of pure IBP systems and their practical consequences are therefore unknown. More economic theory-based assessments of the pros and cons of IBP and studies different from reviews are needed to capture their intricacies and specificities.

Background Over the course of the COVID19 pandemic, global healthcare delivery has declined. Surgery is one of the most resource-intensive area of medicine; loss of surgical care has had untold health and economic consequences. Herein, we evaluate resource utilization, outcomes, and healthcare costs associated with unplanned surgery admissions during the height of the pandemic in 2020 versus the same period in 2019. Methods Retrospective analysis on patients ≥18 years admitted from the emergency department to General & Digestive and Gastrointestinal Surgery Services between February and May 2019 and 2020 at our center; clinical outcomes and unadjusted and adjusted per-person healthcare costs were analyzed. Results Consults and admissions to surgery declined between February and May 2020 by 37% and 19%, respectively, relative to the same period in 2019, with even greater relative decline during late March and early April. Time between onset of symptoms to diagnosis increased from 2±3 days 2019 to 5±22 days 2020 (P = 0.01). Overall hospital stay was two days less in 2020 (P = 0.19). Complications (Comprehensive Complication Index 10.3±23.7 2019 vs. 13.9±25.5 2020, P = 0.10) and mortality rates (3% vs. 4%, respectively, P = 0.58) did not vary. Mean unadjusted per-person costs for patients in the 2019 and 2020 cohorts were 5,886.72€±12,576.33€ and 5,287.62±7,220.16€, respectively (P = 0.43). Following multivariate analysis, costs remained similar (4,656.89€±390.53€ 2019 vs. 4,938.54±406.55€ 2020, P = 0.28). Conclusions Healthcare delivery and spending for unplanned general surgery admissions declined considerably due to COVID19. These results provide a small yet relevant illustration of clinical and economic ramifications of this healthcare crisis.

Background and Aims: Home-based care and oral supplemental nutrition may be an efficient way of managing health resources, freeing up hospital resources and improving patient care and quality of life. For some conditions, such as neurodegenerative diseases and acute neurological conditions, adequate nutritional control of patients at the time of discharge, with home monitoring by a home hospitalization unit (HHU), coupled with the introduction of necessary and appropriate oral nutritional supplements for each patient, is a good strategy for ensuring the efficiency of health resources. The aim of this paper is to analyse the direct health costs, considering home care and oral nutritional supplement, of patients with newly diagnosed neurological diseases and at risk of nutritional problems. Methods: A study was designed to measure direct health care costs of patients with neurological related diseases according to their different nutritional needs. The sample for this study consisted of all patients (n=100) of the Elda University Hospital in Elda, Spain, with newly diagnosed neurological pathology and suspected malnutrition at hospital discharge during a six months period. These patients were included in a home base care program and given oral nutritional supplements afterwards. The nutritional intervention consisted in giving nutritional supplements according to nutritional patients’ needs through a home-based care unit. Nutritional needs could comprise from protein-calorie malnutrition to at risk of malnutrition. Descriptive health care costs analysis was carried out accounting for the nutritional status. Costs are expressed in 2018 euros and for a total time horizon of one year, six months of classical inpatient care and six months of home care monitoring with a nutritional intervention. Results: Mean direct health care cost for neurological patients in the six months of classical inpatient care was €8,309.30 and, the direct healthcare cost of treating these patients according to their nutritional needs from a home care unit was €2,970.18. The subgroup of patients that most benefited from the nutritional intervention and monitoring from the home care unit were those who were in a state of protein-calorie malnutrition or at risk of malnutrition. Under the log transformation of the variables, the Shapiro-Wilk test showed significant differences in mean costs at the 5% level for the two time periods for those suffering from protein-calorie malnutrition or at risk of malnutrition. Conclusions: It is important to measure and economically quantify the direct health care costs of patients with neurological diseases in order to be able to evaluate different hospital and home-care interventions according to different nutritional needs. Oral nutritional supplements and monitoring by the hospital home care unit could be associated with saving money when patients have protein-calorie malnutrition or at risk of malnutrition. Therefore, direct health costs information is needed to future evaluate these different management interventions. info:eu-repo/semantics/acceptedVersion

The aim of this study was to estimate the incremental cost-utility ratio (ICUR) of a multi-modal intervention in frail and pre-frail subjects aged ≥70 years with type-2 diabetes versus usual care g...

BackgroundThe main aim of this study was to determine the socioeconomic and family factors associated with binge drinking (BD) in Spanish adolescents who participated in a web-based computer intervention for the prevention of binge drinking known asAlerta Alcohol.MethodsLongitudinal analyses were carried out in a sample of Andalusian adolescents aged 15 to 19 enrolled in public schools, which was part of a two-arm cluster randomized controlled trial with an intervention group (IG) who received theAlerta Alcoholprogramme and a control group (CG) who did not receive any active intervention. Panel count data and the following econometric procedures were used: negative binomial, a two-part model and a finite mixture model. The endogenous variable in all models was the number of BD occasions in the last 30 days. A total of 1247 subjects in the pre-intervention period, with an average age of 16.8 years, plus 612 adolescents in the follow-up period (4 months later), were included in the analysis.ResultsIn relation to findings, being older (≥17 years old), having more pocket money and higher family alcohol consumption were associated with greater BD. By contrast, subjects who completed the questionnaire on Wednesday, Thursday or Friday, further from the previous weekend, indicated a lower number of BD occasions.ConclusionsOur results suggest the need to include families, especially parents and siblings, in interventions aimed at preventing alcohol use among adolescents, given the association shown between BD and both family alcohol consumption and weekly pocket money or availability of money to adolescents. Given the findings with regard to age, future research aimed at intervening in early adolescence to prevent BD would be justified.Trial registration(ClinicalTrials.gov):NCT03288896. Registration date: September 20, 2017. “Retrospectively registered”.

Objetivo: Evaluar el acceso al mercado de los medicamentos huérfanos en España que a fecha de 31 de diciembre de 2017 tuvieran vigente su designación, y para aquellos comercializados en España estimar los tiempos entre la asignación de código nacional (CN) por parte de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) y la fecha de comercialización efectiva. Método: La base de datos para identificar los medicamentos huérfanos autorizados por la Agencia Europea de Medicamentos (EMA), a fecha 31 de diciembre de 2017 (n = 142), es su Registro Comunitario publicado por la Comisión Europea. La EMA publica los medicamentos huérfanos que han perdido la designación. Las fechas de asignación de CN provienen de la AEMPS, y las de comercialización, de Bot PLUS. Se llevó a cabo un análisis descriptivo de las variables de estudio. Las variables cuantitativas se describieron utilizando la media y mediana, así como la desviación estándar y su rango. Las variables cualitativas se describieron según frecuencias absolutas y relativas. La comparación de resultados se realizó mediante contrastes paramétricos y no paramétricos en función de la aplicabilidad, con un nivel de significación del 5%. Resultados: Entre 2002 y 2017, la EMA autorizó (con designación vigente a 31 de diciembre de 2017) 100 medicamentos huérfanos. De ellos, 86 tienen CN asignado, y de estos, 54 se han comercializado en España (54% de los medicamentos huérfanos vigentes y 63% de aquellos con CN). Para todos los medicamentos huérfanos con fecha de comercialización (53), el tiempo (mediana) desde la asignación del CN hasta su comercialización en España es de 13,4 meses (desviación estándar: 17,0; mínimo: 2,1; máximo: 91,7). La mediana para los comercializados en 2002-2013 y 2014-2017 es de 12,4 meses y 14,0 meses, respectivamente (p = 0,46). Esta diferencia no es estadísticamente significativa, lo que cabría esperar dado el número limitado de medicamentos huérfanos en nuestra «población». Conclusión: Numerosos factores determinan el acceso a los medicamentos huérfanos. La autorización centralizada de comercialización en Europa es un éxito; su acceso es más limitado, dadas las complejidades de evaluación de la evidencia disponible en los procesos de financiación y precio. Es necesario implementar nuevas políticas que reduzcan las desigualdades en el acceso y permitan la sostenibilidad del sistema. Para conseguir estos objetivos, podrían contemplar un proceso acelerado en la decisión de financiación y precio, y el pago por resultados con incertidumbre alta. Objective: To assess the access to orphan medicines in Spain, focusing on those with an active “orphan” designation, as of 31st December 2017; and for those orphan medicines in the Spanish market, estimate the time between being assigned a National Code (NC) by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and being approved for launch. Method: We used the European Commission's Public Register of orphan medicines to identify the orphan medicines authorised by the European Medicines Agency (EMA), as of 31 December 2017, while we sourced expired orphan indications from the EMA's website. Dates when NCs were assigned were sourced from the AEMPS, and commercialisation dates from Bot PLUS. A descriptive analysis of the study variables was done. The quantitative variables were described using means and medians, as well as standard deviations and ranges. The qualitative variables were described according to absolute and relative frequencies. The comparison of results was performed by parametric and non-parametric contrasts according to the applicability, at a 5% significance level. Results: The EMA has approved 100 orphan medicines (with designation as of 31/12/2017) between 2002-2017. Eighty-six have a NC assigned by the AEMPS. Fifty-four have been launched in Spain (representing 54% of the full sample; 63% with NC). For the 53 orphan drugs with launch date in Spain, the median time between receiving its NC and its launch is 13.4 months (standard deviation: 17.0; minimum: 2.1; maximum: 91,7). The median time is 12.4 months and 14.0 months for those medicines launched in Spain between 2002-2013 and 2014-2017 respectively (p = 0.46). This difference is not statistically significant, which is what could be expected given the low numbers of orphan medicines in the “population”. Conclusion: Complex factors determine the access to orphan drugs in Europe. The centralised procedure to obtain marketing authorisation at European level is a success. However, access is more limited, given the complexities of the evaluation of the available evidence for pricing and reimbursement decisions. It is therefore necessary to implement new policies that reduce inequalities in access and help achieve sustainable healthcare systems. To achieve this, they will need to offer the possibility of allowing earlier access, and using payment by results when there is high uncertainty. info:eu-repo/semantics/publishedVersion

Background and Objective: Multi-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. Method: Following 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. Results: The 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. Conclusions: Under 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. info:eu-repo/semantics/publishedVersion

Background and aims Modelling return on investment (ROI) from smoking cessation interventions requires estimates of their costs and benefits. This paper describes a standardized method developed to source both economic costs of tobacco smoking and costs of implementing cessation interventions for a Europe-wide ROI model [European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD)]. Design Focused search of administrative and published data. A standardized checklist was developed in order to ensure consistency in methods of data collection. Setting and participants Adult population (15+ years) in Hungary, Netherlands, Germany, Spain and England. For passive smoking-related costs, child population (0-15 years) was also included. Measurements Costs of treating smoking-attributable diseases;productivity losses due to smoking-attributable absenteeism;and costs of implementing smoking cessation interventions. Findings Annual costs (per case) of treating smoking attributable lung cancer were between (sic)5074 (Hungary) and (sic)52106 (Germany);coronary heart disease between (sic)1521 (Spain) and (sic)3955 (Netherlands);chronic obstructive pulmonary disease between (sic)1280 (England) and (sic)4199 (Spain);stroke between (sic)1829 (Hungary) and (sic)14880 (Netherlands). Costs (per recipient) of smoking cessation medications were estimated to be: for standard duration of varenicline between (sic)225 (England) and (sic)465 (Hungary);for bupropion between (sic)25 (Hungary) and (sic)220 (Germany). Costs (per recipient) of providing behavioural support were also wide-ranging: one-toone behavioural support between (sic)34 (Hungary) and (sic)474 (Netherlands);and group-based behavioural support between (sic)12 (Hungary) and (sic)257 (Germany). The costs (per recipient) of delivering brief physician advice were: (sic)24 (England);(sic)9 (Germany);(sic)4 (Hungary);(sic)33 (Netherlands);and (sic)27 (Spain). Conclusion: s Costs of treating smoking-attributable diseases as well as the costs of implementing smoking cessation interventions vary substantially across Hungary, Netherlands, Germany, Spain and England. Estimates for the costs of these diseases and interventions can contribute to return on investment estimates in support of national or regional policy decisions.

Aims To assess the cost-effectiveness of alternative smoking cessation scenarios from the perspective of the Spanish National Health Service (NHS). Design We used the European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD), a Markov-based state transition economic model, to estimate the return on investment (ROI) of: (a) the current provision of smoking cessation services (brief physician advice and printed self-helped material + smoking ban and tobacco duty at current levels);and (b) four alternative scenarios to complement the current provision: coverage of proactive telephone calls;nicotine replacement therapy (mono and combo) [prescription nicotine replacement therapy (Rx NRT)];varenicline (standard duration);or bupropion. A rate of 3% was used to discount life-time costs and benefits. Setting Spain. Participants Adult smoking population (16+ years). Measurements Health-care costs associated with treatment of smoking attributable diseases (lung cancer, coronary heart disease, chronic obstructive pulmonary infection and stroke);intervention costs;quality-adjusted life years (QALYs). Costs and outcomes were summarized using various ROI estimates. Findings The cost of implementing the current provision of smoking cessation services is approximately (sic)61 million in the current year. This translates to 18 quitters per 1000 smokers and a life-time benefit-cost ratio of 5, compared with no such provision. All alternative scenarios were dominant (cost-saving: less expensive to run and generatedmore QALYs) from the life-time perspective, comparedwith the current provision. The life-time benefit-cost ratios were: 1.87 (proactive telephone calls);1.17 (Rx NRT);2.40 (varenicline-standard duration);and bupropion (2.18). The results remained robust in the sensitivity analysis. Conclusion: s According to the EQUIPTMODmodelling tool itwould be cost-effective for the Spanish authorities to expand the reach of existing GP brief interventions for smoking cessation, provide pro-active telephone support, and reimburse smoking cessationmedication to smokers trying to stop. Such policies wouldmore than pay for themselves in the long run.

Aims To evaluate costs, effects and cost-effectiveness of increased reach of specific smoking cessation interventions in Germany. Design A Markov-based state transition return on investment model (EQUIPTMOD) was used to evaluate current smoking cessation interventions as well as two prospective investment scenarios. A health-care perspective (extended to include out-of-pocket payments) with life-time horizon was considered. A probabilistic analysis was used to assess uncertainty concerning predicted estimates. Setting Germany. Participants Cohort of current smoking population (18+ years) in Germany. Interventions Interventions included group-based behavioural support, financial incentive programmes and varenicline. For prospective scenario 1 the reach of group-based behavioral support, financial incentive programme and varenicline was increased by 1% of yearly quit attempts (= 57915 quit attempts), while prospective scenario2represented a higher reach, mirroringthe levels observed inEngland. Measurements EQUIPTMOD considered reach, interventioncost, number of quitters, quality-of-lifeyears (QALYs) gained, cost-effectivenessand returnon investment. Findings The highest returns throughreduction insmoking-related health-care costswere seen for the financial incentive programme ((sic)2.71 per (sic)1 invested), followed by that of group-based behavioural support ((sic)1.63 per (sic)1 invested), compared with no interventions. Varenicline had lower returns ((sic)1.02 per (sic)1 invested) than the other two interventions. At thepopulationlevel, prospective scenario1led to15 034QALYsgained and (sic)27millioncost-savings, compared with current investment. Intervention effects and reach contributed most to the uncertainty around the return-oninvestment estimates. At a hypothetical willingness-to-pay threshold of only (sic)5000, the probability of being cost-effective is approximately 75% for prospective scenario 1. Conclusion: s Increasing the reach of group-based behavioural support, financial incentives and varenicline for smoking cessation by just 1% of current annual quit attempts provides a strategy to German policymakers that improves the population's health outcomes and that may be considered cost-effective.

Background and Aims Although clear benefits are associated with reducing smoking, there is increasing pressure on public health providers to justify investment in tobacco control measures. Decision makers need tools to assess the return on investment (ROI)/cost effectiveness of programs. The EQUIPT project adapted an ROI tool for England to four European countries (Germany, Netherlands, Spain and Hungary). EQUIPTMOD, the economic model at the core of the ROI tool, is designed to assess the efficiency of packages of smoking cessation interventions. The objective of this paper is to describe the methods for EQUIPTMOD and identify key outcomes associated with continued and cessation of smoking. Methods EQUIPTMOD uses a Markov model to estimate lifetime costs, quality adjusted life years (QALYs) and life years associated with a current and former smoker. It uses population data on smoking prevalence, disease prevalence, mortality and the impact of smoking combined with associated costs and utility effects of disease. To illustrate the tool's potential, costs, QALYs and life expectancy were estimated for the average current smoker for five countries based on the assumptions that they continue and that they cease smoking over the next 12 months. Costs and effects were discounted at country specific rates. Results For illustration, over a lifetime horizon, not quitting smoking within the next 12 months in England will reduce life expectancy by 0.66, reduce QALYs by 1.09 and result in £4,961 higher disease related health care costs - than if the smoker ceased smoking in the next 12 months. For all age-sex categories, costs were lower and QALYs higher for those who quit smoking in the twelve months than those who continued. Conclusions EQUIPTMOD facilitates assessment of the cost effectiveness of smoking cessation strategies. The demonstrated results indicate large potential benefits from smoking cessation at both an individual and population level.

To evaluate preventive interventions on alcohol consumption has been long recommended in Spain. The impact evaluation of structured programs and specific actions for the prevention and treatment of alcohol consumption (PAPTCA) would allow making better informed decisions on public health financing based on the efficiency criteria. To the best of our knowledge, there is no scientific document that illustrates the situation of the PAPTCAs' evaluation in Spain. This paper aims to classify and describe PAPTCAs in Spain, focused on their impact evaluation and information on financing for accountability to society.A systematic literature review of the PAPTCAs implemented in Spain, from 2000 till 2017, at regional (autonomous communities) and local level was carried out, and a descriptive analysis of the PAPTCA database obtained from the literature review was carried out.145 structured programs and 45 specific actions were identified. Only 25% of structured programs provided an impact evaluation, besides, only 15% presented some information about their financing. Regarding the specific actions, the numbers were less encouraging where 10% provided an impact evaluation while a similar figure of PAPTCAs showed financing information.There is a need to systematize the information of the PAPTCA that serves as an instrument to conduct impact evaluations in Spain. This should ease the scarce presence of evaluative culture in this area and promote the accountability of resources spent on public health to society.Hace tiempo que se recomienda evaluar las intervenciones preventivas en España. La evaluación del impacto de los programas estructurados y de las acciones puntuales de prevención y tratamiento del consumo de alcohol (PAPTCA) permitiría tomar las decisiones de financiación mejor informadas en materia de salud pública, desde el punto de vista de la eficiencia. No obstante, no se conoce un documento que ilustre la situación de la evaluación de los PAPTCA en España. Este artículo pretendió clasificar y describir los PAPTCA en España, prestando especial atención a la evaluación de impacto y a la información sobre financiación para la rendición de cuentas.Se realizó una revisión bibliográfica sistematizada de los PAPTCA implementados en España tanto a nivel regional (comunidades autónomas) como local durante el periodo 2000-2017, y se llevó a cabo un análisis descriptivo de la base de datos obtenida de los PAPTCA a partir de la revisión de la bibliografía realizada.Se identificaron 145 programas estructurados y 45 acciones puntuales. Solo el 25% de los programas estructurados evaluaron los resultados. Además, únicamente un tercio de ellos presentaron alguna información sobre su financiación. Por su parte, los números fueron menos alentadores en las acciones puntuales, donde solo el 10% evaluaron sus resultados, y una cifra similar aportó información sobre su financiación.Existe una necesidad de sistematizar la información de los PAPTCA, para que sirva de instrumento en la evaluación de su impacto en España y, de esta manera, paliar la escasa presencia de cultura evaluativa en este ámbito y promover la rendición de cuentas a la sociedad de los recursos en salud pública.

The aim of this paper was to estimate the number of premature deaths, years of potential productive life lost (YPPLL) and labour losses attributable to tobacco smoking due to premature death by gender for the Spanish population. The human capital approach was applied. Employment, gross wage and death data were obtained from the Spanish National Institute of Statistics. Relative risks of death due to cigarette smoking and former smoking were applied. The base case used an annual discount rate of 3% and an annual labour productivity growth rate of 1%. Univariate deterministic sensitivity analysis was performed on discount rates and labour productivity growth rates. Between 2002 and 2016, smoking was estimated to cause around 13,171&ndash, 13,781 annual deaths in the population under 65 years of age (legal retirement age) in Spain. This increase was mostly due to female deaths. YPPLLs for females have increased over the years, while for males they have fallen markedly. Labour losses associated with smoking mortality ranged from &euro, 2269 million in 2002 to &euro, 1541 in 2016 (base year 2016). In fact, labour productivity losses have decreased over the years for men (&minus, 39.8%) but increased sharply for women (101.6%). The evolution of monetary value of lost productivity due to smoking mortality shows clearly differentiated trends by gender.

IntroductionExposure to secondhand aerosol from e-cigarette (SHA) may pose harmful effects to bystanders. This study aims to investigate the prevalence, duration and determinants of SHA exposure in various indoor settings in 12 European countries.MethodsIn 2017–2018, we conducted a cross-sectional study, the TackSHS survey, on a representative sample of the population aged ≥15 years in 12 European countries (Bulgaria, England, France, Germany, Greece, Ireland, Italy, Latvia, Poland, Portugal, Romania and Spain). We described the prevalence and duration of exposure to SHA in several indoor settings among 11 604 e-cigarette non-users. Individual-level and country-level characteristics associated with SHA exposure were also explored using multilevel logistic regression analyses.ResultsOverall, 16.0% of e-cigarette non-users were exposed to SHA in any indoor setting at least weekly, ranging from 4.3% in Spain to 29.6% in England. The median duration of SHA exposure among those who were exposed was 43 min/day. ‘Other indoor settings’ (eg, bar and restaurant) was reported as the place where most of e-cigarette non-users were exposed (8.3%), followed by workplace/educational venues (6.4%), home (5.8%), public transportation (3.5%) and private transportation (2.7%). SHA exposure was more likely to occur in certain groups of non-users: men, younger age groups, those with higher level of education, e-cigarette past users, current smokers, those perceiving SHA harmless and living in countries with a higher e-cigarette use prevalence.ConclusionsWe found inequalities of SHA exposure across and within European countries. Governments should consider extending their tobacco smoke-free legislation to e-cigarettes to protect bystanders, particularly vulnerable populations such as young people.Trial registration numberNCT02928536.

Discrete choice experiments (DCEs) are a way to assess priority-setting in health care provision. This approach allows for the evaluation of individuals’ preferences as a means of adding criteria to traditional quality-adjusted life year analysis. The aim of this systematic literature review was to identify attributes for designing a DCE in order to then develop and validate a framework that supports decision-making on health technologies. Our systematic literature review replicated the methods and search terms used by de Bekker-Grob et al. 2012 and Clark et al. 2014. The Medline database was searched for articles dated between 2008 and 2015. The search was limited to studies in English that reflected general preferences and were choice-based, published as full-text articles and related to health technologies. This study included 72 papers, 52% of which focused on DCEs on drug treatments. The average number of attributes used in all included DCE studies was 5.74 (SD 1.98). The most frequently used attributes in these DCEs were improvements in health (78%), side effects (57%) and cost of treatment (53%). Other, less frequently used attributes included waiting time for treatment or duration of treatment (25%), severity of disease (7%) and value for money (4%). The attributes identified might inform future DCE surveys designed to study societal preferences regarding health technologies in order to better inform decisions in health technology assessment. info:eu-repo/semantics/acceptedVersion

The consistent under-recognition of occupational diseases (OD) in Spain leads to an exchange of patients and resources between the country's National Health System and the Social Security System. We examined the direct healthcare costs of a series of patients diagnosed with OD by the Clinical Occupational Diseases Unit in a Barcelona hospital. Information on all care associated with the diagnosis of PD was systematically reviewed. The economic value of each episode of care was obtained from the hospital cost accounting and billing system. Overall, we computed costs for 524 episodes in 33 patients. The average cost was 345.5€, being highest for hospital admissions (4,032.5€). The average cost per patient was € 5,486.2, and for cancer € 15,223.3. These results highlight the need for coordination between the National Health System and the Social Security System so that OD can be appropriately recognized.El infra-reconocimiento secular de las enfermedades profesionales (EP) en España provoca un intercambio de pacientes y recursos entre el Sistema Nacional de Salud y el de Seguridad Social. Se estimaron los costes asistenciales directos de una serie de pacientes de un hospital de Barcelona diagnosticados de EP por su Unidad de Patología Laboral. La información sobre todas las asistencias asociadas al diagnóstico de EP fue revisada sistemáticamente. El valor económico de cada asistencia se obtuvo de la contabilidad de costes y sistema de facturación del hospital. En total, se computaron 524 asistencias de 33 pacientes, con un coste medio de 345,5€, siendo el más alto para las hospitalizaciones (4.032,5€). El coste medio por paciente fue de 5.486,2€, y para el cáncer de 15.223,3€. Estos resultados ponen de manifiesto la necesidad de coordinación entre el Sistema Nacional de Salud y el de Seguridad Social para un adecuado reconocimiento de EP.

Aim To present a comparison between the effects on health due to a reduction in binge drinking (BD) and health-related quality of life (HRQoL), as a result of ALERTA ALCOHOL, an intervention aimed at reducing BD in Spanish adolescents. Methods A two-arm cluster randomized controlled trial was conducted with an intervention and a control group, randomized at the school level, following individuals over four months. The study population consisted of Andalusian adolescents aged 15 to 19 years who were enrolled in urban public high schools (n = 1247). Participants were assigned randomly to receive the intervention. The main outcomes studied were the number of occasions of BD in the last 30 days, which was directly obtained from the answers given by the adolescents, and HRQoL measured with the EQ-5D-5 L questionnaire. The model of estimation was the generalized estimating equations (GEE) approach. Results The program showed a BD reduction at the 4-month follow-up, although it was not shown to significantly increase the HRQoL in adolescents who reduced the number of occasions of BD and had received the intervention. However, it was shown that those who would predictably reduce the number of occasions of BD controlled by several sociodemographic variables perceived a higher HRQoL, as did those who had a greater adherence to the program. Conclusions Higher adherence to a web-based computer-tailored intervention to prevent BD in adolescents has a positive effect on decreasing the number of occasions of BD in adolescents as well as on increasing participants’ HRQoL, although this second effect is very small, which could be due to the short follow-up time. This fact is quite important and should be assessed extensively to corroborate the results and translate into health policy.

Our aim was to provide a systematic review of studies on the burden of disease due to second-hand smoke (SHS) exposure, reviewing methods, exposure assessment, diseases causally linked to SHS, health outcomes, and estimates available to date. A literature review of studies on the burden of disease from SHS exposure, available in PubMed and SCOPUS, published 2007–2018 in English language, was carried out following the PRISMA recommendations. Overall, 588 studies were first identified, and 94 were eligible. Seventy-two studies were included in the systematic review. Most of them were based on the comparative risk assessment approach, assessing SHS exposure using mainly surveys on exposure at home/workplaces. Diseases more frequently studied were: lung cancer, ischemic heart disease, stroke, chronic obstructive pulmonary disease, asthma and breast cancer in adults; lower respiratory tract infection, otitis media, asthma, sudden infant death syndrome and low birth weight in children. The SHS exposure assessment and the reported population attributable fractions (PAF) were largely heterogeneous. As an example, the PAF from lung cancer varied between 0.6% and 20.5%. Moreover, PAF were estimated applying relative risks and SHS exposures with no consistent definitions or with different age classes. The research gap on the SHS exposure burden is shrinking. However, estimates are not yet available for a number of countries, particularly the Middle Eastern and African countries, and not all diseases with the strongest evidence of causation, such as sudden infant death syndrome, have been explored. Moreover, in some cases the applied methodology revealed relatively low quality of data. info:eu-repo/semantics/acceptedVersion

Background Despite their marginal benefit, about 60% of acute lower respiratory tract infections (ALRTIs) are currently treated with antibiotics in Catalonia. This study aims to evaluate the effectiveness and efficiency of a continuous disease-focused intervention (C-reactive protein [CRP]) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres. Methods/design A cluster randomised, factorial, controlled trial aimed at including 20 primary care centres (N = 2940 patients) with patients older than 18 years of age presenting for a first consultation with an ALRTI will be included in the study. Primary care centres will be identified on the basis of socioeconomic data and antibiotic consumption. Centres will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the societal and national healthcare system perspectives, and the time horizon of the analysis will be 1 year. Two qualitative studies (pre- and post-clinical trial) aimed to identify the expectations and concerns of patients with ALRTIs and the barriers and facilitators of each intervention arm will be run. Family doctors and nurses assigned to the interventions will participate in a 2-h training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the year of the trial period. Primary outcomes will be antibiotic use within the first 6 weeks, duration of moderate to severe cough, and the quality-adjusted life-years. Secondary outcomes will be duration of illness and severity of cough measured using a symptom diary, healthcare re-consultations, hospital admissions, and complications. Healthcare costs will be considered and expressed in 2021 euros (year foreseen to finalise the study) of the current year of the analysis. Univariate and multivariate sensitivity analyses will be carried out. Discussion The ISAAC-CAT project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual clinical guidelines. Trial registration ClinicalTrials.gov, NCT03931577.

Smoke-free legislation reduced second-hand smoke (SHS) exposure in public places, and indirectly promoted private smoke-free settings. Nevertheless, a large proportion of adults is still exposed to SHS at home. The aim of this paper is to quantify the burden of disease due to home SHS exposure among adults in the 28-European Union (EU) countries for year 2017. The burdens by gender from lung cancer, chronic obstructive pulmonary disease (COPD), breast cancer, ischemic heart disease (IHD), stroke, asthma, and diabetes were estimated in an original research analysis using the comparative risk assessment method. Relative risks of death/diseases by gender for adults exposed to SHS at home compared to not exposed ones were estimated updating existing meta-analyses. Prevalence of home SHS exposure by gender was estimated using a multiple imputation procedure based on Eurobarometer surveys. Data on mortality and disability adjusted life years (DALYs) were obtained from the Global Burden of Disease, Injuries and Risk Factors Study. In 2017, 526,000 DALYs (0.36% of total DALYs) and 24,000 deaths (0.46% of total deaths) were attributable to home SHS exposure in the 28-EU countries, mainly from COPD and IHD. South-Eastern EU countries showed the highest burden, with proportion of DALYs/deaths attributable to SHS exposure on total higher than 0.50%/0.70%, whereas northern EU-countries showed the lowest burden, with proportions of DALYs/deaths lower than 0.25%/0.34%. The burden from SHS exposure is still significant in EU countries. More could be done to raise awareness of the health risks associated with SHS exposure at home.

The current study examined symptoms of irritation reported by non-smokers passively exposed to e-cigarette aerosols and their timing and association with the concentrations of volatile organic compounds (VOCs) produced.40 healthy non-smoking adults were exposed to e-cigarette aerosols for 30 min in a 35 m20 males and 20 females, with a mean age of 24.6 years (SD = 4.3) and exhaled CO 7 ppm participated. PM concentrations in both experimental sessions were higher than the Control (p 0.001). The most commonly reported symptoms were burning, dryness, sore throat, cough, breathlessness and headache. During both experimental sessions, ocular, nasal, throat-respiratory symptoms and general complaints increased significantly (p 0.05). Ocular and nasal symptoms returned to baseline by tA 30-min exposure to SHA provoked symptoms of sensory irritation and general complaints that lasted up to 30 min after the exposure and were positively associated with the concentrations of the VOC mixture emitted.

Background The economic evaluation of healthcare technologies has become in many countries a basic tool for reimbursement, pricing and purchasing decisions. Objective The objective of this article is to examine the institutional, legal, and political factors that have impeded the application of economic evaluation and the criterion of efficiency in the process of pricing and reimbursement of new medicines in Spain. Methods Narrative description of the current institutional framework for the use of economic evaluation in pricing and reimbursement in Spain, legal and policy framework in the field of evaluation of new medicines, and stakeholder initiatives and policies related to the use of economic evaluation outside of the pricing and reimbursement process. Results Spain has an institutional framework created and established over the last years that could have facilitated a formal use of economic evaluation in the process of pricing and reimbursement. Nevertheless, the real use of economic evaluation at the central or regional level is still unknown, although application of the efficiency criterion, linking to cost-effectiveness, has been clearly required by Spanish laws and regulations at the national level. We highlight a certain degree of moral hazard from the central government that is not directly responsible for the budget impact of reimbursement and pricing decisions. There are currently a number of ongoing initiatives in the field of economic evaluation by various agents, but they remain uncoordinated. Conclusions Poor governance at the highest level of decision making is the main reason for the lack of interest in economic evaluation. A profound political change, supported by transparency and accountability, is required before the criterion of efficiency can be fully considered in the process of pricing and reimbursement of new medicines in Spain.