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Early access programs (EAPs) generally refer to patient access to medicines/indications before marketing authorization, possibly extended to price and reimbursement approval. These programs include compassionate use, which is usually covered by pharmaceutical companies, and EAPs reimbursed by third-party payers. This paper aims at comparing EAPs in four European countries (France, Italy, Spain, UK) and providing empirical evidence on EAPs in Italy. The comparative analysis was conducted through a literature review (including scientific and grey literature), complemented by 30-min semi-structured interviews with local experts. The Italian empirical analysis employed data available on the National Medicines Agency website. Although EAPs are very different across countries, they exhibit some common features: (i) eligibility criteria refer to the absence of valid therapeutic alternatives and a presumed favourable risk–benefit profile; (ii) payers do not allocate a pre-determined budget to these programs; (iii) total spending on EAPs is unknown. The French EAPs seem to be the most structured, financed through social insurance, covering pre-marketing, post-marketing and pre-reimbursement phases and providing for data collection. Italy's approach to EAPs has been varied, with several programs covered by different payers, including the cohort-based 648 List (for both early access and off-label use), the nominal-based 5% Fund, and Compassionate Use. Most applications to EAPs are from the Antineoplastic and immunomodulating drug class (ATC L). Some 62% of indications in the 648 List are either not under clinical development or have never been approved (pure off-label use). For those subsequently approved, most approved indications coincide with those covered through EAPs. Only the 5% Fund provides data on economic impact (€ 81.2 million in 2021; average cost per patient € 61.5K). Diverse EAPs are a possible source of inequalities in access to medicines across Europe. A harmonization of these programs, though difficult to achieve, could be modelled on the French EAPs and provide key advantages, not least of which a common effort to collect real-world data in parallel with clinical trials and clear separation between EAPs and off-label use programs. [ABSTRACT FROM AUTHOR]

Introduction: the recent economic and financial crisis has affected most Western countries, especially families of low socioeconomic classes. We speculate that worsening of socioeconomic condition associated with the crisis would increase obesity, mainly in disadvantaged families.Material and Methods: cross-sectional study of the 290,111 children aged three to 12 years old attending public school during the term 2014-2015 in Madrid City, by means of a stratified weighted sample randomly chosen, taking into account age (grade), city district and schools. The questionnaire included weight and height (auto-reported), dietary report (weekly frequency of intake), as well as socioeconomic variables.Results: 1,208 questionnaires were evaluated from 64 classes. Half of participants were boys; 42% were younger than five years old, 35% werebetween six and eight years old, and 23% older than eight. Undernutrition was present in 5.0%, and excess of weight (overweight + obesity) in 36.7%. Undernutrition was higher in children under the age of six (9.1%). No relationship was found between undernutrition and the characteristics of the families but was slightly higher in families where both parents were unemployed. Excess of weight was higher in children of non-Spaniard parents (44% vs 32%, p < 0.0001), as well as in those families with economic problems (41% vs 31%, p = 0.0005). Only for meat, grains and dairy, the weekly intake was close to the recommendations.Conclusions: children from lower income households were at a higher risk of being overweight compared with their peers. Participation in a school-based food aid program may reduce food insecurity for children and their families. [ABSTRACT FROM AUTHOR]

Background: Despite an increasing number of studies on the factors mediating the impact of the economic recession on mental health, research beyond the individual employment status is scarce. Our objectives were to investigate in which ways the mental health of employed and unemployed populations is differently affected by the current economic recession along the educational scale and to examine whether financial strain and social support explain these effects of the crisis.Methods: A repeated cross-sectional study, using two waves of the Andalusian Health Survey in 2007 (pre-crisis) and 2011-2012 (crisis). A population aged between 19 and 64 years was selected. The dependent variable was the Mental Component Summary of the SF-12 questionnaire. We performed Poisson regression models stratified by working status, with period, educational level, financial strain and social support as independent variables. We examined interactions between period and educational level. Age, sex, main earner, cohabitation and partner's working status were considered as covariates.Results: The study included 3210 individuals (1185 women) in 2007 and 3633 individuals (1486 women) in 2011-2012. In working individuals the prevalence of poor mental health increased for secondary and complete primary studies groups during crisis compared to the pre-crisis period, while it decreased significantly in the university study group (PR = 0.76, 95% CI: 0.58-0.99). However, in unemployed individuals prevalence ratios for poor mental health increased significantly only in the secondary studies group (PR = 1.73, 95% CI: 1.06-2.83). Financial strain and social support yielded consistent associations with mental health in all subgroups. Only financial strain could partly explain the crisis effect on mental health among the unemployed.Conclusions: Our study supports the finding that current economic recession is associated with poorer mental health differentially according to labour market status and educational level. Those with secondary studies may be at risk in times of economic recession. In connection with this, emerging educational inequalities in mental health among the employed population were observed. Our research also suggests a partial mediating role of financial strain for the effects of crisis on poor mental health among the unemployed. Good social support appears to buffer poor mental health in all subgroups but not specifically during crisis period. [ABSTRACT FROM AUTHOR]

Cystic echinococcosis (CE) is endemic in Spain but has been considered non-endemic in the province of Álava, Northern Spain, since 1997. However, Álava is surrounded by autonomous regions with some of the highest CE prevalence proportions in the nation, casting doubts about the current classification. The purpose of this study is to estimate the frequency of CE in humans and animals and to use this data to determine the societal cost incurred due to CE in the Álava population in 2005. We have identified epidemiological and clinical data from surveillance and hospital records, prevalence data in intermediate (sheep and cattle) host species from abattoir records, and economical data from national and regional official institutions. Direct costs (diagnosis, treatment, medical care in humans and condemnation of offal in livestock species) and indirect costs (productivity losses in humans and reduction in growth, fecundity and milk production in livestock) were modelled using the Latin hypercube method under five different scenarios reflecting different assumptions regarding the prevalence of asymptomatic cases and associated productivity losses in humans. A total of 13 human CE cases were reported in 2005. The median total cost (95% credible interval) of CE in humans and animals in Álava in 2005 was estimated to range between €61,864 (95%CI%: €47,304–€76,590) and €360,466 (95%CI: €76,424–€752,469), with human-associated losses ranging from 57% to 93% of the total losses, depending on the scenario used. Our data provide evidence that CE is still very well present in Álava and incurs important cost to the province every year. We expect this information to prove valuable for public health agencies and policy-makers, as it seems advisable to reinstate appropriate surveillance and monitoring systems and to implement effective control measures that avoid the spread and recrudescence of the disease. Author Summary: Historically, cystic echinococcosis (CE) is one of the most important zoonotic diseases in Spain. The initiation of a number of control campaigns in the second half of the 1980s has led to a substantial reduction of the number of CE infections both in humans and livestock species. As a consequence of this initial success, obligation to report human CE cases was revoked in 1997 in a number of Spanish autonomous regions that were consequently considered non-endemic for CE. This policy has not been translated to livestock species, where the identification of hydatid cysts and the reporting of prevalence data remain compulsory in all national slaughterhouses. We present here an estimation of the human and animal CE associated monetary losses in the province of Álava, North Spain, for the year 2005. Obtained economic data corroborate the epidemiological findings and demonstrate that CE has important socio-economic consequences in Álava. Taking together, our data suggest that surveillance status of CE in Álava (and very likely in other Spanish regions currently classified as non-endemic areas) should be reassessed. The situation also indicates that more accurate and effective methods for detecting and reporting the disease at the regional and national level are greatly needed. [ABSTRACT FROM AUTHOR]

The main goal of this study is to analyze the relation between commercial trade and pandemic severity in society, in order to support new hypotheses which can explain transmission dynamics of COVID-19, as well as promote policy responses to cope with future epidemics similar to COVID-19. This study considers the role of trade in the dynamics of pandemic diffusion, within and between countries, which has not been investigated yet in this emerging field of research. We focus on three large countries in Europe: Italy, France, and Spain. The analysis is performed at regional level (involving in total 52 European regions). Results suggest that the association between trade and pandemic severity seems to be supported by empirical evidence, making it possible to introduce new hypotheses for explaining transmission dynamics of COVID-19 within and between countries. In particular, international trade data is supposed to be used as a comprehensive indicator accounting for population density, economic dynamism, and human mobility. The statistical analyses, also in a multivariate context, strongly support this hypothesis and suggest that crisis management has to focus in the very first place on infections occurring outside the national boundaries, in order to cope with pandemic threat of new waves of COVID-19 and future similar epidemics/pandemics. • The interdisciplinary research is shown to be strategic in pandemic to propose new data analysis and perspectives. • Economic data about international trade are used to describe transmission dynamics of COVID-19. • Comparative analysis involving all the regions of Italy, Spain, and France are presented for the first time. [ABSTRACT FROM AUTHOR]