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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]

Background: In Italy, the State Regions Conference on 1st August 2019 approved the Guidelines for Short-Stay Observation (SSO). At the beginning of 2022, the main Scientific Societies of the pediatric hospital emergency-urgency area launched a national survey to identify the extent to which these national guidelines had been adopted in the emergency rooms and pediatric wards of the Italian Regions. Methods: A survey has been widespread, among Pediatric Wards and Pediatric Emergency Departments (EDs), using both a paper questionnaire and a link to a database on Google Drive, for those who preferred to fill it directly online. Those who did not spontaneously answer, where directly contacted, via email and/or through a phone call and invited to participate. The data collected have been: age of managed children, presence of triage, presence of Sub-intensive Care Unit and Intensive Care Unit and special questions about Pediatric SSO, availability of training courses for workers, number of ED access in the last 4 years. Results: This survey is still ongoing, without a definite deadline, so we presented the preliminary data. Currently, 8/20 Regions have not yet adopted the Guidelines. Till 02 January 2023, data from 253 hospitals were collected. There are currently 180/253 active Pediatric SSO (71.03% of the Hospitals). There are not active SSO in 33.27% of first level ED, in 19.35% of second level ED and in 33.66% of General Hospitals with Pediatric Wards. Active SSO are located mainly (75.97%) within Pediatric Wards. At the moment, the survey has been completed in 16 Regions: in the 8 Regions which are using guidelines, pediatric SSOs are active in all the second level ED (compared to 60.87% of the other 8 regions), in the 91.66% of first level ED (compared to the 33.3%), and in the 97.1% of General Hospitals (compared to 33.3%), with a statistically significance (p < 0.0001). The territorial analysis of these 16 regions highlighted geographical differences in the percentage of SSOs active: 35.22% are active in hospitals in Southern Italy, 88.64% in Central Italy and 91.67% in those of the North. Conclusions: The delay in adopting specific guidelines negatively influences activation of pediatric SSOs in hospital system and prevents the adjustment of welfare level to new needs. To facilitate the activation of SSOs in hospitals, it is also necessary to guarantee adequate economic recognition. It is essential to implement public interventions to overcome the current inequalities in the interest of children and their families: the current delay seriously penalizes emergency pediatric hospital care, especially in the southern Italian Regions. [ABSTRACT FROM AUTHOR]

Mental health is impacted by social, economic, and environmental factors, the Social Determinants of Health (SDH). Migrants experiencing precarious living and working conditions may be more at risk of poor mental health than the majority population. This paper aims to evaluate the relationship of educational attainment and other SDH with depressive symptoms among the resident population, including Italians and migrants. This study examined the respondents to the Italian "Progressi delle Aziende Sanitarie per la Salute in Italia" (PASSI) surveillance system, 2014–18. The sample of 144.055 respondents is composed of the resident working adults aged 25–69 with Italian citizenship (n = 136.514) and foreign citizenship (n = 7.491). Findings show that among Italians high level of education appears to be a protective factor for mental health, in accordance with the international evidence (adjPR: tertiary education 0,74 p-value = 0.000). However, among immigrants high level of education is associated with the presence of depressive symptoms (adjPR: tertiary education: 1.61 p-value = 0.006), particularly for men (adjPR: tertiary education: 2.40 p-value = 0.006). The longer the length of stay in Italy for immigrants the higher the risk of depressive symptoms: adjPR for 10+ years: 2.23 p-value = 0.005. The data show that high education could represent a risk factor for mental health of immigrants. Moreover, among migrants there are some significant mental health inequities between male and female related to the duration of stay in Italy, economic activity and educational level. Considering that health is related to the nature of society as well as to access to technical solutions, multicultural societies require culturally oriented interventions for tackling health inequities. This means developing evidence-based policies in order to tackle health inequalities in the population as a whole, including culturally oriented measures in the larger framework of developing diversity sensitive services. [ABSTRACT FROM AUTHOR]

Mental health is impacted by social, economic, and environmental factors, the Social Determinants of Health (SDH). Migrants experiencing precarious living and working conditions may be more at risk of poor mental health than the majority population. This paper aims to evaluate the relationship of educational attainment and other SDH with depressive symptoms among the resident population, including Italians and migrants. This study examined the respondents to the Italian "Progressi delle Aziende Sanitarie per la Salute in Italia" (PASSI) surveillance system, 2014–18. The sample of 144.055 respondents is composed of the resident working adults aged 25–69 with Italian citizenship (n = 136.514) and foreign citizenship (n = 7.491). Findings show that among Italians high level of education appears to be a protective factor for mental health, in accordance with the international evidence (adjPR: tertiary education 0,74 p-value = 0.000). However, among immigrants high level of education is associated with the presence of depressive symptoms (adjPR: tertiary education: 1.61 p-value = 0.006), particularly for men (adjPR: tertiary education: 2.40 p-value = 0.006). The longer the length of stay in Italy for immigrants the higher the risk of depressive symptoms: adjPR for 10+ years: 2.23 p-value = 0.005. The data show that high education could represent a risk factor for mental health of immigrants. Moreover, among migrants there are some significant mental health inequities between male and female related to the duration of stay in Italy, economic activity and educational level. Considering that health is related to the nature of society as well as to access to technical solutions, multicultural societies require culturally oriented interventions for tackling health inequities. This means developing evidence-based policies in order to tackle health inequalities in the population as a whole, including culturally oriented measures in the larger framework of developing diversity sensitive services. [ABSTRACT FROM AUTHOR]