Italian National Health System Research Articles

The 2022 primary care reform in Italy: Improving continuity and reducing regional disparities?

Several member countries of the Organisation for Economic Co-operation and Development are reforming their primary care systems to improve continuity and co-ordination of care. In May 2022, the Italian health minister issued a new Decree on ‘defining models and standards for the development of primary care in the national health service’, which addresses some of the major challenges outlined by the National Recovery and Resilience Plan. The reform will target many aspects of the Italian national health system by transforming primary care into community care, while aiming to overcome geographical disparities and achieve greater effectiveness of services. The reform seeks to establish a new organisational model of the primary care network. There exists the potential to guarantee the same quality of care nationwide, thereby reducing geographical differences in the provision of services and improving healthcare services overall. Nevertheless, in a decentralised health system such as Italy's, reform implementation could actually proliferate rather than reduce regional disparities. This study explains the main points of the Decree, shows how the primary care models of the Italian regions may evolve in relation to the specified criteria, and examines the Decree's capacity to bridge regional discrepancies.

Family and Community Nurses as a Resource for the Inclusion of Youths with Type 1 Diabetes at School.

School nurses can facilitate the inclusion of students with type 1 diabetes (T1D) at school; this model has been widespread in some countries but not in Italy, which is due to the insufficient number of school nurses that are able to provide medical attention at all times. The National Recovery and Resilience Plan (PNRR) devised a series of aids and support for the reorganization of the Italian National Health System (NHS) through the creation of community houses in addition to family and community nurses (FCNs), who will operate in these structures to promote the integration of the various professional figures and community services. In this study, starting with the needs and suggestions of teachers (No. 79) and parents (No. 48) collected using a survey, we developed a new model for the inclusion of students at school where FCNs who have experience in pediatric T1D have the role of an educator, coordinator, and facilitator' they cannot be on site and available all the time during school hours, so they must make many efforts to improve the school staff's knowledge, intervene to offer training when requested, and solve new emerging problems.

Obstetrics Changes Caused by Covid-19

The COVID-19 pandemic has imposed on all workers in the Italian, European and World National Health System a rapid adaptation in the management of multiple clinical situations. In the obstetric-gynecological area, the care of mothers and newborns has become difficult and full of challenges. The adaptations necessary to ensure good quality obstetric care have concerned the pregnancy management, the recovery of pregnant patients and their children, the labour time and the breastfeeding and puerperal care. The present paper summarizes the impact of COVID-19 on obstetric habits based on scientific evidence and clinical experience in the context of the rapidly evolving regulations promulgated in Italy.

A Clinico-Pathological Multidisciplinary Team Increases the Efficacy of Skin Biopsy and Reduces Clinical Risk in Dermatology.

A clinical risk is an inherent risk in healthcare processes, including skin biopsy procedures, and may lead to misdiagnoses, increased healthcare costs and potential harm to patients. Indeed, clinical and histopathological data must be integrated if we are to reduce clinical risks and improve diagnostic accuracy in the diagnosis of dermatologic diseases. Although dermopathology services used to be part of a dermatologist's duty, the recent centralization of these laboratories has caused a loss of expertise and increased both complexity and safety issues. Some countries have implemented clinical-pathological correlation programs aimed at facilitating communication between clinicians and dermatopathologists. However, Italy has regulatory and cultural barriers that make the implementation of these programs difficult. Therefore, an internal analysis was carried out to assess the efficacy and impact that skin biopsy procedures for inflammatory and neoplastic conditions have on the quality of care in our dermatology department. As the analysis evidenced a high number of descriptive pathologic reports and discordant diagnoses, a multidisciplinary group of four dermatologists, four general pathologists and one dermatopathologist was set up. Herein, we present the results of this analysis and project and describe the structure of the multidisciplinary group. We also discuss the pros and cons, possibilities and limitations of our project, including the regulatory barriers of the Italian National Health System.

"Is the Future of Public Health after Covid-19 Becoming Digital? Electronic Health Records (EHRs) in the Italian National Health System: A Special Case Study"

The recent SARS-CoV-2 pandemic represented a turning point in many health sectors worldwide, particularly in Italy, one of the nations most affected by COVID-19. There is no doubt that the pandemic has accelerated the spread of digital technologies in health care.

Do more targets allow more cancer treatments, or not?

The three current oncology models (histological, agnostic and mutational) mainly differ in clinical, technological and organisational aspects, leading to different regulatory procedures and implications in antineoplastic therapy access by patients. Within the histological and agnostic models, Regulatory Agencies authorise target therapies and define their price, reimbursement, prescription and access based on results from clinical trials including patients affected by the same tumour (histological) or subjects with specific genetic mutations regardless of the tumour site or the histology (agnostic). The mutational model has been developed to identify specific actionable molecular alterations found by next-generation sequencing test-based large platforms on solid and liquid biopsies. Nevertheless, due to the highly uncertain efficacy and possible toxicity of drugs tested within this model, regulatory procedures based on histological or agnostic oncology cannot be followed. Multidisciplinary skills are required (e.g. the molecular tumour board’s (MTB) representatives) to identify the best association between the genomic profile and the drug planned to be used, but quality requirements, practices and procedures of these discussions still need to be standardised. Real-world evidence from clinical practice (i.e. genomic findings, clinical data and MTBs’ choices) lacks, therefore, it is urgently needed as opposed to limited findings from clinical trials. A potential solution for an appropriate access to the therapy chosen by the mutational model can be the indication-value-based sub iudice procedure of authorisation. The access to therapies suggested by extensive molecular profiling could be easily implementable within the Italian national health system, thanks to the existing regulatory procedures, i.e. the managed-entry agreements and the antineoplastic drug monitoring registries, alongside those granted by conventional studies (phase I, II, III, IV) conducted according to the histological and agnostic models.

‘Now I can train myself to be with death’: a phenomenological study with young doctors in care homes supported by a palliative care unit during the second wave of the pandemic in Italy

ObjectiveDuring the second wave of the COVID-19 pandemic, one of the organisational strategies established by the Italian National Health System was the special units for continuity of care (SUCCs). In...

Incidence and Predictors of Switching and Dose Change of Direct Oral Anticoagulants among Elderly Patients with Nonvalvular Atrial Fibrillation: A 5-Year Analysis of a Large Administrative Database

In the last decade, novel oral anticoagulants (NOACs) have emerged as prominent therapeutic options in non-valvular atrial fibrillation (NVAF). We analysed the clinical burden and the switching rate between all available NOACs, and their dosage change over a period of 5 years in a representative population of patients with NVAF aged between 70 and 75 years. Methods and Results: This is a retrospective observational study on administrative databases, covering approximately 6.2 million health-assisted individuals by the Italian National Health System (around 11% of the entire Italian residents). Out of 4640 NVAF patients treated with NOACs and aged 70-75 years in 2017, 3772 (81.3%) patients were still in treatment with NOAC up to 2021 and among them, 3389 (73.0%) patients remained in treatment with the same NOAC during 2017-2021. In fact, 10.2% of patients switched NOAC type and 10.3% changed the dose of the same NOAC. Overall, after switching, the dabigatran and rivaroxaban groups lost, respectively, 13.5% and 2.8% of patients, while apixaban and edoxaban resulted in a relative percentage increase of 6.8% and 44.6% of patients, respectively. By a logistic regression analysis, the treatment with rivaroxaban, apixaban, and edoxaban (respect to dabigatran) was associated with a significant risk reduction of switch of 57%, 68%, and 44%, respectively. On the other hand, several features of high risk were associated with dose reduction. Conclusions. In our 5-year analysis of a large administrative database, a switching among NOACs or a change in NOAC dosages occurred in around 20% of elderly patients with NVAF. The type of NOAC was associated with a high switching rate, while several characteristics of high risk resulted as predictors of dose reduction of NOACs. Moreover, a worsening trend of clinical conditions occurred in patients maintaining the same NOAC treatment across 2017-2021.

Epidemiology, Patients’ Journey and Healthcare Costs in Early-Stage Non-Small-Cell Lung Carcinoma: A Real-World Evidence Analysis in Italy

This real-world analysis aims to estimate the epidemiology and economic burden related to early-stage non-small-cell lung carcinoma (eNSCLC) in the clinical practice Italian setting. An observational analysis was performed using administrative databases linked to pathological anatomy data, covering around 2.5 mln health-assisted individuals. From 2015 to mid-2021, eNSCLC patients staged II-IIIA treated with chemotherapy after surgery were included. Patients were stratified into those presenting loco-regional or metastatic recurrence during follow-up and annualized healthcare direct costs covered by the Italian National Health System (INHS) were estimated. In 2019-2020, the prevalence of eNSCLC was 104.3-117.1/million health-assisted subjects, and the annual incidence was 38.6-30.3/million. Data projected to the Italian population estimated 6206 (2019) and 6967 (2020) prevalent and 2297 (2019) and 1803 (2020) incident cases. Overall, 458 eNSCLC patients were included. Of them, 52.4% of patients had a recurrence (5% loco-regional-recurrence, 47.4% metastatic-recurrence). Healthcare total direct costs/patient averaged EUR 23,607, in particular, in the first year after recurrence, costs averaged EUR 22,493 and EUR 29,337 in loco-regional and metastatic-recurrence patients, respectively. This analysis showed that about one-half of eNSCLC patients stage II-IIIA experience a recurrence, and in recurrence patients, total direct costs were almost two-fold those of no-recurrence patients. These data highlighted an unmet clinical need, as the therapeutic optimization of patients at early stages.

An Integrated Approach to Addictive Behaviors: A Study on Vulnerability and Maintenance Factors.

This study aimed to explore the relationships among the variables involved in a Comprehensive Model of Addiction (CMA), which posits that the presence and severity of addictive behaviors are related to the configuration of seven psychological variables, namely childhood trauma, insecure attachment, affect dysregulation, dissociation, impulsivity, compulsiveness, and obsessiveness. A vulnerability model was proposed, in which it was suggested that affect dysregulation and complex trauma mediated the association between insecure attachment and dissociation. Furthermore, a maintenance model was elaborated, in which it was hypothesized that dissociation influenced affect dysregulation via impulsivity, compulsiveness, and obsessiveness. A clinical sample of 430 individuals with substance use disorder was involved. All participants received a DSM-5 clinical diagnosis of Substance-Related and Addictive Disorders and were recruited from the Italian National Health System. A parallel mediation emerged, confirming the vulnerability model, with complex trauma and affect dysregulation mediating the relationship between insecure attachment and dissociation. Furthermore, a mixed serial-parallel mediation described the maintenance model, where impulsiveness, compulsiveness, and obsessiveness significantly mediated the relationship between dissociation and affect dysregulation. Our findings offer a better understanding of the variables associated with addictive disorders, thus providing important indications for both treatment and preventive interventions.

The Value of Tucatinib in Metastatic HER2-Positive Breast Cancer Patients: An Italian Cost-Effectiveness Analysis

This study was aimed at estimating the appropriate price of tucatinib plus trastuzumab and capecitabine (TXC), as third-line treatment, in HER2+ breast cancer (BC) patients from the Italian National Health System (NHS) perspective. A partitioned survival model with three mutually exclusive health states (i.e., progression-free survival (PFS), progressive disease (PD), and death) was used to estimate the price of tucatinib vs trastuzumab emtansine (TDM-1), considering a willingness to pay (WTP) of 60,000 EUR. Data from the HER2CLIMB trial, the Italian population, and the literature were used as input. The model also estimated the total costs and the life-years (LY) of TXC and TDM1. Deterministic and probabilistic (PSA) sensitivity analyses were conducted to evaluate the robustness of the model. In the base case scenario, the appropriate price of tucatinib was 4828.44 EUR per cycle. The TXC resulted in +0.28 LYs and +16,628 EUR compared with TDM-1. Results were mainly sensitive to therapy intensity variation. In PSA analysis, TXC resulted cost-effective in 53% of the simulations. Assuming a WTP ranging 20,000-80,000 EUR, the tucatinib price ranged from 4090.60 to 5197.41 EUR. This study estimated the appropriate price for tucatinib according to different WTP in order to help healthcare decision makers to better understand the treatment value.

Brentuximab vedotin in combination with doxorubicin, vinblastine and dacarbazine for first-line treatment of stage IV HL: cost impact on subsequent lines in Italy

Introduction: This study estimates the change in the costs of second-line or later (2L+) treatments compared to the current scenario, associated with the introduction of brentuximab vedotin (Adcetris®) (BV) in combination with doxorubicin, vinblastine and dacarbazine (A+AVD) for the treatment of previously untreated (1L) patients with stage IV classical Hodgkin’s lymphoma (cHL). Methods: An economic model has been developed that estimates the variation in treatment costs of 2L+ associated with the introduction of BV in 1L from the point of view of the Italian National Health System over a time horizon of 3 years. The population eligible to receive a treatment of 2L+ has been estimated from the literature, considering an increasing consumption in the three years of A+AVD in 1L. Two main scenarios and several alternative scenarios were considered to address the uncertainty that characterizes the distribution of market shares of 2L+ treatments. Results: In the baseline scenario, over three years, the introduction of BV in 1L is associated with a cumulative reduction in treatment costs of 2L+ of € 1.74 M. In all scenarios, a reduction in treatment costs of 2L+ is confirmed, with a total saving that varies between € 5.6 M and € 1.3 M compared to the main scenarios. Conclusions: The present analysis shows that the introduction of A+AVD in 1L for the treatment of stage IV CD30+ cHL patients is associated with a reduction in treatment costs of 2L+, even if there are some limitations related to the uncertainty of real cost and population estimates.

A New Format for the Italian National Health System: from Hospital to Patient-Centric Care

A New Format for the Italian National Health System: from Hospital to Patient-Centric Care

A real-world economic analysis of biologic therapies for psoriatic arthritis in Italy: results of the CHRONOS observational longitudinal study

BackgroundPsoriatic arthritis (PsA) is a chronic, immune-mediated, spondyloarthropathy characterised by musculoskeletal signs and symptoms with associated joint pain and tenderness. The average worldwide PsA prevalence is 133/100,000, while in the Italian population is 90–420/100,000.Traditionally, nonsteroidal anti-inflammatory drugs, glucocorticoid, and disease-modifying antirheumatic drugs have been used in the treatment of PsA. However, for those patients who are not adequately controlled with conventional therapies, the new biologics compounds represent a valid option. Biologic therapies have been shown to be more effective but also more expensive than conventional systemic treatments. Based on the CHRONOS study, the economic analyses presented in this paper aim to assess the annualised direct costs and the cost-per-responder of biologics in a real-world context assuming the Italian National Health System perspective.MethodsThe economic assessments were carried out on the overall cohort of patients, and on the tumour necrosis factor alpha inhibitors (TNFi) and the secukinumab subgroup, the most prescribed biologic therapies within the CHRONOS study.ResultsThe annual economic impact of PsA in the overall group was €12,622, €11,725 in the secukinumab subgroup, and €12,791 in the TNFi subgroup. Biologics absorbed the main expenditure costs in the treatment of PsA accounting for about the 93% of total costs. At 6 months, secukinumab performed better in all the considered outcomes: cost-per-responder according to EULAR DAS28 and ACR50 response criteria were €12,661- €28,975, respectively, while they were €13,356 - €33,368 in the overall cohort and €13,138 - €35,166 in the TNFi subgroup. At 12 months secukinumab remained the subgroup with the lowest cost-per-responder ratio in EULAR DAS28 and ACR50 response criteria, while TNFi subgroup was the lowest one considered the ACR20.ConclusionDespite some potential methodological limitations, our cost-per-response analysis provides physicians and payers additional insights which can complement the traditional risk-benefit profile assessment and drive treatment decisions.

PP83 Economic Impact Of Missed Vaccinations On The Italian National Health System

IntroductionTo provide a complete picture of the economic impact of the coronavirus disease 2019 (COVID-19) emergency for the Italian National Health System (NHS), an estimate was made of the costs to the NHS of vaccination hesitation. The concept of economic impact was investigated with reference to the volume of hospitalizations and days of intensive care required for patients with COVID-19 related to missed vaccinations, considering a vaccine efficacy of less than 100 percent.MethodsData from the Istituto Superiore di Sanità were analyzed with respect to the number of people vaccinated in the general population, and the number of people with severe acute respiratory syndrome coronavirus 2 infection who were hospitalized or died in a one-month period stratified by vaccination status. The costs for unvaccinated patients admitted to a general hospital ward (Medical Area) or the intensive care unit were calculated.ResultsBased on the number of preventable hospitalizations among unvaccinated people, the economic impact of missed vaccinations on the NHS in the 30-day period from 13 August 2021 to 12 September 2021 was estimated. Among the unvaccinated hospitalized patients, 5,932 would have avoided hospitalization in the Medical Area and 715 would have avoided admission to the intensive care unit. Thus, each unvaccinated hospitalized patient had an average per capita cost of EUR 17,408. The total costs amounted to EUR 69,894,715, comprising EUR 51,166,079 for hospitalizations in the Medical Area and EUR 18,728,636 for hospitalizations in intensive care.ConclusionsBy evaluating the weekly incidence of hospitalizations per 100,000 people stratified by vaccination status (unvaccinated, partially vaccinated, and fully vaccinated), it is possible to see that we are facing two distinct pandemics running together.

EPH18 Neovascular Age-Related Macular Degeneration: Prevalence and Treatment With Anti-VEGF From the Perspective of the Italian National Health System

EPH18 Neovascular Age-Related Macular Degeneration: Prevalence and Treatment With Anti-VEGF From the Perspective of the Italian National Health System

Presumptive treatment or serological screening for schistosomiasis in migrants from Sub-Saharan Africa could save both lives and money for the Italian National Health System: results of an economic evaluation.

Schistosomiasis can lead to severe irreversible complications and death if left untreated. Italian and European guidelines recommend serological screening for this infection in migrants from Sub-Saharan Africa (SSA). However, studies on clinical and economic impact of this strategy in the Italian and European settings are lacking. This study aims to compare benefits and costs of different strategies to manage schistosomiasis in migrants from SSA to Italy. A decision tree and a Markov model were developed to assess the health and economic impacts of three interventions: (i) passive diagnosis for symptomatic patients (current practice in Italy); (ii) serological screening of all migrants and treating those found positive and (iii) presumptive treatment for all migrants with praziquantel in a single dose. The time horizon of analysis was one year to determine the exact expenses, and 28years to consider possible sequelae, in the Italian health-care perspective. Data input was derived from available literature; costs were taken from the price list of Careggi University Hospital, Florence, and from National Hospitals Records. Assuming a population of 100 000 migrants with schistosomiasis prevalence of 21·2%, the presumptive treatment has a greater clinical impact with 86.3% of the affected being cured (75.2% in screening programme and 44.9% in a passive diagnosis strategy). In the first year, the presumptive treatment and the screening strategy compared with passive diagnosis prove cost-effective (299 and 595 cost/QALY, respectively). In the 28-year horizon, the two strategies (screening and presumptive treatment) compared with passive diagnosis become dominant (less expensive with more QALYs) and cost-saving. The results of the model suggest that presumptive treatment and screening strategies are more favourable than the current passive diagnosis in the public health management of schistosomiasis in SSA migrants, especially in a longer period analysis.

Residents about residency: educational integrity and skill assessment

In the last few years, as the COVID-19 pandemic put in the spotlight the flaws of the Italian National Health System (INHS), the Italian National Residency Program (NRP) has aroused more and more interest among several stakeholders. The persistent burden on the Welfare System, caused by the systemic shortage of Specialized Practitioners, inevitably influenced the recent major reforms of the NRP, eventually affecting its quality. Within this emergency scenario, the urge to critically analyze the post-graduate educational program and its methods, became impellent. As the Orthopedics and Traumatology Italian Residents Association (AISOT) showed, despite the newly introduced DL Calabria, in 2020, almost 50% of the Orthopedic Residents would not feel comfortable to be challenged as independent specialists. However, the lack of methodological involvement of Residents in daily practice activities, from their Mentors, if matched with the positive feedback provided from residents who, conversely, experienced the DL Calabria conveniences, raised some concerns about the standard of quality of future Orthopedics. Modern times and technologies may allow a more efficient redesign and less nebulous educational methods and goals, and eventually guarantee a Nationwide equality among each Orthopedic School. A shared future with exhaustive objectives and fair opportunities between all Italian Orthopedic Residents is the key to build a righteous collective intelligentsia and harmony between practitioners of a glorious discipline, with ancient roots, such as Italian Orthopedics.

COVID-19 vaccinations: An overview of the Italian national health system's online communication from a citizen perspective

COVID-19 vaccine hesitancy is still widespread. During the pandemic, the internet has been the preferred channel for health-related information, especially for less-educated citizens who tend to be the most hesitant about vaccination. A well-structured web communication strategy could help both to overcome vaccine hesitancy and to ensure equity in healthcare service access. This study investigated how the various regional and local health authorities in Italy used their institutional websites to inform users about COVID-19 vaccinations between March and April 2021. We browsed 129 institutional websites, checking the availability, quality and quantity, actionability and readability of information using a literature-based common grid. Descriptive statistics and statistical tests were performed. The online public dissemination of COVID-19 vaccination information in Italy was fragmented, both across and within regions. The side effects of vaccinations, were often not reported on the websites, thus missing an opportunity to enhance vaccination uptake. More focus should also be placed on readability, since readability indexes showed that they were difficult to understand. Our research revealed that several actions could be implemented to enhance online communication on COVID-19 vaccination. For instance, simplifying texts can make them more understandable and the information reported actionable.

The prevalence of celiac disease and the appropriateness of the diagnosis in family medicine setting could be lower than expected.

To assess the prevalence of celiac disease (CD) and the appropriateness of this diagnosis in the family medicine setting in Italy. The electronic databases of 16 general practitioners working in Rome (Italy) were analyzed. The prevalence of CD according to the Italian pathology identification code issued by the Italian National Health System was assessed. In addition, patients registered as having celiac disease without being assigned a pathology identification code were interviewed. Overall, a population of 22,064 patients was analyzed. 91 patients had a diagnosis of CD (0.41%), 60 of whom had a pathology identification code (0.27%), and 31 did not (0.14%). 29 of these patients were interviewed, 16 (17.58% of the CD recorded patients) of whom reported being on a gluten-free or gluten restricted diet, with reported improvement in their clinical symptoms. Half of them further stated that they would not agree to resume a restriction free diet in order to make a definitive CD diagnosis, due to the risk of symptom recurrence. In a family medicine setting, the prevalence of CD seems to be lower than expected, and one third of patients diagnosed with CD do not fulfill all diagnostic criteria. Any effort to improve the diagnostic work-up for CD should also be made in this setting.