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Chimeric antigen receptor T-cell therapies (CAR-T therapies) are a type of advanced therapy medicinal product (ATMP) that belong to a new generation of personalised cancer immunotherapies. This paper compares the approval, availability and financing of CAR-T cell therapies in ten countries. It also examines the implementation of this type of ATMP within the health care system, describing the organizational elements of CAR-T therapy delivery and the challenges of ensuring equitable access to all those in need, taking a more systems-oriented view. It finds that the availability of CAR-T therapies varies across countries, reflecting the heterogeneity in the organization and financing of specialised care, particularly oncology care. Countries have been cautious in designing reimbursement models for CAR-T cell therapies, establishing limited managed entry arrangements under public payers, either based on outcomes or as an evidence development scheme to allow for the study of real-world therapeutic efficacy. The delivery model of CAR-T therapies is concentrated around existing experienced cancer centres and highlights the need for high networking and referral capacity. Some countries have transparent and systematic eligibility criteria to help ensure more equitable access to therapies. Overall, as with other pharmaceuticals, there is limited transparency in pricing, eligibility criteria and budgeting decisions in this therapeutic area.

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Multigene panels can analyze high and moderate/intermediate penetrance genes that predispose to breast cancer (BC), providing an opportunity to identify at-risk individuals within affected families. However, considering the complexity of different pathogenic variants and correlated clinical manifestations, a multidisciplinary team is needed to effectively manage BC. A classification of pathogenic variants included in multigene panels was presented in this narrative review to evaluate their clinical utility in BC. Clinical management was discussed for each category and focused on BC, including available evidence regarding the multidisciplinary and integrated management of patients with BC. The integration of both genetic testing and counseling is required for customized decisions in therapeutic strategies and preventative initiatives, as well as for a defined multidisciplinary approach, considering the continuous evolution of guidelines and research in the field.

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The EASY-NET network program (NET-2016-02364191)-effectiveness of audit and feedback (A&F) strategies to improve health practice and equity in various clinical and organizational settings), piloted a novel and more structured A&F strategy. This study compared the effectiveness of the novel strategy against the sole periodic dissemination of indicators in enhancing the appropriateness and timeliness of emergency health interventions for patients diagnosed with acute myocardial infarction (AMI) and ischemic stroke in the Lazio Region. The efficacy of the intervention was assessed through a prospective quasi-experimental design employing a pre- and post-intervention (2021-2022) comparison with a control group. Participating hospitals in the Lazio Region, where professional teams voluntarily engaged in the intervention, constituted the exposed group, while the control group exclusively engaged in routine reporting activities. Effectiveness analysis was conducted at the patient level, utilizing regional health information systems to compute process and outcome indicators. The effectiveness of the intervention was evaluated using difference-in-difference models, comparing pre- and post-intervention periods between exposed and control groups. Estimates were calculated in terms of the difference in percentage points (PP) between absolute risks. Sixteen facilities for the AMI pathway and thirteen for the stroke pathway participated in the intervention. The intervention yielded a reduction in the proportion of 30-day readmissions following hospitalization for ischemic stroke by 0.54 pp in the exposed patients demonstrating a significant difference of -3.80 pp (95% CI: -6.57; -1.03; 5453 patients, 63.7% cases) in the exposed group compared to controls. However, no statistically significant differences attributable to the implemented A&F intervention were observed in other indicators considered. These results represent the first evidence in Italy of the impact of A&F interventions in an emergency setting, utilizing aggregated data from hospitals involved in the Lazio Region's emergency network.

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Background: There is growing evidence of the relevance of designing organization of care around patient characteristics; this is especially true in the case of complex chronic diseases.Purpose: The goal of the paper - that focuses on the analysis of the clinical condition hemophilia in three different centers - is to address two different research questions:1. How can we define, within the same clinical condition, different patient profiles homogeneous in terms of intensity of service required (e.g. number of visits or diagnostics)? 2. What are the conditions to re-organize care around these patient profiles in a multidisciplinary and coordinated manner?Research design: The authors have used a multiple case study approach combining both qualitative and quantitative methodologies; in particularly the semi-structured interviews and the direct observation were aimed to map the process in order to come up with an estimate of the cost of the full cycle of care.Study sample: The research methodology has been applied consistently in three different centers. The selection of the structures has been based on two main different criteria: (i) high standards regarding both organizational and clinical aspects and (ii) willingness from management, nurses and physicians to provide data.Results: The study clearly shows that different patient profiles - within the same clinical condition - trigger a different set of diagnostic and therapeutic activities. It is, thus, important considering patient characteristics in the development and implementation of clinical pathways and this will imply relevant differences in terms of organizational and economic impact.Conclusions: These process-based analyses are very much critical especially if we want to move to a bundled and integrated payment system but, as shown by this study itself, require a lot of time and efforts since our healthcare information systems are still fragmented and vertically designed.

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BACKGROUND: The 30-day hospital re-admission rate is a quality measure of hospital care to monitor the efficiency of the healthcare system. The hospital re-admission of acute stroke (AS) patients is often associated with higher mortality rates, greater levels of disability and increased healthcare costs. The aim of our study was to identify predictors of unplanned 30-day hospital re-admissions after discharge of AS patients and define an early re-admission risk score (RRS). METHODS: This observational, retrospective study was performed on AS patients who were discharged between 2014 and 2019. Early re-admission predictors were identified by machine learning models. The performances of these models were assessed by receiver operating characteristic curve analysis. RESULTS: Of 7599 patients with AS, 3699 patients met the inclusion criteria, and 304 patients (8.22%) were re-admitted within 30 days from discharge. After identifying the predictors of early re-admission by logistic regression analysis, RRS was obtained and consisted of seven variables: hemoglobin level, atrial fibrillation, brain hemorrhage, discharge home, chronic obstructive pulmonary disease, one and more than one hospitalization in the previous year. The cohort of patients was then stratified into three risk categories: low (RRS = 0-1), medium (RRS = 2-3) and high (RRS >3) with re-admission rates of 5%, 8% and 14%, respectively. CONCLUSIONS: The identification of risk factors for early re-admission after AS and the elaboration of a score to stratify at discharge time the risk of re-admission can provide a tool for clinicians to plan a personalized follow-up and contain healthcare costs.

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We assessed challenges that the COVID-19 pandemic presented for mental health systems and the responses to these challenges in 14 countries in Europe and North America. Experts from each country filled out a structured questionnaire with closed- and open-ended questions between January and June 2021. We conducted thematic analysis to investigate the qualitative responses to open-ended questions, and we summarized the responses to closed-ended survey items on changes in telemental health policies and regulations. Findings revealed that many countries grappled with the rising demand for mental health services against a backdrop of mental health provider shortages and challenges responding to workforce stress and burnout. All countries in our sample implemented new policies or initiatives to strengthen mental health service delivery - with more than two-thirds investing to bolster their specialized mental health care sector. There was a universal shift to telehealth to deliver a larger portion of mental health services in all 14 countries, which was facilitated by changes in national regulations and policies; 11 of the 14 participating countries relaxed regulations and 10 of 14 countries made changes to reimbursement policies to facilitate telemental health care. These findings provide a first step to assess the long-term challenges and re-organizational effect of the COVID-19 pandemic on mental health systems in Europe and North America.

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Introduction: Critical pathways (CPs) are effective change management tools used to improve quality in healthcare nationally implemented in Italy in 2015. This study aims to map the country's state-of-the-art regarding the adoption of CPs and to verify the existence of factors that determine the success of their implementation and the relative entity of their impact, by analysing the management of Lung Cancer (LC) as a case-study. Methods: Our methodology followed the SQUIRE guidelines for quality improvement reporting (2015). Starting from the 2017 ranking table published by the National Outcome Program, we selected and included in our sample all Italian hospitals who, according to Ministerial Decree n. 70/2015, met national quality threshold for LC treatment. To investigate regional-level and hospital-level factors believed to be responsible for the successful implementation of a CP, a Google Modules questionnaire was constructed and sent to the selected facilities; subsequently, a web-based research was carried out for missing data. Associations between variables were tested in STATA by means of correlation tests and a linear regression model. Results: 41 hospitals matched our inclusion criteria. Of these, 68% defined an internal Lung Cancer Critical Pathway (LCCP). Our results confirmed the presence of critical success factors that favour the correct implementation of a LCCP. Conclusions: Notwithstanding the availability of CPs, their adoption in routine clinical practice still lacks consistency, suggesting the necessity to resort to digital solutions, to increment the level of regional commitment and workforce commitment and to reinforce quality standards monitoring.

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BACKGROUND: Rising incidence and prevalence of end-stage renal disease is a worldwide concern for sustainability of healthcare systems and societies. Living donor renal transplant [LDRT] provides highest health achievements and cost containment than any alternative form of renal replacement therapy. Nonetheless, about 25% of potential LDRTs are missed for causes directly related with inadequate timing in donor assessment. Our quality improvement (QI) project implement process control tools and strategy aiming at reducing total evaluation time for donor candidates and minimizing dialysis exposure for intended recipients, which are the two main determinants of clinical outcomes and costs. METHODS: The study includes patients who underwent donor nephrectomy between January 1, 2017 and December 31, 2021. Six Sigma DMAIC approach was adopted to assess Base Case performance (Jan2017-Jun2019) and to design and implement our QI project. Study of current state analysis focused on distribution of time intervals within the assessment process, analysis of roles and impacts of involved healthcare providers and identification of targets of improvement. Improved Scenario (Jul2019-Dec2021) was assessed in terms of total lead time reduction, total pre-transplantation dialysis exposure and costs reduction, and increase in pre-emptive transplantations. The study was reported following SQUIRE 2.0 Guidelines for QI projects. RESULTS: Study population includes 63 patients, 37 in Base Case and 26 in Improved Scenario. Total lead time reduced from a median of 293 to 166 days and this in turn reduced pre-transplantation dialysis exposure and costs by 45%. Rate of potential pre-emptive donors' loss changes from 44% to 27%. CONCLUSIONS: Lean methodology is an effective tool to improve quality and efficiency of healthcare processes, in the interest of patients, healthcare professionals and payers.

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Background: Owing to COVID-19, all stakeholders have recognized the advantages of telehealth and they were available for its permanent implementation, both from the normative and economic point of view. It is, therefore, necessary to understand what were the real benefits created in society through telehealth. Objective: Develop a method to identify a social impact of telemedicine in Italy, considering the reduction on the patient moves with a consequent travel cost, time (opportunity costs), and carbon emission savings. Methods: Since March 2020, we have conducted a quality improvement study in 17 centers, collecting sociodemographic variables. To assess the social impact, we transform the data into outcome measures. The protocol used "Telemedicina Subito" allows the rapid implementation of telemedicine, using operating manual, structured according Health Technology Assessment approach. Results: We collected data related to 2,091 televisits, analyzing three different perspectives. First, one patient with a televisit had a saving equal to the median of EUR 97.16 (interquartile range [IQR]: 64.29-159.69), USD 113.88; considering that the median cost for the visit in presence was EUR 105.91 (p-value <0.05) and after the use of telehealth had a median of EUR 0 (mean: EUR 14.70; p-value <0.05). Second, informal caregivers have a median savings of EUR 65.06 (IQR: 55.52-89.21), USD 76.26. Finally, for one single telemedicine visits we can contribute with a median carbon emission savings of ∼13 kg (IQR: 6-24). Conclusions: The evaluation of the social impact on telemedicine facilitated the creation of an important framework for decision-makers.

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This Health system summary is based on the Italy: Health System Review published in 2022 in the Health Systems in Transition (HiT) series. Health system summaries use a concise format to communicate central features of country health systems and analyse available evidence on the organization, financing and delivery of health care. They also provide insights into key reforms and the varied challenges testing the performance of the health system.

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Introduction: The COVID-19 pandemic represented an unprecedented challenge for the healthcare world and the introduction of a new stronger and believable project plays a fundamental role for the quality of work and the provision of qualitative care. Aim: The survey provided by Italian Association for the Quality of Health and Social Care (ASIQUAS) aims to examines the impact of "Health" chapter included in the Recovery Plan, through the assessment of management quality of the COVID-19 pandemic. Methods: Starting from a literature review, in September 2021, a web-based survey has been conducted and administered by e-mail. It has been taken into account measures widely used by different healthcare structures in order to analyze the projects implemented in the face of pandemic and to evaluate the new real possibility to invest funds in new healthcare structures and projects. Results: The survey consists of 19 multiple choices and respondents were from different types of structures, including regional departments and regional health agencies (1.4%), universities, research centers and scientific hospitalization and treatment institutes (IRCCS) (11%), hospitals and university polyclinics (34.2%), Local Health Authorities (39.7%), socio-health organizations and Others (13.7%). The pandemic has highlighted many vulnerabilities at both hospitals and territorial level. The major weaknesses revealed by the survey are mainly due to the lack of support from new staff units and poor availability of specific training tools for COVID-19 procedures. The Recovery Plan is still unclear with a lot of concern about the implementation and many limits of diffusion. Conclusions: It becomes essential to guarantee a new effective and interoperative model of integration. Today we can start more aware for the implementation of a system closer to everyone's needs, making shortcomings the new strength and starting point.

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Background and Aims: In oncology, there is increasing talk of personalized treatment and shared decision-making (SDM), especially when multiple treatment options are available with different outcomes depending on patient preference. The present study aimed to define the set of main dimensions and relative tools to assess the Value brought to patients from a Breast Cancer's Clinical pathway structured according to a dynamic SDM framework. Methods: Starting from our previous systematic review of the literature, a deep search of the main evidence-based and already validated questionnaires was carried out. In the second phase, to corroborate this grid, a Delphi survey was conducted to assess each questionnaire identified for each dimension, against the following seven value-based criteria: Clinical Benefit, Safety, Care Team Well Being, Patient Reported Outcomes Measures, Green Oncology, Impact on Health Budget, and Genomic Profile. Results: The resulting 7-dimension questionnaire is composed of 72 questions. Of these, some quantitatively and objectively assess the evolution of the patient's disease state, whereas others aim to ask patients about their active involvement in decisions affecting them and to investigate whether they were free to explore their preferences. Furthermore, to frame the analyzed phenomenon at the right time, for each questionnaire section, the specific, evidence-based timing of administration is indicated. Conclusion: The resulting questionnaire is validated in its entirety and it is composed of a set of questions and relative time point for data collections to assess the Value brought to patients undertaking a Breast Cancer's Clinical pathway, structured according to a dynamic SDM framework. It constitutes a quantitative instrument to integrate patient centeredness with a personalized perspective in the care management of women with breast cancer.

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This analysis of the Italian health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. Italy has a regionalized National Health Service (SSN) that provides universal coverage largely free of charge at the point of delivery, though certain services and goods require a co-payment. Life expectancy in Italy is historically among the highest in the EU. However, regional differences in health indicators are marked, as well as in per capita spending, distribution of health professionals and in the quality of health services. Overall, Italy's health spending per capita is lower than the EU average and is among the lowest in western European countries. Private spending has increased in recent years, although this trend was halted in 2020 during the coronavirus disease 2019 (COVID-19) pandemic. A key focus of health policies in recent decades was to promote a shift away from unnecessary inpatient care, with a considerable reduction of acute hospital beds and stagnating overall growth in health personnel. However, this was not counterbalanced by a sufficient strengthening of community services in order to cope with the ageing population's needs and related chronic conditions burden. This had important repercussions during the COVID-19 emergency, as the health system felt the impact of previous reductions in hospital beds and capacity and underinvestment in community-based care. Reorganizing hospital and community care will require a strong alignment between central and regional authorities. The COVID-19 crisis also highlighted several issues pre-dating the pandemic that need to be addressed to improve the sustainability and resilience of the SSN. The main outstanding challenges for the health system are linked to addressing historic underinvestment in the health workforce, modernizing outdated infrastructure and equipment, and enhancing information infrastructure. Italy's National Recovery and Resilience Plan, underwritten by the Next Generation EU budget to assist with economic recovery from the COVID-19 pandemic, contains specific health sector priorities, such as strengthening the country's primary and community care, boosting capital investment and funding the digitalization of the health care system.

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Introduction: Vulvar cancer (VC) accounts for <1% of cancers affecting the female gender. Clinical Pathways (CP) and Clinical Outcomes Monitoring are useful for providing high-quality care to these patients. However, it is essential to integrate them with the patient's perspective according to Value-Based Healthcare paradigms. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are tools for assessing outcomes and experiences with health care from the patient's perspective. The aim of this paper is to collect and synthesize PROMs and main stakeholders' experience on the VC CP, according to a value-based approach. Materials and methods: To select the most appropriate instrument, a review was conducted on the main databases and official websites of specific institutions and organizations. In the second phase, a 2-round Delphi survey was conducted to assess the Reported Experience Measures (REMs) tool. Questions were evaluated according to four criteria (general relevance, evidence-based, measurability, actionability) and included if strong agreement was reached. A Principal Component Analysis (PCA) was executed. Cronbach's alpha and McDonald's omega were computed. Fisher's exact test and Wilcoxon rank sum test were used to compare ratings between groups. Descriptive statistics were performed for both PROMs and REMs instruments. Results: For PROMs assessment, EORTC QLQ-C30 questionnaire was selected and administered to 28 patients. Global Health Status/Quality of Life and Functional Scales Scores were high or very high, while symptoms scale reported low or medium scores. The final REMs consists of 22 questions for professionals and 16 for patients and caregivers. It was administered to 22 patients, 11 caregivers, 5 physicians, 2 nurses and 1 clinical senior manager. PCA identified 4 components. Scale reliability was acceptable (α = 0.75 95% CI: 0.61-0.85; ω = 0.69; 95% CI: 0.54, 0.82). A statistically significant difference between the patient/caregiver group and the professionals was found for items 8 (follow-up), 10 (perceived quality), 12 (safety), and 16 (climate) (p = 0.02; p = 0.03; p < 0.001; p < 0.001, respectively). Discussion: PROMs could provide new ways of intercepting patients' needs and feedback, thus acting on them. The proposed REMs tool would allow to detect information not available elsewhere, which, through Audit and feedback strategies, could lead to enhancement of healthcare experience, according to a value-based approach.

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Audit and Feedback (A&F) is an effective multidimensional strategy for improving the quality of care. The optimal methods for its implementation remain unclear. This study aimed to map the state of art of A&F strategies in the hospitals involved in a time-dependent emergency network. For these purposes, a structured questionnaire was defined and discussed within the research group. This consists of 29 questions in three sections: (1) characteristics of the structure, (2) internal feedback systems, and (3) external feedback systems. All structures involved in the network were invited to participate in the e-survey by indicating a Health Management representative and a clinical representative for the Cardiovascular (CaV) and/or for the Cerebrovascular area (CeV). Of 20 structures invited, a total of 13 (65%) responded to the survey, 11 for the CaV area and 8 for the CeV area. A total of 10 of 11 (91%) facilities for the CaV area and 8/11 (75%) for the CeV area reported that they perform A&F activities. All facilities perform at least one of the activities defined as "assimilating A&F procedures." The most frequent is the presentation and discussion of clinical cases (82% CaV and 88% CeV) and the least is the identification of responsible for improvement actions (45% CaV and 38% CeV). In 4/10 (40%) facilities for the CaV area and 4/8 (50%) for the CEV area, corrective actions are suggested or planned when the feedback is returned. These results confirm the need to define, in a synergistic way with the relevant stakeholders, an effective and agreed A&F intervention to improve the level of implementation of A&F strategies.

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This paper conducts a comparative review of the (curative) health systems' response taken by Cyprus, Greece, Israel, Italy, Malta, Portugal, and Spain during the first six months of the COVID-19 pandemic. Prior to the COVID-19 pandemic, these Mediterranean countries shared similarities in terms of health system resources, which were low compared to the EU/OECD average. We distill key policy insights regarding the governance tools adopted to manage the pandemic, the means to secure sufficient physical infrastructure and workforce capacity and some financing and coverage aspects. We performed a qualitative analysis of the evidence reported to the 'Health System Response Monitor' platform of the European Observatory by country experts. We found that governance in the early stages of the pandemic was undertaken centrally in all the Mediterranean countries, even in Italy and Spain where regional authorities usually have autonomy over health matters. Stretched public resources prompted countries to deploy "flexible" intensive care unit capacity and health workforce resources as agile solutions. The private sector was also utilized to expand resources and health workforce capacity, through special public-private partnerships. Countries ensured universal coverage for COVID-19-related services, even for groups not usually entitled to free publicly financed health care, such as undocumented migrants. We conclude that flexibility, speed and adaptive management in health policy responses were key to responding to immediate needs during the COVID-19 pandemic. Financial barriers to accessing care as well as potentially higher mortality rates were avoided in most of the countries during the first wave. Yet it is still early to assess to what extent countries were able to maintain essential services without undermining equitable access to high quality care.

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Provider payment mechanisms were adjusted in many countries in response to the COVID-19 pandemic in 2020. Our objective was to review adjustments for hospitals and healthcare professionals across 20 countries. We developed an analytical framework distinguishing between payment adjustments compensating income loss and those covering extra costs related to COVID-19. Information was extracted from the Covid-19 Health System Response Monitor (HSRM) and classified according to the framework. We found that income loss was not a problem in countries where professionals were paid by salary or capitation and hospitals received global budgets. In countries where payment was based on activity, income loss was compensated through budgets and higher fees. New FFS payments were introduced to incentivize remote services. Payments for COVID-19 related costs included new fees for out- and inpatient services but also new PD and DRG tariffs for hospitals. Budgets covered the costs of adjusting wards, creating new (ICU) beds, and hiring staff. We conclude that public payers assumed most of the COVID-19-related financial risk. In view of future pandemics policymakers should work to increase resilience of payment systems by: (1) having systems in place to rapidly adjust payment systems; (2) being aware of the economic incentives created by these adjustments such as cost-containment or increasing the number of patients or services, that can result in unintended consequences such as risk selection or overprovision of care; and (3) periodically evaluating the effects of payment adjustments on access and quality of care.

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BACKGROUND: Patient registration with a primary care providers supports continuity in the patient-provider relationship. This paper develops a framework for analysing the characteristics of patient registration across countries; applies this framework to a selection of countries; and identifies challenges and ongoing reform efforts. METHODS: 12 jurisdictions (Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, Ontario [Canada], Sweden, Switzerland, United Kingdom) were selected for analysis. Information was collected by national researchers who reviewed relevant literature and policy documents to report on the establishment and evolution of patient registration, the requirements and benefits for patients, providers and payers, and its connection to primary care reforms. RESULTS: Patient registration emerged as part of major macro-level health reforms linked to the introduction of universal health coverage. Recent reforms introduced registration with the aim of improving quality through better coordination and efficiency through reductions in unnecessary referrals. Patient registration is mandatory only in three countries. Several countries achieve high levels of registration by using strong incentives for patients and physicians (capitation payments). CONCLUSION: Patient registration means different things in different countries and policy-makers and researchers need to take into consideration: the history and characteristics of the registration system; the use of incentives for patients and providers; and the potential for more explicit use of patient-provider agreements as a policy to achieve more timely, appropriate, continuous and integrated care.

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