Availability and financing of CAR-T cell therapies: A cross-country comparative analysis.

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.

Challenges facing mental health systems arising from the COVID-19 pandemic: Evidence from 14 European and North American countries.

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.

Critical pathways for continuous quality improvement: a multicentric analysis on the management of patients with lung cancer in Italian best performing hospitals.

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.

A survey of experts on personalized medicine landscape in European Union and China.

INTRODUCTION: Personalized Medicine (PM) is one of the main priorities of the research agenda of the European Commission and the focus of the European Coordination and Support Action titled "Integrating China into the International Consortium for Personalized Medicine" (IC2PerMed). Similar to the European focus, PM is a current priority of the Chinese Government, through dedicated policies and its five-year investment plans. In the context of IC2PerMed, we implemented a survey to understand the state of the art of the implementation of PM related policies in EU and China, and to identify opportunities for future Sino-European collaborations. METHODS: The survey was elaborated by the IC2PerMed consortium and validated by a focus group of experts. The final version, in English and Chinese, was administered online to a pool of accurately selected experts. Participation was anonymous and voluntary. The survey consists of 19 questions in 3 sections: (1) personal information; (2) policy in PM; (3) facilitating and hindering factors for Sino-European collaboration in PM. RESULTS: Forty-seven experts completed the survey, 27 from Europe and 20 from China. Only four participants were aware of the implementation of PM-related policies in their working country. Expert reported that PM areas with greatest policy impact so far were: Big Data and digital solutions; citizen and patient literacy; and translational research. The main obstacles found were the lack of shared investment strategies and the limited application of scientific developments in clinical practice. Aligning European and Chinese efforts, finding common ground across cultural, social, and language barriers, were considered as actions needed to enhance efforts in applying PM strategies internationally. CONCLUSION: To achieve efficiency and sustainability of health systems, it remains crucial to transform PM into an opportunity for all citizens and patients with the commitment of all the stakeholders involved. The results obtained aim to help define common research and development approaches, standards and priorities and increase collaboration at international level, as well as provide key solutions to enable convergence towards a common PM research, innovation, development and implementation approach between Europe and China.

Definition of a tool to assess shared decision-making (SDM) on women with breast cancer: A value-based approach.

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.

Italy: Health System Review.

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.

Early health system responses to the COVID-19 pandemic in Mediterranean countries: A tale of successes and challenges.

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.

Balancing financial incentives during COVID-19: A comparison of provider payment adjustments across 20 countries.

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.

"Integrating China in the International Consortium for Personalized Medicine": The Coordination and Support Action to Foster Collaboration in Personalized Medicine Development between Europe and China.

"Integrating China in the International Consortium for Personalized Medicine" (IC2PerMed) is a coordination and support action funded within the Horizon 2020 work program. Following the guidance of the International Consortium for Personalized Medicine (ICPerMed), the project's overarching aim is to align the European Union and China's research agendas in the field of personalized medicine (PM) to enable a swift development of PM approaches in the EU with strong leverage upon EU-Chinese collaboration. Living in the CO-VID-19 era, we are witnessing how the challenges imposed by the pandemic all around the globe have been acting as a catalyst for collaborations and knowledge sharing among national health systems worldwide. Given the strong interest on behalf of both Europe and China in the advancement of PM approaches, now more than ever, a cross-border collaboration between the 2 powers can accelerate the effective translation of such innovation to healthcare systems, advance research, and ensure that such change follows the directions toward the path of sustainability. IC2PerMed developments will be led by European and Chinese experts equally assembled into 3 Working Groups: (1) people and organization, (2) innovation and market, and (3) research and clinical studies in PM. This complex and dynamic network of actions thrives on dialog, cooperation, and alignment of research at national and global levels; work in the direction taken by IC2PerMed shall pave the way toward the realization of PM's full potential, prevent it from becoming a burden for healthcare systems, and, rather, prove that it provides an essential and irreplaceable contribution to their effectiveness, efficiency, and sustainability.

Success Factors and Barriers in Combining Personalized Medicine and Patient Centered Care in Breast Cancer. Results from a Systematic Review and Proposal of Conceptual Framework.

Breast Cancer (BC) is the leading cause of death due to cancer in women. Ensuring equitable, quality-assured and effective care has increased the complexity of BC management. This systematic review reports on the state-of-the art of available literature investigating the enactment of personalized treatment and patient-centered care models in BC clinical practice, building a framework for the delivery of personalized BC care within a Patient-Centered model. Databases were searched for articles (from the inception to December 2020) reporting on Patient-Centered or Personalized Medicine BC management models, assessing success factors or limits. Out of 1885 records, 25 studies were included in our analysis. The main success factors include clearly defined roles and responsibilities within a multi-professional collaboration, appropriate training programs and adequate communication strategies and adopting a universal genomic language to improve patients' involvement in the decision-making process. Among detected barriers, delays in the use of genetic testing were linked to the lack of public reimbursement schemes and of clear indications in timing and appropriateness. Overall, both care approaches are complementary and necessary to effectively improve BC patient management. Our framework attempts to bridge the gap in assigning a central role played by shared decision-making, still scarcely investigated in literature.

Contactless: a new personalised telehealth model in chronic pediatric diseases and disability during the COVID-19 era.

BACKGROUND: Suspending ordinary care activities during the COVID-19 pandemic made it necessary to find alternative routes to comply with care recommendations not only for acute health needs but also for patients requiring follow-up and multidisciplinary visits. We present the 'Contactless' model, a comprehensive operational tool including a plurality of services delivered remotely, structured according to a complexity gradient, aimed to cover diagnostic procedures and monitor disease progression in chronic pediatric patients. METHODS: A multidisciplinary and multiprofessional project team was recruited, in collaboration with patients' associations, to map a panel of available Evidence-Based solutions and address individual needs in full respect of the concept of personalized medicine. The solutions include a number of services from videoconsultations to more structure videotraining sessions. RESULTS: A modular framework made up of four three Macro-levels of complexity - Contactless Basic, Intermediate and Advanced - was displayed as an incremental set of services and operational planning establishing each phase, from factors influencing eligibility to the delivery of the most accurate and complex levels of care. CONCLUSION: The multimodal, multidisciplinary 'Contactless' model allowed the inclusion of all Units of our Pediatric Department and families with children with disability or complex chronic conditions. The strengths of this project rely on its replicability outside of pediatrics and in the limited resources needed to practically impact patients, caregivers and professionals involved in the process of care. Its implementation in the future may contribute to reduce the duration of hospital admissions, money and parental absence from work.

Missed linkage to care for patients who screened positive for Hepatitis C in a tertiary care centre: Results of the Telepass project.

Italy is one of the countries on track with the WHO's agenda to eliminate hepatitis C virus (HCV) by 2030. Healthcare facilities play a crucial role in seeking patients who are infected but have not yet been treated. We assessed the effectiveness of a recall strategy, named 'Telepass' project, for patients exposed to HCV infection who have not yet been linked to care in a large tertiary care centre. The 'Telepass' project was structured in two phases: (a) a retrospective analysis first identified all anti-HCV-positive subjects among patients who underwent pre-operative assessment in the facility in the course of one year; (b) a following prospective phase, aimed to recall patients in need either of further diagnostic tests (ie HCV-RNA) or treatment. A total of 12246 records of patients tested for HCV antibodies were reviewed. The overall prevalence of anti-HCV-positive subjects was 1.83% (224/12246) with a male/female ratio of 2.07. Out of the 224 anti-HCV-positive patients, 123 (54.91%) did not have documented HCV-RNA tests and were therefore selected for recall. Of these, 123 were reachable and 26 (21.13%) were successfully linked to care. Ten patients (38.46%) tested HCV-RNA positive and initiated treatment with direct-acting antivirals (DAAs). The Telepass study highlights that a recall strategy starting from internal hospital databases can help identify patients with chronic HCV infection who have not yet been linked to care, and provides an epidemiological insight into the prevalence of HCV infection in Italy in the late DAAs era.