The definition of an explicit health benefit package in Italy has gained importance because of devolution of powers from the national level to the regions. The set of services to be guaranteed by the public sector are defined at national level, while regions are accountable for their provision. This contribution discusses the entitlements and the decision criteria adopted by Italian policy-making bodies. Entitlements to services are clearly defined for few sectors (mainly outpatient specialist care); for hospital care the benefit catalogue is vague. The definition of the health benefit package in Italy is an essential element of the relationship between the central government and the regions. It is argued that adequate monitoring systems and accountability procedures are still needed to make the essential levels of care an effective pivotal element of the Italian National Health Service.
Contemporary commentators describe the current period as "an era of fake news" in which misinformation, generated intentionally or unintentionally, spreads rapidly. Although affecting all areas of life, it poses particular problems in the health arena, where it can delay or prevent effective care, in some cases threatening the lives of individuals. While examples of the rapid spread of misinformation date back to the earliest days of scientific medicine, the internet, by allowing instantaneous communication and powerful amplification has brought about a quantum change. In democracies where ideas compete in the marketplace for attention, accurate scientific information, which may be difficult to comprehend and even dull, is easily crowded out by sensationalized news. In order to uncover the current evidence and better understand the mechanism of misinformation spread, we report a systematic review of the nature and potential drivers of health-related misinformation. We searched PubMed, Cochrane, Web of Science, Scopus and Google databases to identify relevant methodological and empirical articles published between 2012 and 2018. A total of 57 articles were included for full-text analysis. Overall, we observe an increasing trend in published articles on health-related misinformation and the role of social media in its propagation. The most extensively studied topics involving misinformation relate to vaccination, Ebola and Zika Virus, although others, such as nutrition, cancer, fluoridation of water and smoking also featured. Studies adopted theoretical frameworks from psychology and network science, while co-citation analysis revealed potential for greater collaboration across fields. Most studies employed content analysis, social network analysis or experiments, drawing on disparate disciplinary paradigms. Future research should examine susceptibility of different sociodemographic groups to misinformation and understand the role of belief systems on the intention to spread misinformation. Further interdisciplinary research is also warranted to identify effective and tailored interventions to counter the spread of health-related misinformation online.
Abstract Background As alcohol-related health problems continue to rise, the attention of policy-makers is increasingly turning to Screening and Brief Intervention (SBI) programmes. The effectiveness of such programmes in primary healthcare is well evidenced, but very few cost-effectiveness analyses have been conducted and none which specifically consider the Italian context. Methods The Sheffield Alcohol Policy Model has been used to model the cost-effectiveness of government pricing and public health policies in several countries including England. This study adapts the model using Italian data to evaluate a programme of screening and brief interventions in Italy. Results are reported as Incremental Cost-Effectiveness Ratios (ICERs) of SBI programmes versus a 'do-nothing' scenario. Results Model results show such programmes to be highly cost-effective, with estimated ICERs of €550/Quality Adjusted Life Year (QALY) gained for a programme of SBI at next GP registration and €590/QALY for SBI at next GP consultation. A range of sensitivity analyses suggest these results are robust under all but the most pessimistic assumptions. Conclusions This study provides strong support for the promotion of a policy of screening and brief interventions throughout Italy, although policy makers should be aware of the resource implications of different implementation options.
Aim Technological and computational advancements offer new tools for the collection and analysis of real-world data (RWD). Considering the substantial effort and resources devoted to collecting RWD, a greater return would be achieved if real-world evidence (RWE) was effectively used to support Health Technology Assessment (HTA) and decision making on medical technologies. A useful question is: To what extent are RWD suitable for generating RWE? Methods We mapped existing RWD sources in Europe for three case studies: hip and knee arthroplasty, transcatheter aortic valve implantation (TAVI) and mitral valve repair (TMVR), and robotic surgery procedures. We provided a comprehensive assessment of their content and appropriateness for conducting the HTA of medical devices. The identification of RWD sources was performed combining a systematic search on PubMed with gray literature scoping, covering fifteen European countries. Results We identified seventy-one RWD sources on arthroplasties; ninety-five on TAVI and TMVR; and seventy-seven on robotic procedures. The number, content, and integrity of the sources varied dramatically across countries. Most sources included at least one health outcome (97.5%), with mortality and rehospitalization/reoperation the most common; 80% of sources included resource outcomes, with length of stay the most common, and comparators were available in almost 70% of sources. Conclusions RWD sources bear the potential for the HTA of medical devices. The main challenges are data accessibility, a lack of standardization of health and economic outcomes, and inadequate comparators. These findings are crucial to enabling the incorporation of RWD into decision making and represent a readily available tool for getting acquainted with existing information sources.
Introduction The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high-risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the whole lifecycle of medical devices. In this paper we address: i) the appropriate level and timing of clinical evidence throughout the lifecycle of high-risk implantable medical devices; and ii) how the clinical evidence generation ecosystem could be adapted to optimize patient access. Areas covered The European regulatory and health technology assessment (HTA) contexts are reviewed, in relation to the lifecycle of high-risk medical devices and clinical evidence generation recommended by international network or endorsed by regulatory and HTA agencies in different jurisdictions. Expert opinion Four stages are relevant for clinical evidence generation: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market. Each stage has its own evaluation needs and specific studies are recommended to generate the appropriate evidence. Effective lifecycle planning requires anticipation of what evidence will be needed at each stage.
The COVID-19 pandemic is a catastrophe. It was also preventable. The potential impacts of a novel pathogen were foreseen and for decades scientists and commentators around the world warned of the threat. Most governments and global institutions failed to heed the warnings or to pay enough attention to risks emerging at the interface of human, animal, and environmental health. We were not ready for COVID-19, and people, economies, and governments around the world have suffered as a result. We must learn from these experiences now and implement transformational changes so that we can prevent future crises, and if and when emergencies do emerge, we can respond in more timely, robust and equitable ways, and minimize immediate and longer-term impacts. In 2020–21 the Pan-European Commission on Health and Sustainable Development assessed the challenges posed by COVID-19 in the WHO European region and the lessons from the response. The Commissioners have addressed health in its entirety, analyzing the interactions between health and sustainable development and considering how other policy priorities can contribute to achieving both. The Commission's final report makes a series of policy recommendations that are evidence-informed and above all actionable. Adopting them would achieve seven key objectives and help build truly sustainable health systems and fairer societies.
Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence. Methods: As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020. Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs. Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limited evidence base compared with pharmaceuticals.
