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The Health Technology Assessment (HTA) Working Group of the Emerging Technology Division of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) aims to develop a methodological approach for producing structured HTA information for laboratory medicine technologies. This approach seeks to support decision-making processes at the country, regional, and/or hospital levels regarding the introduction of specific technologies. The focus of this model will primarily be on defining assessment elements within the domains of 'organizational aspects' and 'costs and economic evaluations', potentially differentiated by the type of diagnostic technology (e.g., genetic tests, molecular tests). To achieve this project's goal, a literature review and examination of websites of international HTA agencies have been conducted. The research aims to identify multidisciplinary methodological approaches used to assess laboratory diagnostic technologies and to pinpoint the domains and assessment elements utilized. We found 7 methodological articles describing methodological approaches adopted to assess laboratory diagnostic technologies. Among the HTA organizations considered, 23 reports were found, of which 7 were produced by the European Network of HTA (EUnetHTA), 4 by the National Institute for Health and Care Excellence Diagnostic Assessment Program (NICE DAP), and 12 by other HTA agencies. The EUnetHTA reports were rapid collaborative assessments covering various domains, while the NICE DAP reports focused on diagnostic guidances, including descriptions of technologies, clinical need and practice, diagnostic tests, accuracy, effectiveness, and cost-effectiveness. Finally, a survey targeting laboratory professionals will be conducted to introduce assessment elements, differentiated by the type of diagnostic technology, primarily for organizational and economic domains. [ABSTRACT FROM AUTHOR]

Introduction: There are an estimated 26 million rare disease patients in Europe, about 2 million in Italy. Access to orphan drugs has been evaluated nationally and internationally, and delays have been observed due to evaluation of price and therapeutic value. The objectives of this study are: to assess the availability of EMA-authorized orphan drugs at national and regional level; to study time trends and regional variability in consumption and spending, and to estimate the time to access in Italian regions. Methods: We evaluate the availability of EMA authorized orphan drugs in Italy. Based on data from the Traceability of medicines dataflow for period 2016-2021 we evaluate the expenditure, consumption and availability of orphan drugs in each region. To estimate the time to access we consider the days between the end of negotiation procedure and the first purchase by regions. Results: In 2021 in Italy are available 94% of EMA authorized orphan drugs. The expenditure and consumption have grown during the last decade. The availability is higher in bigger regions, that also take care of patients from smaller regions. The pro capite expenditure and consumption in DDD/1,000 ab die is similar in all the geographic area. Time to regional access is on average 123 days, that grows to 224 excluding the orphan drugs dispensed before the end of reimbursement procedure. Conclusions: Italy has a high availability of orphan drugs and the time to access is less than European average. In each region the care of rare patients is uniform and guaranteed. [ABSTRACT FROM AUTHOR]

Purpose: To investigate whether the number of nursing diagnoses on hospital admission is an independent predictor of the hospital length of stay. Design: A prospective observational study was carried out. A sample of 2,190 patients consecutively admitted (from July to December 2014) in four inpatient units (two medical, two surgical) of a 1,547‐bed university hospital were enrolled for the study. Methods: Data were collected from a clinical nursing information system and the hospital discharge register. Two regression analyses were performed to investigate if the number of nursing diagnoses on hospital admission was an independent predictor of length of stay and length of stay deviation after controlling for patients' sociodemographic characteristics (age, gender), clinical variables (disease groupers, disease severity morbidity indexes), and organizational hospital variables (admitting inpatient unit, modality of admission). Findings: The number of nursing diagnoses was shown to be an independent predictor of both the length of stay (β =.15; p <.001) and the length of stay deviation (β =.19; p <.001). Conclusions: The number of nursing diagnoses is a strong independent predictor of an effective hospital length of stay and of a length of stay longer than expected. Clinical Relevance: The systematic inclusion of standard nursing care data in electronic health records can improve the predictive ability on hospital outcomes and describe the patient complexity more comprehensively, improving hospital management efficiency. [ABSTRACT FROM AUTHOR]

Introduction: Considering the clinical impact of innovative cancer therapies, policy makers strive to balance timely access and thorough value-assessment. While some European countries promoted early access schemes, Italy does not yet display a consolidated strategy for innovative drugs or for medicines targeting pathologies with a high unmet need., Methods: To better understand the risks and opportunities of early access strategies that could be applied in the Italian setting, we performed a scoping review, searching the PubMed and Web of Science databases and interviewing two field experts. The review results were complemented with an exemplificative quantitative analysis for a subset of innovative oncology drugs, to assess the clinical and economic impact of the price and reimbursement negotiation., Results: Our study suggests that early access schemes developed in Germany and France, combining a free-pricing period, pay-back mechanism, and arbitration, could serve as a basis for developing a feasible strategy in Italy. The quantitative analysis indicated that timely access to innovative drugs could have potentially prevented many cancer progressions, associated with a significant healthcare expenditure., Conclusion: Albeit not allowing to express a conclusive assessment, this study proposes a potential early access strategy for Italy and highlights the need for opening a debate on the opportunities and risks of such schemes., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Defining innovation in the field of medical devices can be extremely challenging due to the peculiarity of the products within this class. Short life-cycle, incrementality, learning curve effect, impact of the organizational setting, uncertainty of effect and level of evidence are only some of these aspects. A clear set of criteria to define innovation would be of paramount relevance in this field. Twelve criteria to define innovation were proposed to a multistakeholder panel within a consensus process. A Delphi method on two rounds was used to reach consensus. In total, 53 of the 93 (47%) invited panelists responded to the first round of the survey. Among them, 51 (96%) completed also the second round. At the first round, consensus was reached for four of the 12 proposed criteria. Three of the remaining eight criteria reached consensus at the second round. It was not possible to reach consensus for the remaining five criteria. The criteria that collected the highest scores (close to 100%) were from the clinical impact domain, namely the ability of the technology to offer significant advantages over existing alternatives in terms of improving relevant clinical outcomes, and the ability to address an unmet need defined in terms of unavailability of diagnosis/treatment alternatives. High levels of consensus (about 80%) were registered on criteria belonging to non-clinical domains of analysis and, in particular, the ability of the technology to introduce organizational benefits, and the ability of the technology to bring cost reduction providing the same clinical benefit of current alternatives., Competing Interests: The authors declare that they have no competing interests., (Copyright © 2024 D’Angela et al.)

Lower respiratory tract infections (LRTIs) cause high morbidity and mortality worldwide. Empiric therapy often base the choice of antibiotic treatment on antibacterial spectrum of the agent rather than on its pharmacological properties or the pathogen resistance profile. Inappropriate prescribing leads to therapeutic failure and antibiotic resistance, with increasing direct and indirect health costs. A consensus on appropriate prescribing in LRTI therapy was appraised by this Delphi exercise, based on a panel of 70 pulmonologists, coordinated by a Scientific Committee of nine experts in respiratory medical care. Full or very high consensus was reached on several issues, including the role of oral cephalosporins in first-line treatments of LRTIs and the appropriateness of cefditoren, with balanced spectrum and high intrinsic activity, in LRTI treatment. Evidence-based medicine approach and a comprehensive process of disease management, from diagnosis to therapy and follow-up, should guide antibiotic prescribing.

Background: Cost-effectiveness of ivabradine was assessed by the National Institute for Health and Clinical Excellence (NICE) in 2012, based on the data derived from the SHIFT trial: NICE considered ivabradine cost-effective for treating chronic heart failure, supporting drug reimbursement by the national healthcare system (NHS). The aim of this study was to assess the cost-effectiveness of ivabradine on top of standard care in heart failure therapy, by adapting a Markovian model to the Italian population and organization, previously developed for submission to national regulatory bodies., Methods: The demographic and clinical characteristics of the Italian population were derived from both the SHIFT trial and the IN-HF Outcome registry (Italian real practice data). Costs were drawn from the Italian NHS information system. All analyses adopted the Italian NHS perspective., Results: In a lifetime horizon, in the base case, our assessment confirms that adoption of ivabradine seems socially acceptable with a cost per quality-adjusted life year (QALY) of €17,434.86 (incremental cost of €2,952.85 and QALYs gained 0.21). The incremental cost/life-year gained (LYG) is €15,557.24 (LYG gained 0.24) and hospitalization costs avoided are €3,420.77 (avoided hospitalizations 0.76). A probabilistic sensitivity analysis showed that ivabradine on top of standard treatment is cost-effective in more than 87% of cases accepting a threshold of €30,000, and in more than 93% of cases with a threshold of €40,000., Conclusions: The results obtained for the Italian population and in the organizational context of the Italian NHS show social acceptability (cost per QALY) of ivabradine therapy in the treatment of heart failure.

Background. Acute heart failure (AHF) is a common and clinically relevant condition that usually implies the need for hospitalization. The aim of this study was to provide data about hospital activity related to AHF at a national and regional level. Methods. The analysis describes acute hospitalization (year 2010) for AHF in both public and private accredited facilities in the Italian Regions and Autonomous Provinces, using as source the hospital discharge records collected by the Italian Ministry of Health. Results. Our findings are consistent with available data in the literature, although they show relevant outcome variability regarding hospitalization rates and mean length of hospital stay. Conclusions. Evaluation of hospitalization costs confirms that the burden of hospitalization is quite high, though characterized by a great variability.