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Background: According to scientific literature, some 99% of patients affected by Alzheimer's disease (AD) suffer from behavioral and psychological symptoms of dementia (BPSD), also known as neuropsychiatric symptoms (NPSs). In particular, agitation is one of the most difficult disorders to treat. States of agitation represent a very serious problem as they make these subjects dangerous for themselves and others and worsen as the disease advances. To date, there are no specific solutions for treating agitation. The only authorized drug is risperidone (as well as brexpiprazole, approved by the FDA on 11 May 2023), which can be used for no longer than 6–12 weeks because it increases the risk of death—owing to cardiocerebrovascular accidents—by 1.6–1.7 times. Methods: In order to address the latter noteworthy unmet medical need, NanoBEO was produced. The aim of the present work is to generate the health technology assessment (HTA) of this nanotechnological device. The latter consists of a controlled release system, based on solid lipid nanoparticles loaded with bergamot essential oil (BEO). Results: The results of the present research assessed the current evidence in the field of non-pharmacological treatments for this condition, including relevant primary preclinical and clinical data studies supporting the use of this device and the production of the operative plan for its launch on the market. The findings offer recommendations for decision-making on its implementation in dementia. Conclusions: NanoBEO represents a public-worth innovation in this neglected area, marking a significant advancement in the history of dementia, moving from academic research to product development. [ABSTRACT FROM AUTHOR]

Background/Objectives. Many vaccines have been developed in recent decades, and many more will be available in the future. When new safe and effective vaccines are available, decision-makers must extensively assess them before including them in the national immunization plan and issuing recommendations. The Health Technology Assessment (HTA) could be an objective, transparent, and comprehensive approach to guiding the decision-making process for the use of vaccines. Objectives and Methods. The aim of this study was to review the indications for HTA use contained in Italian institutional documents on vaccination, namely the National Immunization Plans (NIPs) and available full Italian HTA reports on vaccines, assessing their availability at the time of national recommendations' introductions. Results. HTA has been recognised as an eligible approach to deciding upon the introduction of vaccines through the NIPs of 2012–2014 and 2017–2019, and the last NIP, of 2023–2025, highlights the lack of funding dedicated to the production of independent HTA reports that can be used for issuing recommendations. In 2007–2023, twenty full HTA reports on vaccines were published in Italy: eight reports on influenza vaccines, five on Human Papilloma Virus (HPV), three each on meningococcal and pneumococcal vaccines, and one on rotavirus vaccine. HTA was applied with different purposes, namely the evaluation of new vaccines or their re-assessment, but it was not always timely with respect to both the marketing authorisation and the issuing of national recommendations for use. Conclusions. As HTA can be considered the best tool to disentangle the overall value of vaccines, it would be desirable for it to be used more and more to provide the evidence for efficient resource use. This calls for action to improve the transfer of HTA results to decision-makers, to try to fill the gap between research and decision and foster evidence-based recommendations. [ABSTRACT FROM AUTHOR]

Chronic RhinoSinusitis with Nasal Polyps (CRSwNP) represents a condition mainly caused by the type 2 inflammation presence and marked by the existence of polyps within the nasal and paranasal sinuses. The standard of care includes intranasal steroids, additional burst of systemic steroids, if needed, and surgery. However, recurrence is common, especially among patients with comorbid type 2 inflammatory diseases. Recently, biological drugs, addressing the underlying cause of the disease, have been approved in Italy (dupilumab, omalizumab, and mepolizumab). A Health Technology Assessment was conducted to define multidimensional impact, assuming Italian NHS perspective and a 12-month time horizon. The EUnetHTA Core Model was deployed, using the following methods to analyze the domains: (i) literature evidence; (ii) administration of semi-structured questionnaires to 17 healthcare professionals; (iii) health economics tools to define the economic sustainability for the system. Evidence from NMA and ITC showed a more favorable safety profile and better efficacy for dupilumab compared with alternative biologics. All the analyses, synthesizing cost and efficacy measures, showed that dupilumab is the preferable alternative. Specifically, the cost per responder analysis for dupilumab, exhibiting a 67.0% response rate at Week 52, is notably economical at 14,209EUR per responder. This presents a more economical profile compared with the cost per responder for omalizumab (36.2% response rate) at 24,999EUR and mepolizumab (28.5% response rate) at 31,863EUR. These results underscore dupilumab's potential, not merely in terms of clinical outcomes, but also in terms of economic rationality, thereby solidifying its status as a valid and preferrable alternative in the management of CRSwNP, in the context of the Italian NHS. [ABSTRACT FROM AUTHOR]

To ensure that limited domestic resources are invested in the most effective interventions, immunization programs in low- and middle-income countries (LMICs) must prioritize a growing number of new vaccines while considering opportunities to optimize the vaccine portfolio, as well as other components of the health system. There is a strong impetus for immunization decision-making to engage and coordinate various stakeholders across the health system in prioritization. To address this, national immunization program decision-makers in LMICs collaborated with WHO to structure deliberation among stakeholders and document an evidence-based, context-specific, and transparent process for prioritization or selection among multiple vaccination products, services, or strategies. The output of this effort is the Country-led Assessment for Prioritization on Immunization (CAPACITI) decision-support tool, which supports using multiple criteria and stakeholder perspectives to evaluate trade-offs affecting health interventions, taking into account variable data quality. Here, we describe the user feedback from Indonesia and Ethiopia, two initial countries that piloted the CAPACITI decision-support tool, highlighting enabling and constraining factors. Potential immunization program benefits and lessons learned are also summarized for consideration in other settings. [ABSTRACT FROM AUTHOR]

AlN epilayers were grown on magnetron-sputtered (MS) (11–22) AlN buffers on m-plane sapphire substrates at 1450 °C via hydride vapour phase epitaxy (HVPE). The MS buffers were annealed at high temperatures of 1400–1600 °C. All the samples were characterised using X-ray diffraction, atomic force microscopy, scanning electron microscope and Raman spectrometry. The crystal quality of epilayers regrown by HVPE was improved significantly compared to that of the MS counterpart. With an increasing annealing temperature, the crystal quality of both MS buffers and AlN epilayers measured along [11–23] and [1–100] improved first and then decreased, maybe due to the decomposition of MS buffers, while the corresponding anisotropy along the two directions decreased first and then increased. The optimum quality of the AlN epilayer was obtained at the annealing temperature of around 1500 °C. In addition, it was found that the anisotropy for the epilayers decreased significantly compared to that of annealed MS buffers when the annealing temperature was below 1500 °C. [ABSTRACT FROM AUTHOR]

New therapies in a publicly funded healthcare system are first appraised by health technology assessment agencies that provide funding recommendations to the payers. Treatment with Chimeric Antigen Receptor-T cell (CAR-T) therapy is revolutionizing the management of patients with relapsed/refractory aggressive B-cell lymphoma by providing an effective alternative to the standard of care. Yet, the implementation of CAR-T treatment has a substantial impact on the healthcare system due to its high cost, complex manufacturing process, and requirement for highly specialized services and expertise. CAR-T Cells, as a "living drug", are fundamentally different from usual medications, and their approvals and funding recommendations pose unique challenges to the health technology agency. In this paper, we explore the specific challenges that face the health technology agencies in reviewing reimbursement recommendations for CAR-T therapy. We take a Canadian perspective and use CAR-T treatment of relapse/refractory aggressive B-cell lymphoma as an example. [ABSTRACT FROM AUTHOR]

Highly mechanized forestry operations are essential for efficient timber harvesting. Therefore, the skills of harvester operators appear to be key to productive and sustainable use of the machines. Recent research has revealed a knowledge deficit regarding the work practices of forest machine operators. This urges systematic research into forestry machine handling and a corresponding refinement of analytical methods. Current analyses of operator tasks in forestry are less formalized and focus predominantly on machine efficiency and overall performance, but not so much on the human-related conditions of work performance and workload. Therefore, the objective of this paper is to introduce hierarchical task analysis (HTA) into forestry science. HTA is a versatile, formalized human-factors method that can be used to describe the work objectives of forest machine operators. HTA is suitable, for example, for describing (in)efficient work practices and thus as a basis for designing machine operator training and for systematically evaluating assistive technologies. The task analyses in this paper draw on a recently published empirical approach to analyzing work practices, workflows, and machine operator behavior for optimal human–machine collaboration in forestry application research. Specifically, the main work methods of clearcutting and thinning stand in European forestry were considered, with examples from Scandinavian and German method application. The process of HTA is described and a prototypical approach to HTA for both working methods provided. As a result, this work could show that a single work practice affects operator goals within different work elements and sets out how inefficient work practices can be described in terms of operator goals. With the introduction and exemplary application of HTA, a structured task definition in human-centered approaches is encouraged to analyze work practices, workflows, and machine operator behavior for optimal human–machine collaboration in forestry application research. [ABSTRACT FROM AUTHOR]

Objectives: Italy was the first European country to introduce universal vaccination of adolescents, for both males and females, against Human Papilloma Virus (HPV) starting in 2017 with the NIP 2017–2019′s release. However, vaccine coverage rates (VCRs) among adolescents have shown a precarious take-off since the NIP's release, and this situation worsened due to the impact of the COVID-19 pandemic in 2020. The aim of this work is to estimate the epidemiological and economic impact of drops in VCRs due to the pandemic on those generations that missed the vaccination appointment and to discuss alternative scenarios in light of the national data. Methods: Through an analysis of the official ministerial HPV vaccination reports, a model was developed to estimate the number of 12-year-old males and females who were not vaccinated against HPV during the period 2017–2021. Based on previously published models that estimate the incidence and the economic impact of HPV-related diseases in Italy, a new model was developed to estimate the impact of the aggregated HPV VCRs achieved in Italy between 2017 and 2021. Results: Overall, in 2021, 723,375 girls and 1,011,906 boys born between 2005 and 2009 were not vaccinated against HPV in Italy (42% and 52% of these cohorts, respectively). As compared with the 95% target provided by the Italian NIP, between 505,000 and 634,000 girls will not be protected against a large number of HPV-related diseases. For boys, the number of the unvaccinated population compared to the applicable target is over 615,000 in the 'best case scenario' and over 749,000 in the 'worst case scenario'. Overall, between 1.1 and 1.3 million young adolescents born between 2005 and 2009 will not be protected against HPV-related diseases over their lifetime with expected lifetime costs of non-vaccination that will be over EUR 905 million. If the 95% optimal VCRs were achieved, the model estimates a cost reduction equal to EUR 529 million, the net of the costs incurred to implement the vaccination program. Conclusion: Suboptimal vaccination coverage represents a missed opportunity, not only because of the increased burden of HPV-related diseases, but also in terms of economic loss. Thus, reaching national HPV immunization goals is a public health priority. [ABSTRACT FROM AUTHOR]

This paper is aimed at addressing all the critical aspects linked to the implementation of intensive care ventilators in a pediatric setting, highlighting the most relevant technical features and describing the methodology to conduct health technology assessment (HTA) for supporting the decision-making process. Four ventilator models were included in the assessment process. A decision-making support tool (DoHTA method) was applied. Twenty-eight Key Performance Indicators (KPIs) were identified, defining the safety, clinical effectiveness, organizational, technical, and economic aspects. The Performance scores of each ventilator have been measured with respect to KPIs integrated with the total cost of ownership analysis, leading to a final rank of the four possible technological solutions. The final technologies’ performance scores reflected a deliver valued, contextualized, and shared outputs, detecting the most performant technological solution for the specific hospital context. HTA results had informed and supported the pediatric hospital decision-making process. This study, critically identifying the pros and cons of innovative features of ventilators and the evaluation criteria and aspects to be taken into account during HTA, can be considered as a valuable proof of evidence as well as a reliable and transferable method for conducting decision-making processes in a hospital context. [ABSTRACT FROM AUTHOR]

Reimbursement decisions on new oncology drugs are now often made while uncertainty remains about a drug's risk–benefit profile. One consequence of this is a delay in patient access to valuable new medicines. We share our perspectives on strategies to mitigate sources of uncertainty in the health technology assessment process. These include flexible approaches for evaluating the additional benefit, such as better use of surrogate endpoints and health-related quality of life data, and renewed research efforts to define the optimal target population and generate real-world evidence post-authorisation. [ABSTRACT FROM AUTHOR]

Human-robot collaboration (HRC) is a complex procedure in manufacturing due to the problems posed by compatibility and operational safety among humans and robots, and by task definitions among them in a collaborative order. In this paper, the research results of the human-robot collaboration study for the case of an automotive brake disc assembly is presented. The analytic hierarchy process (AHP) is proposed as a decision-making method for the human-robot collaboration system, and detailed hierarchical task analysis (HTA) is applied to allocate operational tasks to humans and robots, thus reducing the chance of duty interference. Additionally, a virtual environment software (Tecnomatix Process Simulate, version 11.1,80, Siemens, Munich, BY, Germany, 2012) is used to model the assembly workstation, providing an opportunity to evaluate the feasibility of the process through different scenarios. Finally, an experimental test is conducted to evaluate the performance of the assembly procedure. This research proves that, although human-robot collaboration increases the total process time slightly, this collaboration improves human ergonomics considerably and reduces the operator injury risk. [ABSTRACT FROM AUTHOR]

The present study aims at defining the economic and organizational impacts of the introduction of chimeric antigen receptor T-cell therapy (CAR-T) in Italy, for the management of diffuse large B-cell lymphoma (DLBCL) patients in third-line therapy, defining the overall level of sustainability for both hospitals and the National Healthcare System (NHS). The analysis focused on CAR-T and Best Salvage Care (in the following BSC), assuming the Italian hospital and NHS perspectives, over a 36-month time horizon. Process mapping and activity-based costing methodologies were applied to collect the hospital costs related to the BSC and CAR-T pathways, including adverse event management. Anonymous administrative data on services provided (diagnostic and laboratory examinations, hospitalizations, outpatient procedures, and therapies) to 47 third-line patients with lymphoma, as well as any organizational investments required, were collected, in two different Italian Hospitals. The economic results showed that the BSC clinical pathway required less resources in comparison with CAR-T (excluding the cost related to the therapy) (BSC: 29,558.41 vs. CAR-T: EUR 71,220.84, -58.5%). The budget impact analysis depicts that the introduction of CAR-T would generate an increase in costs ranging from 15% to 23%, without considering treatment costs. The assessment of the organizational impact reveals that the introduction of CAR-T therapy would require additional investments equal to a minimum of EUR 15,500 to a maximum of EUR 100,897.49, from the hospital perspective. Results show new economic evidence for healthcare decision makers, to optimize the appropriateness of resource allocation. The present analysis suggests the need to introduce a specific reimbursement tariff, both at the hospital and at NHS levels, since no consensus exists, at least in the Italian setting, concerning the proper remuneration for the hospitals who guarantee this innovative pathway, assuming high risks related to timely management of adverse events.

High-quality AlN film is a key factor affecting the performance of deep-ultraviolet optoelectronic devices. In this work, high-temperature annealing technology in a nitrogen atmosphere was used to improve the quality of AlN films with different polarities grown by magnetron sputtering. After annealing at 1400–1650 °C, the crystal quality of the AlN films was improved. However, there was a gap between the quality of non-polar and polar films. In addition, compared with the semi-polar film, the quality of the non-polar film was more easily improved by annealing. The anisotropy of both the semi-polar and non-polar films decreased with increasing annealing temperature. The results of Raman spectroscopy, scanning electron microscopy and X-ray photoelectron spectroscopy revealed that the annihilation of impurities and grain boundaries during the annealing process were responsible for the improvement of crystal quality and the differences between the films with different polarities. [ABSTRACT FROM AUTHOR]

Background: The elderly, commonly defined as subjects aged ≥65 years, are among the at-risk subjects recommended for annual influenza vaccination in European countries. Currently, two new vaccines are available for this population: the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) and the high-dose quadrivalent influenza vaccine (hdQIV). Their multidimensional assessment might maximize the results in terms of achievable health benefits. Therefore, we carried out a Health Technology Assessment (HTA) of the aQIV by adopting a multidisciplinary policy-oriented approach to evaluate clinical, economic, organizational, and ethical implications for the Italian elderly., Methods: A HTA was conducted in 2020 to analyze influenza burden; characteristics, efficacy, and safety of aQIV and other available vaccines for the elderly; cost-effectiveness of aQIV; and related organizational and ethical implications. Comprehensive literature reviews/analyses were performed, and a transmission model was developed in order to address the above issues., Results: In Italy, the influenza burden on the elderly is high and from 77.7% to 96.1% of influenza-related deaths occur in the elderly. All available vaccines are effective and safe; however, aQIV, such as the adjuvanted trivalent influenza vaccine (aTIV), has proved more immunogenic and effective in the elderly. From the third payer's perspective, but also from the societal one, the use of aQIV in comparison with egg-based standard QIV (eQIV) in the elderly population is cost-effective. The appropriateness of the use of available vaccines as well as citizens' knowledge and attitudes remain a challenge for a successful vaccination campaign., Conclusions: The results of this project provide decision-makers with important evidence on the aQIV and support with scientific evidence on the appropriate use of vaccines in the elderly.

Combining insights from collaborative governance, performance management, and health technology assessment (HTA) literature, this study develops an integrated framework to systematically measure and monitor the performance of HTA network programmes. This framework is validated throughout an action research carried out in the Italian HTA network programme for medical devices. We found that when building up collaborative performance management systems, some elements such as the participation in the design and the use of context specific performance assessment framework, facilitate their acceptance by managers and policy makers especially in high professionalized and sector-specific organizations because it reflects their distinctive language and culture. The hybrid framework may help health authorities and policymakers to understand the HTA network, monitor its performance, and ensure network sustainability over time. [ABSTRACT FROM AUTHOR]

Prosthetic technology for people with missing limbs has made great progress in recent decades. However, acceptance rates and user satisfaction are not only dependent on technical aspects, but also to a great extent on social and psychological factors. We propose that these factors should receive greater attention in order to improve prosthetic care and give recommendations how to incorporate the findings from social science in research and development (R&D) and in care practice. Limited access due to high costs of new prosthetic technology combined with rising costs in health care systems in general is a further issue we address. Our legal and ethical analysis of the reimbursement process in Germany shows that this issue requires further empirical investigation, a stakeholder dialogue and maybe even policy changes. Social science knowledge and participatory methods are of high relevance to answer questions about the benefit of prosthetics for users, based on individual needs and preferences, which should be at the core of debates on ethical resource allocation. [ABSTRACT FROM AUTHOR]

The aim of this study is to analyze the potential advantages of emtricitabine/tenofovir alafenamide (FTC/TAF) introduction, creating evidence-based information to orient strategies to reduce costs, thus preserving effectiveness and appropriateness. An Health Technology Assessment (HTA) was implemented in the years 2017-2018 comparing the dual backbones available in the Italian market: FTC/TAF, FTC/TDF (tenofovir disoproxil fumarate/emtricitabine) and ABC/3TC (abacavir/lamivudine). From an efficacy point of view, FTC/TAF ensured a higher percentage of virologic control and a better safety impact than FTC/TDF (improving the renal and bone safety profile, as well as the lipid picture). From an economic point of view, the results revealed a 4% cost saving for the Italian National Healthcare Service NHS with FTC/TAF introduction compared with the baseline scenario. Qualitative perceptions' results showed that FTC/TAF would decrease the burden of adverse events management, increasing the accessibility of patients to healthcare providers (FTC/TAF: 0.95, FTC/TDF: 0.10, ABC/3TC: 0.28; p -value: 0.016) and social costs (FTC/TDF: -0.23, FTC/TAF: 1.04, ABC/3TC: 0.23; p -value < 0.001), improving patient quality of life (FTC/TDF: 0.31, FTC/TAF: 1.85, ABC/3TC: 0.38; p -value < 0.001). Healthcare services may consider the evidence provided by the present study as an opportunity to include HIV patients in a more adequate antiretroviral treatment arm, guaranteeing a personalized clinical pathway, thus becoming more efficient and effective over time., Competing Interests: The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Background: This paper presents a generic Multi-Criteria Decision Analysis (MCDA) model for Health Technology Assessment (HTA) decision-making, which can be applied to a wide range of HTA studies, regardless of the healthcare technology type under consideration., Methods: The HTA Core Model ® of EUnetHTA was chosen as a basis for the development of the MCDA model because of its common acceptance among European Union countries. Validation of MCDA4HTA was carried out by an application with the HTA study group of the Turkish Ministry of Health. The commitment of the decision-making group is completed via an online application of 10 different questionnaires. The Analytic Hierarchy Process (AHP) is used to determine the weights. Scores of the criteria in MCDA4HTA are gathered directly from the HTA report. The performance matrix in this application is run with fuzzy Technique for Order Preference by Similarity to Ideal Solution (TOPSIS), fuzzy Vise Kriterijumska Optimizacija I Kompromisno Resenje (VIKOR), and goal programming MCDA techniques., Results: Results for fuzzy VIKOR, fuzzy TOPSIS, and goal programming are 0.018, 0.309, and 0.191 for peritoneal dialysis and 0.978, 0.677, and 0.327 for hemodialysis, respectively., Conclusions: Peritoneal dialysis is found to be the best choice under the given circumstances, despite its higher costs to society. As an integrated decision-making model for HTA, MCDA4HTA supports both evidence-based decision policy and the transparent commitment of multi-disciplinary stakeholders., Competing Interests: The authors declare no conflict of interest.

Background and objectives:  MCDA is a decision-making tool with increasing use in the healthcare sector, including HTA (Health Technology Assessment). By applying multiple criteria, including innovation, in a comprehensive, structured and explicit manner, MCDA fosters a transparent, participative, consistent decision-making process taking into consideration values of all stakeholders. This paper by FIFARMA (Latin American Federation of Pharmaceutical Industry) proposes the deliberative (partial) MCDA as a more pragmatic, agile approach, especially when newly implemented. Methods:Literature review including real-world examples of effective MCDA implementation in healthcare decision making in both the public and private sector worldwide and in LA. Results and conclusion: It is the view of FIFARMA that MCDA should strongly be considered as a tool to support HTA and broader healthcare decision making such as the contracts and tenders process in order to foster transparency, fairness, and collaboration amongst stakeholders. [ABSTRACT FROM PUBLISHER]

Background: Despite the guidelines for Economic and Public Health Assessment Committee (CEESP) submission having been available for nearly six years, the dossiers submitted continue to deviate from them, potentially impacting product prices. Objective: to review the reports published by CEESP, analyse deviations from the guidelines, and discuss their implications for the pricing and reimbursement process. Study design: CEESP reports published until January 2017 were reviewed, and deviations from the guidelines were extracted. The frequency of deviations was described by type of methodological concern (minor, important or major). Results: In 19 reports, we identified 243 methodological concerns, most often concerning modelling, measurement and valuation of health states and results presentation and sensitivity analyses; nearly 63% were minor, 33% were important and 4.5% were major. All reports included minor methodological concerns, and 17 (89%) included at least one important and/or major methodological concern. Global major methodological concerns completely invalidated the analysis in seven dossiers (37%). Conclusion: The CEESP submission dossiers fail to adhere to the guidelines, potentially invalidating the health economics analysis and resulting in pricing negotiations. As these negotiations tend to be unfavourable for the manufacturer, the industry should strive to improve the quality of the analyses submitted to CEESP. [ABSTRACT FROM PUBLISHER]