Daniele Bellavia

Objective: The aim of this study was to define the economic and organizational impacts related to a broader utilization of bictegravir/emtricitabine/alafenamide (BIC/FTC/TAF) in Italian clinical practice. Methods: A budget impact analysis—representing the evolution of the Italian National Healthcare Service (NHS) healthcare expenditure over 3 years—was developed, considering the overall Italian population treated for human immunodeficiency virus (HIV). Model input variables were treatment history, therapeutic regimen, development of adverse events, achievement of an undetectable viral load and total direct healthcare costs. Besides the BIA, an organizational impact assessment was conducted to determine the impact on the use of healthcare resources, assessing the release of organizational hospital assets, focusing on the management of drug-related adverse events. Data were collected from scientific evidence, Italian national and regional legislations and healthcare professionals’ reports. To verify the robustness of the economic and organizational impact assessment, sensitivity analyses were performed. Results: Results demonstrate economic savings of about 26 million euros in total health spending, assuming a higher penetration rate for BIC/FTC/TAF. This change in the current case mix would lead to a reduction in the specific costs related to adverse event management (0.9 million euros; − 2.09%) and in the medical management of patients (38 million euros; − 7.79%), with a positive impact on the achievement of virological control. From an organizational perspective, a wider use of BIC/FTC/TAF generates a reduction in the utilization of healthcare resources due to a decrease in adverse events and complications. The model estimated a 19.64% reduction in HIV-related inpatient days, which freed up healthcare professional time. Conclusions: Capable of improving both economic and organizational sustainability for the entire HIV care continuum, BIC/FTC/TAF is an efficient therapeutic strategy for people with HIV.

Background/Objectives: European healthcare systems are increasingly adopting automation technologies to improve efficiency. This study evaluates the economic viability of
hospital automation and medication management digitalization. Methods: An economic
evaluation was based on a standardized hospital model comprising 561 beds, representative of an average acute care hospital across EU27 + UK. For each technology, several cost
items were estimated using country-specific parameters such as labor costs, medication
error rates, healthcare expenditure, and money discount rate. The financial metrics (Return
On Investment—ROI, Net Present Value—NPV, Payback Time—PBT) were first calculated
at the hospital level. These results were then extrapolated to the national level by scaling
the per-hospital estimates according to the total number of hospital beds reported in each
country. Finally, national results were aggregated to derive the overall European impact.
Results: The analysis estimated a total European investment of EUR 3.55 billion, with an
average PBT of 4.46 years and annual savings of 1,96 billion. ROI averaged 167%, and
the total NPV was 8.21 billion. A major saving driver was the reduction in Medication
Administration Errors that has an impact of 37.2% on the total savings. Payback times
ranged from 3 years in high-GDP countries, to 7 years in lower-GDP nations. Conclusions:
These findings demonstrate how providing structured data on hospital automation benefits
could support decision-making processes, highlighting the organizational and economic
feasibility of the investment across different European national contexts.

Introduction: Given the availability of a growing number of HIV treatment options, it becomes essential to have a clear understanding of the related economic-organizational evidence, to operate informed and conscious choices. The study aims to define the economic and organizational impact related to a consolidated use of Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), within the Italian National Healthcare Service (NHS), for the treatment of both naïve and experienced HIV individuals. Materials and methods: A budget impact analysis was developed assuming the NHS perspective and considering a 36-month time horizon. Scenario A, representative of the current situation of consumption of the different therapeutic alternatives (derived from the most update guidelines), was compared with Scenario B, assuming a greater adoption of BIC/FTC/TAF. An organizational impact analysis was conducted to define any advantages for hospitals, devoted to the management of any ART-related adverse events. Results: The BIA revealed an economic saving of 0.97% (26,040,271.36 €) given a higher penetration rate for BIC/FTC/TAF, for the treatment of HIV individuals assuming ART in Italy. From an organizational perspective, a greater BIC/FTC/TAF administration would generate a reduction in the overall hospital accesses devoted to the management of adverse events, generating an overall saving of 245,938 hours, considering the time spent by the healthcare professionals involved in the care and treatment of individuals with HIV. Conclusions: BIC/FTC/TAF represent an interesting possibility for the rapid initiation of ART, as well as for switches, being able to optimize the clinical pathway of a patient with HIV, from an economic and organizational perspective.

Background: Automated Drug Dispensing (ADD) systems are considered to be strategic hospital assets used to reduce errors and enhance economic and organizational sustainability. With regards to efficacy and safety, the literature evidence demonstrates the incremental benefits of centralised or decentralised systems compared to manual dispensing. Analyses about organisational and economic sustainability are still lacking and the present study aims to perform a Health Technology Assessment (HTA), producing multidimensional evidence on the use of ADD systems within hospitals. Methods: In 2023, a comprehensive HTA draws insights from healthcare professionals across six European nations: Italy, France, Germany, the Netherlands, the United Kingdom, and Belgium. This appraisal juxtaposed four drug dispensing scenarios: manual methods, centralized ADD systems, decentralized ADD systems, and integrated solutions employing cutting-edge technologies in both central pharmacies and wards. The study deployed an Activity-Based Costing approach that was combined with a cost-effectiveness and Budget Impact Analysis to evaluate economic impacts. Qualitative questionnaires were implemented to assess ethical, legal, organizational, safety, and efficacy aspects. Results: From a multidimensional perspective, healthcare professionals acknowledged ADD manifold advantages of ADD systems. From an organizational perspective and within a 12-month timeframe, transitioning to automation may face initial challenges that are attributed to potential resistance from professionals and significant investments. However, 36 months past its adoption, automation's superiority over manual methods was recognized. Economically, savings burgeoned from +17.9% in UK to +26.6% in Belgian hospitals that adopted integrated systems in comparison to traditional manual approaches. Conclusion: Compared to traditional methods, implementing ADD systems could improve the logistic management of drug in the hospital setting, thereby enhancing safety and efficacy, streamlining the healthcare professionals' workflow, and bolstering financial stability.

The increasing pharmaceutical expenditure in many countries has raised concerns regarding the sustainability of healthcare services. To address this issue, accurate forecasting of pharmaceutical demand is crucial for healthcare planning and policy development. This paper proposes a novel prediction framework that integrates different types of historical data and simulates a part of the generative process that produces pharmaceutical consumption, considering both exogenous and endogenous factors, such as per capita consumption trends and population dynamics. The output of the framework is a distribution of likely values, enabling the use not only of the central value for making a prediction but also of the explicitly stated uncertainty, which is crucial for decision-makers in such a critical and complex context. The reliability and consistency of the framework are ensured through backtesting and comparing the predicted results with actual data.

The present feasibility study aims at investigating the potential multidimensional advantages, related to an innovative telehealth ecosystem (whose name is T-CUBE), grounding on digital technologies (DTs), designed as a telemonitoring, telerehabilitation and telesupporting integrated program. Given robust efficacy and safety results , amply demonstrated for DTs in scientific evidence, the study would explore the economic and organizational sustainability, as well as the healthcare professionals' technology acceptance, that are topics little investigated in the literature stream devoted to telemedicine ecosystems and DTs. To explore the rise of emerging ecosystems in healthcare, T-CUBE was tested within the COVID-19 and chronic diseases settings, compared with the usual care, based on the on-site monitoring, supporting and rehabilitation activities, thus conducting an ex-ante impact assessment. Results demonstrated the sustainability of T-CUBE implementation, within the Lombardy Region setting, with important economic benefits (ranging from 47% to 77%), and an improvement (+51%) in the overall accessibility to care. Healthcare professionals would effectively use the innovative ecosystem to guarantee the taking in charge and the continuity of care of patients. According to the results and given the scalable nature of T-CUBE, healthcare providers should be knowledgeable about the telemedicine solutions that could freeing up economic resources to be reinvested in the enlargement of population taken in charge.

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.

A fronte delle attuali esigenze del sistema sanitario, è fondamentale sviluppare modelli gestionali innovativi che valorizzino le micro-reti assistenziali sul territorio, composte da medici, operatori sanitari, sociosanitari e pazienti con i loro caregiver. In quest’ottica, acquista nuova luce il passaggio generazionale in medicina, che deve essere valorizzato per garantire la continuità delle cure e la qualità dell’assistenza ai pazienti.