- New
- Addendum
- 10.33393/grhta.2026.3730
- Feb 4, 2026
- Global & Regional Health Technology Assessment
- Agostino Fortunato + 6 more
[This corrects the article DOI: 10.33393/grhta.2026.3606.].
- New
- Supplementary Content
- 10.33393/grhta.2026.3725
- Feb 2, 2026
- Global & Regional Health Technology Assessment
- Davide Petruzzelli + 10 more
- New
- Research Article
- 10.33393/grhta.2026.3646
- Jan 16, 2026
- Global & Regional Health Technology Assessment
- Pierfrancesco Tozzi + 5 more
The use of fibrobronchoscopy increased significantly for collecting airway microbiological samples and during percutaneous tracheostomies and difficult intubations. Reusable bronchoscopes pose risks of contamination and damage due to their fragile structure and difficulties of cleaning and sterilization; single-use bronchoscopes have been introduced, offering reliability in terms of vision, maneuverability, suctioning capacity, and sterility, reducing the risk of hospital-acquired infections and improving logistical management. The study analyzed healthcare workers' and management's perceptions of single-use bronchoscopes versus reusable ones. Among the main objectives were to evaluate the organizational impact, quality, and performance of bronchoscopes, while also analyzing opinions on device features, safety in infection prevention, and ease of use during training. In this analysis 66% of clinicians rated optimal image quality, and 90% of respondents highly appreciated the "plug & play" feature of disposable endoscopes; also, 45% of clinicians noted no significant differences in aspiration performance. Healthcare professionals felt more exposed to infectious agents with reusable endoscopes, believing disposable endoscopes required less vigilance and monitoring. In training, 80% of doctors and 100% of nurses considered disposable endoscopes more suitable due to their greater ease of use. Finally, the Overall Satisfaction of all healthcare workers was 75%. The analysis of results demonstrated that the use of single-use bronchoscopes in anesthesia and resuscitation is highly comparable in terms of clinical effectiveness to reusable ones and that significant advantages in costs and organizational impact were highlighted, positively impacting the daily workflow of healthcare workers.
- Research Article
- 10.33393/grhta.2026.3606
- Jan 12, 2026
- Global & Regional Health Technology Assessment
- Agostino Fortunato + 6 more
Introduction: The clinical management of ostomy and urinary incontinence poses a substantial challenge forhealthcare systems and patients, as it necessitates the provision of specialized medical devices. In Italy, thesedevices are distributed through multiple distribution modalities.Methods: This study aims to update a previous Budget Impact analysis on home distribution, using real-worlddata collected via surveys and applying an ABC approach. Structured questionnaires were administered to theASL of four Italian regions, collecting data on staff involvement, operational times, and resource utilization. TheBIM analysis compared two scenarios: the current distribution scenario and a hypothetical scenario with incremental adoption of home delivery.Results: The estimated average annual personnel costs per patient were € 153 for direct distribution, € 107 forhome delivery, and € 80 for indirect distribution. The revised scenario resulted in an increased resource consumption of € 214,475,929 over three years. This increase was offset by significant cost reductions in direct(-€ 165,195,792) and indirect distribution (-€ 52,704,435), yielding a cumulative saving of € 3,424,299 over theanalysis period. Sensitivity analysis confirmed the robustness of the results with respect to the main parameters.Conclusion: The integration of real-world data significantly improves the accuracy and robustness of the BIManalysis. The results support home distribution as a cost-efficient choice for the Italian National Health Service(SSN). The evidence generated provides valuable insights for policymakers to optimize resource allocation anddistribution strategies for stoma and urinary incontinence devices.
- Research Article
- 10.33393/grhta.2026.3615
- Jan 2, 2026
- Global & Regional Health Technology Assessment
- Davide Croce + 4 more
Automated unit-dose (UD) medication distribution systems are increasingly recognized as enabling technologies for safer, more efficient, and traceable drug administration in hospitals. Closed-loop UD systems integrate electronic prescribing, automated dispensing, and bedside barcode scanning to ensure full traceability throughout the medication process. This study evaluated the clinical effectiveness, organizational impact, and cost-effectiveness of a closed-loop UD system implemented at a 930-bed national referral hospital in Northern Italy, compared with the previous ward-stock system. A convergent mixed-methods mini-Health Technology Assessment combined administrative, clinical, and financial data (2018-2021) with literature evidence and 18 semi-structured staff interviews. Outcomes included medication administration errors (MAEs), adverse drug reactions (ADRs), and preventable hospitalizations. Cost-effectiveness was assessed from the Italian National Health Service perspective, and qualitative findings were analyzed using framework analysis. Based on literature-derived parameters, the model suggests a reduction in MAE rate from 10.6% to 5.0%, preventing an estimated 57,247 errors, 4,294 ADRs, and 42 hospitalizations per year. These outcomes were associated with net annual savings of €1.32 million and an ICER of €48.67 per error avoided. The model also indicated that around 34,000 nursing hours could be reallocated to direct patient care, while qualitative evidence highlighted improved staff satisfaction and medication traceability. Sensitivity analyses confirmed economic robustness in 95% of simulations. Implementation of a closed-loop UD system enhances medication safety, workflow efficiency, and cost-effectiveness, supporting its scalability as a strategic innovation aligned with institutional goals for quality and sustainability.
- Research Article
- 10.33393/grhta.2025.3598
- Dec 31, 2025
- Global & Regional Health Technology Assessment
- Claudio Jommi + 4 more
Introduction: This document illustrates the results of a multi-disciplinary and multi-stakeholder Working Group(WG), focused on planning and allocation of resources for pharmaceuticals from the Regions to the Health Authorities. The WG was carried out during the Fourth Edition of the Regional Pharmaceutical Policies Forum.Methods: The WG designed a model of resources planning and allocation, that can be adapted to the regionalcontexts. The discussion moved from pharmaceutical expenditure forecasting methods, resource allocation criteriaand processes from the Central Government to the Regions and a survey on the current methods of allocationof resources for pharmaceuticals from the Regions to the Health Authorities.Results: The proposal, that can be adapted to each single Region, provides: (i) that the allocation of resources isconsistent with the regional pharmaceutical policies and objectives given to the Health Authorities General Managers; (ii) for a transparent and simplified approach, avoiding expenditure sub-targets; (iii) for a timeline witha first provisional allocation in January, the final allocation by March and possible adjustments until August; (iv)for a level of sophistication that can be adapted to the regional capacity and the willingness to invest in planningby politicians; (v) for a monitoring system possibly on a monthly basis and based upon reports supporting theadoption of remedial actions.Conclusions: Finally, the WG hoped for overcoming silos budgets and advocated for a broader resources planningand allocation, that should consider the whole journey of the patient, from treatment eligibility to the managementof any organizational impact of therapies on the follow-up of the patient.
- Supplementary Content
- 10.33393/grhta.2025.3618
- Dec 15, 2025
- Global & Regional Health Technology Assessment
- Matteo Nicola Dario Di Minno + 7 more
The advances that have marked the history of hemophilia represent a concrete example of therapeutic evolution.The progress made over the years has been able to revolutionize its treatment, bringing about a radical changeboth in the therapeutic algorithm and in life expectancy. Considering the recent milestones achieved, it would beanachronistic to maintain the same therapeutic goals as in the past; the normalization of hemostasis is the pathleading to the ultimate therapeutic goal, which should be the achievement of health equity: a life comparable tothat of a person without such a condition.This article highlights the need for a multidisciplinary approach to the management of hemophilia, as raisedfrom the different perspectives of the stakeholders who contributed: pharmacologists, patients, clinicians,bioethicists, pain therapists, and pharmacoeconomists. This has made it possible to gain a comprehensive viewthat reflects the complexity of managing a chronic disease such as hemophilia.
- Research Article
- 10.33393/grhta.2025.3607
- Dec 4, 2025
- Global & Regional Health Technology Assessment
- Filippo Rumi + 30 more
- Research Article
- 10.33393/grhta.2025.3599
- Nov 14, 2025
- Global & Regional Health Technology Assessment
- Patrizia Popoli + 4 more
Introduction: The European regulatory landscape is undergoing a profound transformation with the entry into force of the new EU Regulation 2021/2282 on Health Technology Assessment (HTA), designed to harmonize HTA assessments and ensure equity of access to health technologies in different Member States. Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JCS), which allow developers to engage in prior discussion with the bodies responsible for HTA assessments, are key elements in this context where the need for collaborative and structured dialogue between companies and regulatory agencies is growing. The objective of the following work was to identify areas of improvement related to the dialogue between stakeholders and to find solutions for a more effective interaction.Methods: In the context of the Seventh Edition of “The Mogliano Veneto Seminars” held in Mogliano Veneto on September 26 and 27, 2024, a multidisciplinary Working Group composed of about 30 experts in different disciplines, including institutional and stakeholder subjects from different fields (Companies, clinicians, health economists, patients’ associations) discussed the interactions between AIFA and Companies.Conclusions: The key elements to be considered for a more effective interaction between the parties are timing, processes, and the tools to be used. According to what emerged during the discussion, three moments of interaction were identified (pre-submission to EMA, pre-submission to AIFA, and post-submission to AIFA), during which an active dialogue between Companies and AIFA should accelerate and streamline negotiations. The solutions proposed by the experts would bring tangible opportunities of improvement.
- Supplementary Content
1
- 10.33393/grhta.2025.3623
- Oct 27, 2025
- Global & Regional Health Technology Assessment
- Gustavo H Marin + 1 more
Scientific and technological advances have increased the capacity to prevent diseases, perform diagnoses, and develop innovative treatments. To analyze whether these technologies should be incorporated into healthcare systems, Health Technology Assessment (HTA) Committees were created. There is a debate about who should be part of such committees. Typically, committee members are scientific experts, agents of funding entities (Ministries of Health), and patients as representatives of the community. It is important to reflect on the conflicts of interest that each member may have. Those who come from the scientific sector (universities, research centers) have fewer conflicts of interest and more independence for decision-making. The agents designated as members by the Ministries of Health of each country are usually qualified professionals, but still employees of those who will later have to pay for the technology. The third type of members are patients representing the community. This participation is considered a guarantee of neutrality, however, since patients are affected by the same health problem that is being analyzed, it exists a personal interest in expecting that a new medicine could be accepted to benefit other patients with the same condition (horizontal equity); with a potential risk of not showing the same empathy in recognizing the impact of this decision on other health problems (vertical equity). This text discusses the composition of HTA Committees, the conflicts of interest of its members, and the potential impact of these decisions on equity in access to the population to essential goods.