Global & Regional Health Technology Assessment最新文献

Background: In the Italian healthcare landscape, the management of chronic pathologies is a priority. Often, the elderly patient suffers from several pathologies at once and is commonly on polytherapy: this can easily bring potentially harmful errors in drug therapy. The D.I.Ri.M.O. project took place in an Internal Medicine department and aimed to reduce medication errors and improve the state of health through the Pharmacological Reconciliation procedure.

Methods: From June to October 2022, the team archived therapies for 70 hospitalized patients aged over 65 years and suffering from two or more chronic diseases. For each patient enrolled, the team developed a reconciliation board; afterward, the physician and the pharmacist proceeded to remodulate therapies, especially in those patients with serious interactions.

Results: The team collected 287 drug interactions and then classified them according to the Intercheck Web software classification: 36 class D (very serious), 49 class C (major), 174 class B (moderate), and 28 class A (minor). The modified therapies at discharge were 77.14%. This restriction brought about the removal of unnecessary drugs. After six months, the team observed an improvement in the health conditions of the patients enrolled.

Conclusions: By increasing the patient's awareness and reducing the number of potentially inappropriate prescriptions, it is possible to improve the effectiveness of therapies. It is also possible to look at a saving policy to make the economic resources better allocated.

Introduction: Heart valve diseases constitute a significant public health challenge with substantial clinical and economic implications. The ageing population, coupled with advancements in surgical techniques, has led to increased hospitalizations for cardiac valve interventions over the past decade. Despite progress, the economic burden of heart valve diseases remains underexplored, particularly in the context of the Italian healthcare system. This study aims to comprehensively assess the economic burden of heart valve diseases in Italy through a real-world analysis.

Methods: Using data from the national Italian Hospital Discharge Records (SDO), we identified the number of adult patients undergoing interventions on the aortic, mitral, and tricuspid valves, along with the associated costs borne by the National Health System. Additionally, we estimated indirect costs by analyzing social security benefit applications related to valve diseases from 2016 to 2019.

Results: A notable rise in hospitalizations for cardiac valve interventions, particularly for the aortic (+53.3%) and mitral valves (+29.5%) was revealed through the study period. In-hospital mortality rates declined, reflecting advancements in perioperative care. The economic burden of heart valve diseases in Italy was substantial, with hospitalization costs reaching €808 million in 2018. Social security benefit applications also increased, adding an annual cost of €29 million.

Conclusions: Heart valve diseases represent a growing clinical and socio-economic challenge in Italy. This study underscores the imperative for a multidisciplinary approach to effectively manage these conditions. Emphasizing prevention, early diagnosis, and timely interventions is crucial to mitigate the economic impact and enhance the quality of life for patients.

Objectives: To describe the seasonal respiratory syncytial virus (RSV) burden in Italy considering the current prophylaxis strategy with palivizumab recommended only for high-risk infants (representing only 4.4% of an estimated birth cohort) and to evaluate the potential benefits of a new prophylaxis strategy targeting all infants with nirsevimab.

Methods: A static decision analytic model previously used in the US was adapted to evaluate the RSV-related health and cost outcomes associated with nirsevimab versus standard of care (SoC) for the prevention of RSV medically attended lower respiratory tract infections (RSV-MA-LRTIs). Monthly probabilities of RSV infections, health events, mortality, and complications associated with RSV infections were obtained from the literature. Costs associated with each event were obtained using the available literature and through real-world data analysis of National Hospital Discharge Records.

Results: For one RSV season, in the current SoC, the model estimated 216,100 RSV-MA-LRTIs, 15,121 associated complications, and 16 RSV-deaths-corresponding to an economic burden of approximately €50.5 million related to RSV-MA-LRTIs management, €10.9 million associated with potential complications due to RSV and €3 million in lost productivity due to RSV-deaths. Nirsevimab is expected to prevent 100,208 RSV-MA-LRTIs, 6,969 complications, and 6 deaths due to RSV infections, corresponding to an economic saving of about €23.3, €5, and €1.2 million, respectively.

Conclusion: Nirsevimab is a new prophylaxis strategy that helps to protect all infants against RSV disease and could substantially reduce the clinical and economic burden of RSV in Italy in infants experiencing their first RSV season.

Background: Activated phosphoinositide 3-kinase (PI3K) δ Syndrome (APDS) is an ultra-rare, potentially life-threatening disease that lacks approved treatments in Spain. This study aimed to apply Multi-Criteria Decision Analysis (MCDA) to assess the value of the first pharmacological treatment for APDS in Spain.

Methods: A multidisciplinary group of 8 experts evaluated the selective PI3Kδ inhibitor leniolisib against Standard of Care (SoC). An MCDA framework tailored for Orphan Drugs (ODs), consisting of 5 comparative and 2 quantitative non-comparative criteria, was used. Re-scoring followed a group discussion.

Results: Leniolisib scored higher than SoC in all criteria, including efficacy and safety. It was deemed highly valuable as the first disease-modifying treatment, with a positive therapeutic impact and potential to improve patients' quality of life. Additionally, leniolisib may lead to cost savings. The supporting data was considered of high quality.

Conclusion: Based on MCDA methodology and stakeholder experience in APDS management, leniolisib is seen as a value-added treatment option compared to SoC in Spain.

There has been a lot of discussion on the technical aspects of the soon to be implemented European Union's Health Technology Assessment (EU HTA) regulation. However, there has been limited discussion on the implementation aspects and the potential limitations from a policy perspective. In May 2024, a group of HTA experts with previous policy responsibilities met in Rome to propose some policy aspects to be considered. As a result of the discussion, several proposals were made. Building mutual trust, improving collaboration and engaging all relevant stakeholders seems a must. Equally important are the communication aspects, and ensuring equal commitment by all parties, allocating the appropriate incentives at all levels. Finally, it is noted that the EU HTA regulation has to be seen from the perspective of a wider policy change within the large EU legal framework.

Introduction: The infections of multidrug-resistant organisms (MDROs) associated with duodenoscopes during endoscopic retrograde cholangiopancreatography (ERCP) procedure have become a significant cause for concern, especially in fragile patients. While the clinical impacts of these infections are well-documented, their economic implications remain underexplored. This study assesses the incidence and economic burden of post-ERCP infections in Italy using an administrative database.

Methods: We conducted a retrospective observational study using administrative databases from A.O.U. Città della Salute e della Scienza di Torino. The study included all patients who underwent their first inpatient ERCP between 2018 and 2021. Infections were identified using ICD-9-CM codes for Pseudomonas aeruginosa, Clostridium difficile, Escherichia coli, Klebsiella spp., and Staphylococcus aureus. A 1-year follow-up was defined in order to estimate healthcare resource utilization and related costs, including readmissions, drug prescriptions, and outpatient specialist and laboratory services.

Results: The study included 686 inpatient ERCP cases, an overall infection rate of 4.2% was observed. Higher infection rates were observed in women (4.6%), patients over 70 years old (4.6%), emergency admissions (5.1%), and transplant patients (19.1%). The average hospital stay doubled for infected patients (24.3 vs. 11.3 days; p=0.001). Post-ERCP infections led to a 28% increase in average costs (€12,256 vs. €9,561; p=0.048). With an annual volume of 25,000 ERCP procedures, post-ERCP infections in Italy contribute approximately €2.9 million in additional direct costs per year.

Conclusion: Post-ERCP infections impose substantial financial burdens on the healthcare system, underscoring the critical importance of implementing cost-effective prevention strategies to mitigate this public health threat in Italy.