COVID-19 impact on the decision process of the Italian Medicine Agency: a quantitative assessment.

Background: Since the COVID-19 pandemic has placed more attention on drugs' approval process and the importance of rapid decision-making in the healthcare sector, it is crucial to assess how time to market (TTM) of drugs varied.

Objective: To estimate the impact of the COVID-19 pandemic on TTM of drugs in Italy.

Methods: An IQVIA database was used to retrieve information on drugs that obtained positive opinion from the Committee for Medicinal Products for Human Use between January 2015 and December 2021.

Cost-effectiveness analysis of Vaborem in Carbapenem-resistant Enterobacterales (CRE) -Klebsiella pneumoniae infections in Italy.

Background: Vaborem is a fixed dose combination of vaborbactam and meropenem with potent activity against target Carbapenem-resistant Enterobacterales (CRE) pathogens, optimally developed for Klebsiella pneumoniae carbapenemase (KPC). The study aims to evaluate the cost-effectiveness of Vaborem versus best available therapy (BAT) for the treatment of patients with CRE-KPC associated infections in the Italian setting.

Methods: A cost-effectiveness analysis was conducted based on a decision tree model that simulates the clinical pathway followed by physicians treating patients with a confirmed CRE-KPC infection in a 5-year time horizon.

An Italian individual-level data study investigating on the association between air pollution exposure and Covid-19 severity in primary-care setting.

Background: Several studies have been focusing on the potential role of atmospheric pollutants in the diffusion and impact on health of Covid-19. This study's objective was to estimate the association between ≤10 μm diameter particulate matter (PM) exposure and the likelihood of experiencing pneumonia due to Covid-19 using individual-level data in Italy.

Methods: Information on Covid-19 patients was retrieved from the Italian IQVIA® Longitudinal Patient Database (LPD), a computerized network of general practitioners (GPs) including anonymous data on patients' consultations and treatments.

Epidemiology of primary biliary cholangitis in Italy: Evidence from a real-world database.

Background: Primary biliary cholangitis is an autoimmune disease affecting the interlobular bile ducts. Limited information is available on its epidemiology and treatment in Italy.

Aims: To describe primary biliary cholangitis epidemiology and investigate treatment patterns for Italian patients with this disease.

Overview of external reference pricing systems in Europe.

Background And Objectives: External reference pricing (ERP) is a price regulation tool widely used by policy makers in the European Union (EU) Member States (MS) to contain drug cost, although in theory, it may contribute to modulate prices up and down. The objective of this article was to summarise and discuss the main findings of part of a large project conducted for the European Commission ('External reference pricing of medicinal products: simulation-based considerations for cross-country coordination'; see www.ec.

Novel methodology for pharmaceutical expenditure forecast.

Background And Objective: The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the 'EU Pharmaceutical expenditure forecast'; see http://ec.

EU pharmaceutical expenditure forecast.

Background And Objectives: With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States' pharmaceutical budgets.

Pharmaceutical expenditure forecast model to support health policy decision making.

Background And Objective: With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project 'European Union (EU) Pharmaceutical expenditure forecast' - http://ec.europa.