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Glob Reg Health Technol Assess ; 10: 46-52, 2023.
Article in English | MEDLINE | ID: covidwho-20233754


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. The available observations were divided into three groups (Pre COVID, Partially COVID, and Fully COVID) according to the timing of their negotiation process. Differences in average TTM among the three groups were analyzed in three steps: (1) descriptive statistics; (2) univariate analysis; (3) multivariate analysis, using a matching estimator. Results: A total of 363 unique combinations of molecule and indication met the inclusion criteria: 174 in the Pre COVID group, 69 in the Partially COVID group, and 123 in the Fully COVID group. Descriptive statistics and univariate analysis found a statistically significant difference in TTM among the three periods, with average TTM increasing during the pandemic (+136 days, p = 0.00) and then decreasing afterward (-23 days, p = 0.09). In the matching analysis, results for the Partially COVID period were confirmed (+108 days, p = 0.00) while results for the Fully COVID period lost significance but maintained a negative sign. Conclusions: The results suggest that after an adjustment phase in the Partially COVID period, a return to the status quo was reached.

BMC Public Health ; 21(1): 902, 2021 05 12.
Article in English | MEDLINE | ID: covidwho-1225766


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 (PM10) 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. All patients with a Covid-19 diagnosis during March 18th, 2020 - June 30th, 2020 were included in the study. The date of first Covid-19 registration was the starting point of the 3-month follow-up (Index Date). Patients were classified based on Covid-19-related pneumonia registrations on the Index date and/or during follow-up presence/absence. Each patient was assigned individual exposure by calculating average PM10 during the 30-day period preceding the Index Date, and according to GP's office province. A multiple generalized linear mixed model, mixed-effects logistic regression, was used to assess the association between PM10 exposure tertiles and the likelihood of experiencing pneumonia. RESULTS: Among 6483 Covid-19 patients included, 1079 (16.6%) had a diagnosis of pneumonia. Pneumonia patients were older, more frequently men, more health-impaired, and had a higher individual-level exposure to PM10 during the month preceding Covid-19 diagnosis. The mixed-effects model showed that patients whose PM10 exposure level fell in the second tertile had a 30% higher likelihood of having pneumonia than that of first tertile patients, and the risk for those who were in the third tertile was almost doubled. CONCLUSION: The consistent findings toward a positive association between PM10 levels and the likelihood of experiencing pneumonia due to Covid-19 make the implementation of new strategies to reduce air pollution more and more urgent.

Air Pollutants , Air Pollution , COVID-19 , Air Pollutants/adverse effects , Air Pollutants/analysis , Air Pollution/adverse effects , Air Pollution/analysis , COVID-19 Testing , Environmental Exposure/adverse effects , Environmental Exposure/analysis , Humans , Italy/epidemiology , Male , Particulate Matter/adverse effects , Particulate Matter/analysis , SARS-CoV-2