Human Papilloma Virus Vaccination and Cervical Screening in the Italian Regions: An Overview of the Current State of the Art.

Human Papilloma Virus (HPV) infection and HPV-related cancers can be prevented through vaccinations and mass cervical screening programmes. The Ministry of Health in Italy provides recommendations on primary and secondary prevention of HPV-related diseases, but the 19 Italian regions and 2 autonomous provinces have organisational and decision-making autonomy, with differences in the strategies for offering prevention. The aim of this study is to describe the HPV vaccination and cervical screening offered in all Italian regions. Regional official documents up until 31 December 2021 were first identified. Subsequently, primary and secondary prevention experts from each region were interviewed to validate the previously collected data. The National Immunisation Plan (NIP) 2017-2019 recommends HPV vaccination from the age of 11 for both sexes, with a coverage target of 95%. HPV vaccination is offered free of charge or co-payment. All regions have screening programmes for cervical cancer, using PAP or HPV-DNA tests every three to five years. All regions have an electronic registry for vaccination and screening status. All regions have developed awareness-raising campaigns. It is important to harmonise regional policies with the implementation of information systems integration. The collected data could enhance both regional and national public health initiatives, bolstering the resilience of vaccination programs.

Cost-Effectiveness of Pneumococcal Vaccination in Adults in Italy: Comparing New Alternatives and Exploring the Role of GMT Ratios in Informing Vaccine Effectiveness.

In Italy, a sequential pneumococcal vaccination with conjugate vaccine (PCV) and polysaccharide vaccine (PPSV23) is recommended for individuals aged ≥ 65 years and those at risk for pneumococcal disease (PD) aged ≥ 6 years. The aim of this study was to assess the cost-effectiveness of the new vaccines, i.e., approved 15-valent and 20-valent PCVs. A published Markov model was adapted to evaluate the lifetime cost-effectiveness of vaccination with PCV15 + PPSV23 versus PCV13 + PPSV23, PCV20 alone, PCV20 + PPSV23, and No Vaccination. Simulated cohorts representing the Italian population, including individuals aged ≥ 65 years, those at risk aged 50-100 years, and those deemed high risk aged 18-100 years were assessed. Outcomes were accrued in terms of incremental PD cases, costs, quality-adjusted life years, life years, and the cost-utility ratio relative to PCV13 + PPSV23. The conservative base case analysis, including vaccine efficacy based on PCV13 data, showed that sequential vaccination with PCV15 or PCV20 in combination with PPSV23 is preferred over sequential vaccination with PCV13 + PPSV23. Especially in the high-risk group, PCV15 + PPSV23 sequential vaccination was dominant over No Vaccination and resulted in an ICUR of €3605 per QALY gained. Including PCV20 + PPSV23 into the comparison resulted in the domination of the PCV15 + PPSV23 and No Vaccination strategies. Additionally, explorative analysis, including the geometric mean titer (GMT) informed vaccine effectiveness (VE) was performed. In the low-risk and high-risk groups, the results of the GMT scenarios showed PCV15 + PPSV23 to be dominant over the other sequential vaccines. These findings suggest that if real-world studies would confirm a difference in vaccine effectiveness of PCV15 and PCV20 versus PCV13 based on GMT ratios, PCV15 + PPSV23 could prove a highly immunogenic and effective vaccination regime for the Italian adult population.

Respiratory Syncytial Virus in Veneto Region: Analysis of Hospital Discharge Records from 2007 to 2021.

Respiratory Syncytial Virus (RSV) is a known cause of acute lower respiratory infections in infants and young children. The present study aims to analyze the temporal trends and characteristics of hospitalization related to RSV in the Veneto region (Italy) in the period between 2007 and 2021. The analysis is performed on all the hospital discharge records (HDRs) of public and accredited private hospitals corresponding to hospitalizations occurring in the Veneto region (Italy). HDRs are considered if they included at least one of the following ICD9-CM codes: 079.6-Respiratory Syncytial Virus (RSV); 466.11-acute bronchiolitis due to RSV; and 480.1-pneumonia due to RSV. Total annual cases, sex, and age-specific rates and trends are evaluated. Overall, an increasing trend in the number of hospitalizations due to RSV was observed between 2007 and 2019, with a slight drop in RSV seasons 2013-2014 and 2014-2015. From March 2020 to September 2021, almost no hospitalization was registered, but in the last quarter of 2021, the number of hospitalizations reached its highest value in the series. Our data confirm the preponderance of RSV hospitalizations in infants and young children, the seasonality of RSV hospitalizations, and acute bronchiolitis as the most frequent diagnosis. Interestingly, the data also show the existence of a significant burden of disease and a non-negligible number of deaths also in older adults. The present study confirms RSV is associated with high rates of hospitalization in infants and sheds light on the burden in the 70+ age group in which a considerable number of deaths was observed, as well as the parallelism with other countries, which is consistent with a wide underdiagnoses issue.

The Economic Burden of Pneumococcal Disease in Children: A Population-Based Investigation in the Veneto Region of Italy.

Despite widespread childhood immunization programs, pneumococcal disease (PD) continues to be associated with significant clinical and economic burden worldwide. This retrospective study assessed the PD-related economic burden in children from the Veneto region of Italy following the introduction of a 13-valent pneumococcal conjugate vaccine (PCV13) to the Italian immunization schedule in 2010. Between 2010 and 2017, the annual incidences of pneumonia, acute otitis media (AOM), and invasive pneumococcal disease (IPD), as well as syndromic-disease-related episodes, declined. In our analysis of data from regional expenditure and healthcare resource utilization (HCRU) databases related to children < 15 years of age, we found that regional expenditures decreased between 2010 and 2017 for pneumonia (EUR 8.88 to EUR 3.59 million), AOM (EUR 3.78 to EUR 2.76 million), and IPD (EUR 1.40 to EUR 1.00 million). Despite reductions in PD-related expenditure following the introduction of PCV13, there continues to be an economic burden associated with PD in Veneto, Italy.

Incidence of Hospitalisation and Emergency Department Visits for Pneumococcal Disease in Children, Adolescents, and Adults in Liguria, Italy: A Retrospective Analysis from 2012-2018.

Streptococcus pneumoniae infection is responsible for significant morbidity and mortality, particularly in young children and older adults. The aim of this study was to investigate the incidence of hospitalisation and emergency department (ED) visits in relation to episodes of pneumococcal disease (PD) following the introduction of pneumococcal conjugate vaccines (PCVs) into the Liguria region of Italy. Between 2012 and 2018, episodes of all-cause pneumonia (80,152), pneumococcal-specific pneumonia (1254), unspecified pneumonia (66,293), acute otitis media (AOM; 17,040), and invasive PD (IPD; 1788) were identified from in-patient claims, ED and hospital discharge records, and the Liguria Chronic Condition Data Warehouse. In children < 15 years of age, pneumococcal pneumonia-related hospitalisations decreased from 35 to 13 per 100,000 person-years during the study period (p < 0.001); this decrease is potentially related to PCV use in children. All-cause pneumonia hospitalisations remained stable, whereas IPD hospitalisations increased and AOM hospitalisations decreased. In adults, hospitalisations for all-cause pneumonia increased from 5.00 to 7.50 per 1000 person-years (+50%; p < 0.001). Pneumococcal and unspecified pneumonia hospital admissions increased significantly during the study period, considerably affecting those ≥ 65 years of age. IPD hospitalisations varied across all age groups, but a significant change was not observed. Despite pneumococcal vaccination, substantial burden remains for PD in children and adults in Liguria, Italy.

Economic burden of pneumococcal disease in children in Liguria, Italy.

Vaccinations against Streptococcus pneumoniae are included in infant immunization programs globally. However, a substantial burden due to pneumococcal disease (PD) remains. This study aimed to estimate the cost of emergency department (ED) visits and hospitalizations associated with invasive pneumococcal disease, all-cause pneumonia, and acute otitis media in children <15 years of age in the Liguria region of Italy between 2012 and 2018. The retrospective cohort study used data from the Liguria Region Administrative Health Databases and the Ligurian Chronic Condition Data Warehouse, which contain information on hospital stays, outpatient visits, laboratory/imaging techniques, surgical procedures, and pharmaceutical prescriptions. Patients with one or more ED or inpatient claim for PD (based on International Classification of Diseases, Ninth Revision, Clinical Modification codes) were included. Cost of ED visits and hospitalizations were estimated from the diagnosis-related group system and procedures performed in the ED. In Ligurian children <15 years of age during 2012-2018, the median annual number of hospitalizations plus ED visits due to PD was 4,009, and the median estimated annual cost was €3.6 million. All-cause pneumonia accounted for the majority of hospitalization costs during the study period. Number and costs of ED visits and hospitalizations increased from 2012 to 2018. Despite widespread infant immunization in Liguria, economic costs due to PD-associated ED visits and hospitalizations remained high in children 0-14 years of age.

A Retrospective Analysis to Estimate the Burden of Invasive Pneumococcal Disease and Non-Invasive Pneumonia in Children <15 Years of Age in the Veneto Region, Italy

Despite advances in preventative interventions, invasive pneumococcal disease and pneumonia cause significant morbidity and mortality in children. We studied the annual incidence of pneumococcal-specific and syndromic invasive disease and non-invasive pneumonia in children <15 years of age during the early (2010−2013) and late (2014−2017) 13-valent pneumococcal conjugate vaccine (PCV13) periods in Veneto, Italy. In this retrospective observational study, pneumococcal-specific and syndromic invasive disease and non-invasive pneumonia cases were identified from several sources, including the Pedianet database. Interrupted time series analysis and Mann−Kendall tests were conducted to explore trends in incidence rates (IRs). Among 72,570 patients <15 years of age between 2010−2017, 88 episodes of pneumococcal-specific and syndromic invasive disease and 3926 episodes of non-invasive pneumonia were reported. Overall IR of pneumococcal-specific and syndromic invasive disease was 0.4/1000 person-years and did not change significantly (p = 0.46) throughout the study. Overall IR of non-invasive pneumonia was 10/1000 person-years and decreased significantly (−0.64, p = 0.026) over the study period. Following PCV13 introduction, the IRs of non-invasive pneumonia in children <15 years of age declined significantly, with no significant change in the IRs of pneumococcal-specific and syndromic invasive disease. There is a continuing clinical burden associated with pediatric pneumococcal diseases in Veneto, Italy.

A Retrospective Database Analysis to Estimate the Burden of Acute Otitis Media in Children Aged <15 Years in the Veneto Region (Italy)

This study aimed to assess trends in the incidence of acute otitis media (AOM), a common childhood condition, following the introduction of the 13-valent pneumococcal conjugate vaccine (PCV13) in the Veneto region of Italy in 2010. AOM episodes (overall, simple, and recurrent (≥3 or ≥4 episodes in 6 or 12 months, respectively, with ≥1 episode in the preceding 6 months)) in children <15 years of age were identified in Pedianet from 2010−2017. Interrupted time series analyses were conducted to assess changes in the annual incidence rates (IRs) in early (2010−2013) and late (2014−2017) PCV13 periods. In total, 72,570 children (402,868 person-years) were identified; 21,048 had 41,683 AOM episodes. Mean annual AOM IR was 103/1000 person-years (95% confidence interval: 102−104), decreasing from 126 to 79/1000 person-years. AOM IRs were highest in children 2−4 years of age, followed by <2 and 5−14 years of age. Overall and simple AOM IRs decreased among children 0−14 years of age, including 2−4 and 5−14 years of age, while recurrent AOM IRs decreased in children <2 years of age. Following PCV13 introduction, AOM IRs decreased substantially in children <15 years of age, with the greatest benefit observed in older children, driven by a reduction in simple AOM IRs. AOM disease burden remains substantial.

Economic Burden of Pneumococcal Disease in Individuals Aged 15 Years and Older in the Liguria Region of Italy.

Despite the availability of vaccines against Streptococcus pneumoniae, the global incidence and economic cost of pneumococcal disease (PD) among adults is still high. This retrospective cohort analysis estimated the cost of emergency department (ED) visits/hospitalizations associated with non-invasive pneumonia and invasive pneumococcal disease among individuals ≥15 years of age in the Liguria region of Italy during 2012-2018. Data from the Liguria Region Administrative Health Databases and the Ligurian Chronic Condition Data Warehouse were used, including hospital admission date, length of stay, discharge date, outpatient visits, and laboratory/imaging procedures. A ≥30-day gap between two events defined a new episode, and patients with ≥1 ED or inpatient claim for PD were identified. The total mean annual number of hospitalizations for PD was 13,450, costing ~€49 million per year. Pneumonia accounted for the majority of hospitalization costs. The median annual cost of hospitalization for all-cause pneumonia was €38,416,440 (per-capita cost: €26.78) and was €30,353,928 (per-capita cost: €20.88) for pneumococcal and unspecified pneumonia. The total number and associated costs of ED visits/hospitalizations generally increased over the study period. PD still incurs high economic costs in adults in the Liguria region of Italy.