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This study aimed at estimating the health and economic outcomes of universal infant vaccination with seven-valent pneumococcal conjugate vaccine (PCV-7) in Italy. A Markov model simulated lifetime evolution of a birth cohort (538,138 children): universal vaccination would avert 769 invasive infections, 18 deaths and 1323 life years. At base-case analysis, universal three-dose vaccination would cost € 26,449 (95% CI: €1975–62,075) and €38,286 (95% CI: 22,164–70,801) per life year-saved in the societal and the NHS perspective, respectively. In the hypothesis of a 5-year long protection period, vaccination would cost € 32,694 and €43,115 per life-year saved. Considering yearly incidence of invasive pneumococcal disease reported for Veneto and Sardinia regions, PCV-7 vaccination would result highly cost-effective determining a cost of €10,479 and €16,890 per life year-save in the NHS and the societal perspective, respectively.

Pneumococcal vaccine is effective in preventing invasive pneumococcal disease in adults >or=65 years of age, but it is not widely used in Western Europe. In this study, data from an earlier (1995) cost-effectiveness study on Belgium, France, Scotland, Spain, and Sweden are updated, and data on five new countries--Denmark, the UK (specifically, England and Wales), Germany, Italy and The Netherlands--are added. Epidemiological and economic variables specific for each country were used, and it was assumed that pneumococcal and influenza vaccines would both be administered during the same physician visit. In the base-case analyses, the cost-effectiveness ratios ranged from euro 9239 to euro 23,657 per quality-adjusted life-year. Because the incidence and mortality of invasive pneumococcal disease were underestimated in most countries, a country-by-country analysis was performed, assuming an incidence of 50 cases per 100,000 population and mortality rates of 20, 30 and 40%. For a mortality of 20%, the cost-effectiveness ratios ranged from euro 4,778 to euro 17,093, and for a mortality of 30%, they ranged from euro 3,186 to euro 11,395. Pneumococcal vaccination to prevent invasive pneumococcal disease in elderly adults was very cost-effective in all 10 countries. This evidence justifies the wider use of the vaccine in Western Europe.

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a multisystem condition destined to become pandemic in the coming decades. This study aimed at evaluating the economic impact of MASLD in the Italian population from the Italian National Healthcare Service (NHS) perspective. The economic impact of the MASLD was assessed by developing a calculation model in Microsoft Excel from the Italian NHS perspective, considering healthcare resources and direct costs. The target population was based on the prevalence data. Through a literature search, complications of MASLD were identified, including MASH, with relative risk of evolution into CC, DCC, HCC, T2DM, cardiovascular diseases, in particular AMI and stroke, CKD, and CRC. The differential impact between complication development in the population with MASLD and the same sample size population without-MASLD was evaluated. Differential risk data, mortality rates, and event unit costs were drawn from the published international literature. Frequency and cost data were applied to the total target population, the total annual costs and mortality data, referring to the two arms, were then calculated, and the differential value was obtained. Based on an estimated 11,546,370 MASLD target population, an annual illness impact of €12,251,631,822 was calculated, corresponding to a difference of €7,731,674,054 compared with the same sample size without MASLD. Moreover, the MASLD population is expected to experience 13,438 additional deaths annually. The growing epidemiological impact of MASLD and its complications represent a huge economic burden for healthcare services worldwide. An integrated approach, including changes in lifestyle behaviors, will be the first step. Specific drugs for MASLD are not yet available; however, studies are underway, and combined pharmaceutical therapies may be an inevitable choice to achieve adequate control of MASLD and its complications.

The underdiagnosis of chronic kidney disease (CKD) remains a significant public health concern. The Early chroNic kiDney disease pOint of caRe Screening (ENDORSE) project aimed to evaluate the clinical and economic implications of a targeted training intervention for general practitioners (GPs) to enhance CKD awareness and early diagnosis. Data on estimated Glomerular Filtration Rate (eGFR) and Urinary Albumin-Creatinine Ratio (uACR) were collected by 53 Italian GPs from 112,178 patients at baseline and after six months. The intervention involved six months of hybrid training provided by 11 nephrologists, which included formal lectures, instant messaging support, and joint visits for complex cases. The results demonstrated a substantial increase in the use of eGFR (+44.7%) and uACR (+95.2%) tests. This led to a 128.9% rise in the number of individuals screened for CKD using the KDIGO classification, resulting in a 62% increase in CKD diagnoses. The intervention's impact was particularly notable in high-risk groups, including patients with type 2 diabetes, hypertension, and heart failure. A budget impact analysis projected cumulative five-year savings of €1.7 million for the study cohort. When these findings were extrapolated to the entire Italian CKD population, potential savings were estimated at €106.6 million, highlighting significant cost savings for the national health service. The clinical simulation assumed that early diagnosed CKD patients would be treated according to current indications for dapagliflozin, which slows disease progression. The ENDORSE model demonstrated that targeted training for GPs can significantly improve early CKD detection, leading to better patient outcomes and considerable economic benefits. This approach shows promise for broader implementation to address the underdiagnosis of CKD on a national and potentially international scale.

Paroxysmal nocturnal hemoglobinuria is a rare, acquired disease characterized by hemolytic episodes and associated with significant clinical burden. The introduction of C5 inhibitory monoclonal antibodies (C5i) represented a major breakthrough in PNH treatment, effectively reducing intravascular hemolysis (IVH) but showing limited impact on extravascular hemolysis (EVH). In 2021, the C3 inhibitor pegcetacoplan was approved by EMA and recently reimbursed in Italy, which also has the advantages in the reduction of both IVH and EVH, increasing hemoglobin values and simultaneously improving the quality of life and fatigue of patients. A cost-utility analysis was developed to compare pegcetacoplan to C5i (eculizumab and ravulizumab) in the PNH population who remain anemic after treatment with C5i for at least 3 months. The analysis employed a Markov model with a 5-year time horizon whereby patients can transition among 3 PNH health states, adopting the perspective of the Italian NHS. Efficacy data were sourced from the PEGASUS study, with drug prices reflecting ex-factory costs. Additionally, costs associated with resource utilization, adverse events, and complications were estimated based on outpatient and hospital care rates, excluding indirect expenses. Utility and disutility values related to transfusions were also considered, with pegcetacoplan allowing for dose escalation. The cumulative cost of treatment per individual patient at 5 years was estimated to be €1,483,454 for pegcetacoplan, €1,585,763 for eculizumab, and €1,574,826 for ravulizumab. Pegcetacoplan demonstrated a superior increase in quality-adjusted life years (QALYs) compared to both eculizumab (0.51 increase) and ravulizumab (0.27 increase). Furthermore, pegcetacoplan showed a reduction in complication management costs (€22,891 less compared to eculizumab and €22,611 less compared to ravulizumab) and lower transfusion-related expenses (€14,147 less than both C5i treatments). Pegcetacoplan emerged as the dominant strategy in this analysis, being more effective, less expensive and improves quality of life in the analyzed population affected by PNH.

Background: Aim of our study is to evaluate the economic impact of NASH among diabetic population in Italy and potential benefits of treatments that can slow the disease progression. Methods: A Markov model was conducted from the Italian National Healthcare System perspective reporting results at 3, 5, 10 and 15 years. The model included NASH and T2DM patients with all stages of fibrosis (F0-F3), compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC), liver transplant (LT), post-LT and death. A 1-year model cycle length was considered, with each patient passing through the stages and exiting the model when reached one of mortality states. Transition probabilities and annual cost related to health states were derived from published literature. Moreover, the model made it possible to develop a scenario analysis to simulate the impact of treatments capable of slowing the disease progression in phases F0-F4 (CC). Results: The results highlighted an economic burden of NASH in T2DM patients of approximately 1.4 billion [euro], 3.1 billion [euro], and 9.4 billion [euro], respectively, after 3, 5 and 10 years, reaching about 17.3 billion [euro] after 15 years. The slowing down of the progression in the early stages of the disease (fibrosis F0-CC) has led to significant savings corresponding to 2.3 billion [euro] at 15 years. These savings were generated by the reduction of the patients in the advanced stages of the disease, which is linked to a reduction in deaths, equal to 92,208 deaths avoided over a 15-year time horizon. Conclusion: Patients with NASH and T2DM reported an important burden in Italy. It is important to investigate the potential clinical and economic benefits of antidiabetic drugs that have been shown to be effective in preventing the transition to advanced disease, simultaneously acting on the therapeutic goals of diabetic disease. Keywords: non-alcoholic steatohepatitis, type 2 diabetes mellitus, burden of illness, treatment perspectives

Psoriasis is a chronic inflammatory, immune-mediated skin disorder that affects 1.5-1.8 million people in Italy. The most common form of the disease is chronic plaque psoriasis, affecting about 90% of psoriasis patients, with about 20%-30% of them suffering from a moderate or severe condition. Little information is available about the economic impact of psoriasis in European countries. The primary objective of this study was to perform a cost-of-illness analysis of patients with moderate and severe plaque psoriasis in Italy. Therefore, direct, indirect costs, and intangible costs (quality of life - QoL) were assessed. In this national, multicenter, prospective, 3-month cost-of-illness study of moderate and severe plaque psoriasis, direct and indirect costs were assessed from the patient, third-party payer (National Health Service, NHS), and societal perspectives. From November 2003 to October 2004 consecutive patients were enrolled over a 1-year period, in order to minimize seasonal fluctuations in disease severity. 150 patients enrolled in 6 investigational sites in Italy, completed the study, and were eligible to be analyzed according to the study protocol. Intangible costs (QoL) were measured using SF36 and DLQI questionnaires. The mean total cost for psoriasis (average Psoriasis Area Severity Index [PASI] score 21.4), including direct and indirect items, was euro8,371.61 per patient per year. The mean cost for patients with moderate disease (PASI 20) was euro11,434.40 per year. Disease heavily affected QoL measured using SF36, and the impairment was greater in patients affected by a more severe form of disease. Moderate and severe plaque psoriasis is associated with extremely high costs, which are related to disease severity. Data from this study show that the more severe plaque psoriasis, the higher the direct and indirect costs for its management. Direct costs are higher than indirect costs; hospitalization represents the most significant item, accounting for 30% of the total expenses. QoL in moderate and severe plaque psoriasis is low compared with the population at large, confirming the high impact of plaque psoriasis on QoL. The relatively high average annual costs per patient point to the need for a more efficient and long-term control of psoriasis.

This paper reports the data concerning the net economic cost savings attributable to influenza vaccination in healthy children aged 2–5 years, and may be useful when deciding the best recommendations for the use of influenza vaccine in pediatrics. A total of 303 previously unprimed healthy children aged 2–5 years (163 males; mean age ± S.D.: 3.22 ± 2.43 years) were prospectively, blindly randomised in a 2:1 ratio to receive two doses of an inactivated, trivalent, virosome-formulated subunit influenza vaccine (Inflexal V, Berna Biotech, Berne, Switzerland) or no vaccination. The results show that influenza vaccination of healthy children aged 2–5 years substantially reduces influenza-like illnesses and related costs in the children themselves and their families. However, larger and longer running study spanning multiple seasons may be warranted before suggesting the universal vaccination of this group of subjects.

Icodec, once-weekly basal insulin, aims to simplify therapy management by reducing injection frequency for diabetic patients. The efficacy and safety of icodec were evaluated in the ONWARDS clinical development program. This study evaluates icodec economic and quality of life impact from the Italian National Healthcare System (NHS) perspective. A pharmacoeconomic study was developed to assess the once-weekly insulin icodec value, highlighting its potential to decrease needle use while improving adherence and quality of life. In the base case, a differential cost and cost-utility analysis over one year compared to once-daily insulin degludec were developed. Based on the comparison with degludec, a scenario analysis was planned between icodec and the mix of basal insulins available on the market. Economic evaluations included drug and administration costs, needles, and impact on adherence. The cost-utility analysis measured the utility associated with the weekly injection compared to the daily ones, resulting in an incremental cost-effectiveness ratio (ICER), measured as Δ€/ΔQALY (Quality Adjusted Life Years). To assess the robustness of the results, a deterministic one-way sensitivity analysis and a probabilistic sensitivity analysis were carried out. At an annual cost 25% higher than degludec, considering the economic benefits generated by the needle use reduction (-€51.10) and adherence improvement (-€54.85), once-weekly icodec grants no incremental cost and even potential savings per patient. Furthermore, icodec reported a utility advantage (0.023). It achieved a dominant incremental cost-effectiveness ratio (ICER) compared to degludec. The comparison with the mix of basal insulins also reported a cost-effectiveness profile. Sensitivity tests conducted confirmed the robustness of the findings, highlighting the key drivers of the analysis. Icodec represents a new therapeutic option to simplify basal insulin treatment. It also improves the patient's management and his quality of life, without increasing the economic burden for the Italian NHS, while guaranteeing an excellent cost-effectiveness profile.