Artificial Urinary Sphincters as a Treatment for Post-Prostatectomy Severe Urinary Incontinence in Italy: A Cost-Utility Analysis

Abstract Objective: This study aimed at evaluating the cost-utility of artificial urinary sphincter (AUS) in men affected by postprostatectomy severe urinary incontinence and identifying the most cost-effective alternative among the various devices analyzed in Italy. Methods: A 5-year cycles Markov model was developed to simulate the disease evolution. The analysis compared conservative therapy, ZSI 375®, single-cuff (SC) AMS 800TM, and double-cuff (DC) AMS 800TM. A Probabilistic Sensitivity Analysis (PSA) was performed. One thousand Monte Carlo simulations were conducted to generate the Cost-Effectiveness Acceptability Curve for each intervention strategy. A sensitivity analysis on the price of the device was conducted. Results: From the Italian National Health Service perspective, DC AMS 800TM was the most cost-effective alternative in comparison with conservative therapy, with an Incremental Cost-Effectiveness Ratio (ICER) value equal to € 12,893. From the NHS + patient perspective, both the AMS 800TM devices (SC and DC) were dominant in comparison with conservative therapy. From the societal perspective, ICER was dominant for all the alternatives considered in terms of cost-effectiveness. The PSA showed that DC AMS 800TM had a greater probability to be cost-effective with respect to the other strategies considered in the analysis. The sensitivity analysis on the price of the device showed that in all the cases analyzed the incremental cost per QALY gained would be below € 25,000. Conclusions: This cost-utility analysis confirms that AUSs are cost-effective options in the Italian context with respect to conservative therapy. Among AUSs, DC AMS 800TM has the greatest probability to be cost-effective

Economic Consequences of Anti-HCV Treatment of Patients Diagnosed Through Screening in Italy: A Prospective Modelling Analysis

Aim To evaluate the cost-consequences of the investment for anti-hepatitis C virus (HCV) treatment by the Italian National Health System (NHS) for patients who will be newly diagnosed through active HCV screening, implemented in Italy from 2020. Methods A previously published Markov model was used to estimate the disease complications avoided and the associated savings over 20 years to treat a standardised population of 10,000 HCV-infected patients diagnosed as a result of screening. Disease progression probabilities and fibrosis stage distribution were based on previously reported data in the literature. Real-life treatment effectiveness and medical expenses for disease management were estimated starting from a representative cohort of HCV-treated patients in Italy (Italian Platform for the Study of Viral Hepatitis Therapies). The breakeven point in time (BPT) was defined as the years required for the initial investment in treatment to be recovered in terms of cumulative costs saved. Results Over a 20-year time horizon, the treatment of 10,000 standardized patients diagnosed through active HCV screening results in 7769 avoided events of progression, which are associated with euro838.73 million net savings accrued by the Italian NHS. The initial investment in treatment is recouped in 4.3 years in the form of savings from disease complications avoided. Conclusion Investment in treatment of newly diagnosed patients will bring a significant reduction in disease complications, which is associated with great economic benefits. This type of action can reduce the infection rate as well as the clinical and economic disease burden of HCV in Italy

Economic burden of diverticular disease : an observational analysis based on real world data from an Italian region

INTRODUCTION: Diverticular disease (DD), a herniation of the colonic mucosa through the muscle layer, covers a wide variety of conditions associated with the presence of diverticula in the colon. The most serious form is an acute episode of diverticulitis, which can lead to hospitalization and surgery with various types of consequences. The main aim of this study is to evaluate the economic burden of hospitalizations arising from acute episodes of diverticulitis using data from the administrative databases used in the Marche region in Italy and, as a secondary objective of this real-world data analysis, to study patient outcome variables following initial hospitalization for diverticulitis. METHOD: A deterministic linkage was performed at individual user level between the different administrative sources of the Marche region through anonymous ID number for a period of analysis between 1 January, 2008 and 31 December, 2014. We enrolled all patients with at least one hospitalization for "diverticulitis of the colon without mention of haemorrhage" (ICD-9-CM code 562.11) or "diverticulitis of the colon with haemorrhage" (ICD-9-CM code 562.13) as primary or secondary diagnosis. For each patient we assessed the cost of hospitalization, of medicines and of specialist services considering a time-scale of one year or cohort analysis 365days after first admission. RESULTS: The total number of residents in the Marche region who had at least one hospitalization for diverticulitis in the period 2008-2014 was 2987 (427 patients a year, corresponding to about 35 patients per 100,000 adult residents); the total number of admissions was 3453 (just over 490 a year). The direct healthcare costs incurred by the Marche region for episodes of diverticulitis in 2008-2014 amounted to approximately €11.4 million (€1.6 million a year), of which €10.9 million (95.5%) for the hospitalizations, € 246,000 (2.1%) for pharmaceutical treatment and €270,000 (2.4%) for specialist outpatient services. The average annual cost per patient was €3826, of which €3653 was for hospitalization, while pharmaceutical expenditure and specialist services accounted for €83 and €90, respectively. The cohort of patients undergoing a first admission for diverticulitis between 2010 and 2013 was made up of 1729 people (54.4% women, mean age 68.9 years), of whom 1500 (86.8%) did not undergo surgery while in hospital. Hospital mortality, recorded only for the over-65 age class, averaged 1.2%; for patients not receiving surgery during the initial hospitalization it was 0.5%, reaching 5.2% in patients undergoing surgery. The percentage of patients with one or more readmissions for diverticulitis within a year of the first was on average 7.8% and in 48% of cases this resulted in surgery. CONCLUSIONS: Our study is the first analysis in Italy to use real-world data to measure the financial impact of diverticular disease. Assuming that the diagnostic and therapeutic behaviour identified in the Marche region could be representative of the situation nationwide, the estimated annual number of hospitalizations in Italy for acute episodes of diverticulitis is 19,000. The total amount of economic resources needed to treat patients suffering from acute episodes of diverticulitis is estimated at €63.5 million a year

Economic burden of disease of uncontrolled acromegalic patients : the acromegaly Italian collaborative study group

Background: Acromegaly is a rare, serious and disabling disease associated with increased mortality if not properly treated. The objective of this study was to estimate indirect and direct costs associated to uncontrolled acromegalic patients in Italy. Methods: a specific questionnaire was developed in order to obtain specific information from the patient perspective and administrated to subsequent patients treated in 17 Italian endocrinology centres. Indirect cost from patients and caregivers perspective were estimated considering the Human Capital Approach while direct cost were evaluated considering the patients perspective. assuming that our sample were representative of the general uncontrolled acromegalic patients. Results: 86 patients were enrolled in the study and complete the questionnaire. Of these 51.16% were employed, 23.26% were unemployed for reasons unrelated to the illness, 8,14% were unemployed due to the illness and 17.44% were inactive. The total costs per patient amounted to about € 3,832 per year, of which 5.1% are mobility costs, while the indirect costs come to € 7.7 million, of which 45.7% is due to illness-related to unemployment. Conclusions: To our knowledge, this study represents the first attempt to quantify the costs of uncontrolled acromegalic patients in Italy

Probabilistic cost-effectiveness analysis of controlled ovarian stimulation with recombinant FSH plus recombinant LH vs. human menopausal gonadotropin for women undergoing IVF

Background The association of recombinant FSH plus recombinant LH in 2:1 ratio may be used not only to induce ovulation in anovulatory women with hypogonadotropic hypogonadism but also to achieve multiple follicular developments in human IVF. The aim of this analysis was to estimate the cost-effectiveness of Controlled Ovarian Stimulation (COS) with recombinant FSH (rFSH) plus recombinant LH (rLH) in comparison with highly purified human menopausal gonadotropin (HP-hMG) in the woman undergoing in vitro fertilization (IVF) in Italy. Methods A probabilistic decision tree was developed to simulate patients undergoing IVF, either using r-FSH + r-LH or HP-hMG to obtain COS. The model considers the National Health System (NHS) perspective and a time horizon equal to two years. Simulations were reported considering the number of retrieved oocytes (5–9, 10–15 and > 15) and transition probabilities were estimated through specific analyses carried out on the population of 848 women enrolled in the real-life. Results The model estimated that patients undertaking therapeutic protocol with r-FSH + r-LH increase the general success rate (+ 6.6% for pregnancy). The incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) of r-FSH + r-LH was below the willingness to pay set at €20,000 for all the considered scenarios. Conclusions The cost-utility analysis demonstrated that the r-FSH + r-LH is a cost-effective option for the Italian National Health System (NHS)

Economic burden of HPV9-related diseases : a real world cost analysis from Italy

The objectives of this study were to estimate the economic burden of HPV in Italy, accounting for total direct medical costs associated with nine major HPV-related diseases, and to provide a measure of the burden attributable to HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 infections

The impact of direct acting antivirals on hepatitis C virus disease burden and associated costs in four european countries

Background and Aims We assessed the clinical and economic impact of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) in England, Italy, Romania and Spain.Methods An HCV progression Markov model was developed considering DAA eligibility and population data during the years 2015-2019. The period of time to recover the investment in DAAs was calculated as the cost saved by avoiding estimated clinical events for 1000 standardized treated patients. A delayed treatment scenario because of coronavirus disease (COVID-19) was also developed.Results The estimated number of avoided hepatocellular carcinoma, decompensated cirrhosis and liver transplantations over a 20-year time horizon was: 1,057 in England; 1,221 in Italy; 1,211 in Romania; and 1,103 in Spain for patients treated during 2015-2016 and 640 in England; 626 in Italy; 739 in Romania; and 643 in Spain for patients treated during 2017-2019. The cost-savings ranged from euro 45 to euro 275 million. The investment needed to expand access to DAAs in 2015-2019 is estimated to be recovered in 6.5 years in England; 5.4 years in Italy; 6.7 years in Romania; and 4.5 years in Spain. A delay in treatment because of COVID-19 will increase liver mortality in all countries.Conclusion Direct-acting antivirals have significant clinical benefits and can bring substantial cost-savings over the next 20 years, reaching a Break-even point in a short period of time. When pursuing an exit strategy from strict lockdown measures for COVID-19, providing DAAs should remain high on the list of priorities in order to maintain HCV elimination efforts