High costs, low quality of life, reduced survival, and room for improving treatment: an analysis of burden and unmet needs in glioma.

Gliomas are a group of heterogeneous tumors that account for substantial morbidity, mortality, and costs to patients and healthcare systems globally. Survival varies considerably by grade, histology, biomarkers, and genetic alterations such as IDH mutations and MGMT promoter methylation, and treatment, but is poor for some grades and histologies, with many patients with glioblastoma surviving less than a year from diagnosis. The present review provides an introduction to glioma, including its classification, epidemiology, economic and humanistic burden, as well as treatment options. Another focus is on treatment recommendations for IDH-mutant astrocytoma, IDH-mutant oligodendroglioma, and glioblastoma, which were synthesized from recent guidelines. While recommendations are nuanced and reflect the complexity of the disease, maximum safe resection is typically the first step in treatment, followed by radiotherapy and/or chemotherapy using temozolomide or procarbazine, lomustine, and vincristine. Immunotherapies and targeted therapies currently have only a limited role due to disappointing clinical trial results, including in recurrent glioblastoma, for which the nitrosourea lomustine remains the de facto standard of care. The lack of treatment options is compounded by frequently suboptimal clinical practice, in which patients do not receive adequate therapy after resection, including delayed, shortened, or discontinued radiotherapy and chemotherapy courses due to treatment side effects. These unmet needs will require significant efforts to address, including a continued search for novel treatment options, increased awareness of clinical guidelines, improved toxicity management for chemotherapy, and the generation of additional and more robust clinical and health economic evidence.

An Analysis of the Distribution of Direct Cost of Diabetes Care in Selected Districts in Italy.

INTRODUCTION: This study aims to define the distribution of direct healthcare costs for people with diabetes treated in two healthcare regions in Italy, based on number of comorbidities and treatment regimen. METHODS: This was a retrospective analysis using data from two local health authority administrative databases (Campania and Umbria) in Italy for the years 2014-2018. Data on hospital care, pharmaceutical and specialist outpatient and laboratory assistance were collected. All people with diabetes in 2014-2018 were identified on the basis of at least one prescription of hypoglycemic drugs (ATC A10), hospitalization with primary or secondary diagnosis of diabetes mellitus (ICD9CM 250.xx) or diabetes exemption code (code 013). Subjects were stratified into three groups according to their pharmaceutical prescriptions during the year: Type 1/type 2 diabetes (T1D/T2D) treated with multiple daily injections with insulin (MDI), type 2 diabetes on basal insulin only (T2D-Basal) and type 2 diabetes not on insulin therapy (T2D-Oral). RESULTS: We identified 304,779 people with diabetes during the period for which data was obtained. Analysis was undertaken on 288,097 subjects treated with glucose-lowering drugs (13% T1D/T2D-MDI, 13% T2D-Basal, 74% T2D-Oral). Average annual cost per patient for the year 2018 across the total cohort was similar for people with T1D/T2D-MDI and people with T2D-Basal (respectively €2580 and €2254) and significantly lower for T2D-Oral (€1145). Cost of hospitalization was the main driver (47% for T1D/T2D-MDI, 45% for T2D-Basal, 45% for T2D-Oral) followed by drugs/devices (35%, 39%, 43%) and outpatient services (18%, 16%, 12%). Average costs increased considerably with increasing comorbidities: from €459 with diabetes only to €7464 for a patient with four comorbidities. Similar trends were found across all subgroups analysis. CONCLUSION: Annual cost of treatment for people with diabetes is similar for those treated with MDI or with basal insulin only, with hospitalization being the main cost driver. This indicates that both patient groups should benefit from having access to scanning continuous glucose monitoring (CGM) technology which is known to be associated with significantly reduced hospitalization for acute diabetes events, compared to self-monitored blood glucose (SMBG) testing.

Screening strategy to advance HCV elimination in Italy: a cost-consequence analysis.

BACKGROUND AND AIMS: Italy has the greatest burden of hepatitis C virus (HCV) infection in Western Europe. The screening strategy represents a crucial prevention tool to achieve HCV elimination in Italy. We evaluated the cost-consequences of different screening strategies for the diagnosis of HCV active infection in the birth cohort 1948-1968 to achieve the HCV elimination goal. METHODS: We designed a probabilistic model to estimate the clinical, and economic outcomes of different screening coverage uptakes, considering the direct costs of HCV management according to each liver fibrosis stage, in the Italian context. A decision probabilistic tree simulates 4 years of HCV testing of the 1948-1968 general population birth cohort, (15,485,565 individuals to be tested) considering different coverage rates. A No-screening scenario was compared with two alternative screening scenarios that represented different coverage rates each year: (1) Incremental approach (coverage rates equal to 5%, 10%, 30%, and 50% at years 1, 2, 3, and 4, respectively) and (2) Fast approach (50% coverage rate at years 1, 2, 3 and 4). Overall 106,200 cases were previously estimated to have an HCV active infection. A liver disease progression Markov model was considered for an additional 6 years (horizon-time 10 years). RESULTS: The highest increased number of deaths and clinical events are reported for the No-screening scenario (21,719 cumulative deaths at the end of ten years; 10,148 cases with HCC and/or 7618 cases with Decompensated Cirrhosis). Following the Fast-screening scenario, the reductions in clinical outcomes and deaths were higher compared with No-screening and Incremental-screening. At ten years time horizon, less than 5696 liver deaths (PSA CI95%: - 3873 to 7519), 3,549 HCC (PSA CI95%: - 2413 to 4684) and less than 3005 liver decompensations (PSA CI 95%: - 2104 to 3907) were estimated compared with the Incremental-scenario. The overall costs of the Fast-screening, including the costs of the DAA and liver disease management of the infected patients for 10 years, are estimated to be € 43,107,543 more than no-investment in screening and € 62,289,549 less compared with the overall costs estimated by the Incremental-scenario. CONCLUSION: It is necessary to guarantee dedicated funds and efficiency of the system for the cost-efficacious screening of the 1948-1968 birth cohort in Italy. A delay in HCV diagnosis and treatment in the general population, yet not addressed for the HCV free-of-charge screening, will have important clinical and economic consequences in Italy.

Financial Burden of Transcatheter Aortic Valve Implantation.

Given the increasing population eligible for transcatheter aortic valve implantation (TAVI), resource utilization has become an important focus in this setting. We aimed to estimate the change in the financial burden of TAVI therapy over 2 different periods. A probabilistic Markov model was developed to estimate the cost consequences of increased center experience and the introduction of newer-generation TAVI devices compared with an earlier TAVI period in a cohort of 6,000 patients. The transition probabilities and hospitalization costs were retrieved from the OBSERVANT (Observational Study of Effectiveness of AVR-TAVI procedures for severe Aortic steNosis Treatment) and OBSERVANT II (Observational Study of Effectiveness of TAVI with new generation deVices for severe Aortic stenosis Treatment) studies, including 1,898 patients treated with old-generation devices and 1,417 patients treated with new-generation devices. The propensity score matching resulted in 853 pairs, with well-balanced baseline risk factors. The mean EuroSCORE II (6.6% vs 6.8%, p = 0.76) and the mean age (82.0 vs 82.1 y, p = 0.62) of the early TAVI period and new TAVI period were comparable. The new TAVI period was associated with a significant reduction in rehospitalizations (-30.5% reintervention, -25.2% rehospitalization for major events, and -30.8% rehospitalization for minor events) and a 20% reduction in 1-year mortality. These reductions resulted in significant cost savings over a 1-year period (-€4.1 million in terms of direct costs and -€19.7 million considering the additional cost of the devices). The main cost reduction was estimated for rehospitalization, accounting for 79% of the overall cost reduction (not considering the costs of the devices). In conclusion, the introduction of new-generation TAVI devices, along with increased center experience, led to significant cost savings at 1-year compared with an earlier TAVI period, mainly because of the reduction in rehospitalization costs.

HPV Vaccination during the COVID-19 Pandemic in Italy: Opportunity Loss or Incremental Cost.

OBJECTIVES: Italy was the first European country to introduce universal vaccination of adolescents, for both males and females, against Human Papilloma Virus (HPV) starting in 2017 with the NIP 2017-2019's release. However, vaccine coverage rates (VCRs) among adolescents have shown a precarious take-off since the NIP's release, and this situation worsened due to the impact of the COVID-19 pandemic in 2020. The aim of this work is to estimate the epidemiological and economic impact of drops in VCRs due to the pandemic on those generations that missed the vaccination appointment and to discuss alternative scenarios in light of the national data. METHODS: Through an analysis of the official ministerial HPV vaccination reports, a model was developed to estimate the number of 12-year-old males and females who were not vaccinated against HPV during the period 2017-2021. Based on previously published models that estimate the incidence and the economic impact of HPV-related diseases in Italy, a new model was developed to estimate the impact of the aggregated HPV VCRs achieved in Italy between 2017 and 2021. RESULTS: Overall, in 2021, 723,375 girls and 1,011,906 boys born between 2005 and 2009 were not vaccinated against HPV in Italy (42% and 52% of these cohorts, respectively). As compared with the 95% target provided by the Italian NIP, between 505,000 and 634,000 girls will not be protected against a large number of HPV-related diseases. For boys, the number of the unvaccinated population compared to the applicable target is over 615,000 in the 'best case scenario' and over 749,000 in the 'worst case scenario'. Overall, between 1.1 and 1.3 million young adolescents born between 2005 and 2009 will not be protected against HPV-related diseases over their lifetime with expected lifetime costs of non-vaccination that will be over EUR 905 million. If the 95% optimal VCRs were achieved, the model estimates a cost reduction equal to EUR 529 million, the net of the costs incurred to implement the vaccination program. CONCLUSION: Suboptimal vaccination coverage represents a missed opportunity, not only because of the increased burden of HPV-related diseases, but also in terms of economic loss. Thus, reaching national HPV immunization goals is a public health priority.

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 €838.73 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.

Optimizing diagnostic algorithms to advance Hepatitis C elimination in Italy: A cost effectiveness evaluation.

OBJECTIVES: Optimized diagnostic algorithms to detect active infections are crucial to achieving HCV elimination. We evaluated the cost effectiveness and sustainability of different algorithms for HCV active infection diagnosis, in a context of a high endemic country for HCV infection. METHODS: A Markov disease progression model, simulating six diagnostic algorithms in the birth cohort 1969-1989 over a 10-year horizon from a healthcare perspective was used. Conventionally diagnosis of active HCV infection is through detection of antibodies (HCV-Ab) detection followed by HCV-RNA or HCV core antigen (HCV-Ag) confirmatory testing either on a second sample or by same sample reflex testing. The undiagnosed and unconfirmed rates were evaluated by assays false negative estimates and each algorithm patients' drop-off. Age, liver disease stages distribution, liver disease stage costs, treatment effectiveness and costs were used to evaluate the quality-adjusted life-years (QALYs) and the incremental cost-effectiveness ratios (ICER). RESULTS: The reference option was Rapid HCV-Ab followed by second sample HCV-Ag testing which produced the lowest QALYs (866,835 QALYs). The highest gains in health (QALYs=974,458) was obtained by HCV-RNA reflex testing which produced a high cost-effective ICER (€891/QALY). Reflex testing (same sample-single visit) vs two patients' visits algorithms, yielded the highest QALYs and high cost-effective ICERs (€566 and €635/QALY for HCV-Ag and HCV-RNA, respectively), confirmed in 99.9% of the 5,000 probabilistic simulations. CONCLUSIONS: Our data confirm, by a cost effectiveness point of view, the EASL and WHO clinical practice guidelines recommending HCV reflex testing as most cost effective diagnostic option vs other diagnostic pathways.

An Analysis of the Social and Economic Costs of Breast Cancer in Italy.

BACKGROUND: Breast cancer is the most prevalent cancer affecting women and it represents an important economic burden. The aim of this study was to estimate the socio-economic burden of breast cancer (BC) in Italy both from the National Health Service (NHS) and the government perspectives (costs borne by the social security system). METHODS: The economic analysis was based on the costs incurred by the NHS from 2008 to 2016 (direct costs related to hospitalizations) and by the National Social Security Institute (INPS) from 2009 to 2015 (costs of social security benefits) for patients with breast cancer. The analysis was based on the Hospital Information System (HIS) and Disability Insurance Awards databases. For both databases, patients affected by a malignant neoplasm of the female breast, carcinoma in situ, or secondary malignant neoplasm of the breast were considered. RESULTS: Results show that more than 75,000 women were hospitalized for breast cancer every year, with an overall cost for hospitalization of about €300 million per year. From the Social Security analysis, a number of 29,000 beneficiaries each year was estimated. Considering per patient social costs, breast cancer at the primary stage cost €8828 per year, while secondary neoplasms cost €9780, with an average total economic burden of €257 million per year. CONCLUSIONS: This analysis focused on the economic impact of breast cancer in Italy, showing that an advanced stage of the disease was associated with a higher cost.

Drug Prices and Value of Oncology Drugs in Italy.

OBJECTIVE: The main objective of this study was to evaluate the potential role of efficacy data and other information available at the time of price and reimbursement (P&R) decision-making process within the definition of oncology treatment costs in Italy. METHODS: The study included all P&R dossiers submitted to the Italian Medicines Agency between July 2015 and December 2017. It prospectively collected the data of the P&R process starting from dossier submission up to the Italian Health Service reimbursement decision. The cost of treatment per patient was estimated using both the list price ("gross cost") and the confidential net price ("net cost") of drug packages and applied to the median duration of treatment. A 2-sample stage Heckman decomposition model was used to evaluate the potential role of efficacy data and other information available at the time of P&R decision making on the gross and net cost. RESULTS: A total of 37 oncology drugs related to 58 therapeutic indications were analyzed. The multivariate model showed that the variation of progression-free survival is the only variable predictor statistically associated with treatment cost, but this effect was observed only when confidential net prices were used (P=.026). CONCLUSIONS: Considering the perspective of a developed country having a public healthcare service with a central reimbursement negotiation is determined a relevant reduction in the treatment cost purchased by public payers. This is a useful approach to guarantee the affordability of innovative oncology drugs and to contain public expenditures on healthcare. Furthermore, the negotiation of confidential discounts and agreement clauses in managed entry agreements seemed to reward oncology drugs displaying an added therapeutic benefit.

[Economic burden of diabetic patients with established atherosclerotic cardiovascular disease or risk factors for atherosclerotic cardiovascular disease.] / Analisi dei costi associati ai pazienti con diabete di tipo 2 a rischio di malattia cardiovascolare aterosclerotica o con malattia cardiovascolare aterosclerotica accertata.

OBJECTIVES: The analysis aimed to quantify the number and costs of patients with type 2 diabetes and atherosclerotic cardiovascular disease or with risk factors for atherosclerotic cardiovascular disease from the Regional Health Service (RHS) perspective of the Marche region. MATERIALS AND METHODS: A cost of illness (COI) model was developed to estimate the economic burden associated with diabetes and established atherosclerotic cardiovascular disease or risk factors for atherosclerotic cardiovascular disease. Data were extrapolated from the administrative database of the Marche region and specific inclusion criteria for enrolling patients were adapted from DECLARE-TIMI 58 clinical trial. RHS perspective (drugs, hospitalizations, monitoring cost) and 1 and 4-year time horizons were considered. RESULTS: The analysis estimated a total number of 92,205 diabetic patients in Marche region in 2014. Of these, 66,306 were patients (5.9% of the resident population) with established atherosclerotic cardiovascular disease (13,104 patients) or risk factors for atherosclerotic cardiovascular disease (53,202 patients). The annual expenditure associated with patients analysed amounted to € 98.8 million (average cost per patient € 1,480) in Marche region. Of these, 52% was associated with hospitalizations. Considering a 4-year time horizon, the overall economic burden rises to over € 301 million per year with an average cost per patient of € 4,545. Stratifying patients between patients hospitalized for heart failure and patients not hospitalized for heart failure, the average annual cost per patient was equal to € 15,896 and equal to € 3,998 respectively. CONCLUSIONS: An important epidemiological and economic burden associated with type 2 diabetes patients were estimated from the analysis due to the disease and the associated comorbidities. The ability to prevent comorbidity risks, especially cardiovascular ones, represents not only a clinical advantage but also a positive reduction in expenditure. Early and effective intervention represents the best strategy to avoid or slow down the evolution of complications of the disease.

Addressing HCV Elimination Barriers in Italy: Healthcare Resource Utilization and Cost Impact Using 8 Weeks' Glecaprevir/Pibrentasvir Therapy.

INTRODUCTION: In Italy, hepatitis C virus (HCV) elimination is achievable; however, barriers remain to achieving the World Health Organization's elimination targets, and have become more pronounced with the spread of COVID-19. Glecaprevir/pibrentasvir (G/P) is a direct-acting antiviral therapy for HCV, approved for 8-week treatment in patients without cirrhosis, and with compensated cirrhosis (CC). Previously, 12 weeks of therapy was recommended for patients with CC. Shortened treatment may reduce the burden on healthcare resources, allowing more patients to be treated. This study presents the benefits that 8-week vs 12-week treatment with G/P may have in Italy. METHODS: A multicohort Markov model was used to assess the collective number of healthcare visits and time on treatment with 8-week vs 12-week G/P in the HCV-infected population of Italy from 2019 to 2030, using healthcare resource data from post-marketing observational studies of G/P. Increased treatment capacity and downstream clinical and economic benefits were also assessed assuming the reallocation of saved healthcare visits to treat more patients. RESULTS: Modeled outcomes showed that by 2030, 8-week treatment saved 27,006 years on therapy compared with 12-week treatment, with 21,065 fewer hepatologist visits. Reallocating these resources to treat more patients could increase capacity to treat 5064 (1.4%) more patients with 8 weeks of G/P, all with CC. This increased treatment capacity would further avoid 2257 cases of end-stage liver disease, 893 liver-related deaths, and provide net savings to the healthcare system of nearly €70 million. CONCLUSION: The modeled comparisons between 8- and 12-week treatment with G/P show that shorter treatment duration can lead to greater time and resource savings, both in terms of healthcare visits and downstream costs. These benefits have the potential to enable the treatment of more patients to overcome elimination barriers in Italy through programs aimed to engage and treat targeted HCV populations.

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 € 45 to € 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.

Economic Impact of Schizophrenia from a Hospital and Social Security System Perspective in Italy.

BACKGROUND: Schizophrenia is one of the mental disorders with the highest economic and social costs, with an important burden on patients, caregivers, and society. OBJECTIVE: The objective of this study was to estimate the direct and social security costs of schizophrenia in Italy. As far as direct costs are concerned, those related to hospitalizations and pharmaceutical expenditure have been analyzed, while disability benefits (DBs) and incapacity pensions (IPs) have been considered for the social security costs. METHODS: In order to provide annual economic burden of schizophrenia using the real-world data, we analyzed the main regional and national databases related to hospitalizations and pharmaceuticals. Hospitalizations have been analyzed considering the Hospital Information System, which collects all the information regarding hospital discharges from all public and private hospitals (psychiatric wards or residential facilities have not been considered). Hospitalizations with a discharge date between 2009 and 2016, and with a primary or secondary diagnosis of schizophrenia (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 295.xx) were selected. Hospital costs have been estimated considering the national tariffs associated with each selected hospitalization. In addition, using the same inclusion criteria, the average DBs (for workers with reduced working capacity) and IPs (for workers without working capacity) provided each year have been analyzed from the social security benefit applications database. The estimate of pharmaceutical expenditure was prepared based on the OsMed 2018 Report (Italian Medicines Agency, latest issue 18 July 2019). A one-way deterministic sensitivity analysis was conducted to examine the robustness of the results. RESULTS: In Italy from 2009 to 2016, schizophrenia had an important economic impact from a social perspective. On average, 13,800 patients were hospitalized, with an average of 2.98 hospitalizations per patient. From a National Health Service (NHS) perspective and with specific reference to hospitalizations, the annual economic burden was €101.4 million, with an average cost per patient of €7338. On the other hand, pharmaceutical expenditure amounts to over €147 million each year, while residential, semi-residential, and specialist facilities amount to approximately €1 billion. Again, schizophrenia led to approximately 15,000 recipients of social security benefits (DBs and IPs) yearly from 2009 to 2015, with an average annual expenditure of €160.1 million (average cost per patient = €10,675). CONCLUSIONS: Our study estimates an economic burden of schizophrenia of €1250 million per year in direct costs, of which 20% is related to hospitalizations and pharmaceutical expenditure. With regard to social security benefits, an average annual expenditure of €160.1 million was calculated (average cost per patient = €10,675).

Osteoporosis: Economic Burden of Disease in Italy.

BACKGROUND AND OBJECTIVE: Today, osteoporosis is the most common bone disease and an important public health problem in all developed countries. The objective of this study was to estimate the costs associated with the management and treatment of osteoporosis in order to assess the economic burden in Italy for 2017, in terms of direct medical costs and social security costs. METHODS: A cost of illness model was developed to estimate the average cost per year sustained by the NHS (National Health Service) and Social Security System in Italy. A systematic literature review was performed to obtain epidemiological, direct and indirect costs parameters where available. Hospitalisation costs were calculated considering the administrative database of the hospital discharge records for the period 2008-2016. Patients were enrolled in the analysis if they report the subsequent inclusion criteria: age ≥ 45 years and presence of osteoporosis in primary or secondary diagnosis (ICD9-CM 733.0) and/or presence of a major fracture in primary or secondary diagnosis (excluding road accidents) in the following locations: spine (codes ICD9-CM: 805;806), femur (codes ICD9-CM: 820; 821), radius and ulna (codes ICD9-CM: 813.4; 813.5), humerus (codes ICD9-CM: 812.0-812.5), pelvis (code ICD9-CM: 808), tibia and fibula (codes ICD9-CM: 823), ankle (code ICD9: 824) and ribs (codes ICD9-CM: 807.0; 807.1). Costs were estimated considering the diagnosis-related group (DRG) national tariff associated with each hospitalisation. Finally, the administrative databases of the Italian National Social Security Institute (INPS) (2009-2015) were analysed for the estimate the pension and disability costs from the social perspective. RESULTS: The model estimated an average annual economic burden of osteoporosis in Italy of €2.2 billion. Of this cost, approximately 80% (€1.8 billion) was associated with hospitalisations, 16% (€351 million) for pharmacological treatments, 3% (€71 million) for ambulatory visits, and 0.6% (€13 million) for social security costs. The average yearly cost per patient was equal to €8691 (€8591 for hospitalisations). Analysing severe patients, hospitalisation costs increase to €12,336 (+ 44% if compared to non-severe osteoporosis patients). CONCLUSIONS: The analysis showed that osteoporosis represents one of the main health problems in Italy and the ability to maintain patients in a non-severe health state could decrease the economic burden from both NHS and social perspective.

Budget Impact Analysis of Dalbavancin in the Treatment of Acute Bacterial Skin and Skin Structure Infections in Three European Countries.

BACKGROUND AND OBJECTIVE: Acute bacterial skin and skin structure infections (ABSSSIs) have been defined by the US Food and Drug Administration (FDA) in 2013 to include a subset of complicated skin and skin structure infections commonly treated with parenteral antibiotic therapy. Inpatient treatment of ABSSSIs involves a significant economic burden on the healthcare system. This study aimed to evaluate the economic impact on the National Health System associated with the management of non-severe ABSSSIs treated in hospitals with innovative long-acting dalbavancin compared to standard antibiotic therapy in Italy, Spain, and Austria. METHODS: A budget impact analysis was developed to evaluate the direct costs associated with the management of ABSSSI from the national public health system perspective. The model considered the possibility of early discharge of patients directly from the Emergency Department (ED), after 1 night in the hospital, or after two or three nights in the hospital. A scenario with Standard of Care was compared with a dalbavancin scenario, where patients had the possibility of being discharged early. The epidemiological and cost parameters were extrapolated from national administrative databases and from a systematic literature review for each country. The analysis was conducted in a 3-year time horizon. A one-way deterministic sensitivity analysis was conducted to examine the robustness of the results. RESULTS: The model estimated an average annual number of patients with non-severe ABSSSI in Italy, Spain, and Austria equal to 5396, 7884, and 1788, respectively. A total annual expenditure of about €9.9 million, €13.5 million, and €3.4 million was estimated for treating the full set of ABSSSI patients in Italy, Spain, and Austria, respectively. Dalbavancin reduced the in-hospital length of stay in each country. In the first year of its introduction, dalbavancin significantly reduced the total economic burden in Italy and Spain (- €352,252 and - €233,991, respectively), while it increased the total economic burden in Austria (€80,769, 0.7% of the total expenditure for these patients); in the third year of its introduction, dalbavancin reduced the total economic burden in each Country (- €1.1 million, - €810,650, and - €70,269, respectively). CONCLUSIONS: The introduction of dalbavancin in a new patient pathway to treat non-severe ABSSSI could generate a significant reduction in hospitalized patients and the overall patient length of stay in hospital.