Dalbavancin is a new innovative long-acting antimicrobial treatment that allows clinicians to endorse an early discharge program for patients suffering from acute bacterial skin and skin structure Infections (ABSSSI). The aim of this study was to develop a spending predictor model for evaluating the direct costs associated with the management of ABSSSI from the National Health Service (NHS) perspective of Italy, Spain, and Romania. The main purpose is to compare the hospitalization and drug costs due to the treatment of ABSSSI patients treated with standard antibiotics therapy or innovative long-acting treatment dalbavancin.

A decision-analytic model was performed to evaluate the diagnostic and clinical pathways of ABSSSI patients in the hospital, based on clinicians’ expert opinion. The standard of care scenario was compared with the dalbavancin scenario. The epidemiological and cost parameters were extrapolated from national administrative databases (hospital information system) and from a systematic literature review for each country. Only direct costs in the national payer's perspective were considered. Probabilistic sensitivity analysis (PSA) and one-way sensitivity analysis (OSA) were performed to check the robustness of the model assumptions.

Overall, the model estimated an average annual number of patients with ABSSSI equal to around 50,000 in Italy, Spain, and Romania. The introduction of dalbavancin reduced the length of stay of, on average, 3.3 days per ABSSSI patient. From the economic point of view, dalbavancin did not incur any additional cost from the NHS perspective with homogenous results between countries. The PSA and OSA demonstrated the robustness of the results.

The preliminary results highlight that the introduction of dalbavancin could generate a significant reduction in term of length of stay with no incremental cost from the NHS perspective. This model could represent a good tool for policymakers to provide information on the early discharge approach in the ABSSSI management.

The objectives of this study were to estimate the economic burden of human papillomavirus (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.

A cost-of-illness incidence-based model was developed to estimate the incidences and costs of invasive cervical cancer, cervical dysplasia, cancer of the vulva, vagina, anus, penis, oropharyngeal, anogenital warts, and recurrent respiratory papillomatosis (RRP) in the context of the Italian National Health System (NHS). We used data from hospital discharge records (HDRs) of an Italian region and conducted a systematic literature review to estimate the lifetime cost per case, the number of incident cases, the prevalence of HPV9 types. Costs of therapeutic options not included in the diagnosis-related group (DRG) tariffs were estimated through a scenario analysis.

The total annual direct costs were EUR 540.7 million, with a range of EUR 338.3 – EUR 789.7 million. These costs could increase considering innovative therapies for cancers treatment (range EUR 16.2 – EUR 37.6 million). The fraction attributable to the HPV9 genotypes without innovative cancers treatment was EUR 329.2 million (range EUR 150.1 – EUR 576.7 million), accounting for sixty-one percent of the total annual burden of HPV-related diseases in Italy. Of this amount, EUR 136.7 million (forty-two percent) was related to men, accounting for sixty-four percent of the costs associated with non-cervical conditions.

The infections by HPV9 strains and the economic burden of non-cervical HPV-related diseases in men were found to be the main drivers of direct costs. The fraction of the total direct lifetime costs attributable to infections by HPV9 strains and the economic burden of non-cervical HPV-related diseases in men were found to be the main drivers of direct costs.

The introduction of new biologic treatments has radically changed the management of Immune-mediated inflammatory diseases (IMID). Due to the high costs of the treatments a strong control and monitoring of claims databases could help decision makers to understand the consequences of their decisions.

The objective of the study was to identify the cohort of biologics treatment-naïve patients in the years 2011–2013 in the Lazio region (6 millions of inhabitants), in order to investigate the parameters influencing the biologic treatment expense at the regional level.

Patients were enrolled based on administrative databases of the Lazio region. Treatment-naïve patients were defined as subjects who did not have a prescription in the two years before the index prescription. Switcher patients were defined as those who had an Anatomical Therapeutic Chemical classification (ATC) prescription different than the one at enrolment, within one year of the index date. Treatment adherence was estimated as the number of doses actually prescribed as compared to the number indicated in the Summary of Product Characteristics (SPC).

From a total number of 10,120 patients treated with biologic drugs between 2011–2013 in the Lazio region, 2,929 were estimated as treatment-naïve patients (42 percent male). The most frequently used drugs were etanercept (31 percent), adalimumab (30 percent) and infliximab (17 percent). Considering the disease treatment distribution, 28.6 percent of patients were treated for rheumatoid arthritis, 25.5 percent for psoriatic arthritis, 16.4 percent for psoriasis and the remaining patients for other diseases. Some patients switched biologic therapy (367), of which 22.6 percent were within the first 120 days. Total mean adherence was estimated in 87.7 percent: 21.5 percent of patients showed a low adherence (SPC< 60 percent) while 18.1 percent were estimated as dose increase patients (SPC>110 percent), 11.4 percent for rheumatic diseases, 32.3 percent for dermatological diseases and 26.9 percent for inflammatory bowel disease.

The study provides a map of the current treatment settinga with biologics in the Lazio region considering the disease, adherence and prescribed treatments. A considerable number of treatment-naïve patients were identified (2,929), 12.5 percent of whom switched ATC within 1 year. Total mean adherence was estimated in 87.7 percent, low adherence occurred in 21.5 percent of patients, while dose-increase was in 18.1 percent.

Inhibitors of Vascular Endothelial Growth Factor (VEGF) have made possible the treatment of the Retinal Vascular Diseases (RVD) for which there were limited therapeutic resources. The aim of this work was to estimate annual direct costs of major macular edema diseases in Italy in particular Choroidal Neovascularization (CNV), Diabetic Macular Edema (DME) and Retinal Vein Occlusions (RVO) from the hospital perspectives.

This descriptive study was aimed at quantifying direct costs incurred by five hospitals in Italy. Administrative and clinical databases of Policlinico Tor Vergata in Rome were analyzed for a 6-year period. In this context, it was possible to stratify patients depending on the disease and number of eyes treated. From these results, a survey with structured questionnaires was developed involving four other hospitals in Italy. Thanks to that, direct costs (drugs and specialist) were estimated from the hospitals perspective in 2016.

Interviews included 7,356 individuals of which 1,860 were treated in both eyes. Within the considered five hospitals, 64 percent of treated patients had CNV, 21 percent DME, and 15 percent RVOs. The average annual administration rate of anti-VEGF treatment resulted in 4.03 (Standard Deviation, SD 3.46) per patient eye: 4.69 (SD 1.75) for cases enrolled for less than one year (naïve) and 3.38 (SD 0.82) per patients treated for more than one year (experienced). Naïve patients had a mean per capita annual cost of EUR2,368 per eye (EUR2,536 for CNV; EUR2,280 RVO; EUR1,986 DME) of which EUR2,952 was related to the administration of on-label drugs mainly Eylea, Lucentis, Macugen, Ozurdex and EUR49 due to off-labels such as Avastin. Experienced patients average annual cost per eye was EUR1,689: EUR2.179 for the on-label drugs, EUR34 due to off-labels (EUR1,839 for CNV; EUR1,327 RVO; EUR1,399 DME). The average rate of the specialist annual visit was four times; the most frequent types were Optical Coherence Tomography (OCT), Angiography, and Fundus Photography (FP).

This is a first attempt to study direct costs incurred from the hospital perspective associated with RVD with overexpression of VEGF in Italy. This might represent a first step for further analysis assessing the burden of RVD diseases from the Italian National Health System perspective globally.

Schizophrenia is a severe mental disease that affects approximately 1 percent of the population with a relevant chronic impact on social and occupational functioning, and daily activities. The aim of this analysis was to evaluate the clinical and economic consequences of long-acting injectable (LAI) treatment in patients with psychotic disorders, with a special focus on schizophrenia, in Italian real world practice.

A retrospective, observational mirror-study was developed to analyze outcomes measure referred to patients with psychotic disorders. Five hospital centers were involved in this study that collected patient level data from clinical databases. Retrospective data for each patient were referred to 6 months before LAI drug administration and 6 months after. A paired-Samples t-test was performed in order to identify statistical differences between pre- and post-LAI administration.

A total number of 308 patients were enrolled in the study (65.6 percent male). Of these 221 were eligible for our analysis (119 with schizophrenia). In the six months after LAI administration period we estimate a 47.3 percent reduction of the antipsychotic drugs (43.8 percent for schizophrenic patients), 94.7 percent reduction of hospitalizations (94.0 percent for schizophrenic patients) and adherent patients increase to 198/221 patients (78/221 in pre-LAI administration period). All differences between pre- and post- LAI administration period were statistically significant with a p< .005. In Italy over 152 thousand schizophrenic treated patients were estimated. Assuming that 20–40 percent of patients are eligible to the Mo.Ma (Model of Management) approach, our model estimates a direct cost reduction during the first year of implementation of around EUR12 million. Additionally, EUR18 million of direct costs in the mid-term and EUR58 million of indirect costs could be saved in the mid-term estimating a total cost reduction, due to the Mo.Ma approach, of about EUR90 million.

This new therapeutic approach could change the cost structure of schizophrenia by decreasing costs with efficient economic resource allocation guaranteed from efficient diagnostic and therapeutic pathways.

The aim of the study was to estimate the benefits provided and pension costs of patients with central nervous system (CNS) diseases and specifically for multiple sclerosis (MS), between 2009 and 2015 by age in the Italian regions.

The database of approved claims was analyzed and the mean cost per benefit of the National Institute of Social Security (INPS) determined for four types of social security benefits: incapacity pensions (for workers without work ability), disability pensions and disability benefits (for workers with reduced work ability) and attendance allowance (for people without work ability with physical and/or mental disability). From this data we estimated the total benefit provided and the total costs for CNS and MS, considering the regional distribution and age of the applicants. A probabilistic model with a Monte Carlo simulation was developed in order to estimate the total benefits provided and costs.

The model estimated for CNS diseases a total of incapacity pensions paid (thirteen grants for each beneficiary for every single year) from 2009 to 2015 of about 1.7 million (13,000 beneficiaries on average annually with a mean annual increase of 1 percent) corresponding to EUR1.1 billion (EUR165 million each year with a mean annual increase of 2 percent); a total of disability pensions paid of about 9.8 million (180,000 annual beneficiaries with a mean annual decrease of -10 percent) for a cost of EUR5.3 billion (EUR763 million each year with a mean annual decrease of -9 percent) and a total of disability benefits provided of about 2.7 million (30,000 annual beneficiaries with a mean annual increase of 5 percent) corresponding to EUR1.8 billion (EUR255 million every year with a mean annual increase of 7 percent). For the attendance allowance the model estimated a total of 8,900 beneficiaries in 2015 for a total cost of EUR57 million. The results of the regional analysis showed that the central and part of the southern regions (in particular the Sardinia region) reported the highest rates of benefits provided related to the resident population.

The most important indirect costs in Italy from 2009 to 2015 were represented by disability pensions (64 percent of the total cost), followed by disability benefits (21 percent of total indirect cost).