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Background: Cabozantinib use in everyday clinical practice for advanced or metastatic renal cell carcinoma (RCC) is relatively recent, and real-world data on treatment persistence, adherence and sequencing are still limited. Methods: We conducted an analysis based on an integrated administrative database, covering around 6.9 million health-assisted Italian individuals, to explore the use of cabozantinib for RCC. Patients with at least one prescription for cabozantinib during 2017-2020 were searched. These were characterized during all available period (i.e. from 2010 onwards) before the index date and were observed after inclusion. Results: A total of 113 patients treated with cabozantinib in second or subsequent line were included, and their demographic, clinical and treatment characteristics were described. About half of these RCC patients were aged >65 years (47.8%). Sixty patients (53.1%) were highly adherent to cabozantinib therapy, and the median cabozantinib treatment duration of use was 8.7 months (95% confidence interval: 5.8-11.1). During the first year of follow-up, the average total cost per patient was €32,508. Conclusions: We described second or subsequent line cabozantinib treatment for RCC in a real-world setting and the economic burden of disease in Italy, taking advantage of large, integrated administrative databases.

Background and aim: The ageing of the general population, with the increase in chronic diseases, poses the need for using technological innovation to face the growing healthcare needs. The present analysis applied the Activity-Based Costing tool in migraine patients followed at the IRCCS Mondino of Pavia to formalize and quantify the costs of the whole patient’s management process and to estimate the overall economic burden of migraine from the perspective of the National Health Service (NHS). Methods: A two-stage analysis was conducted. The first stage aimed at drawing patient’s pathway, defining all the possible activities and actors involved in the healthcare delivery and treatment for migraine at the IRCCS during year 2022. The second phase was the development of a model to estimate the costs of the entire process by pricing the individual activities. Results: The described model yielded an estimated total annual cost for the overall management of migraine of € 1,222,392, corresponding to a direct cost for a therapy of approximately 6 months per single patient of € 814. The most impactive items on the estimated annual expenditures were hospitalizations, followed by diagnostic examinations after follow-up visits and drugs dispensed by Hospital Pharmacy for home-administration (monoclonal antibodies). Conclusions: This analysis allowed detailing the single activities and resources used in migraine patient’s pathway and then estimating the direct costs sustained by the NHS. The model could be translated to other diseases for optimizing the diagnostic/therapeutic and economic management of assisted patients and improving healthcare resource allocation.

Introduction: Heart failure (HF) affects 1% of subjects aged 45-55 and over 10% of subjects aged ≥ 80 and in Italy represents the third leading cause of hospitalization. Objective: To analyse the clinical and economic burden of HF in the Italian real clinical practice. Methods: A retrospective analysis was conducted on the administrative databases of healthcare institutions for 4.2 million health-assisted residents. Between January 2012 and March 2021, patients with a hospital discharge diagnosis for HF were included. Among healthcare utilization and costs, treatments, hospitalizations, and specialist services were evaluated. The HF group was compared with a population without HF (no-HF) similar for age, sex distribution, and cardiovascular risk factors. Results: The same number of patients with (N = 74,085) and without HF (N = 74,085) was included. A profile of cardiovascular comorbidities emerged in the HF group, mainly hypertension (88.6%), cardiovascular disease (61.3%) and diabetes (32.1%). Hospitalizations from any cause were 635.6 vs 429.8/1,000 person-year in the HF vs no-HF group. At one-year follow-up, all-cause mortality was 24.9% in HF patients and 8.4% in no-HF. Resource utilization/patient was respectively 26.8 ± 15.9 vs 17.1 ± 12.5 for medications, 0.8 ± 1.2 vs 0.3 ± 0.8 for hospitalizations, and 9.4 ± 12.6 vs 6.5 ± 9.8 for specialist services. This resource utilization resulted in significantly higher total healthcare costs in the HF group vs no-HF group (€ 5,910 vs € 3,574, p < 0.001), mainly related to hospitalizations (€ 3,702 vs € 1,958). Conclusions: HF patients show a significantly higher clinical and economic burden than no-HF, with total healthcare costs being about 1.7 times the costs of the no-HF group. Keywords: Cardiovascular comorbidities, Healthcare costs, Heart failure, Hospitalizations

Introduction: The therapeutic control of LDL-cholesterol is essential in cardiovascular prevention, as recommended by the recent guidelines. Objective: To evaluate gender differences in terms of demographic and clinical characteristics, treatment pattern, treatment adherence and healthcare costs in patients on lipid-lowering therapy, stratified by cardiovascular risk in the Italian real clinical practice. Methods: An observational analysis was conducted on the administrative databases of healthcare institutions, covering about 6.1 million health-assisted subjects. After inclusion of all patients on lipid-lowering therapy between January 2017 and June 2020, the population was investigated in the period before the first prescription of a lipid-lowering drug and followed-up for at least 12 months. Clinical and demographic variables were compared after stratification by gender and by cardiovascular risk (very high/high/other risk). The main outcome measures were treatment adherence and direct healthcare costs during follow-up. Results: Of the 684,829 patients with high/very high cardiovascular risk, 337,394 were men and 347,435 women, aged on average 69.3 years and 72.1 years, respectively (p < 0.001). Men were characterised by a worse comorbidity profile. Regardless of cardiovascular risk, female subjects were associated with larger utilisation of low-potency statins and lower adherence (p < 0.001). The annual healthcare costs per patient during follow-up were higher in men than in women (p < 0.001). Conclusions: The results highlighted larger utilisation of low-potency statins, a lower adherence and a milder comorbidity profile in women, the latter feasibly explaining the reduced healthcare costs compared to men.

Felice Alfonso Nava,1 Alessandra Mangia,2 Marco Riglietta,3 Lorenzo Somaini,4 Francesco Giuseppe Foschi,5 Ernesto Claar,6 Ivana Maida,7 Claudio Ucciferri,8 Francesca Frigerio,9 Candido Hernandez,10 Melania Dovizio,11 Valentina Perrone,11 Luca Degli Esposti,11 Massimo Puoti12 1U.O. Sanità Penitenziaria e Area Dipendenze, Azienda ULSS 6 Euganea, Padova, Italy; 2UOS Epatologia, Istituto di Ricovero e Cura “Casa Sollievo della Sofferenza”, S. Giovanni Rotondo, Italy; 3UOC Dipendenze, ASST Papa Giovanni XXIII, Bergamo, Italy; 4Servizio per le Dipendenze, SERT di Cossato, Biella, Italy; 5UOC Medicina Interna, Ospedale di Faenza, Faenza, Italy; 6UOC Medicina Interna, Ospedale Evangelico “Villa Betania”, Napoli, Italy; 7UOC Malattie Infettive e Parassitarie, Azienda Ospedaliero Universitaria di Sassari, Sassari, Italy; 8Clinica di Malattie Infettive Ospedale “SS Annunziata”, Chieti, Italy; 9Gilead Sciences, Milano, Italy; 10Gilead Sciences, Global Medical Affairs, Stockley Park, London, UB11 1BD, UK; 11CliCon S.R.L. Società Benefit, Health Economics and Outcomes Research, Bologna, Italy; 12SC Malattie Infettive, ASST Grande Ospedale Metropolitano Niguarda, Milano, ItalyCorrespondence: Luca Degli Esposti, CliCon S.r.l. Società Benefit, Health, Economics & Outcomes Research, Via Murri, 9, Bologna, 40137, Italy, Tel +39 544 38393, Fax +39 544 212699, Email luca.degliesposti@clicon.itPurpose: Hepatitis C virus (HCV) spreads from contact with blood of an infected person. HCV infections are common among people who use drugs (PWUDs), when sharing needles, syringes, or other equipment for injected drugs. The advent of pangenotypic direct-antiviral agents (DAA) in 2017 transformed the treatment landscape for HCV, but PWUDs remain a complex and hard-to-treat population with high risk of HCV reinfection. The aim of this real-world analysis was to characterize the demographic and clinical features of PWUDs in Italy, also focusing on comorbidity profile, treatment wit

Valentina Perrone,1 Serena Losi,2 Silvia Sabatino,2 Maurizio Mezzetti,3 Melania Dovizio,1 Diego Sangiorgi,1 Luca Degli Esposti1 1CliCon S.r.l., Società Benefit-Health Economics and Outcomes Research, Bologna, 40137, Italy; 2Eli Lilly Italy S.p.A, Sesto Fiorentino, Italy; 3Eli Lilly Italy S.p.A, Rome, ItalyCorrespondence: Valentina Perrone, CliCon S.r.l., Società Benefit-Health Economics and Outcomes Research, Via Murri 9, Bologna, 40137, Italy, Tel +39 544 38393, Fax +39 544 212699, Email valentina.perrone@clicon.itPurpose: An Italian real-world retrospective study was conducted in patients with psoriasis (PSO) to evaluate their characteristics, treatment patterns, and biological/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) drug utilization.Patients and Methods: The retrospective analysis was carried out on real-world data collected from administrative databases of selected Italian health-departments; the dataset covered approximately 22% of the Italian population. PSO patients (identified by PSO hospitalization, and/or active exemption code and/or a topical anti-psoriatic medication prescription) were included. In prevalent patients identified during 2017– 2018-2019-2020, baseline characteristics and treatment patterns were investigated. Moreover, b/tsDMARD drug utilization (focusing on persistence, monthly dosage, and mean duration between prescriptions) was evaluated in bionaïve patients included during 2015 and 2018.Results: PSO was diagnosed in 241,552 (in 2017), 269,856 (in 2018), 293,905 (in 2019) and 301,639 (in 2020) patients. At the index date, almost 50% of patients had not received systemic medications, and 2% had received biological treatment. Among the b/tsDMARD-treated patients, a decrease in the use of tumour necrosis factor (TNF) inhibitors (60.0– 36.4%, from 2017 to 2020) and an increase in the use of interleukin (IL) inhibitors (36.3– 50.6%, from 2017 to 2020) were observed. In 2018, the persistence rates of TNF inh

Stefano Fagiuoli,1 Pierluigi Toniutto,2 Nicola Coppola,3 Domenica Daniela Ancona,4 Margherita Andretta,5 Fausto Bartolini,6 Fulvio Ferrante,7 Alessandro Lupi,8 Stefano Palcic,9 Francesca Vittoria Rizzi,10 Davide Re,11 Gema Alvarez Nieto,12 Candido Hernandez,13 Francesca Frigerio,14 Valentina Perrone,14 Luca Degli Esposti,14 Alessandra Mangia15 1Department of Medicine and Surgery, University of Milan Bicocca & Gastroenterology Hepatology and Transplantation Unit, ASST Papa Giovanni XXIII, Bergamo, Italy; 2Hepatology and Liver Transplantation Unit, Azienda Ospedaliero Universitaria, Udine, Italy; 3Infectious Diseases Unit, University of Campania L. Vanvitelli, Naples, Italy; 4Dipartimento Farmaceutico ASL BAT, Trani, Italy; 5UOC Assistenza Farmaceutica Territoriale, Azienda Ulss 8 Berica, Vicenza, Italy; 6Dipartimento Farmaceutico-Usl Umbria 2, Terni, Italy; 7Dipartimento Diagnostica Ed Assistenza Farmaceutica – ASL Frosinone, Frosinone, Italy; 8Struttura Complessa Di Cardiologia – ASL VCO, Omegna, Italy; 9Farmaceutica Territoriale- Azienda Sanitaria Universitaria Integrata Giuliano-Isontina (ASUGI), Trieste, Italy; 10UOS Farmacovigilanza e Monitoraggio Spesa Farmaceutica- ASL BAT, Trani, Italy; 11Servizio Farmaceutico Territoriale ASL Teramo, Teramo, Italy; 12Gilead Sciences, Medical Affairs Italy, Milan, Italy; 13Gilead Sciences, Global Medical Affairs, London, UK; 14Clicon S.r.l., Health Economics and Outcomes Research, Bologna, Italy; 15Gastroenterology and Transplant Hepatology, Papa Giovanni XXIII Hospital, Bergamo, 24127, ItalyCorrespondence: Luca Degli Esposti, CliCon S.r.l. Società Benefit, Health, Economics & Outcomes Research, Via Murri, 9, Bologna, 40137, Italy, Tel +390544 38393, Email luca.degliesposti@clicon.itPurpose: The study aims at investigating the impact of polymedication and aging in the prevalence of multiple drug-drug interactions (DDIs) on HCV patients treated with sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE