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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

Valentina Perrone,1 Chiara Veronesi,1 Melania Dovizio,1 Domenica Daniela Ancona,2 Margherita Andretta,3 Fausto Bartolini,4 Arturo Cavaliere,5 Alessandro Chinellato,6 Andrea Ciaccia,7 Mariarosaria Cillo,8 Adele De Francesco,9 Nicola Enieri,6 Fulvio Ferrante,10 Simona Gentile,11 Cataldo Procacci,2 Loredana Ubertazzo,12 Adriano Vercellone,13 Domenico Lucatelli,14 Michela Procaccini,14 Luca Degli Esposti1 1CliCon S.r.l., Società Benefit-Health, Economics & Outcomes Research, Bologna, Italy; 2Dipartimento Farmaceutico, ASL BAT, Andria, Italy; 3UOC Assistenza Farmaceutica Territoriale, Azienda ULSS 8 Berica, Vicenza, Italy; 4Dipartimento Farmaceutico, USL Umbria 2, Terni, Italy; 5Farmaceutica Aziendale, ASL Viterbo, Viterbo, Italy; 6Unità Operativa Farmacia Ospedaliera, ULSS 3 Serenissima, Mestre, Italy; 7ASL Foggia, Foggia, Italy; 8Dipartimento Farmaceutico, ASL Salerno, Salerno, Italy; 9Azienda Ospedaliero-Universitaria “Mater Domini”, Catanzaro, Italy; 10ASL Frosinone, Frosinone, Italy; 11Direzione Generale per la Salute, Campobasso, Italy; 12ASL Roma 4, Civitavecchia, Roma, Italy; 13ASL Napoli 3 sud, Napoli, Italy; 14Angelini Pharma, Roma, ItalyCorrespondence: Valentina Perrone, CliCon S.r.l., Società Benefit-Health, Economics & Outcomes Research, Via Murri 9, Bologna, 40137, Italy, Tel +39 3450316494, Email valentina.perrone@clicon.itPurpose: A retrospective analysis was conducted to estimate the number of patients with focal epilepsy and drug-resistant epilepsy (DRE) and their characteristics, the therapeutic patterns, the consumption of health resources in a real-world Italian setting.Patients and Methods: A retrospective study was carried out on the administrative databases of a sample of Italian Health Departments, covering approximately 8.7 million health-assisted individuals. All adult patients with at least one hospitalization for focal epilepsy and an electroencephalogram (between 01/2010 and 12/2019), and at least one prescription of antiseizu

Valentina Perrone,1 Elisa Giacomini,1 Diego Sangiorgi,1 Margherita Andretta,2 Fausto Bartolini,3 Alessandro Lupi,4 Fulvio Ferrante,5 Stefano Palcic,6 Davide Re,7 Luca Degli Esposti1 1CliCon S.r.l. Società Benefit – Health, Economics & Outcome Research, Bologna, Italy; 2UOC Assistenza Farmaceutica Territoriale, Azienda ULSS 8 Berica, Vicenza, Italy; 3Dipartimento Farmaceutico-USL Umbria 2, Terni, Italy; 4ASL VCO, Omegna (VB), Italy; 5ASL Frosinone, Frosinone, Italy; 6Azienda Sanitaria Universitaria Integrata Giuliano-Isontina (ASUGI), Trieste, Italy; 7U.O.C. Servizio Assistenza Farmaceutica Territoriale, ASL Teramo, Teramo, ItalyCorrespondence: Valentina Perrone, CliCon S.r.l. Società Benefit – Health, Economics & Outcome Research, Via Murri 9, Bologna, 40137, Italy, Tel +39 3450316494, Email valentina.perrone@clicon.itPurpose: The study aimed to analyze, in hypercholesterolemic patients under statin medication, patient characteristics and their lipid profile at baseline, the therapeutic pathway, and the pharmaco-utilization, using real-world data in Italy.Patients and Methods: A retrospective study was conducted using administrative databases of a sample of entities covering 6.5 million health-assisted individuals. Between January 2010 and June 2019, patients with non-familial hypercholesterolemia (nFH) were identified by 1) ≥ 1 low-density lipoprotein cholesterol (LDL-C) measurement (LDL-C assessment date was the index-date) and 2) statin prescription during 6 months before the index-date (pharmaco-utilization period). FH patients were defined by LDL-C evaluation, statin treatment during the pharmaco-utilization period, and a score ≥ 6 according to the Dutch Lipid Clinic Network criteria. nFH patients were divided into four exclusive cohorts based on CV-risk class: 1) with previous CV disease (CVD); 2) with diabetes mellitus; 3) with mixed-dyslipidemia diagnosis; 4) in primary-prevention. Based on LDL-C index values, patient was defined with LDL-C

Luca Degli Esposti,1 Chiara Veronesi,1 Domenica Daniela Ancona,2 Margherita Andretta,3 Fausto Bartolini,4 Alberto Drei,5 Alessandro Lupi,6 Stefano Palcic,7 Davide Re,8 Francesca Vittoria Rizzi,2 Elisa Giacomini,1 Valentina Perrone1 1CliCon S.r.l. Health, Economics & Outcomes Research, Bologna, Italy; 2Dipartimento Farmaceutico, ASL BAT, Trani, Italy; 3UOC Assistenza Farmaceutica Territoriale, Azienda ULSS 8 Berica, Vicenza, Italy; 4Dipartimento Farmaceutico, Umbria 2, Terni, 05100, Italy; 5Deloitte, Milano, Italy; 6Cardiology Unit, ASL VCO, Omegna, Italy; 7Farmaceutica Territoriale, Azienda Sanitaria Universitaria Integrata Giuliano-Isontina, Trieste, Italy; 8UOC Assistenza Farmaceutica Territoriale, ASL Teramo, Teramo, ItalyCorrespondence: Valentina Perrone, Clicon Srl, Health, Economics and Outcomes Research, Via Murri 9, Bologna, 40137, Italy, Tel +39 544 38393, Fax +39 544 212699, Email valentina.perrone@Clicon.itPurpose: This real-world study investigates the direct healthcare costs from the perspective of the Italian Healthcare National Service of experienced statin users according to their level of adherence to therapy and to their cardiovascular (CV) profile in Italian settings of outpatients clinical practice.Patients and Methods: A retrospective observational analysis was performed based on administrative databases covering approximately 6 million health-assisted individuals. Adult patients with statins prescription between January 2014 and December 2016 were screened, and first prescription within this period was the index date. Follow-up lasted 1 year after index date. Only patients receiving statins prior index date (experienced statin users) were included and distributed in clusters based on their CV profile. Adherence was calculated during follow-up as proportion of days covered (PDC) and classified in low adherence (PDC< 40%), partial adherence (PDC=40– 79%) and adherence (PDC≥ 80%). Mean direct healthcare costs of drugs, hospitalizations

Valentina Perrone,1 Diego Sangiorgi,1 Margherita Andretta,2 Giuseppe Ducci,3 Bruno Forti,4 Pier Cesare Francesa Morel,5 Marco Gambera,6 Giuseppe Maina,7 Claudio Mencacci,8 Francesco Saverio Mennini,9,10 Enrico Zanalda,11 Luca Degli Esposti1 1CliCon S.r.l., Health, Economics & Outcomes Research, Bologna, Italy; 2UOC Assistenza Farmaceutica Territoriale, Azienda ULSS 8 Berica, Vicenza, Italy; 3Mental Health Department, ASL Roma 1, Rome, Italy; 4Mental Health Department - Azienda ULSS n 1 “Dolomiti”, Veneto Region, Italy; 5Janssen-Cilag SpA, Milano, Italy; 6“OSPEDALE P. PEDERZOLI” Casa di Cura Privata S.p.A., Peschiera del Garda, Verona, Italy; 7Department of Neuroscience “Rita Levi Montalcini”, University of Turin, University Hospital San Luigi Gonzaga, Turin, Italy; 8Department of Neuroscience, ASST Fatebenefratelli Sacco, Milan, Italy; 9EEHTA - CEIS (Centre for Economic and International Studies), Faculty of Economics, University of Rome “Tor Vergata”, Rome, Italy; 10Institute for Leadership and Management in Health Care, Kingston University, London, UK; 11Department of Mental Health ASL TO3 & AOU San Luigi Gonzaga, Collegno, TO, ItalyCorrespondence: Valentina PerroneCliCon S.r.l. Health, Economics & Outcomes Research, via Murri, 9, Bologna, 40137, ItalyTel +39 0544 38393Fax +39 0544 212699Email valentina.perrone@clicon.itPurpose: To analyse the healthcare resource consumption and related costs for the Italian National Health System of patients estimated to be affected by treatment-resistant depression (TRD) in Italy.Patients and Methods: This was an observational retrospective study based on administrative databases, including those related to residential/semiresidential structures, of Veneto Region and the Local Health Unit of Bergamo in Italy (for a total of around 6 million health-assisted subjects). Between July 2011 and December 2017, all adult patients with a third antidepressant (AD) after ≥ 2 AD (each one with at least ≥ 4 we

Valentina Perrone,1 Elisa Giacomini,1 Margherita Andretta,2 Loredana Arenare,3 Maria Rosaria Cillo,4 Marisa Latini,5 Alessandra Mecozzi,6 Romina Pagliaro,5 Adriano Vercellone,7 Luca Degli Esposti1 1CliCon S.r.l. Health, Economics & Outcomes Research, Bologna, Italy; 2UOC Assistenza Farmaceutica Territoriale, Azienda ULSS 8 Berica, Vicenza, Italy; 3UOC Farmaceutica e Territoriale e Integrativa– Asl Latina, Latina, Italy; 4Pharmaceutical Department Local Health Unit (LHU) Salerno, Salerno, Italy; 5U.O.C. Farmaceutica Territoriale – Asl Roma 5, Roma, Italy; 6UOC Farmacia SE/CTO Asl Roma 2, Roma, Italy; 7Department of Pharmacy, Local Health Unit (LHU) Naples 3 South, Napoli, ItalyCorrespondence: Valentina PerroneCliCon S.r.l. Health, Economics & Outcomes Research, via Murri, Bologna, 9 - 40137, ItalyTel +39 0544 38393Fax +39 0544 212699Email valentina.perrone@clicon.itPurpose: To date, litte evidence is reported about the real-life dosage of tyrosine kinase inhibitors prescribed in Italy. The present observational retrospective study aimed to evaluate the mean daily dose of nilotinib prescribed as first- and second-line therapy among patients suffering from chronic myeloid leukemia (CML) in settings of clinical practice in Italy.Patients and Methods: Data were obtained from the administrative databases of a sample of Italian entities. All adult patients prescribed nilotinib were included from January 2013 to December 2016 if they were using it as first-line and from January 2015 to December 2018 as second-line therapy. The mean daily dose was calculated considering the dosage between first and last nilotinib prescription date or last BCR/ABL test date.Results: Among CML patients treated with nilotinib as first-line (N=87), the mean daily dose of nilotinib was 500.5 mg during a mean treatment duration of 798.9 days and of 498.54 mg considering the last determination of BCR/ABL test (mean duration of 811 days). A total of 103 CML patien

Valentina Perrone,1 Elisa Giacomini,1 Diego Sangiorgi,1 Margherita Andretta,2 Anna Michela Menti,2 Mariantonietta Naclerio,3 Daniela Ritrovato,3 Luca Degli Esposti1 1CliCon S.r.l. Health, Economics & Outcomes Research, Ravenna, Italy; 2Health Technology Assessment Unit, Azienda Zero, Padova, Italy; 3Novartis Farma Italy, Origgio, VA, ItalyCorrespondence: Valentina PerroneClicon Srl, Health, Economics and Outcomes Research, Via Salara, 36, 48100, Ravenna, ItalyTel +39 544 38393Fax +39 544 212699Email valentina.perrone@clicon.itPurpose: To analyze the treatment patterns of psoriatic arthritis (PSA) or ankylosing spondylitis (AS) patients under biological therapies and to evaluate in this population the health-care resource consumption and related costs.Patients and Methods: A retrospective analysis was performed on administrative databases of the Veneto region. Patients ≥ 18 years with at least one prescription of biological drugs and a diagnosis at any level for PSA or AS from January 1, 2011 to December 31, 2016 (inclusion period) were included. Index date (ID) was defined as date of first biological drug prescription during inclusion period. Patients were characterized the year before ID and followed-up for one year after ID. The drug utilization profile in terms of adherence, persistence and therapeutic regimen changes, and the health-care resource consumption was analyzed during follow-up.Results: A total of 2602 patients were included: 1857 with PSA and 745 with AS. In the PSA cohort, 40.3% of patients were prescribed adalimumab, 35.6% etanercept, 8.0% golimumab, 7.5% infliximab, 5.6% ustekinumab and 3.0% certolizumab. Percentage of PSA patients adherent to treatment was higher among ustekinumab patients (91.3%) and lower among etanercept users (54.3%). Persistence ranged from 53.2% (infliximab) to 70.3% (etanercept). Regarding AS cohort, 45.5% of patients were prescribed adalimumab, 26% etanercept, 17.3% infliximab, 9.7% golimumab and 1.5% certol

Luca Degli Esposti,1 Valentina Perrone,1 Diego Sangiorgi,1 Stefano Buda,1 Margherita Andretta,2 Maurizio Rossini,3 Giampiero Girolomoni4 1CliCon Srl, Health Economics and Outcomes Research, Ravenna, Italy; 2Pharmaceutical Department Local Health Unit, ULSS 9 Scaligera, Verona, Italy; 3Department of Medicine, Section of Rheumatology, University of Verona, Verona, Italy; 4Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy Objectives: To describe the therapeutic pathways of patients with psoriasis (PSO) and psoriatic arthritis (PsA) before and after treatment with biological therapies in a real-world setting and to determine the relative consumption of health care resources.Design: Retrospective observational study.Setting: Real-life clinical setting in 5 Italian local health units.Participants: A total of 351 male and female patients with at least 1 prescription for a biological drug from January 1, 2010 to December 31, 2013; patients with concomitant rheumatoid arthritis, ankylosing spondylitis, or Crohn’s disease were excluded.Results: The major health care cost (excluding drug costs) was represented by hospitalizations, mainly related to PSO /PsA-associated disorders and cardiometabolic disorders. Use of conventional drugs among biologics-naïve patients reached 50% in PSO and 80% in PsA; their use decreased following initiation of biological therapy. After the start of biological treatment, the incidence of hospitalization decreased both for PSO (from 12.3% to 3.2% in day hospital regimen and from 2.4% to 0.4% for conventional admission) and for PsA (from 11.1% to 8.1% and from 10.1% to 3.0%, respectively). Mean annual costs for hospitalization before biological treatment were €217 and €537 for PSO and PsA, respectively, while mean annual cost for concomitant drugs slightly increased after biologics initiation: from €249.8 to €269.4 for PSO and from €331