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In the last decade, novel oral anticoagulants (NOACs) have emerged as prominent therapeutic options in non-valvular atrial fibrillation (NVAF). We analysed the clinical burden and the switching rate between all available NOACs, and their dosage change over a period of 5 years in a representative population of patients with NVAF aged between 70 and 75 years. Methods and Results: This is a retrospective observational study on administrative databases, covering approximately 6.2 million health-assisted individuals by the Italian National Health System (around 11% of the entire Italian residents). Out of 4640 NVAF patients treated with NOACs and aged 70–75 years in 2017, 3772 (81.3%) patients were still in treatment with NOAC up to 2021 and among them, 3389 (73.0%) patients remained in treatment with the same NOAC during 2017–2021. In fact, 10.2% of patients switched NOAC type and 10.3% changed the dose of the same NOAC. Overall, after switching, the dabigatran and rivaroxaban groups lost, respectively, 13.5% and 2.8% of patients, while apixaban and edoxaban resulted in a relative percentage increase of 6.8% and 44.6% of patients, respectively. By a logistic regression analysis, the treatment with rivaroxaban, apixaban, and edoxaban (respect to dabigatran) was associated with a significant risk reduction of switch of 57%, 68%, and 44%, respectively. On the other hand, several features of high risk were associated with dose reduction. Conclusions. In our 5-year analysis of a large administrative database, a switching among NOACs or a change in NOAC dosages occurred in around 20% of elderly patients with NVAF. The type of NOAC was associated with a high switching rate, while several characteristics of high risk resulted as predictors of dose reduction of NOACs. Moreover, a worsening trend of clinical conditions occurred in patients maintaining the same NOAC treatment across 2017–2021.

This real-world analysis conducted on administrative databases of a sample of Italian healthcare entities was aimed at describing the role of therapeutic pathways and drug utilization in terms of adherence, persistence, and therapy discontinuation in HIV-infected patients under antiretroviral therapies (ART) and Tenofovir Alafenamide (TAF)-based regimens on healthcare resource consumption and related direct healthcare costs. Between 2015 and 2019, adults (≥18 years) prescribed with TAF-based therapies were identified and characterized in the year prior to the first prescription (index-date) for TAF-based therapies and followed-up until the end of data availability. Overall, 2658 ART-treated patients were included, 1198 of which were under a TAF-based regimen. TAF-based therapies were associated with elevated percentages of adherence (83.3% patients with proportion of days covered, PDC > 95% and 90.6% with PDC > 85%) and persistence (78.5%). The discontinuation rate was low in TAF-treated patients, ranging from 3.3% in TAF-switchers to 5% in naïve. Persistent patients had lower overall mean annual healthcare expenditures (EUR 11,106 in persistent vs. EUR 12,380 in non-persistent, p = 0.005), and this trend was statistically significant also for costs related to HIV hospitalizations. These findings suggest that a better therapeutic management of HIV infection might result in positive clinical and economic outcomes.

The determinants of the susceptibility to severe acute respiratory syndrome‐coronavirus‐2 (SARS‐CoV‐2) infection and severe coronavirus disease 2019 (COVID‐19) manifestations are yet not fully understood. Amino‐bisphosphonates (N‐BPs) have anti‐inflammatory properties and have been shown to reduce the incidence of lower respiratory infections, cardiovascular events, and cancer. We conducted a population‐based retrospective observational cohort study with the primary objective of determining if oral N‐BPs treatment can play a role in the susceptibility to development of severe COVID‐19. Administrative International Classification of Diseases, Ninth Revision, Clinical ModificationI (ICD‐9‐CM) and anatomical‐therapeutic chemical (ATC) code data, representative of Italian population (9% sample of the overall population), were analyzed. Oral N‐BPs (mainly alendronate and risedronate) were included in the analysis, zoledronic acid was excluded because of the low number of patients at risk. Incidence of COVID‐19 hospitalization was 12.32 (95% confidence interval [CI], 9.61–15.04) and 11.55 (95% CI, 8.91–14.20), of intensive care unit (ICU) utilization because of COVID‐19 was 1.25 (95% CI, 0.38–2.11) and 1.42 (95% CI, 0.49–2.36), and of all‐cause death was 4.06 (95% CI, 2.50–5.61) and 3.96 (95% CI, 2.41–5.51) for oral N‐BPs users and nonusers, respectively. Sensitivity analyses that excluded patients with prevalent vertebral or hip fragility fractures and without concomitant glucocorticoid treatment yielded similar results. In conclusion, we found that the incidence of COVID‐19 hospitalization, intensive care unit (ICU) utilization, and COVID‐19 potentially related mortality were similar in N‐BPs–treated and nontreated subjects. Similar results were found in N‐BPs versus other anti‐osteoporotic drugs. We provide real‐life data on the safety of oral N‐BPs in terms of severe COVID‐19 risk on a population‐based cohort. Our results do not support the hypothesis that oral N‐BPs can prevent COVID‐19 infection and/or severe COVID‐19; however, they do not seem to increase the risk. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Chronic myeloid leukemia (CML) is a hematopoietic myeloproliferative disorder that accounts for 20% of all leukemias of adults. The introduction of tyrosine kinase inhibitors (TKIs) (imatinib, bosutinib, dasatinib, nilotinib, ponatinib) has yielded significant benefits for patients with CML in terms of survival and quality of life. This real-world analysis evaluated the economic burden for managing patients with CML in 2nd or ≥ 3rd TKI lines in Italian settings of clinical practice.A retrospective observational analysis was performed exploiting the administrative databases of a sample of entities covering around 15 million inhabitants. From 2015 to 2018, the study included adult patients with at least one prescription for TKIs, (and for some TKI with at least one hospitalization discharge diagnosis for CML, or at least one prescription for BCR-ABL examination). The index date was the first TKI prescription. Healthcare resource consumption and costs for patients with CML in 2nd and ≥ 3rd line treatment with TKIs were analyzed for drug prescriptions, hospitalizations, specialist visits, and diagnostic services.In total 635 patients were included, 491 in 2nd line and 144 in 3rd line with TKIs. Dasatinib was the most frequently prescribed drug in 2nd line (28.9%) and imatinib in later lines (26.4%). With progressing lines of treatment, healthcare consumption showed a trend towards increased non-TKI prescriptions per patient (8 for 2nd line and 9.7 for ≥ 3rd line). The management of patients with CML in later lines resulted in increased overall healthcare burden, with hospitalizations accounting for about half of total expenditure, whatever the treatment line and type of TKI.This analysis in Italian real-life clinical practice reported economic expenditure for patients with CML in 2nd or ≥ 3rd lines with TKIs, mostly burdened by hospitalizations. Such clinical complexity suggests that further efforts are needed to improve the therapeutic management of later lines of CML.

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 weeks duration, ≥ 1 prescription at maximum dosage reported in datasheets, a grace period ≤ 30 days when switching AD and treatment maintained ≥ 9 months) were included. Overall and psychiatry-related healthcare resources consumption and related costs were estimated on a 12-months based analysis. Data were re-proportioned to the Italian population.Results: We have previously estimated a total of 101,455 patients with TRD in Italy (130,049 considering the mean maximum dosage of AD). Of them, 44.2% had at least a psychiatric hospitalization/visit or accessed a residential/semiresidential structure, and 31% added another AD or a mood stabilizer/antipsychotic drug. Patients with at least one psychiatry-related hospitalization increased over the number of antidepressant lines from 12.0% during first line up to 24.5% during fourth line. Direct healthcare costs increased from € 4,405 for first line to € 9,251 from fifth line onwards. Psychiatry-related costs went from € 1,817 (first line) to € 4,606 (fifth line onwards) and were mainly driven by residential/semiresidential structures and hospitalizations.Conclusion: An upward trend with number of AD lines was observed for all healthcare resource utilization and consequently for all direct costs, thus indicating an increasing burden for patients as they move forward AD lines.Keywords: depression, healthcare costs, real-world, TRD

Background Hyperkalemia is relatively frequent in CKD patients treated with renin-angiotensin-aldosterone-system inhibitors (RAASi). Aim The aim of the present study was to estimate the increased risk of cardiovascular events and mortality due to sub-optimal adherence to RAASi in CKD patients with hyperkalemia. Methods An observational retrospective cohort study was conducted, based on administrative and laboratory databases of five Local Health Units. Adult patients discharged from the hospital with a diagnosis of CKD, who were prescribed RAASi between January 2010 and December 2017, were included. We evaluated the appearance of documented episodes of hyperkalemia, RAASi therapy adherence and the effects of these two variables on cardiovascular events, death and dialysis inception for study patients. Results Of the 9241 selected patients, 4451 met all the criteria for study inclusion. Among them, 1071 had at least one documented episode of hyperkalemia, while 3380 did not. After propensity score matching based on several variables we obtained 2 groups of patients. The appearance of hyperkalemia caused treatment discontinuation in 21.8% of patients previously on RAASi therapy, and sub-optimal adherence (proportion of days covered Conclusions In a large cohort of CKD patients treated with RAASi, we observed that following hyperkalemia onset, non-adherence to RAASi medication can result in an increased risk of cardiovascular events and death. Graphical abstract

Aims The aims of this study were to evaluate if the risk of cardiovascular events and all‐cause mortality was higher in the presence of hyperkalaemia (HK) in patients with heart failure (HF) treated with renin–angiotensin–aldosterone system inhibitors (RAASi), and to investigate in this cohort the increased risk of cardiovascular events and all‐cause mortality among HK patients with non‐optimal adherence to RAASi therapy. Methods and results In this retrospective cohort study based on administrative databases of five Italian Local Health Units, all adult patients with a HF diagnosis between January 2010 and December 2017 were included only if they were prescribed RAASi therapy during the first 3 months after the index date, that corresponded to the date of first HF diagnosis during the inclusion period. Patients were considered to have HK if serum potassium level was ≥5.5 mmol/L. A propensity score matching was applied before evaluation of hazard ratios. Patients with HK were 37% (P

Real world data are becoming a crucial tool to understand how cancer is treated in routine daily practice. This real-world analysis aims to describe the characteristics of patients with CML in 2nd or ≥3rd tyrosine kinase inhibitors (TKI) lines of therapy, to evaluate their treatment sequence and utilization in settings of Italian clinical practice in Italy. A retrospective analysis was performed using an administrative databases covering around 15.3 million cases. All adult patients prescribed with TKI as 2nd or ≥3rd lines (L) of therapy for CML during January 2015–December 2018 were included. A total of 491 patients in 2nd and 144 in ≥3rd L was included. In both cohorts, hypertension was the most reported comorbidity, followed by metabolic and blood count alterations. In each calendar inclusion year, an increment of 97.6% was observed in the number of patients treated in ≥3rd L. In the 2nd L cohort, 18.7% had a switch to 3rd L, while 26.4% of ≥3rd L patients switched to a subsequent line. Around 40% in both lines discontinued their treatment after a median time of 5.5 (2nd L) and 4.3 (≥3rd L) years. The results provided insights into CML management clinical practice, indicating a heavy disease burden for patients in later lines that showed an increasing complex management, and suggest that a need for novel treatment strategies might exists.

To evaluate the prevalence of ankylosing spondylitis (AS) and associated treatment patterns and drug utilization in real-world clinical practice in Italy.This observational study used data from administrative databases of selected Italian entities and included patients with AS diagnosis identified by ICD-9-CM and/or exemption codes. Patients without biologic disease-modifying antirheumatic drug (bDMARD) prescriptions prior to inclusion were defined bio-naïve. A cross-sectional analysis identified treatment patterns from 2016 to 2018. A longitudinal analysis investigated bDMARD utilization (persistence, switch, discontinuing treatment) among bio-naïve patients, with 2014 and 2017 as inclusion periods. Follow-up extended from first bDMARD prescription (index date) to end of data availability.The prevalence of AS was 75.5 per 100,000 (88.3 per 100,000 in adults) in 2018. In total, 5,942 AS patients were identified in 2016, 6,554 in 2017, and 7,146 in 2018. bDMARDs were prescribed to 21.4% (2016), 22.0% (2017), and 16.9% (2018) of the patients. Among the 349 patients included in 2014, 9.5% switched therapies, 13.8% discontinued treatment. In 2017, 12.2% of the 262 patients included switched therapies, 27.1% discontinued treatment.This study provided an up-to-date prevalence of AS diagnosis in Italy. Bio-naïve patients showed an increasing tendency toward switch of therapy and discontinuation.

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 “controlled” if its levels were ≤ 70mg/dl (CVD), ≤ 100mg/dl (diabetes, FH), ≤ 130mg/dl (mixed-dyslipidemia, primary-prevention).Results: Overall 164,161 nFH patients were included (mean age 72 years, 51% male); of these, 46,782 (28.5%) were CVD (mean age 74 years, 66% male), 34,803 (21.2%) were diabetic (mean age 72 years, 51% male), 1617 (1%) were with mixed-dyslipidemia (mean age 71 years, 48% male) and 80,959 (49.3%) were in primary-prevention (mean age 71 years, 42% male). The proportion of nFH patients with controlled LDL-C was 41.2% for CVD, 73.6% for diabetic, 80.7% for mixed-dyslipidemia, and 79.5% for primary-prevention patients; 49% of nFH patients were adherent to therapy. Overall, 1287 FH patients (mean age 64 years, 42% male) were included; in 39.2% of the patients, LDL-C was controlled, and 44% of the patients were adherent to therapy.Conclusion: The results of this study highlighted non-optimal therapeutic management of hypercholesterolemic patients in Italian clinical practice, with a notable quote of patients non-adherent to therapy.Keywords: lipid-lowering agents, pharmacoutilization, real-world evidence, clinical practice

Real-world data can inform the use of biologics for psoriasis (PSO).The aim was to evaluate treatment patterns and analyze pharmacoutilization in PSO patients in a real-world Italian setting, with a focus on the biologics most recently introduced.An observational study based on administrative databases was conducted. Patients were included based on PSO diagnosis identified by either discharge diagnosis or exemption code or prescription of anti-psoriatic topical drugs (proxy of diagnosis). To describe patient characteristics and treatment patterns using the most up-to-date data, two different approaches were used: a cross-sectional study performed during 2016-2018, and a longitudinal study conducted with patients who received their first biological/targeted synthetic drugs (naïve patients) in 2014 and 2017 (the inclusion periods).During 2016-2018, the number of prevalent patients diagnosed with PSO was 194,054 (2016), 210,830 (2017), and 225,171 (2018). The percentage of patients receiving biologics or targeted synthetic agents ranged from 1.5 to 2.1%. Among them, naïve patients receiving interleukin (IL) inhibitors increased from 37.5% (2016) to 69.4% (2018), while those receiving anti-tumor necrosis factor (anti-TNF) decreased from 62.5% (2016) to 30.6% (2018). The longitudinal analysis included 894 and 1218 naïve patients in 2014 and 2017, respectively, of whom 7.2% (2014) and 6.9% (2017) switched therapy after a mean of 7.1 (2014) and 6.9 (2017) months. Overall, 259 patients were prescribed ixekizumab starting in 2017, of whom 73% were naïve. Ixekizumab was prescribed as monotherapy to 52.5%.The proportion of patients receiving biologics appeared constant over the years, with an increasing number of naïve patients being prescribed IL-17 inhibitors. Ixekizumab patients were mostly naïve.

Objectives: Aim of the study was to describe the use and pharmacoutilization profiles of recommended drugs for HF patients, hospital re-admission rates, mortality rates and determine healthcare res...

Background: The aim of this study is to assess treatment patterns and pharmaco-utilization in patients with psoriatic arthritis (PsA) in Italy. Methods: A retrospective analysis using administrative databases of six Local Health Units was performed. All adult patients with PsA diagnosis and ≥1 prescription for biologic/targeted-synthetic (b/ts) disease-modifying antirheumatic drugs (DMARDs) from January 2010 to March 2017 were included. The date of first b/tsDMARD prescription was defined index-date. Follow-up lasted 1-year post index-date. Patients without b/tsDMARDs prescription pre index-date were defined bionaïve. Results: Of the 1,056 patients included, 33% received adalimumab, 30% etanercept, 10% golimumab, 9% secukinumab, 7% infliximab, 6% ustekinumab, 4% certolizumab, and 1% apremilast. During follow-up, persistence with b/tsDMARDs was observed in 79.8% of patients, 10.8% switched therapies, dose change occurred in 15.8% of patients, 47.4% received an add-on. Among bionaïve patients (n = 591), 67.0% were persistent with b/tsDMARDs, 10.1% switched therapy, 14.5% required a dose change and 45.8% an add-on. Discontinuation was observed in 10.6% of total PsA population and in 24.8% of bionaïve patients. Conclusion: This analysis provided insights on drug utilization patterns for PsA in an Italian real-world setting. Our results show that treatment regimen changes occur in a high proportion of PsA patients.

Objective. To provide estimates of patients with rheumatoid arthritis (RA) eligible for biotechnological therapy and to evaluate their healthcare costs. Method. An observational analysis was performed based on data-linkage between administrative databases of selected Italian Regional/Local healthcare departments. Data were then re-proportioned to the Italian population. Patients with RA diagnosis defined by discharge diagnosis and/or exemption code during 01/01/2013- 31/12/2017 were included. The criteria applied to evaluate the elegibility for biotechnological therapy were: 1) methotrexate (MTX)-treatment failure ≥6 months and start of a different conventional-synthetic diseasemodifying antirheumatic drugs (csDMARD); 2) corticosteroid ≥6 months with dosage ≥7.5 mg/die; 3) MTX-contraindication (therapy or hospitalization for renal damage/interstizial lung disease/hepatic failure). Mean annual costs per patient included drugs, hospitalizations, outpatient services. Results. Data re-proportioned to the Italian population estimated 318,328 RA patients: 43,361 with, 274,967 without biotechnological agents. Among the latter, 26,487(9.6%) patients met ≥1 criteria applied for eligibility: 1,896 had MTX-treatment failure and started another csDMARD; 15,833 received corticosteroid ≥7.5 mg/die; 7,788 had MTX-contraindication. Regarding patients fulfilling two criteria, 107 had MTX-treatment failure followed by another csDMARDs and corticosteroid ≥7.5 mg/die, 53 were treated with another csDMARDs after MTX-treatment failure and also presented MTX-contraindication, 810 had corticosteroid ≥7.5 mg/die and MTX-contraindication. Mean total annual costs for patients estimated eligible for biotechnological therapy was € 3,132, of which € 177 related to drugs indicated for RA and € 2,955 related to other direct costs. Conclusions. According to our estimates, around 10% RA patients not currently treated with biotechnological agents are eligible for such therapies, highlighting a trend of under-use in clinical practice for RA management.

As primary aim the study evaluated the monthly average dose for biologic drugs used for psoriasis (PSO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in real-world settings.This retrospective analysis was based on administrative databases of Italian Entities. Adult patients diagnosed PSO, PsA or AS with ≥1 prescription of biologic drugs indicated for these diseases were included during 01/01/2011 - 30/06/2017. Monthly average dose and persistence were evaluated during 6-months after inclusion (follow-up).Overall, 6,179 patients prescribed biologic drugs were included: 2,373 represented the 1.1% of PSO-patients, 2,756 the 37.4% of PsA-patients, 1,050 the 17.8% of AS-patients. Monthly average dose was: 69 mg (PSO), 73 mg (PsA), 70 mg (AS) for adalimumab; 152 mg (PSO), 155 mg (PsA), 147 mg (AS) for etanercept; 140 mg (PSO), 133 mg (PsA), 166 mg (AS) for infliximab; 255 mg (PSO), 183 mg (PsA), 154 mg (AS) for secukinumab. Persistance to adalimumab was 76%(PSO), 78%(PsA), 74%(AS); with etanercept 77% in each disease-cohort; with infliximab 67%(PSO), 71%(PsA), 88%(AS); with secukinumab 91%(PSO) and 85%(PsA).The study described real-world dosing patterns of biologics indicated for PSO, PsA, or AS, suggesting a trend of monthly average dose generally lower than the dosage indicated in the datasheet.

This retrospective observational study aimed to provide insights on the use of clinical nutrition (CN) (enteral and parenteral feeding) and outcomes in an Italian real-world setting. The data source comes from administrative databases of 10 Italian Local Health Units. Patients diagnosed with malignant neoplasms from 1 January 2010 to 31 December 2015 were included. Metastasis presence was ascertained by discharge diagnosis in the hospitalization database. CN was identified by specific codes from pharmaceutical and hospitalization databases. Two cohorts were created&mdash, one for metastatic patients (N = 53,042), and one for non-metastatic patients (N = 4379) receiving CN. Two survival analyses were set for the cohort of metastatic patients&mdash, one included patients receiving CN and the second included malnourished patients. Our findings show that (1) administration of CN is associated with positive survival outcomes in metastatic patients with gastrointestinal, respiratory, and genitourinary cancer, (2) CN in malnourished metastatic patients with gastrointestinal and genitourinary cancer was associated with significant improvement in survival, (3) early administration of CN was associated with improvement in survival in non-metastatic patients with gastrointestinal cancer (HR 95%CI: 0.5 (0.4&ndash, 0.6), p-value &lt, 0.05). This study highlights the need to improve the assessment of nutritional status in oncologic patients and suggests a potential survival benefit of CN treatment in metastatic disease.

Background and importance Novel treatment approaches for the management of severe refractory asthma include monoclonal antibodies (Mabs). Aim and objectives The study aimed to estimate the number of the most suitable patients with severe uncontrolled asthma who are eligible for new Mabs therapy and related costs in the Veneto region (Italy). Material and methods The regional administrative database was retrospectively analysed to identify specific eligibility and assessment criteria. All patients aged ≥6 years with an exemption code for asthma (007) (level 1 patients (L1)) between 1 January 2011 and 31 December 2016 were screened. The following parameters were considered in succession: spirometry (codes: 89.37, 89.38)–(level 2 patients (L2)); inhaled corticosteroids (ICS) in combination with long acting beta adenoreceptor agonists (LABA) and/or theophylline (ATC: R03DA04), and/or antileucotriene (ATC: R03DC), and/or anticholinergics (ATC: R03BB)–(level 3 patients (L3)); high dose ICS therapy (ATC: R03BA, R03AK)–(level 4 patients (L4)); adherence to each medication–(level 5 patients (L5)); asthma hospitalisation (ICD9: 493) or treatment with systemic corticosteroids (ATC: H02)–(level 6 patients (L6)). For each patient level, the mean annual healthcare costs per patient, based on total resource consumption, were assessed. Results For a total of 4.6 million beneficiaries, aged ≥6 years, 103 138 (2.2%) patients were screened (L1). Spirometry tests were prescribed in 28 611 patients (27.7%) (L2), of whom 13 432 (46.9%) had a prescription for ICS with LABA or other agents (L3). In 5782 (43%) patients treated with previous combinations, high dose ICS therapy was prescribed (L4), and of them, 3307 (57.2%) were treatment adherent (L5) and 1136 (35.2%) had a hospital admission for asthma or treatment with systemic corticosteroids (L6). For this last level of patients, centres specialising in Mabs prescription evaluated eligibility. Total costs of the illness according to disease progression were €1279.6 for L1, €1567.7 for L2, €2045.3 for L3, €2524.2 for L4, €3233.2 for L5 and €4326.2 for L6; overall asthma related treatment and hospitalisation costs were €274.2 for L1, €400.1 for L2, €598.5 for L3, €784.3 for L4, €1118.4 for L5 and €1449.9 for L5. Conclusion and relevance This analysis allowed estimation of the number of asthma patients eligible for Mabs therapy in the Veneto region. Our findings on healthcare costs highlighted that the average cost per patient increased by severity level. Post marketing, it will be possible to assess the appropriateness of Mabs prescriptions through indicators such as over- and under-use. References and/or acknowledgements No conflict of interest.

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% certolizumab. Adherence ranged from 46.9% (etanercept) to 90.9% (certolizumab) and persistence from 62.8% (adalimumab) to 81.8% (certolizumab). Mean annual health-care costs (including costs for drug treatment, diagnostic services, specialist visits and hospital admissions) ranged from € 9727 (certolizumab) to € 14,994 (ustekinumab) among PSA patients and from € 9875 (infliximab) to € 12,991 (golimumab) among AS patients.Conclusion: This study in Veneto region gave a picture of biological treatment patterns among PSA and AS patients in a real-world setting. Our findings showed the high degree of variability concerning utilization of each biological drug and provided insight on the economic burden of both diseases.Keywords: psoriatic arthritis, ankylosing spondylitis, biologic drugs, drug utilization, real-world

Background The use of real-world data in oncology is gaining increasing interest, as it can provide valuable insights into treatments and related outcomes in routine daily oncology practice, thus integrating the evidence coming from clinical trials. The study aims to describe the characteristics of patients (pts) with chronic myeloid leukemia (CML) in 2 nd or ≥3 rd tyrosine kinase inhibitors (TKI) lines of therapy, analyze their drug utilization and evaluate healthcare direct costs for the Italian National Health Service in order to estimate the impact of disease burden. Methods This retrospective observational analysis was based on administrative databases covering around 15.3 million subjects in Italy. All adult pts with prescription of the TKIs bosutinib (BOS), dasatinib (DAS), imatinib (IMA), nilotinib (NIL), ponatinib (PON) in 2 nd or ≥3 rd line of therapy during 01/2015-12/2018 were included. Specifically, those with IMA, DAS or PON prescription were enrolled if they also presented ≥1 CML hospitalization or previous prescription for NIL or BOS or ≥1 BCR-ABL1 RQ-PCR test without hospitalization for acute lymphoid leukemia. Pts enrolled in clinical trials were not captured. Index date was 1 st prescription date for a TKI in 2 nd or ≥3 rd line. Comorbidities were assessed by hospitalization diagnosis codes and/or presence of specific drugs as proxy of diagnosis. Mean annual healthcare resource costs were evaluated during follow-up (from index date to end of study) in terms of drugs other than TKI (excluded), visits, tests, hospitalizations (overall and comorbidity-related during treatment). Results Overall, 491 pts in 2 nd and 144 in ≥3 rd line were included. In each calendar year from 2015 to 2018, the incidence of pts who entered a 2 nd line changed from 22.6% to 28.7%, whereas the ≥3 rd line fluctuated from 37% to 46.7%. An increment of 97.6% was observed in the number of pts treated in ≥3 rd line from 2015 to 2018 (figure 1). As 2 nd line, 40.9% was represented by DAS, 28.9% NIL, 12.2% BOS, 10.2% PON and 7.8% IMA. Mean age ranged from 56.1 (PON) to 68.2 (BOS) years. At baseline, hypertension was the most reported comorbidity (from 64.1% for NIL to 91.7% for BOS), followed by metabolic (from 27.9% in DAS pts to 63.2% for IMA) and blood count (from 28.4% for DAS to 58.0% for PON) alterations. Among pts in ≥3 rd line, 26.3% received imatinib, 22.2% PON, 18.8% NIL, 16.7% BOS, 16% DAS. Mean age was 57 years for NIL, 64.8 PON and 69.5 BOS pts. Same trend of comorbidities was reported in the ≥3 rd line cohort, with hypertension detected in all pts starting BOS to a minimum of 65.2% pts in DAS group, followed by blood count alteration (34.8% for DAS to 59.4% for PON) and metabolic alterations (37.0% for NIL to 50.0% for BOS). Baseline cardiovascular comorbidities were present in 22.8% of pts starting a 2 nd line and in 35.4% of pts starting ≥3 rd line. After a median follow up of 3.0 and 2.6 years, 13% and 19% of pts died in 2 nd and ≥3 rd lines, respectively, around 40% in both lines discontinued their treatment. Median time to discontinuation was 5.5 (95%CI: 4.7-6.2) (2 nd line) and 4.3 (95%CI: 3.2-5.2) (≥3 rd line) years. Mean number of annual hospitalizations was 0.6 (from 0.4 for NIL to 1.1 for PON) in 2 nd line, and 0.5 (from 0.4 for IMA and NIL to 0.7 for PON) in ≥3 rd line. Total mean annual costs/pts (TKI excluded) were of €10,168 (PON), €6,106 (BOS), €5,086 (DAS), €4,779 (NIL) and €3,905 (IMA), with hospitalizations comorbidity-related accounting for €3,245 among PON, €2,820 BOS, €1,739 NIL, €1,573 DAS and €1,448 IMA pts. Mean annual costs per lines are shown in figure 2. Conclusions This real-world study provided a demographic and clinical profile of CML pts in 2 nd and ≥3 rd TKI lines and described drug utilization and resource consumption in the Italian clinical practice setting. An increase of pts treated with TKIs in ≥3 rd line was reported, reflecting the availability of multiple TKIs over the years; moreover, a highly comorbid population suggests an increasingly complex CML management. Our results underlined a heavy clinical and economic burden for pts in 2 nd or ≥3 rd lines, especially in terms of comorbidities, treatment discontinuation and hospitalizations suggesting the need of novel therapeutic options for management of later lines CML. Figure 1 Figure 1. Disclosures Breccia: Novartis: Consultancy; Pfizer: Consultancy; BMS: Consultancy; INCYTE: Consultancy; Abbvie: Consultancy. Chiodi: Novartis: Current Employment. Valsecchi: Novartis Farma SpA: Current Employment. Rendace: Novartis Farma S.p.A.: Current Employment. Coco: Novartis Farma S.p.A.: Current Employment. Premoli: Novartis Farma SpA: Current Employment.

Diego Sangiorgi,1 Valentina Perrone,1 Stefano Buda,1 Lucio Boglione,2 Giuseppe Cariti,2 Cinira Lefevre,3 Carmela Nappi,4 Luca Degli Esposti1 1Health, Economics and Outcomes Research, CliCon Srl, Ravenna, Italy; 2Unit of Infectious Diseases, Department of Medical Sciences, Amedeo di Savoia Hospital, Universityof Turin, Turin, Italy; 3Center of Observational Research and Data Sciences, Bristol-Myers Squibb, Rueil-Malmaison, France; 4Health Economics, Bristol-Myers Squibb S.r.l., Rome, Italy Objective: The objectives of this study were to estimate the prevalence of Hepatitis C among six Italian Local Health Units (LHUs), to describe patient and antiviral drug characteristics, and to estimate the health care consumption rates and related costs for the management of patients affected by hepatitis C virus (HCV) infection by using data from routine clinical practice.Methods: We conducted a retrospective study using administrative databases of six Italian LHUs. All patients who had a record related to HCV during the enrollment period (July 1, 2009, to December 31, 2014) and who had at least 6 months of data available prior to the first HCV record were included. The date of the first record related to HCV during the enrollment period was considered as a proxy of diagnosis and used as the index date. Patients were followed from the index date up to 1 year, death, or exiting the database. Using the overall cohort of HCV adult patients as the numerator, we estimated the prevalence of HCV among six LHUs. The denominators were obtained from the National Institute of Statistics (N=1,665,682). We also evaluated descriptive patient’s characteristics and treatment patterns, and estimated health care consumption rates and related costs for the management of the HCV patients. Results: A total of 7,550 patients were analyzed, of whom 57% were male with a mean age of 57.6±16.4 years. The prevalence of HCV was estimated to be 0.45% (95% confidence interval 0.44–0.46). During the follow-up period, 78.6% of HCV patients had received no antiviral treatment. The annual health care cost associated with HCV infection was €6,022.7 (±7,922.6) while the cost specific to HCV care was €3,154.6 (±4,972.0)Conclusion: Our findings showed that, in the Italian real-world setting, only a small proportion of HCV-infected patients received an antiviral treatment. Despite the current low prevalence of HCV, the economic impact of such disease remains high. Keywords: hepatitis C virus infection, prevalence, antiviral drug, health care resources use, real-world data

Valentina Perrone,Diego Sangiorgi,Stefano Buda,Luca Degli Esposti Clicon S.r.l. Health, Economics & Outcomes Research, Ravenna, Italy Aim: The objectives of this study were to: 1) analyze the drug utilization pattern among adult psoriasis patients who were newly prescribed with topical medication; and 2) assess their adherence to topical therapy and the possibility of switching to other strategies in the treatment process. Methods: An observational retrospective analysis was conducted based on administrative databases of two Italian local health units. All adult subjects who were diagnosed with psoriasis or who were newly prescribed for topical medication with at least one prescription between January 1, 2010, and December 31, 2014, were screened. Only patients who were “non-occasional users of topical drugs” (if they had at least two prescriptions of topical drugs in a time space of 2 years) were considered for the first and second objectives in the analysis. The date of the first prescription of topical agents was identified as the index date (ID), which was then followed for all time available from ID (follow-up period). The adherence to therapy was assessed on the basis of cycles of treatment covered in the 6 months before the end of the follow-up period. The mean health care costs in patients who switched to disease-modifying antirheumatic drugs (DMARDs) or biologics after the ID were evaluated. Results: A total of 17,860 patients with psoriasis who were newly prescribed for topical medication were identified. A total of 2,477 were identified as “non-occasional users of topical drugs”, of whom 70.2% had a prescription for a topical fixed combination regimen at ID. Around 19% adhered to their medication, whereas 6% switched to other options of psoriasis treatment. Multivariable logistic regression model shows that patients on fixed combination treatment were less likely to be non-adherent to treatment and less likely to switch to other treatments. The annual mean pharmaceutical costs were €567.70 and €10,606.10 for patients who switched to DMARDs and biologics, respectively. Conclusion: Our findings show that the use of fixed combination topical treatment can lead to improve the likelihood of patients being adherent to treatment and can decrease the likelihood of switching the treatment to DMARDs or biologics. Keywords: psoriasis, topical antipsoriatic drugs, real-world data

The presence of hyperkalemia (HK) in patients with heart failure (HF)or chronic kidney disease (CKD) increases the risk of death. The aims of the present study have been: i) to evaluate if the risk of cardiovascular (CV) events and mortality increases in two cohorts of patients with heart failure (HF) or chronic kidney disease (CKD) affected by hyperkalemia (HK) and treated with renin-angiotensin-aldosterone system inhibitors (RAASi). We have also evaluated the risk of dialysis among CKD patients; ii) to provide an estimate of the increased risk of CV events and mortality caused among HK patients by a non-optimal adherence to RAASi therapy in both HF and CKD cohorts. This is a retrospective study, based on the administrative databases of five Italian Local Health Units. All patients ≥18-year-old discharged from hospital with a diagnosis of HF (ICD-9-CM 428) or CKD (ICD-9-CM585) between January 2010 and December 2017 were enrolled. We defined as index date (ID) the date of first diagnosis during the enrolment period. Only patients that were prescribed RAASi therapy during the first three months after the ID were considered. Serum potassium level was tested in the three months before and after ID. The patients were considered as having HK if they presented a serum potassium level ≥5.5 mmol/l. Results show that patients with HK treated with RAASi were respectively 46% (HF) and 31% (CKD) more at risk of CV events and 88% (HF) and 72% (CKD) more at risk of dying. Moreover, the risk of dialysis in CKD patients increased by 458%. After the onset of HK, non-optimal adherence to RAASi in patients with HK was found to increase notably the risk of CV events (65% HF, 34% CKD) and mortality (127% HF, 122% CKD) in both cohorts.

This study aimed to evaluate the treatment patterns and pharmacoutilization of patients with rheumatoid arthritis (RA) in real-world settings in Italy. This retrospective observational analysis was based on administrative databases of selected Italian entities. All adult patients with RA diagnosis confirmed by ≥1 discharge diagnosis of RA (ICD-9-CM code = 714.0) or an active exemption code (006.714.0) were enrolled in 2019. Two cohorts were created: one included patients prescribed baricitinib, the other those prescribed biological disease-modifying antirheumatic drugs (bDMARDs). Overall, 47,711 RA patients were identified, most of them without DMARD prescription. As a first-line prescription, 43.2% of patients were prescribed conventional synthetic DMARDs (csDMARDs), 5.2% bDMARDs and 0.3% baricitinib. In 2019, 82.6% of csDMARD users continued with the same DMARD category, 15.9% had a bDMARD, while 1.5% had baricitinib as second-line therapy. Overall, 445 patients used baricitinib during 2019. During follow-up, baricitinib was prescribed as monotherapy to 31% of patients, as cotreatment with csDMARDs and corticosteroids to 27% of patients, with corticosteroids to 28% of patients and with csDMARDs to 14% of patients. In line with previous findings, a trend of bDMARD undertreatment was observed. The treatment patterns of baricitinib patients could help to better characterize patients eligible for new therapeutic options that will be available in the future.

Objective This study aimed to evaluate prevalence of prescription of and adherence to selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) and whether adherence to these classes of drugs affects overall medication adherence in older persons. Methods In a cross-sectional analysis of administrative data comprehensive of all prescribed drugs reimbursed by the Italian national health care system, new prescriptions of SSRIs and SNRIs to persons aged 65 years or older were analyzed (n = 380,400 in 2011; 395,806 in 2012; 409,741 in 2013, from a total sample of 3,762,299 persons aged 65 years or older) as well as prescriptions of antihypertensives, statins, other psychiatric drugs, antidiabetics, antiplatelets, anticoagulants, drugs for chronic obstructive pulmonary disease, and antiosteoporotics. Adherence was estimated by calculating the proportion of days covered by drugs dispensed during a period of 365 days. Adherence was defined as a proportion of days covered of more than 80%. Results Prevalence of SSRI and SNRI prescriptions varied from 11.4% in 2011 to 12.1% in 2013. Adherence to SSRI and SNRI prescriptions ranged from 31.2% in persons aged ≥ 95 years in 2011 to 41.8% in persons aged 75-84 years in 2013. Persons adherent to SSRI and SNRI prescriptions were more likely to be adherent to the other medications, after adjustment for age, gender, and number of drugs prescribed. The highest association was found for adherence to psychiatric drugs (OR = 1.9; 95% CI, 1.8-2.0). Conclusions Adherence to SSRI and SNRI prescriptions is poor in older persons. However, people adherent to these classes of antidepressants are more likely to be adherent to the other medications they are prescribed. Studies are needed to evaluate the reasons for and the potential benefits of increasing adherence to antidepressants on overall adherence.

Luca Degli Esposti,1 Ennio Giulio Favalli,2 Diego Sangiorgi,1 Roberta Di Turi,3 Giuseppina Farina,4 Marco Gambera,5 Roberto Ravasio,6 1CliCon S.r.l. – Health, Economics& Outcomes Research, Ravenna, 2Department of Rheumatology, Istituto Ortopedico Gaetano Pini, Milan, 3Local Pharmaceutical and Supplementary Assistance Unit, Roma Local Health Authority D, Rome, 4Internal Management Control Unit – Pharmaceutical Spending Control Sector, Caserta Local Health Authority, Caserta, 5Local Pharmaceutical Service, Bergamo Local Health Authority, Bergamo, 6Health Publishing & Services Srl, Milan, Italy Objectives: The aim of this analysis was to provide an estimate of drug utilization indicators (persistence, switch rate and drug consumption) on biologics and the corresponding costs (drugs, admissions and specialist care) incurred by the Italian National Health Service in the management of adult patients with rheumatoid arthritis (RA).Methods: We conducted an observational retrospective cohort analysis using the administrative databases of three local health units. We considered all patients aged ≥18years with a diagnosis of RA and at least one biologic drug prescription between January 2010 and December 2012 (recruitment period). Persistence was defined as maintenance over the last 3months of the follow-up period of the same biological therapy administered at the index date. A switch was defined as the presence of a biological therapy other than that administered at the index date during the last 3months of the follow-up period. Hospital admissions (with a diagnosis of RA or other RA-related diagnoses), specialist outpatient services, instrumental diagnostics and pharmaceutical consumption were assessed.Results: The drug utilization analysis took into account only biologics with at least 90 patients on treatment at baseline (adalimumab n=144, etanercept n=236 and infliximab n=94). In each year, etanercept showed better persistence with initial treatment than adalimumab or infliximab. Etanercept was characterized by the lowest number of patients increasing the initial drug consumption (2.6%) and by the highest number of patients reducing the initial drug consumption (10.5%). The mean cost of treatment for a patient persisting with the initial treatment was €12,388 (€14,182 for adalimumab, €12,103 for etanercept and €11,002 for infliximab). The treatment costs for patients switching from initial treatment during the first year of follow-up were higher than for patients who did not switch (€12,710 vs. €11,332).Conclusion: Persistence, switch rate and drug consumption seem to directly influence treatment costs. In subjects not persisting with initial treatment, other health care costs were approximately three times higher than for persistent patients. This difference could suggest a positive effect on the quality of life for persistent patients. Etanercept showed the highest persistence with treatment. Keywords: rheumatoid arthritis, biologic drugs, real-life clinical conditions

Valentina Perrone, Diego Sangiorgi, Stefano Buda, Luca Degli Esposti CliCon S.r.l. Health, Economics andOutcomes Research, Ravenna,Italy Aim: The objective of this study was to evaluate the different outcomes associated with the use of budesonide/formoterol compared to fluticasone/salmeterol in fixed combinations in patients with COPD in a “real-world” setting. The outcomes included exacerbation rates and health care costs.Patients and methods: An observational retrospective cohort analysis, based on administrative databases of three local health units, was conducted. Patients with at least one prescription of fixed-dose combination of inhaled corticosteroids and long-acting β2-agonists (budesonide/formoterol or fluticasone/salmeterol), at dosages and formulations approved for COPD in Italy, between January 1, 2009 and December 31, 2011 (inclusion period), were included. Patients were followed until December 2012, death or end of treatment (follow-up period), whichever occurred first. Patients were included if they were aged ≥40years and had at least 6months of follow-up. Propensity score matching was performed to check for confounding effects. Number of hospitalizations for COPD and number of oral corticosteroid and antibiotic prescriptions during follow-up were analyzed using Poisson regression models. The cost analysis was conducted from the perspective of the National Health System.Results: After matching, 4,680 patients were analyzed, of which 50% were males with a mean age of 64±13years. In the Poisson regression models, the incidence rate ratio for budesonide/formoterol as compared to fluticasone/salmeterol was 0.84 (95% confidence interval [CI]: 0.74–0.96, P=0.010) for number of hospitalizations, 0.89 (95% CI: 0.87–0.92,P