[Not Available].

The role of Real-World Evidence (RWE) concerns the entire drug lifecycle; despite widely recognised in the post-marketing, it is still debated in the pre-marketing, mainly as per the identification and analysis of target populations (TPs) for new drugs or indications. Through administrative healthcare databases, Research and Health Foundation (ReS), in collaboration with experts, develops algorithms to select and analyse TPs. As of March 2024, 85 TPs in 15 clinical areas have been analysed, of which oncology is the most represented.

Clinical characteristics, use and switch of drugs for obstructive airway diseases among patients with COPD experiencing an exacerbation: a retrospective analysis of Italian administrative healthcare data.

Background: Chronic obstructive pulmonary disease (COPD) represents an important health challenge, despite being preventable and manageable thanks to up-to-date recommendations. In Italy, the pharmaceutical care of COPD patients is still ill-timed and inaccurate. This study aimed to describe the treatment of COPD patients in Italy and possible switches following an exacerbation.

[The care pathway of patients with diffuse large B-cell lymphoma described through Italian administrative healthcare data.].

Introduction: The diffuse large B-cell lymphoma (Dlbcl) is the most common non-Hodgkin lymphoma and at highest incidence among the elderly. Despite the improved outcomes of patients treated with the first-line (1L) standard of care until the end of 2022, composed by rituximab and polychemotherapy (R-Chop), during the last 20 years, the rate of relapsed and refractory Dlbcl (rrDlbcl) remains elevated. This study has identified and analyzed patients newly diagnosed with Dlbcl and treated with 1L, from the perspective of the Italian National Health Service (Ssn).

Italian healthcare resource consumption for patients on hemodialysis treated for chronic kidney disease-associated pruritus (CKD-aP).

Background: Chronic kidney disease-associated pruritus (CKD-aP) affects patients on hemodialysis. This study identified hemodialysis patients presumably affected or not affected by CKD-aP and integrated healthcare costs, from the perspective of the Italian administrative healthcare data.

Methods: Through cross-linkage of Italian administrative healthcare data collected between 2015 and 2017 (accrual period) in the database of Fondazione ReS (Ricerca e Salute), patients undergoing in-hospital/outpatient hemodialysis were selected.

[The population affected by neovascular age-related macular degeneration and treated with anti-Vegf through Italian administrative healthcare data.].

Introduction: The neo-vascular age-related macular degeneration (nAmd) is a frequent cause of vision loss, although the intravitreal (Ivt) injections of anti-Vegf (vascular endothelial growth factor) have improved functional outcomes. This study has assessed the healthcare and economic burden on the Italian national health service (Inhs) for patients with nAmd and new users of anti-Vegf.

Methods: From the database of Fondazione Ricerca e Salute (ReS), people aged ≥55 and with an in-hospital diagnosis of nAmd and/or an injection of anti-Vegf (aflibercept, ranibizumab, pegaptanib; index date) in 2018 are selected.

[Community acquired pneumoniae and chronic obstructive pulmonary disease: the RWE analysis of events that required hospitalizations, and healthcare integrated costs.].

Introduction: The community-acquired pneumonia (Cap) and the acute exacerbation of chronic obstructive pulmonary disease (Aecopd) frequently receive wrong therapies, leading to the increase of healthcare consumption resources, direct and indirect costs, and antimicrobial resistance. This study identified Cap and Aecopd hospitalized events, and analyzed them in terms of comorbidities, antibiotic use, re-hospitalizations, diagnostics and costs, from the perspective of the Italian national health service (Inhs).

Methods: From the database of Fondazione Ricerca e Salute (ReS), hospitalizations for Cap and Aecopd from 2016 to 2019.

Acute myeloid leukemia: Incidence, transplantation and survival through Italian administrative healthcare data.

Objective: To identify newly diagnosed patients with acute myeloid leukemia in 2017 treated with intensive chemotherapy or unfit for intensive chemotherapy, and to assess their probability of receiving allogeneic stem cell transplantation and survival, from the Italian National Health Service perspective.

Patients And Methods: From the Ricerca e Salute database, adults with an in-hospital diagnosis of acute myeloid leukemia (International Classification of Disease-9th version-Clinical Modification code 205.0x) in 2017 (index date), without any identifying acute myeloid leukemia criteria within the preceding year, were selected.

[Occurrence of cardiovascular events within a large population of patients affected by rheumatoid arthritis with or without diabetes.].

Introduction: Rheumatoid arthritis (Ra) and diabetes are often associated with chronic multimorbidity and share the high risk of development of major cardiovascular events (Mace). This study aimed to identify and analyse patients with only Ra, Ra + diabetes, and only diabetes, in terms of comorbidities and new occurrence of Cv events, from the perspective of the Italian national health service (Inhs).

Methods: Starting from the Fondazione ricerca e salute (ReS)'s database, through the record linkage of administrative healthcare data, cohorts with only Ra, Ra + diabetes and only diabetes have been selected, characterized (age and sex), and analysed by comorbidity (depression, dyslipidemia, hypertension, hemorrhagic stroke and ischemic stroke/transient ischemic attack - Tia, coronary artery disease - Cad, heart failure - Hf, chronic liver disease, periphery artery disease - Pad, chronic kidney disease, asthma/chronic obstructive pulmonary disease - Copd, neoplasia) and by new Cv events (Hf, Cad and ischemic stroke/Tia) within two follow-up years (Kaplan-Meier curves).

[A view of care pathways approved by Italian Regions, to face the challenge of the community-based healthcare: a quali-quantitative analysis of the Pdta Net database.].

Introduction: The adoption of a Care Pathway (CP) allows the healthcare management of patients suffering from high-epidemiological impact chronic diseases. The continuity of care of these patients is one of the main purposes of the community-based healthcare reform, foreseen in the 6th Mission of the National recovery and resilience plan. Fondazio-ne Ricerca e Salute (ReS) collects and analyses regional CPs approved in Italy, through the Pdta Net database.

Prescription Pattern of Monoamine Oxidase B Inhibitors Combined with Levodopa: A Retrospective Observational Analysis of Italian Healthcare Administrative Databases.

Background: Parkinson's disease is still incurable, and several factors are considered when defining pharmacological therapy.

Objective: The aim of this study was to describe the prescription pattern of monoamine oxidase B inhibitors (MAO-BIs) marketed in Italy (selegiline, rasagiline, safinamide) as an add-on to levodopa among new users of MAO-BIs, from the perspective of the Italian National Health Service.

Patients And Methods: Through cross-linkage of administrative healthcare data in the Ricerca e Salute (ReS) database, adults with a supply of one or more MAO-BIs in 2017, and with no other MAO-BI use since 2013, were selected.

[Uremic pruritus through healthcare administrative data].

This retrospective observational study aimed at describing patients on hemodialysis with/without uremic pruritus (UP), their healthcare resource consumption and costs from the perspective of the Italian National Health Service (INHS). Through the cross-linkage of the healthcare administrative data collected in the ReS (Ricerca e Salute) database from 2015 to 2017, patients undergoing in-hospital/outpatient hemodialysis (index date) for ≥2 years were selected. After the exclusion of subjects with other causes of pruritus, UP/non-UP cohorts were created based on the presence/absence of UP-related treatment supplies and characterized.

Acute lower respiratory infections: real-world evidence of antibiotic prescription pattern and costs from a large administrative Italian database.

Objective: This observational retrospective analysis aimed to describe antibiotic prescription pattern in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and community-acquired pneumonia (CAP) and their costs, from the Italian National Health Service perspective.

Methods: From the ReS database, a cross-linkage of Italian healthcare administrative databases through a unique anonymous code allowed to select subjects aged ≥12 years, supplied with at least an antibacterial for systemic use (ATC code: J01) from 01/01/2017 to 12/31/2017 and evaluable until the end of 2018. Prescriptions of different antibiotics on the same date were excluded.

[Catheter ablation in hospitalized patients diagnosed with atrial fibrillation: real-world evidence from Italian health administrative databases.].

Background: Catheter ablation (CA) is recommended for treating paroxysmal/persistent atrial fibrillation (AF) as an alternative to antiarrhythmic drugs after failure or intolerance, or as first-line in limited cases. This study has described patients affected by AF and treated or not with CA, from the perspective of the Italian National Healthcare System (INHS).

Methods: From the healthcare administrative data collected in the ReS (Ricerca e Salute) database, from 2016 to 2017, patients with main/secondary diagnosis of AF (index date) were split into two cohorts by presence/absence of CA procedure in the same hospital discharge form.

Coronary Artery Disease in Patients Older than 35 and Eligible for Cardiovascular Secondary Prevention: An Italian Retrospective Observational Analysis of Healthcare Administrative Databases.

Background: This study describes patients with coronary artery disease (CAD) who are eligible for secondary prevention and assesses their healthcare consumption and costs from the perspective of the Italian National Health Service (INHS).

Methods: From the Fondazione Ricerca e Salute's database, which collects Italian healthcare administrative data, all patients aged ≥ 35, with ≥1 primary in-hospital CAD diagnosis and/or procedure on the coronary arteries, or with the specific disease exemption code, and who are suitable for long-term secondary prevention treatments, were identified in 2018 and analyzed. Demographics, comorbidities, one-year supplied drugs, hospitalizations, and costs were analyzed.

[Second-generation antipsychotics and cardio-metabolic events: real-world analysis and healthcare costs].

Objective: This analysis has identified and characterized new users of second-generation antipsychotics (SGA) in Italy and has assessed the occurrence of cardio-metabolic (CM) events over 3 years after the SGA starting therapy and the annual healthcare costs, in the perspective of the Italian National Health System (INHS).

Methods: Starting from the Fondazione ReS (Ricerca e Salute)'s database, adults treated with SGA in 2015 (index supply) were selected. By analyzing 2 previous years, treatment incidence and presence/absence of CM diseases or predisposing conditions (PC) to these events were defined and 3 cohorts were identified: A) with CM or predisposing conditions, B) only with PC, C) without neither CM nor predisposing conditions.

[Chronic use of the unfixed combination of ACE-inhibitors and beta-blockers in Italy from 2013 to 2019 through the healthcare administrative data.].

Introduction: The association between an ACE-inhibitor and a beta-blocker is recommended in case of complicated arterial hypertension and heart failure with reduced ejection fraction. This retrospective drug-utilization study has described its chronic use from the Italian National Healthcare Service perspective.

Methods: From the ReS (Ricerca e Salute) database, collecting Italian healthcare administrative data, patients receiving an ACE-inhibitor or a beta-blocker from 2013 to 2019 were selected.

[Mutational oncology of lung cancer: molecular markers, drugs, negotiation conditions and experiences in national reference centers.].

The gradual availability of genomic profiling tests and the "agnostic approvals" from FDA and EMA have opened the oncology mutational model phase, which complements and integrates the traditional hystological approach. The non-small-cell lung cancer (NSCLC) is characterized by many molecular alterations and represents the need of a change from the traditional diagnostic, therapeutic and organisational paradigms to the "mutational" ones. From the Italian National Healthcare System point of view, access and reimbursement of drugs based on the hystological model were managed thorugh the Italian Medicines Agency's (AIFA) monitoring registries and the managed entry agreements: risk-sharing, cost-sharing and payment by results.

Insights into real-world treatment of cluster headache through a large Italian database: prevalence, prescription patterns, and costs.

: This study aimed at estimating the treated cluster headache (CH) prevalence and describing prescription patterns and direct costs paid by the Italian National-Health-System.: Through the ReS database (healthcare administrative data collection of a large sample of the Italian population), adults in treatment for CH (acute therapy with sumatriptan/subcutaneous or oxygen, associated with preventive therapy with verapamil or lithium) were selected. A cross-sectional analysis described the prevalence of CH-treated subjects repeated annually in 2013-2017.

[Therapeutic drug plans: how many and which ones? Overview of a prescriptive and care appropriateness tool.].

Therapeutic plans (TPs) were introduced in Italy in 2004 in order to ensure the continuity in the prescription of new drugs between specialist physicians and general practitioners (GPs). Over the years this prescription tool was updated several times: starting from a paper form without any template ("paper TP") to a template defined by AIFA to collect specific clinical information, up to a web-based form to collect all information into a database. Over time-critical issues concerning its usefulness have been raised, especially when AIFA established several extensions for TP validity to ensure the social distancing required by the covid-19 pandemic.