Characteristics of Real-World Data Landscape in Italy: A Scoping Review
Author(s)
Nilixa Raval, MDS, MPH1, Nency Joshipura, MD1, Ami Vyas, MBA, MS, PhD2, Amit D. Raval, PhD3.
1Nyra Health LLC, Piscataway, NJ, USA, 2The University of Rhode Island, Kingston, RI, USA, 3University of North Texas Health Science Center, Fort Worth, TX, USA.
1Nyra Health LLC, Piscataway, NJ, USA, 2The University of Rhode Island, Kingston, RI, USA, 3University of North Texas Health Science Center, Fort Worth, TX, USA.
OBJECTIVES: With the rise in the use of real-world data (RWD) in regulatory and reimbursement decision-making, it is essential to understand the availability and characteristics of RWDs. Italy is the third most populous country in the European Union, with a population of 59 million people, primarily covered by universal health coverage. Therefore, we conducted a scoping review to identify and summarize characteristics of distinct RWDs available in Italy.
METHODS: We systematically searched PubMed to identify studies utilizing ≥ 1 RWD published between January 2019 and July 2024, along with a search in European RWD catalogs.
RESULTS: Of 345 identified citations, 141 studies with 60 distinct RWDs met inclusion. Claims were the most commonly utilized type of RWD source, followed by registries, EMRs, and network/consortium. Given the 19 autonomous regions that have administered health insurance systems, regional claims were frequently utilized sources, with Veneto, Campania, Lazio, Caserta, Sicily, and Lombardy being more common ones. IQVIA database also had multi-regional claims and EMR data. Coding semantics include ICD/SNOMED for medical conditions, SNOMED/RxNorm/ATC for medications, and ICD for procedures. In addition, 30 different registries were identified, with rare diseases being the most common, followed by cardiometabolic, oncology, and COVID-19 registries. Three distinct consortium or network databases were identified, with one disease-specific program-based data consisting of chart-review-based data on a cross-sectional snapshot of treatment and disease characteristics. Most databases had a latency period of 6 months to a year. Limited data sources were available in a common data model format.
CONCLUSIONS: The review findings suggest the widespread use of claims databases and registries in Italy, specific to particular regions or selected diseases.
METHODS: We systematically searched PubMed to identify studies utilizing ≥ 1 RWD published between January 2019 and July 2024, along with a search in European RWD catalogs.
RESULTS: Of 345 identified citations, 141 studies with 60 distinct RWDs met inclusion. Claims were the most commonly utilized type of RWD source, followed by registries, EMRs, and network/consortium. Given the 19 autonomous regions that have administered health insurance systems, regional claims were frequently utilized sources, with Veneto, Campania, Lazio, Caserta, Sicily, and Lombardy being more common ones. IQVIA database also had multi-regional claims and EMR data. Coding semantics include ICD/SNOMED for medical conditions, SNOMED/RxNorm/ATC for medications, and ICD for procedures. In addition, 30 different registries were identified, with rare diseases being the most common, followed by cardiometabolic, oncology, and COVID-19 registries. Three distinct consortium or network databases were identified, with one disease-specific program-based data consisting of chart-review-based data on a cross-sectional snapshot of treatment and disease characteristics. Most databases had a latency period of 6 months to a year. Limited data sources were available in a common data model format.
CONCLUSIONS: The review findings suggest the widespread use of claims databases and registries in Italy, specific to particular regions or selected diseases.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD29
Topic
Health Service Delivery & Process of Care, Real World Data & Information Systems, Study Approaches
Topic Subcategory
Data Protection, Integrity, & Quality Assurance, Health & Insurance Records Systems, Reproducibility & Replicability
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), No Additional Disease & Conditions/Specialized Treatment Areas, Oncology, Rare & Orphan Diseases, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)