The Increased Burden of Sickle Cell Disease in Italy: Findings from the Greatalys (Generating Real world Evidence Across ITALy In SCD) Study

Introduction. Sickle Cell Disease (SCD) is an evolving public health issue with a significant impact on patient survival, quality of life and costs for health systems also in Italy, a multiethnic country where epidemiology has deeply changed. We present final results from the GREATalyS study that aimed to better understand the SCD burden in Italy in terms of prevalence, clinical features, treatments and resource consumption in the clinical practice setting. Methods. Retrospective observational analysis of administrative databases for health resources consumption from a representative sample of Region/Local Health Units in Italy, covering approximately 15.3 million inhabitants. All patients with ≥1hospitalization (outside Emergency Room, ER) with main or secondary discharge diagnosis of SCD (with/without crisis) identified by ICD-9-CM codes were included between January-2010 to December-2017 (up to December 2018 for epidemiologic analysis). Prevalence of SCD in 2018 was projected to the Italian population. Patients were followed-up from the first diagnosis identified within the inclusion period (index date) to death or end of data availability. Treatments and healthcare resource consumption were evaluated on patients with at least 1 year of data availability before and after index date. SCD treatments were classified as SCD-specific, SCD-related, SCD-complication-related. Both day hospitals and ordinary hospitalizations were evaluated. Vaso-occlusive crisis (VOCs) (identified by hospitalization discharge diagnosis for SCD with crisis) and main SCD organ complications were assessed during follow-up. Mean annual healthcare resource costs were analyzed during follow-up according to the NHS perspective in terms of overall treatments, all-cause hospitalizations and out-patients services. Results. SCD prevalence in 2018 was 13 cases per 100,000 inhabitants. Prevalence projected to Italian population estimated in total 7,977 SCD patients in Italy in 2018 (of whom 1,690 and 6,287 were Conclusions. This Italian real-world study may have revealed a SCD sub-population probably not noticed yet to SCD centers of reference, and still probably underestimated since ER flows were not present. Similarly, also VOC could be underestimated as only most severe episodes requiring hospitalization were captured. Proportion of patients with antithrombotic agents might be an indicator of the underlying multiorgan complications. The present data describe an SCD population with high resource utilization and heavy economic burden and warrants further efforts to increase an earlier patient identification that could lead to a timely and comprehensive treatment with less SCD-related complications. Figure 1 Figure 1. Disclosures Forni: Bluebirdbio: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Castiglioni: Novartis Farma SpA: Current Employment. Condorelli: Novartis Farma SpA: Current Employment. Valsecchi: Novartis Farma SpA: Current Employment. Premoli: Novartis Farma SpA: Current Employment. Fiocchi: Novaris Farma SpA: Current Employment.