POS1245 PREVALENCE AND ECONOMIC BURDEN OF PRIMARY SJÖGREN’S SYNDROME IN ITALY: A REAL-WORLD ANALYSIS OF ADMINISTRATIVE HEALTHCARE DATA
Authors: E. Bartoloni, G. Cafaro, C. Perricone, G. Ronconi, S. Calabria, L. Dondi, L. Dondi, A. Pedrini, I. Esposito, R. Gerli, N. Martini
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Primary Sjögren's syndrome (pSS) prevalence is highly variable ranging from 0.02% to 3.5% according to classification criteria, study geographical setting, data collection and study design. The largest population-based studies estimate a prevalence range from 0.01% to 0.05%. Moreover, due to chronic course and concomitant comorbidities, pSS is associated with remarkable costs and work disability as direct consequence of the disease, of delayed disease diagnosis as well reduced physical function. To date, real-world data on pSS prevalence and economic burden in the Italian population have not been evaluated. <h3>Objectives:</h3> To estimate pSS prevalence and its direct burden on the Italian National Health Service (INHS), in terms of healthcare delivered and costs, by the analysis of an Italian administrative healthcare data system. <h3>Methods:</h3> A retrospective analysis by the cross linkage of the administrative healthcare data collected by the Fondazione Ricerca e Salute's database (~5 million inhabitants/year, about 8% of the Italian population beneficiary of the INHS care) and by local and regional Health Authorities (HAs) was performed. People with at least one in-hospital primary or secondary diagnosis of pSS (ICD-9-CM code: 710.2) or with the disease waiver claim (code: 030) in 2018 were identified as affected by pSS. Demographic data, mean healthcare consumptions, drugs supplied, local outpatient specialist services and direct costs at one year following index date (first in-hospital diagnosis/disease waiver claim) were analysed through an individual direct matched pair case-control analysis (age, sex, local HA of residency). <h3>Results:</h3> The study included 1.746 pSS cases and 1.746 matched controls with 3.8/10,000 inhabitants identified as affected by pSS in Italy in 2018 (females 93.6%, mean age 61±13 years). In the year following index date, 53.7% of cases and 42.7% of controls received ≥1 drug (p&lt;0.001); mean per capita cost was €501 and €161, respectively (p&lt;0.01). Immunosuppressants accounted for the highest cost of the total expenditure per case (€ 75/501; 15.0%), followed by antiacids (€ 34/501; 6.7%) and ophtalmologics (€ 24/501; 4.7%). At least one hospitalization occurred to 7.8% of cases and 3.9% of controls (p&lt;0.001) with mean per capita costs of €416 and €129, respectively (p=0.46). The most common hospitalization cause among cases was "diffuse diseases of connective tissue" (34/1,746; 1.9%). Finally, at least one outpatient specialist service was performed in 49.8% of cases, mainly for laboratory tests (43.2%) and general examinations (37.1%), and in 30.6% of controls (p&lt;0.001); mean per capita costs were €200 and €75, respectively (p&lt;0.01). Overall, in the year following index date, the INHS spent € 1,171 per case and € 372 per control (p &lt; 0.01) (Figure 1). <h3>Conclusion:</h3> The study allowed to estimate for the first time the prevalence of pSS in a very large representative Italian sample population. In line with previous population-based studies, disease prevalence resulted 3.8 per 10,000 inhabitants, which may be consistent with an orphan disease. Moreover, in comparison to the general population, pSS exerts a considerable impact on healthcare system with about threefold higher burden in terms of healthcare resource consumption and direct INHS costs related to both disease issues and comorbidities. These findings confirm the need for a multidisciplinary approach to pSS by the Italian HAs, encompassing all aspects of patient care, by including early diagnosis, access to INHS health services and long-term follow-up. <h3>REFERENCES:</h3> <b>NIL.</b> <h3>Acknowledgements:</h3> We thank the Italian Association of people with Sjögren's syndrome (A.N.I.Ma.S.S. ODV - Associazione Nazionale Italiana Malati Sindrome Sjögren) for the unconditional support. <h3>Disclosure of Interests:</h3> <b>None declared.</b>