Cost Description on a Cohort of 659 Patients with Adult MDS Included into the Italian Lazio Region Registry (the GROM-L)
Authors: Lazzaro Carlo , Aloe-Spiriti Maria Antonietta , Voso Maria Teresa , Latagliata Roberto , Buccisano Francesco , Fenu Susanna , Maurillo Luca , Ricci Roberto , Fianchi Luana , Zini Gina 
Published: October 2019

Abstract
Intro:Myelodysplastic syndromes (MDS) are a heterogeneous group of hematology neoplasms ranging from indolent to very aggressive conditions. The reported incidence is of 5/100,000/year in the whole population changing up to 50/100,000/year after the age of 60 and up to 165 after 65. Due to the heterogeneity of MDS, patients are stratified into subgroups according to prognostic score systems (IPSS) to identify the best risk-adapted treatment strategy. These therapeutic strategies are not univocally agreed, creating differences among groups. Moreover data on economic aspects are partial and sometimes controversial, owing to different healthcare resources considered (transfusions, medications, procedures, hospitalization, treatment of comorbidities, first of all infectious complications). The adoption of Regional Hemato-Oncology Registries of Diagnostic Service Registries can allow for better quality in diagnostic procedures and treatment as well as improving the evaluation of healthcare costs in these patients.
Methods: In the Italian Lazio Region the Rome and Lazio Group of Myelodysplasias (GROM-L) is presently active as a registry of MDS in adults, exploiting the collaboration of all Hematology Centers in the Region: diagnostic procedures and therapeutic protocols of patients included into this registry are harmonized. In the present study we report the results of the evaluation of costs of the healthcare resources supplied to 659 patients with MDS in the Lazio Region during the period 2002-2009, adopting the ‎ third party payer viewpoint (.e. the Healthy Service of the Lazio Region -SSR Lazio). In Table 1 is reported the distribution of the MDS diagnostic categories in our cohort of patients. The following healthcare resources are included: Red Blood Cell (RBC) and Platelet (Plt) transfusions, Erythropoietic Stimulating Agents, antineoplastic and immunomodulatory drugs, hospitalization and treatment of infectious (bacterial, viral and fungal) complications (Table 2). Healthcare resources are valued according to published ‎sources. Costs are expressed in Euros (€) 2013. Costs occurred after 2002 are discounted at 3% real social rate.
Results:The overall cost for the 659 patients of the GROM-L Registry is €22.05 millions (US$24.21 millions), with an average cost per patient of €33.455,65 (US$ 36.727) (Table 3). The estimated annual cost for the SSR Lazio for the management of all the resident patients with adult MDS (around 183 per year) reaches €1.23millions (US$ 1.35millions). Data on costs related with MDS diagnostic subgroups are available too. In particular our data confirm that the transfusion dependency do represent one of the more valid predictor index of the healthcare costs in patients with MDS (Frytak et al., 2009, Drummond et al. 2005, Goldberg et al. 2012). The reduction of transfusion dependency in these patients do represent a new challenge for improving not simply the healthcare costs but the Health-Related Quality of Life- HRQoL) in these patients (Drummond et al. 2005; Brazier et al. 2007, Szende et al. 2009).
Acknowledgments
The study was supported by a grant from Regione Lazio: " Sindromi mielodisplastiche dell'adulto nell'area di Roma e del Lazio: Grant 2011-Progetti di farmacovigilanza -Area tematica 5". The authors would like to thank all the patients and investigators who took part in the study.
Table 1. Distribution of the 659 patients among the WHO diagnostic categories of MDS. WHO MDS categories RARS RA RCMD RAEB-1 RAEB-2 5q- MDS-U Patients 33 246 148 96 81 27 28
Table 2. Health care resources supplied to 659 patients with adult MDS in the period 2002-2009 included in the Italian Lazio Region. 659 Patients in Total Treatment Quantity Transfusions RBC 7875 Units Plt 74 Units High cost therapies Azacytidine 126 cycles Lenalidomide 34 cycles Erythropoietin 554 cycles Hospitalizations due to infectious complications Antibacterial 345 cycles Antiviral 25 cycles Antifungal 42 cycles
Table 3. Cost details of 659 patients with adult MDS included into the GROM-L Registry in the period 2002-2009 in the Italian Lazio Region. Healthcare resources Overall Costs Average cost per patient % of the overall costs RBC transfusions €3.04 millions €4.606,32 13,77% Plt transfusions €28.619,07 €43.43 0,13% High cost therapies €18.55 millions €28.146,41 84,13% Treatment for infectious complications €0.43 millions €659.50 1,97% Grand total €22.05 millions €33,455.65 100,00%

Disclosures
Voso: Celgene: Honoraria, Research Funding.