88: Accessibility to teduglutide treatment at a single center in Argentina

Introduction: Teduglutide (TED) was approved by the Argentinean government´s regulatory agency (ANMAT) in October 2020 for the treatment of intestinal failure (IF) due to short bowel syndrome. Before its approval, TED was prescribed under compassionate special permit and its coverage was not always granted. Our center started prescribing TED in 2014 for adults and in 2017 for children. In Argentina the health care (HC) is provided by a multi-payer system (public, social security and pre-paid health coverage). Visceral disability (VD) is defined in Argentina as the deficit of an internal organ and the limitations, disadvantages and restrictions that it generates. Chronic IF was included as a VD in 2011 allowing full access to HC coverage including the whole spectrum of chronic IF therapies, from home PN to TED and intestinal transplant. Aim: to describe patients’ demographics and accessibility to TED treatment in adult and pediatric patients at a single center. Methods: retrospective observational study with data extracted form a prospectively filled database comprising all patients treated with TED from 6/2014 to 12/2022. Statistical analysis was done using Mann Whitney test, SPSS 20.Continuous variables are expressed as median and Interquartile range (M/IQR). Results: 26 patients (10 children) were treated with TED in the studied period, all were on home PN and all but one had VD certificate. Four patients (3 children, 1 adult) temporarily discontinued TED due to lack of provision; 3 adults discontinued TED permanently (1 due to lack of coverage, 1 due to lack of adherence, 1 due to lack of clinical response); 1 child and 6 adults electively discontinued TED more than 6 months after achieving intestinal autonomy, and 4 (2 children, 2 adults) are electively under alternating days regime. Table 1 shows type of HC coverage, time form TED prescription to initiation, if an appeal for protection was used for coverage. When analyzing patients that obtained TED through an appeal for protection, time elapsed from prescription to initiation was longer (p 0.13) (appeal for protection (5 patients) median/IQR 17(6.5-23.5) vs.no an appeal for protection median/IQR 4 (3-10) months).Time form from TED prescription to initiation was median/IQR 10(6.2-22.2) months when covered by social security, and median/IQR 4 (3.0-8.8) months when covered by pre-paid health coverage (p 0.042).Time from TED prescription to initiation was median/IQR 4.5 (4.0-8.7) months in children and median/IQR 6 (3-10) months in adults (p 0.39). Patients that started TED after the ANMAT´s approval, obtained it in a significantly shorter period of time (pre-approval median/IQR 9.0 (4.0-20.7) vs. post approval median/IQR 3.5 (3.0-4.0) months, p 0.019). Conclusion: TED treatment in Argentina is covered by the health care system although it is costly. Time to approval was variable according to the type of health coverage. ANMAT´s approval allowed shortening the approval time by HC coverage.