Assessing drug cost avoidance in clinical trials: An observational study in a Spanish tertiary hospital.

Abstract

8 Background: Clinical trials (CTs) are pivotal to progress in cancer treatments, but their benefits reach further. Economically, they contribute to the sustainability of the healthcare system through drug cost avoidance (DCA). Despite its importance, the literature quantifying this economic advantage remains sparse. The aim of this study was to assess the DCA in a tertiary-level hospital in the northwest of Spain. Methods: We conducted a retrospective observational study of CTs in a tertiary-level hospital between January 2020 and December 2022. The study included CTs carried out by the Oncology Department involving patients undergoing active treatment, with a comparator provided by the sponsor, and with an impact on the avoided cost in the hospital budget. The therapeutic alternative was agreed upon by a multidisciplinary team of oncologists and pharmacists. The estimation of the DCA considered the theoretical administrations of the therapeutic alternative that the patient would have received if not included in the CT. The selling price of the considered alternatives (RP+VAT-discounts) was extracted from the Pharmacy Department's economic management program. Results: In the 2020-2022 period, 89 CTs met the criteria. Most were phase III (56/89 trials) and industry sponsored. A total of 281 patients were treated on a CT, averaging 2 patients/trial (range 1 - 24). The total DCA during the study period was €6,372,718, yielding an average DCA per trial of €71,604 (€40 - €949,892). Yearly breakdown of DCA is as follows: 2020 - €1,866,345; 2021 - €2,255,404; and 2022 - €2,250,969. Conclusions: DCA, resulting from participation in CTs, effectively curbs drug-related costs, contributing to the economic robustness of the healthcare system. Moreover, these trials play a pivotal role in advancing scientific knowledge in oncology. As such, promoting the development and active participation in CTs is a strategy of crucial importance for long-term healthcare stability. [Table: see text]