Abstract
30 Background: There are currently few treatment options for relapsed/refractory (RR) indolent non-Hodgkin’s lymphoma (iNHL) patients. Idelalisib (IDELA) is a first-in class PI3Kδ inhibitor with substantial clinical efficacy in iNHL patients refractory to rituximab and an alkylating agent. A single-arm clinical trial (Study 101-09) showed RR iNHL patients treated with IDELA have a median of 11 and 20.3 months of progression-free and overall survival (PFS and OS), respectively. Efficacy was also demonstrated in patients with iNHL subtypes such as follicular lymphoma (FL). The objective of this study was to project the health outcomes of IDELA versus the current standard of care for US FL patients. Methods: A partitioned survival model simulated a cohort of RR FL patients over 10 year time horizon. Patients first received IDELA or an aggregate comparator of current RR iNHL chemotherapy regimens in a progression-free state before transitioning to a progressive-disease state where they received palliative care until death. Survival data was fit and extrapolated from Study 101-09 (IDELA) for FL patients. A real-world database claims analysis provided survival, disease- and treatment-related adverse event (AEs) profiles, and medical resource utilization data for RR iNHL patients for the comparator. All outcomes were discounted at 3%. Results: Claims data predicted a median of 6.16 and 13.04 months of PFS and OS, respectively, for the comparator. Our model suggests that IDELA treatment improved health outcomes over 10 years versus the comparator, increasing life-months (LMs) and progression-free life-months (PFLMs) by 9.94 and 4.63 mos, respectively. Over 1 year, IDELA reduced both AEs and hospitalisations in FL patients by 40.3% and 49.8%, respectively. Deterministic and probabilistic sensitivity analyses demonstrated the model results are robust across different methods of survival extrapolation. Conclusions: IDELA was projected to improve health outcomes in RR FL patients compared to current treatments, largely driven by improved PFS and OS; short-term reductions in AEs and hospitalisation were specifically related to a delayed disease progression.
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