Abstract

Estimate the cost-effectiveness of Venetoclax in combination with Obinutuzumab (Ven+O) for the treatment of first-line unfit Chronic Lymphocytic Leukemia (CLL) patients from the perspective of the Colombian Healthcare System. A three-state (progression-free, post-progression, dead) partitioned-survival model was used over 7 years to estimate cost-effectiveness comparing Ven+O vs Chlorambucil+Obinutuzumab (Clb+O) based on the CLL14 clinical trial. The relative efficacy vs Ibrutinib (a subgroup analysis was performed vs fludarabine, cyclophosphamide, and rituximab -FCR- in all fit population) was estimated using a network meta-analysis. Adverse events (EA) and utilities were taken from published studies. Both costs and health outcomes had an annual rate discount of 5%. The use of health-care resources (CLL treatment, routine care and monitoring, EAs, disease progression and end-of-life care) was estimated based on the guideline proposed by NCCN and validated by two Colombian clinical experts. The costs (expressed in COP 2020) were estimated using public databases in Colombia (according IETS methodology). The Results were tested using deterministic and probabilistic sensitivity analysis. Total drug-related costs were, for Ven+O, $205.856.528; Clb+O, $43.695.102; ibrutinib, $711.760.070. Total disease management costs were, for Ven+O, $11.267.983; Clb+O, $11.736.309; ibrutinib, $11.363.741. Subsequent treatment costs were, for VEN+O, $33.696.782; Clb+O, $230.913.374; ibrutinib, $369.935.165. Other cost, as terminal care and AEs were, for Ven+O, $27.058.230; Clb+O, $26.242.685; ibrutinib, $22.265.075. Total discounted costs were, for Ven+O, $277.879.523; Clb+O, $312.587.469; ibrutinib, $1.115.324.050. Total discounted QALYs were, for Ven+O, 3.47; Clb+O, 3.35; ibrutinib, 3.34. VEN+O was dominant versus Clb+O and versus ibrutinib; also, was dominant vs FCR (ΔQALY’s: 0.45; ΔCosts: $-201.845.667). Base case Results are robust and consistent according the sensitivity analysis. Analysis suggests that Ven+O is a cost-effective treatment for patients with 1L unfit CLL and can be considered as a standard treatment option in Colombian Healthcare System.

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