PCN75 Cost-Minimization and Budget Impact Analysis of Venetoclax plus Obinutuzumab versus Ibrutinib in High-Risk Patients with Untreated Chronic Lymphocytic Leukemia in the Brazilian Unified Health System (SUS)

Abstract

Assess the economic impact of the fixed duration regimen of venetoclax and obinutuzumab (VenO) versus the continuous treatment with ibrutinib (Ibr) in 17pdeletion/TP53 and IGVH non-mutated patients with untreated Chronic Lymphocytic Leukemia (1L CLL) at SUS. Cost-minimization (CMM) and budget impact (BIM) models were developed in the context of the Brazilian public market. Due to the lack of direct comparisons between VenO and Ibr in high-risk 1L CLL and limitations of indirect analysis, similar efficacy results were applied in clinical practice for both comparators. It was assumed a similar 5 years benefit for both regimens. Only direct costs related to dosage according to respective labels were considered. Purchased prices were obtained from price-reference list, from the Brazilian Regulatory Agency (ANVISA-Jun/2020), considering list prices (PF18%) and Price Adjustment Index (CAP) of 20.09% for each drug in accordance with Brazilian Ministry of Health guideline. The CMM analyzed, in term of incremental costs, the total treatment costs in 2 years. A sub-analysis was developed considering expected use-time of Ibr in high-risk 1L (5 years). The BIM considered the eligible 17pdeletion/TP53 and IGVH non-mutated population at SUS with a reference scenario (100% Ibr) and alternative scenario (100% VenO). An access expansion sub-analysis was also included. According to CMM, over 2 years VenO generated an incremental cost-savings of U$61,627 per patient. Although in the first year VenO offers incremental cost of U$7,920, in the second year it saves U$69,548 per patient. Over 5 years, VenO offers incremental cost-savings of U$270,270 per patient. According to BIM, VenO offers the potential to reduce budget impact in U$2,168,328,050 in 5 years. The fixed treatment duration of VenO provide cost-minimization compared to continuous treatment with Ibr monotherapy. In all assessed scenarios, VenO generates significant resource-savings to the Brazilian Health Public System without compromising efficacy in 1L high-risk CLL patients.