Cost-effectiveness of targeted treatment vs chemoimmunotherapy in treatment-naïve unfit CLL without TP53 aberrations.

Several targeted treatments, such as venetoclax + obinutuzumab (VenO) and ibrutinib, have emerged to treat treatment-naïve patients with chronic lymphocytic leukemia (CLL) and have been shown to improve progression-free survival (PFS) compared to chlorambucil + obinutuzumab (ClbO). However, novel targeted agents are associated with a significant cost investment. The objective of this study was to investigate the cost-effectiveness of VenO compared to ClbO and ibrutinib in treatment-naïve CLL without del17p/TP53 mutation in Denmark. We employed a decision analytic modeling approach to simulate hypothetical cohorts of patients with CLL patients from initiation of first-line treatment until death, including the full treatment pathway and second-line therapy. VenO, ClbO, or ibrutinib was included as first-line therapy followed by either Ven plus rituximab or ibrutinib. Model outcomes were expected quality-adjusted life-years (QALYs), life-years (LYs), and cost per patient, which were used to calculate incremental cost-effectiveness ratios (ICERs) with a willingness to pay of EUR 23,600-35,600 per QALY. Compared with ClbO, VenO was associated with a QALY gain of 1.30 (1.42 LYs) over a lifetime. The incremental cost was €12,360, resulting in an ICER of €9,491/QALY gained, indicating VenO is cost-effective. Compared with VenO, ibrutinib was associated with a QALY gain of 0.82 (1.74 LYs) but at a substantially increased incremental cost of €247,488 over a lifetime horizon. The ICER was €302,156/QALY, indicating that ibrutinib in first-line treatment would not be considered cost-effective in Danish healthcare compared to VenO. Future analyses in fit patients with CLL patients are needed to determine the cost-effectiveness of VenO.