Cost-utility analysis of venetoclax in combination with obinutuzumab as first-line treatment of chronic lymphocytic leukaemia in Spain.

OBJECTIVE

Venetoclax in combination with obinutuzumab has significantly improved efficacy versus immunochemotherapy (progression-free survival) in patients with chronic lymphocytic leukaemia who have not  received prior treatment. The objective of this study was to evaluate its efficiency in Spain using a cost-utility analysis.

METHOD

Using a partitioned-survival analysis model adapted to the Spanish  context and based on three health states (progression-free survival, survival  after progression, and death), a simulation of the evolution of patients who  were candidates for initiating first-line treatment was conducted for a lifetime  time horizon. Venetoclax in combination with obinutuzumab was compared to  the most commonly used therapeutic options for these patients at the time of  study design: chlorambucil in combination with obinutuzumab, ibrutinib,  fludarabine in combination with cyclophosphamide and rituximab, and  bendamustine in combination with rituximab. In order to estimate survival  curves, efficacy data were derived from the CLL14 trial and a network meta- analysis. The  analysis was conducted from the perspective of the Spanish  National Healthcare System and included direct healthcare costs (i.e.  pharmacological costs and their administration), and those associated with the management of the disease and adverse events. The resource use was validated by an expert group. Quality of life data were used to estimate the  quality-adjusted life years obtained for each alternative. A threshold of  €25,000/quality-adjusted life years was used. The robustness of the model was evaluated using deterministic and probabilistic sensitivity analyses.

RESULTS

Venetoclax in combination with obinutuzumab was shown to be a  dominant alternative compared to the rest of the treatment alternatives, with a  lower cost per patient (€-67,869 compared to chlorambucil in combination  with obinutuzumab, €-375,952 compared to ibrutinib, €-61,996 compared to  fludarabine in combination with cyclophosphamide and rituximab, and €- 77,398 compared to bendamustine in combination with rituximab). It also had  a greater gain in quality-adjusted life years (0.551 quality-adjusted life years  gained compared to chlorambucil in combination with obinutuzumab and  ibrutinib, 1.639 quality-adjusted life years gained compared to fludarabine in  combination with cyclophosphamide and rituximab, and 1.186 quality-adjusted  life years gained compared to bendamustine in combination with  rituximab). Between 68% and 85% of the simulations performed in the  sensitivity analysis showed that venetoclax in combination with obinutuzumab  had lower costs and more quality-adjusted life years gained.

CONCLUSIONS

Venetoclax in combination with obinutuzumab is an efficient and  dominant alternative for treating previously untreated patients with chronic lymphocytic leukaemia compared to the available  alternatives and from the perspective of the Spanish National Health System.