Dapagliflozin for the treatment of heart failure with reduced ejection fraction in Brazil: a cost-effectiveness analysis

Background Heart failure, a complex clinical syndrome with high morbidity and mortality, has become a significant burden on public health. Recently, a new class of antidiabetic agents-the sodium-glucose cotransporter 2 (SGLT2) inhibitors-was associated with a significant reduction on mortality and hospitalization in HF with reduced ejection fraction (HFrEF) when added to standard pharmacological treatment. Considering the lack of data on its cost-effectiveness, the present study aims to estimate the incremental cost-effectiveness ratio of add-on dapagliflozin treatment for HFrEF from the Brazilian public healthcare system perspective. Methods We built a Markov model to estimate the clinical outcomes and costs of 1,000 hypothetical subjects with established HFrEF in a lifetime horizon. The model inputs were based on the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) trial and local data. The main outcome was the incremental costeffectiveness ratio (ICER) per quality-adjusted life year (QALY) gained. Deterministic and probabilistic sensitivity analyses, as well as scenario analyses, were performed. Findings The addition of dapagliflozin to standard care treatment in 1,000 HFrEF patients yielded an expected value of 366.99 additional QALYs at an incremental cost of US$ 1,517,878.49, resulting in an ICER of US$ 4,136.08 per QALY gained, being a cost-effective strategy considering the Brazilian official cost-effectiveness threshold (US$ 8,000/ QALY). In probabilistic sensitivity analyses, 96.60% of the simulations were also cost-effective. In the scenario analyses, results were similar for individuals with and without diabetes. Interpretation Dapagliflozin is likely to be cost-effective when added to standard HFrEF therapy in Brazil. Funding This study was supported by the National Institute of Science and Technology for Health Technology Assessment (Instituto de Avalia & ccedil;& atilde;o de Tecnologias em Sa & uacute;de-IATS).