RESUMO
BACKGROUND AND OBJECTIVE: Type 2 diabetes mellitus (T2DM) accounts for approximately 95% of all diabetes cases and is associated with a substantially elevated risk for cardiovascular disease (CVD) that is 2- to 4-times higher in patients with T2DM compared to those without. The aim of present study was to evaluate the cost effectiveness of empagliflozin compared to dapagliflozin for the treatment of patients with T2DM and established CVD in Greece. METHODS: A published health economic model was used to project clinical and economic outcomes of T2DM patients receiving empagliflozin compared to those receiving dapagliflozin. Individual patient-level discrete-event simulation was conducted to predict time-to-event for CV, renal, and adverse events over patients' lifetimes. Hazard ratios for dapagliflozin versus empagliflozin on each clinical event was estimated from DECLARE-TIMI 58 and EMPA-REG OUTCOME trials' data using an indirect treatment comparison. Following a public payer perspective, only direct medical costs related to drug acquisition, fatal/non-fatal diabetes-related complications and adverse events were considered (2020). Model extrapolated outcomes included life years (LY), quality-adjusted life years (QALYs), costs as well as incremental cost-effectiveness ratio (ICER). Sensitivity analyses explored the impact of changes in input data. RESULTS: Over a patient's lifetime, empagliflozin was associated with longer mean survival (17.23 LY with empagliflozin vs 16.07 LY with dapagliflozin) and reduced rate of CV mortality resulting in 0.48 more QALYs (9.27 vs 8.79), at additional costs of 462. The generated ICER of empagliflozin was 965 per QALY gained. Deterministic sensitivity analysis confirmed empagliflozin's cost-effective profile. Probabilistic sensitivity analysis revealed that the probability of empagliflozin being cost effective over dapagliflozin was 100%, at the defined threshold of 36,000 per QALY gained. CONCLUSION: Empagliflozin was estimated to be a highly cost-effective treatment option compared to dapagliflozin for the treatment of T2DM patients with established CVD in Greece.
Assuntos
Compostos Benzidrílicos/administração & dosagem , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glucosídeos/administração & dosagem , Hipoglicemiantes/uso terapêutico , Doenças Cardiovasculares/tratamento farmacológico , Análise Custo-Benefício , Grécia , Humanos , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND AND OBJECTIVE: Type 2 diabetes mellitus (T2DM) is frequently associated with co-morbidities that exacerbate cardiovascular (CV) risk. CV disease is the leading cause of death in people with diabetes across the world and accounts for approximately half the deaths in the T2DM population. Hence, the objective of present study was to evaluate the cost-effectiveness of empagliflozin, in addition to standard of care (SoC), for the treatment of adult patients with T2DM and high CV risk in Greece. METHODS: A health economic model was used to project clinical and economic outcomes of patients receiving empagliflozin plus SoC compared with those receiving SoC alone over a lifetime horizon. CV and renal event rates were derived from patient level data from the EMPA-REG-OUTCOME® trial by fitting time-dependent parametric survival functions. 5000 individual patient profiles randomly sampled from the trial were simulated using a time-to-event approach. Model extrapolated outcomes included life years (LYs), quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER). Following a Greek third-party payer perspective, only direct medical costs related to drug acquisition as well as fatal and non-fatal diabetes-related complications were considered (2016). Cost units and utility data were extracted from the literature and publicly available official sources. Sensitivity analyses explored the impact of changes in input data. RESULTS: Over a patient's lifetime, empagliflozin was predicted to result in longer mean survival (14.01 LY vs. 11.87 LY with SoC) and reduced rate of clinical events accumulating 7.75 QALYs versus 6.83 QALYs on SoC alone at additional costs of 4235. The generated ICER of empagliflozin was 4633 per QALY gained. One-way sensitivity analysis confirmed empagliflozin's cost-effective profile. At the defined willingness-to-pay threshold of 34,000 per QALY gained, probabilistic sensitivity analysis showed that empagliflozin was estimated to have a 100% probability of being cost-effective relative to SoC. CONCLUSIONS: Empagliflozin added to SoC was estimated to be a highly cost-effective treatment option for the treatment of T2DM in adults with increased CV disease risk in Greece.