CELESTIA: Cost-Effectiveness Analysis of Empagliflozin Versus Sitagliptin in Patients with Type 2 Diabetes in Greece.

Purpose: Globally, the prevalence of diabetes is on the rise, with the number of affected individuals predicted to cross 700 million by 2045. In Greece, in 2015, almost 700,000 people received prescribed medication for type 2 diabetes. The CELESTIA study aims to assess the cost-effectiveness of empagliflozin compared to branded sitagliptin in type 2 diabetes patients both with and without established cardiovascular disease in Greece from a third payer perspective. Methods: The IQVIA Core Diabetes Model was used and analyses were conducted from the Greek healthcare payer perspective. Patients received either empagliflozin or sitagliptin until HbA1c threshold of 8.5% (69 mmol/mol) was exceeded. Subsequently, patients were assumed to intensify to insulin therapy. Baseline cohort characteristics and treatment effects were derived from clinical trial data. Literature data were used for input (utilities, treatment costs and costs of diabetes-related complications costs). A lifetime time horizon (50 years) was applied, and costs and benefits were discounted at an annual rate of 3.5%. Results: Over a lifetime horizon, for empagliflozin, the estimated ICER was of €6,587 and €966 per quality-adjusted life years gained versus sitagliptin, in patients without established cardiovascular disease and in patients with established cardiovascular disease, respectively. Probabilistic sensitivity analysis confirmed the robustness of the analysis. Conclusion: The analysis demonstrated that for type 2 diabetes patients, empagliflozin is a cost-effective treatment option versus branded sitagliptin in Greece.

Cost-effectiveness of Empagliflozin Compared with Dapagliflozin for the Treatment of Patients with Type 2 Diabetes Mellitus and Established Cardiovascular Disease in Greece.

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.

Incidence and cost of bleeding events requiring hospitalization in patients with atrial fibrillation treated with acenocoumarol in Greece.

BACKGROUND: To estimate the incidence of hemorrhagic events in patients with atrial fibrillation (AF) treated with acenocoumarol, and the management cost of those requiring hospitalization in Greece. METHODS: A nationwide telephone survey was conducted between December 2017 and January 2018, to identify cardiologists who treat AF patients with acenocoumarol. A total of 300 cardiologists were selected and reported the number of AF acenocoumarol-treated patients during the past 12 months and the number of those who experienced a hemorrhagic event. The hospital charges to sickness fund and the cost of resource utilization of AF patients hospitalized between January 2013 and June 2017 at a tertiary hospital in Athens due to acenocoumarol-related bleedings were retrieved. RESULTS: Out of 48,255 AF patients, 12,633 (26.2%) were treated with acenocoumarol. In all, 5.1% of patients experienced a hemorrhagic event with the incidence of bleeding requiring hospitalization being 1.7%. The most common bleeding site was the gastrointestinal system (51.5%). The mean (95% CI) management cost per bleeding event requiring hospitalization was €1,202 (€1,058-€1,420). The higher cost was that of intracranial bleeding €3,887 (€2,700-€5,046). The expected annual economic burden for the management of bleedings related to acenocoumarol and requiring hospitalization was estimated at €1,463,955. CONCLUSIONS: The incidence of bleeding events in AF acenocoumarol-treated patients in Greece as well as the estimated annual economic burden for the management of bleeding events requiring hospitalization, emphasize the need to comply with the current guidelines and to optimize therapeutic strategies for the management of AF side effects with oral anticoagulants, particularly in patients with high bleeding risk.

The cost-saving switch from inhaled corticosteroid-containing treatments to dual bronchodilation: a two-country projection of epidemiological and economic burden in chronic obstructive pulmonary disease.

PURPOSE: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 recommendations support maintenance treatment with long-acting bronchodilators in most symptomatic patients with chronic obstructive pulmonary disease (COPD). While restricting the overuse of inhaled corticosteroids (ICS) may influence healthcare utilization required to treat inadvertent respiratory (exacerbations and pneumonia) and diabetes-related events, it may also change the total medication cost. This analysis was performed to estimate the 5-year budget impact of switching from ICS-containing treatment combinations to dual bronchodilation, in line with the recommendations. METHODS: The model quantified the budget impact of treatment and healthcare resource utilization when COPD patients were anticipated to switch from ICS-containing treatments to dual bronchodilation. Three switch scenarios were calculated with increasing proportions of patients on dual long-acting bronchodilators, to the detriment of ICS-containing double and triple combinations. Clinical and cost input data were based on results from clinical trials and Greek and Portuguese healthcare cost databases. RESULTS: Healthcare resource use to manage exacerbations, pneumonia and diabetes-related events were projected to increase between 2019 and 2023 in parallel with the growing COPD patient population and associated costs were estimated at 52-57% of the total disease cost in the Greek and Portuguese base case scenarios. Total cost savings between 21 and 112 million EUR were projected when the proportion of patients on double and triple ICS-containing treatments was gradually reduced to 50% in scenario A, 20% in scenario B and 7% in scenario C. Sensitivity analyses showed that none of the model assumptions had a major impact on the projected savings. CONCLUSION: The alignment of COPD treatment with current recommendations may bring clinical benefits to patients, without substantial cost increases and even cost savings for payers. The reviews of this paper are available via the supplemental material section.

Cost-Effectiveness of Empagliflozin for the Treatment of Patients with Type 2 Diabetes Mellitus at Increased Cardiovascular Risk in Greece.

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.