Cost-effectiveness analysis of empagliflozin treatment in people with Type 2 diabetes and established cardiovascular disease in the EMPA-REG OUTCOME trial.

AIM: In the EMPA-REG OUTCOME trial, empagliflozin therapy reduced cardiovascular death by 38% compared with placebo when added to standard of care. Using the trial results, we created a discrete-event simulation model to assess lifetime health economic outcomes in people with Type 2 diabetes and established cardiovascular disease. METHODS: Time-dependent survival regression analysis was performed on data from EMPA-REG OUTCOME for 10 cardiovascular and renal events (e.g. stroke, heart failure hospitalization, macroalbuminuria, cardiovascular mortality) to capture event rates over time, and interaction between events. Model performance was assessed by comparing predicted and observed outcomes at 3 years. Costs in the United Kingdom (UK) and health utilities were obtained from published literature. Outcomes included cumulative event rates, life-years, costs and quality-adjusted life-years (QALYs). RESULTS: The model predicted an 18% relative increase (by 2.1 life-years) in survival for empagliflozin (14.0 life-years) vs. standard of care (11.9 life-years), attributable to direct treatment effect on cardiovascular mortality, and to indirect effect via reductions in other events. Participants treated with empagliflozin may experience improved quality of life (1.0 QALY) and higher costs (£3737/participant), yielding an incremental cost-effectiveness ratio (ICER) of £4083/QALY. Sensitivity analyses confirmed the robustness of these results to changes in input parameters. CONCLUSIONS: Based on extrapolation of EMPA-REG OUTCOME trial data using a participant-level simulation model, empagliflozin in addition to standard of care is projected to be highly cost-effective using UK healthcare costs. The impact in other countries will vary due to differences in drug pricing and accrual of other costs. (Clinical Trial Registry No: NCT01131676).

Acetic acid-enhanced chromoendoscopy is more cost-effective than protocol-guided biopsies in a high-risk Barrett's population.

To examine the efficacy and potential cost implications of acetic acid (AA) chromoendoscopy in the assessment of Barrett's neoplasia. Our prospective database of patients referred between 2005 and 2010 with suspected early neoplasia was reviewed. High-resolution Fujinon gastroscopes and EPX-4400 processor were used. Inspection of Barrett's neoplasia was carried out using white light followed by AA. Neoplastic areas were noted, and targeted biopsy was carried out. This was followed by quadrantic biopsies of the remaining Barrett's neoplasia. The cost of protocol-guided biopsies was compared with AA-guided biopsy protocols. Two hundred sixty-three procedures on 197 patients were examined. High-risk neoplasia was found during 143 procedures. In 96% of cases it was identified with AA. The cost of histological evaluation by Cleveland protocol would be £139,416.30. The cost by AA-targeted biopsy followed by random biopsies in one pot would be £25,032.50. For AA-targeted biopsies alone the cost would be £9,541.8 but results in a 4% miss rate. AA localizes neoplastic lesions in the majority of patients and could potentially represent a significant cost saving in patients with suspected neoplasia.