Abstract
AimsThe Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial assessed once-weekly exenatide (EQW) vs. placebo, added to usual care in 14,752 patients with type 2 diabetes mellitus (Clinicaltrials.gov: NCT01144338). We assessed the lifetime cost-effectiveness of adding EQW vs. usual care alone from a healthcare perspective. MethodsMedical resource use and EQ-5D utilities were collected throughout the study. Within-trial results were extrapolated to a lifetime horizon using the UK Prospective Diabetes Study Outcomes Model version 2 (UKPDS-OM2), predicting predict cardiovascular and microvascular events. Cost-effectiveness was evaluated separately for US and UK settings, with outcomes measured in quality-adjusted life-years (QALYs). ResultsEQW plus usual care gained 0.162 QALYs at an additional cost of $41,545/patient, compared with usual care in a US setting. The incremental cost-effectiveness ratio (ICER) was $259,223/QALY. In a UK setting, the QALY gain was 0.151 at an additional cost of £6357: an ICER of £42,589/QALY. Sensitivity analyses ranged between $34,369–$269,571 and £3430–£46,560 per QALY gained. ConclusionsIn a lifetime extrapolation, adding EQW to usual care increased QALYs and costs compared with usual care alone. The base-case ICERs exceeded the commonly-cited cost-effectiveness thresholds of $100,000/QALY and £20,000/QALY. However, ICERs were considerably lower in some subgroups, and in sensitivity analyses.
Highlights
The prevalence of type 2 diabetes and associated health problems continue to rise, imposing significant burden on healthcare systems.[1]
In a UK setting, the estimated net gain was 0.151 quality-adjusted life-year (QALY) (p < 0.001) at an additional cost of British pounds (GBP) 6357 (p < 0.001), giving an incremental cost-effectiveness ratio (ICER) of GBP 42,589/QALY
The cost-effectiveness planes shown in Fig. 1 show that for both the US and UK analysis, all of the 800 bootstrap iterations for each of the 28 imputed data sets lie in the northeast quadrant, finding Once-weekly exenatide (EQW) to be more costly and more effective than usual care using data from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial
Summary
The prevalence of type 2 diabetes and associated health problems continue to rise, imposing significant burden on healthcare systems.[1] Individuals with type 2 diabetes are at higher risk of long-term complications and death from any cause,[2] and experience lower quality of life due to diabetes-related complications such as cardiovascular disease (CVD), stroke, heart failure, renal failure, amputation, and blindness.[3] While improved glycemic control has been associated with improved microvascular outcomes,[4] effects on macrovascular outcomes are more modest.[5] Exenatide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), has been shown to reduce glucose levels in individuals with type 2 diabetes, along with modest reductions in body weight, blood pressure, and lipid levels.[6]. Previous trials have compared EQW to an active comparator, such as other GLP-1 RAs, but had a smaller sample size or a shorter follow-up than EXSCEL.[10,11,12,13] Our analysis combines the clinical data from the trial with the data on within-trial costs and quality of life and extrapolates the events and risk factors beyond the end of the trial to evaluate lifetime cost-effectiveness
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