Lifetime cost-effectiveness simulation of once-weekly exenatide in type 2 diabetes: A cost-utility analysis based on the EXSCEL trial

Frauke Becker,Helen A Dakin,Shelby D Reed,Yanhong Li,José Leal,Stephanie M Gustavson,Eric Wittbrodt,Adrian F Hernandez,Alastair M Gray,Rury R Holman

doi:10.1016/j.diabres.2021.109152

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

Introduction

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

Methods

Results

Conclusion