Pdb20 Empagliflozin vs Sitaglitpin, Saxagliptin and Liraglutide in Spain. A Budget Impact Model Based on the Core Diabetes Model and Cardiovascular Outcomes Trials

Abstract

Objectives: The 9.5 version of IQVIA-CORE-Diabetes-Model (CDM) includes a simplified foot ulcer (FU) submodel. The current study aims to explain the differences between the new and previous FU submodel and assess their impact on health economic outputs. Methods: The updated FU submodel is a five-health-state Markov Model (no history of ulcer, active ulcer, history of ulcer, history of amputation, death) with an annual cycle length, using the UKPDS82 risk equations (user defined inputs are optional). The previous FU submodel comprised nine health-states with monthly cycles and included options of screening and several treatment types. To test this update, cohorts were simulated with baseline characteristics and treatment effects from the observational EDGE study comparing metformin+vildagliptin (M+V) with metformin+sulphonylurea (M+S), with mean age of 57.8 years and time horizon of 50 years. Patients had no history of ulcer and amputation. Cumulative Incidence (CI) of FU complications, total and quality-adjusted life years (LY, QALY) were determined. The economic analysis employed UK 2018 costs and applied an annual discount rate of 3.5% on costs and outcomes. Results: The updated FU model leads to moderate differences in first ulcer CI (M+V: 2.86% to 3.45%; M+S: 2.90% to 3.64%) and amputation rate (M+V: 1.10% to 0.82%; M+S: 1.08% to 0.85%). Changes benefit the most effective arm, which also reflects in a limited difference in costs between the two arms (10 GBP). FU-related costs are reduced (M+V: -4.67%; M+S: -1.12%). The new model results in higher LY (M+V: +0.224; M+S: +0.258) and QALY (M+V: +0.038; M+S: +0.052), mainly due to the updated renal submodel, which reduces end-stage renal disease CI (M+V: 9.91% to 2.39%; M+S 10.03% to 2.41%). The Incremental Cost-Utility Ratio (ICUR) increases from 8,455 to 10,410 GBP/QALY. Conclusions: Using the simplified ulcer model of v9.5 CDM results in small differences in FU-related incidence, benefiting the most effective treatment arm.