The Cost-Effectiveness of Oral Semaglutide in Spain: A Long-Term Health Economic Analysis Based on the PIONEER Clinical Trials.

Abstract

Novel glucagon-like peptide-1 (GLP-1) receptor agonist oral semaglutide has demonstrated greater improvements in glycated hemoglobin (HbA1c) and body weight versus oral medications empagliflozin and sitagliptin, and injectable GLP-1 analog liraglutide, in the PIONEER clinical trial program. Based on these data, the present analysis aimed to evaluate the long-term cost-effectiveness of oral semaglutide versus empagliflozin, sitagliptin and liraglutide in Spain. Outcomes were projected over patients' lifetimes using the IQVIA CORE Diabetes Model (v9.0), discounted at 3.0% annually. Cohort characteristics and treatment effects were sourced from PIONEER 2 and 4 for the comparisons of oral semaglutide 14mg versus empagliflozin 25mg and liraglutide 1.8mg, respectively, and PIONEER 3 for oral semaglutide 7 and 14mg versus sitagliptin 100mg. Costs were accounted from a healthcare payer perspective in 2020 euros (EUR). Patients were assumed to receive initial therapies until HbA1c exceeded 7.5% and then treatment-intensified to basal insulin. Oral semaglutide 14mg was associated with improvements in quality-adjusted life expectancy of 0.13, 0.19 and 0.06 quality-adjusted life years (QALYs) versus empagliflozin 25mg, sitagliptin 100mg and liraglutide 1.8mg, respectively, with direct costs EUR168 higher versus empagliflozin and EUR236 and 1415 lower versus sitagliptin and liraglutide, respectively. Oral semaglutide 14mg was associated with an incremental cost-effectiveness ratio (ICER) of EUR1339 per QALY gained versus empagliflozin and was considered dominant (clinically superior and cost saving) versus sitagliptin and liraglutide. Additional analyses demonstrated that oral semaglutide 7mg was associated with improvements of 0.11QALYs and increased costs of EUR226 versus sitagliptin and was therefore associated with an ICER of EUR2011 per QALY gained. Oral semaglutide 14mg was dominant versus sitagliptin and liraglutide, and cost-effective versus empagliflozin, for the treatment of type 2 diabetes in Spain.