Strengths, Gaps, and Opportunities in the Evidence Base For GLP-1 Receptor Agonists: Implications for Market Access Strategy

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Publication Date

11-18-2025

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Presentation: 16:23

Abstract

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have emerged as one of the most impactful therapeutic classes for obesity and type 2 diabetes, supported by extensive evidence demonstrating meaningful weight-loss efficacy, improvements in glycemic control, and significant reductions in major adverse cardiovascular events. However, despite the strong trial evidence, payer decision-making increasingly depends on real-world evidence, economic evaluations, and concerns about long-term affordability. The purpose of this capstone was to synthesize clinical, humanistic, and economic evidence for GLP-1 RAs, identify key gaps that limit payer and health-system decision-making, and propose an evidence-generation framework to support market access for a hypothetical next-generation agent. A rapid literature review was conducted using PubMed, Google Scholar, and Embase to identify pivotal randomized control trials (RCTs), real-world adherence and persistence studies, meta-analyses, patient-reported outcome evaluations, and cost-effectiveness analyses. Evidence was extracted into structured tables and synthesized across clinical, economic, and humanistic domains. GLP-1 RAs demonstrate substantial strengths, including 10-20% weight loss in RCTs, proven cardiovascular and renal protection, and consistent cost-effectiveness compared with basal insulin and other weight loss agents. However, major gaps persist. Real-world persistence is only 32-48% at 12-24 months, undermining expected long-term value. High prices and projected national budget impact exceeding $100 billion annually remain significant barriers to equitable access. Evidence gaps include limited long-term safety data, sparse quality-of-life outcomes, inadequate representation of diverse populations, and residual confounding in observational studies. Based on these findings, an evidence-generation framework is proposed, emphasizing long-term registries, real-world adherence interventions, value-based contracting, and improved humanistic and economic data collection. Strengthening the evidence base across these domains is essential to support sustainable and equitable market access for current and future GLP-1 therapies.

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English

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