Presentation (CTI)

OBJECTIVES: Glucagon-like peptide-1 (GLP-1) receptor agonists provide significant benefits in type 2 diabetes and obesity, with evidence of improvement in related comorbidities. However, their expanding use has raised US payer concerns about affordability and budget impact. This study evaluates the implications of GLP-1-based therapy adoption for US market access and coverage decisions, integrating HTA evidence with payer-relevant considerations.
METHODS: We analyzed the Institute for Clinical and Economic Review (ICER) value assessment reports for GLP-1 therapies in diabetes and obesity and conducted a targeted US-focused literature review assessing cost-effectiveness, budget impact, access barriers, and policy responses related to GLP-1 therapies benchmarks: tirzepatide, semaglutide, and liraglutide.
RESULTS: GLP-1 therapies are clinically valuable and cost-effective for diabetes at US willingness-to-pay thresholds, embedded in treatment algorithms and payer policies. In obesity management, however, their use is projected to generate unprecedented spending for a single therapeutic class. ICER’s 2025 assessment found semaglutide and tirzepatide to meet reasonable cost-effectiveness thresholds (<$100k/QALY, no price cuts, shift from 2022); however, uncertainty remained regarding long-term benefit durability and population-level budget impact. Economic models showed heterogeneous cost-effectiveness results, sensitive to key assumptions. As eligible populations expand, multiple analyses estimate annual spending on GLP-1 therapies could exceed $100 billion within five years. Payers are responding with restrictive coverage policies (enhanced prior authorization, temporary coverage denial), utilization management strategies (provider network management, carve-out obesity management programs), and alternative payment approaches (innovative arrangements), resulting in heterogeneous real-world access. No single strategy was found to fully resolve the tension between affordability, access, and potential population benefit.
CONCLUSIONS: GLP-1 therapies offer substantial clinical and economic value in diabetes, but their rapid adoption for obesity presents major budget challenges. Policymakers and payers must balance clinical benefit with affordability to ensure sustainable patient access, particularly as new indications and formulations further expand GLP-1 utilization.