Cost-Effectiveness Analysis of RefluxStop for Treatment of Chronic Gastro-esophageal Reflux Disease: A US Medicare Perspective
Author(s)
Samuel Peter Harper, BA, MSc1, Khanh Ha Bui, DPhil2, Stuart Mealing, MSc1, John Lipham, MD3.
1York Health Economics Consortium, York, United Kingdom, 2Implantica Trading AG, Zug, Switzerland, 3University of Southern California, Los Angeles, CA, USA.
1York Health Economics Consortium, York, United Kingdom, 2Implantica Trading AG, Zug, Switzerland, 3University of Southern California, Los Angeles, CA, USA.
OBJECTIVES: Gastro-oesophageal reflux disease (GORD/GERD) imposes an economic burden exceeding $10 billion/year on the US healthcare system. The standard of care for GORD/GERD including proton pump inhibitors (PPIs) and anti-reflux surgery (ARS), such as Nissen fundoplication, are fraught with limitations. The deficiencies of PPIs include poor-to-no response in 40% of patients while postoperative sequelae such as dysphagia compromise clinical benefits of ARS. RefluxStop, a novel implantable device that aims to restore the defunct anti-reflux barrier, confers durable effectiveness and safety in GORD/GERD treatment. Payer evidence demonstrates the relative cost-effectiveness of RefluxStop in European countries and the UK. A cost-effectiveness analysis of RefluxStop compared to PPIs, Nissen fundoplication, and magnetic sphincter augmentation (MSA) from a US Medicare perspective is presented.
METHODS: A Markov model, adapted from the UK National Health Service, was employed with a lifetime horizon, monthly cycles, and 3% annual discount rate. Health states included initial PPI use, PPI relapse, surgery, reoperation, high-dose PPI, Barrett’s oesophagus, oesophageal cancer, and death. Costs and clinical effectiveness were derived from published literature, with outcomes measured in quality-adjusted life years (QALYs). Deterministic and probabilistic sensitivity analyses evaluated parameter uncertainties.
RESULTS: RefluxStop demonstrated lifetime cost differences of $15,282, $6,415, and -$4,704/patient compared to PPIs, Nissen fundoplication, and MSA, respectively. RefluxStop yielded QALY gains of 0.87, 0.28, and 0.35/patient, with incremental cost-effectiveness ratios (ICERs) of $17,486, $23,136/QALY-gained, and full dominance against PPIs, Nissen fundoplication, and MSA, respectively. At a threshold of $100,000/QALY, RefluxStop was cost-effective with probabilities of 100% vs PPIs, 87% vs Nissen fundoplication, and 98% vs MSA. Sensitivity analyses confirmed the robustness of findings over a 10-year horizon.
CONCLUSIONS: RefluxStop demonstrates robust cost-effectiveness at favourable costs from a US Medicare perspective, reinforcing a compelling value proposition aligned with corresponding payer evidence from Europe and the UK.
METHODS: A Markov model, adapted from the UK National Health Service, was employed with a lifetime horizon, monthly cycles, and 3% annual discount rate. Health states included initial PPI use, PPI relapse, surgery, reoperation, high-dose PPI, Barrett’s oesophagus, oesophageal cancer, and death. Costs and clinical effectiveness were derived from published literature, with outcomes measured in quality-adjusted life years (QALYs). Deterministic and probabilistic sensitivity analyses evaluated parameter uncertainties.
RESULTS: RefluxStop demonstrated lifetime cost differences of $15,282, $6,415, and -$4,704/patient compared to PPIs, Nissen fundoplication, and MSA, respectively. RefluxStop yielded QALY gains of 0.87, 0.28, and 0.35/patient, with incremental cost-effectiveness ratios (ICERs) of $17,486, $23,136/QALY-gained, and full dominance against PPIs, Nissen fundoplication, and MSA, respectively. At a threshold of $100,000/QALY, RefluxStop was cost-effective with probabilities of 100% vs PPIs, 87% vs Nissen fundoplication, and 98% vs MSA. Sensitivity analyses confirmed the robustness of findings over a 10-year horizon.
CONCLUSIONS: RefluxStop demonstrates robust cost-effectiveness at favourable costs from a US Medicare perspective, reinforcing a compelling value proposition aligned with corresponding payer evidence from Europe and the UK.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE218
Topic
Economic Evaluation, Health Technology Assessment, Medical Technologies
Disease
Gastrointestinal Disorders