A Nonactive Implant for the Treatment of Chronic Gastro-esophageal Reflux Disease: A Cost-Effectiveness Evaluation From the Perspective of German Healthcare
Author(s)
Samuel Peter Harper, BA, MSc1, Khanh Ha Bui, DPhil2, Stuart Mealing, MSc1, Moustafa Elshafei, MD3.
1York Health Economics Consortium, York, United Kingdom, 2Implantica Trading AG, Zug, Switzerland, 3St. Elisabethen Hospital, Frankfurt, Germany.
1York Health Economics Consortium, York, United Kingdom, 2Implantica Trading AG, Zug, Switzerland, 3St. Elisabethen Hospital, Frankfurt, Germany.
OBJECTIVES: The annual economic impact of Gastro-oesophageal Reflux Disease (GORD/GERD) in Germany surpasses €685 million, affecting 14-16% of the population. Standard treatments, including proton pump inhibitors (PPIs) and conventional anti-reflux surgery (ARS), have notable limitations. PPIs show suboptimal-to-no efficacy in up to 40% of patients, while postoperative sequelae diminish clinical benefits of conventional ARS. RefluxStop, a non-active implantable device that aims to comprehensively repair the defective anti-reflux barrier, has demonstrated long-term effectiveness and safety in GORD/GERD treatment and cost-effectiveness in several European countries. The cost-effectiveness of RefluxStop vs. PPIs, laparoscopic Nissen fundoplication (LNF), and magnetic sphincter augmentation (MSA) was evaluated within the German healthcare system.
METHODS: A Markov model with lifetime horizon, one-month cycle length, and 3% annual discount rate was constructed from the statutory health insurance perspective. The health states of the model included PPI use and relapse, follow-on surgery, reoperation, high-dose PPI, Barrett's oesophagus, oesophageal cancer, and death. PPIs and surgical adverse events were considered, with benefits measured in quality-adjusted life-years (QALYs). Costs were sourced from German diagnostic-related group tariffs and the literature, while efficacy data were obtained from published studies. Deterministic and probabilistic sensitivity analyses assessed uncertainty.
RESULTS: Compared with PPIs, LNF, and MSA, RefluxStop conferred lifetime cost savings of €4,615, €1,331, and €14,231/person and QALY gains of 3.66, 1.78, and 3.30, respectively. Base case results showed RefluxStop dominated all comparators on the efficiency frontier, per the German Institute for Quality and Efficiency in Health Care (IQWiG) framework. Using the WHO threshold of GDP per capita (€50,000/QALY), the model showed a high probability of cost-effectiveness;100% vs PPIs and MSA, and 98% vs LNF, sustained over a 10-year horizon.
CONCLUSIONS: RefluxStop demonstrates cost-effectiveness versus standard GORD/GERD treatments in Germany, supporting a strong value proposition aligned with the European payer evidence.
METHODS: A Markov model with lifetime horizon, one-month cycle length, and 3% annual discount rate was constructed from the statutory health insurance perspective. The health states of the model included PPI use and relapse, follow-on surgery, reoperation, high-dose PPI, Barrett's oesophagus, oesophageal cancer, and death. PPIs and surgical adverse events were considered, with benefits measured in quality-adjusted life-years (QALYs). Costs were sourced from German diagnostic-related group tariffs and the literature, while efficacy data were obtained from published studies. Deterministic and probabilistic sensitivity analyses assessed uncertainty.
RESULTS: Compared with PPIs, LNF, and MSA, RefluxStop conferred lifetime cost savings of €4,615, €1,331, and €14,231/person and QALY gains of 3.66, 1.78, and 3.30, respectively. Base case results showed RefluxStop dominated all comparators on the efficiency frontier, per the German Institute for Quality and Efficiency in Health Care (IQWiG) framework. Using the WHO threshold of GDP per capita (€50,000/QALY), the model showed a high probability of cost-effectiveness;100% vs PPIs and MSA, and 98% vs LNF, sustained over a 10-year horizon.
CONCLUSIONS: RefluxStop demonstrates cost-effectiveness versus standard GORD/GERD treatments in Germany, supporting a strong value proposition aligned with the European payer evidence.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE24
Topic
Economic Evaluation, Health Technology Assessment, Medical Technologies
Disease
Gastrointestinal Disorders