A BUDGET IMPACT ANALYSIS OF REFLUXSTOP FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE IN GERMANY
Author(s)
Hinrich Köhler, MD1, Samuel Peter Harper, BA, MSc2, Khanh Ha Bui, DPhil3, Stuart Mealing, MSc2, Hristina Markova-Gjorgjijoska, MD1, Thorsten Lehmann, MD4, Moustafa Elshafei, MD5.
1Herzogin Elisabeth Hospital, Braunschweig, Germany, Braunschweig, Germany, 2York Health Economics Consortium, York, United Kingdom, 3Health Economics Manager, Implantica, LONDON, United Kingdom, 4Department of Visceral Surgery, Klinikum Friedrichshafen, Friedrichshafen, Germany, 55. Department of General and Visceral Surgery, Marien Hospital Mainz, Mainz, Germany.
1Herzogin Elisabeth Hospital, Braunschweig, Germany, Braunschweig, Germany, 2York Health Economics Consortium, York, United Kingdom, 3Health Economics Manager, Implantica, LONDON, United Kingdom, 4Department of Visceral Surgery, Klinikum Friedrichshafen, Friedrichshafen, Germany, 55. Department of General and Visceral Surgery, Marien Hospital Mainz, Mainz, Germany.
OBJECTIVES: Gastroesophageal reflux disease (GERD) affects 14-43% of the German population, the financial burden being €688 million annually. Current therapies limitations include: suboptimal pharmacologic response, effects from prolonged medication use, burdensome postoperative sequelae, and limited surgical durability, often requiring costly reinterventions. RefluxStop i reconstructs the antireflux barrier without encircling the esophagus, potentially reducing postoperative sequelae common with conventional ARS, while preserving food passageway patency. Favorable long-term clinical outcomes of the device have been established in the literature. Our parallel German study showed an increased cost-effectiveness for RefluxStop compared to standard-of-care treatment (Nissen fundoplication, medical therapy, and MSA). This study reports the modelled budget impact of RefluxStop implementation in Germany.
METHODS: A budget impact model, consistent with international practice recommendations, was developed from the perspective of the Gesetzliche Krankenversicherung (GKV), Germany's statutory public health insurance system, over a 5-year time horizon. Two theoretical scenarios were analyzed: the first included standard care, laparoscopic Nissen fundoplication while excluding RefluxStop; and the second with RefluxStop integrated. The evaluation considered both the clinical benefits and costs associated with each treatment.
RESULTS: Over the 5-year analysis period, the introduction of RefluxStop was projected to circumvent 197 surgical failures, 22 reoperations, and 135 esophageal procedures compared with standard care alone. The budget impacts of introducing RefluxStop over 1, 3, and 5 years were €327,790, €1,256,570, and €2,089,163, respectively, corresponding to annual increases of 0.002%, 0.006%, and 0.008% in GERD-related expenditures by the GKV. Halved market uptake rates of RefluxStop resulted in 1-year increases in expenditures of 0.001%, and 5-year increases of 0.004%, respectively.
CONCLUSIONS: RefluxStop implementation for GERD treatment in Germany notably reduces unwanted re-intervention (surgical failures, reoperations, esophageal dilatations), thus aligning with our favorable cost-effectiveness analysis of RefluxStop in Germany, at a very insignificant (small fraction of a percent) budget impact.
METHODS: A budget impact model, consistent with international practice recommendations, was developed from the perspective of the Gesetzliche Krankenversicherung (GKV), Germany's statutory public health insurance system, over a 5-year time horizon. Two theoretical scenarios were analyzed: the first included standard care, laparoscopic Nissen fundoplication while excluding RefluxStop; and the second with RefluxStop integrated. The evaluation considered both the clinical benefits and costs associated with each treatment.
RESULTS: Over the 5-year analysis period, the introduction of RefluxStop was projected to circumvent 197 surgical failures, 22 reoperations, and 135 esophageal procedures compared with standard care alone. The budget impacts of introducing RefluxStop over 1, 3, and 5 years were €327,790, €1,256,570, and €2,089,163, respectively, corresponding to annual increases of 0.002%, 0.006%, and 0.008% in GERD-related expenditures by the GKV. Halved market uptake rates of RefluxStop resulted in 1-year increases in expenditures of 0.001%, and 5-year increases of 0.004%, respectively.
CONCLUSIONS: RefluxStop implementation for GERD treatment in Germany notably reduces unwanted re-intervention (surgical failures, reoperations, esophageal dilatations), thus aligning with our favorable cost-effectiveness analysis of RefluxStop in Germany, at a very insignificant (small fraction of a percent) budget impact.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE487
Topic
Economic Evaluation, Health Technology Assessment, Medical Technologies
Topic Subcategory
Budget Impact Analysis
Disease
Gastrointestinal Disorders