OBJECTIVES: In the U.S., the prevalence of gastroesophageal reflux disease (GERD) ranges from 18-27%, with an annual economic burden of $15-20 billion. While proton pump inhibitors are the first-line treatment, up to 44% of GERD patients are refractory to medication. Treatment of medication-refractory GERD may involve surgery with laparoscopic Nissen Fundoplication (LNF), a non-reversible procedure with adverse side-effects. Removable magnetic sphincter augmentation devices such as the LINX Reflux Management System are an alternative surgical option that have demonstrated clinical benefits for medication-refractory patients with some lower esophageal sphincter function; however, economic data are limited. The objective of this study is to assess the economic impact of introducing LINX into current practice from a U.S. payer perspective.

METHODS: A budget impact model comparing two treatment practices over a 1-year time-horizon was developed: 1) current practice, which included patients who are medically managed but refractory to their medication or those who receive LNF; and 2) future practice, which included patients managed with current practice or those who receive LINX. Resources included those related to the index procedure, reoperations, readmissions, and general healthcare use (healthcare visits, diagnostic tests, and medications). Eligible patient population, market share, and resource use were estimated using market research, published literature, and a survey of 99 clinicians. Costs were informed from Medicare payments in 2018.

RESULTS: One percent of a hypothetical commercial insurance population of one million members were eligible for treatment, specifically those with medication-refractory mechanical GERD. The base-case analysis estimated use of LINX could save $48,116 (i.e., $5.01 per patient), primarily driven by avoided inpatient procedures and reoperations with LINX. Analyses predicted approximate budget neutrality with alternative plausible future scenarios.

CONCLUSIONS: Results of the analysis predicted the introduction of LINX may lead to favorable budget impact for payers. Future analyses will benefit from inclusion of middle-ground treatments and longer time-horizons.