A budget impact analysis of a magnetic sphincter augmentation device for the treatment of medication-refractory mechanical gastroesophageal reflux disease: a United States payer perspective.
BACKGROUND
Medication-refractory gastroesophageal reflux disease (GERD) is sometimes treated with laparoscopic Nissen fundoplication (LNF); however, this is a non-reversible procedure associated with important side effects and the need for repeat surgery. Removable magnetic sphincter augmentation (MSA) devices are an alternative, effective, and safe treatment option for such patients who have some lower esophageal sphincter function. The objective of this study was to assess the economic impact of introducing MSA technology (i.e., LINX Reflux Management System) into current practice from a US-payer perspective.


METHODS
An economic budget impact model was developed over a 1-year time horizon that compared current treatment of GERD patients who are medically managed (but refractory) or receiving LNF to future treatment of GERD patients that included a mix of patients treated with medical management only, LNF, or MSA. Resources included within the analyses were index procedures (inpatient and outpatient use), reoperations (revisions and removals), readmissions, healthcare visits, diagnostic tests, procedures, and medications. Medicare payment rates were typically used to inform unit costs.


RESULTS
Assuming a hypothetical commercial insurance population of 1 million members, the base-case analysis estimated a net cost savings of $111,367 with introduction of the MSA. This translates to a savings of $0.01 per member per month. Results were largely driven by avoided inpatient procedures with use of the MSA device. Alternative analyses exploring the potential impact of increasing surgical volumes predicted that results would remain cost saving if the proportion of MSA market share taken from LNF was ≥ 90%.


CONCLUSIONS
This study predicts that the introduction of the MSA device would lead to favorable budget impact results for the treatment of medication-refractory mechanical GERD for commercial payers. Future analyses will benefit from inclusion of middle-ground treatments as well as longer time horizons.
['Pandolfino|John|J|', 'Lipham|John|J|', 'Chawla|Amarpreet|A|', 'Ferko|Nicole|N|', 'Hogan|Andrew|A|', 'Qadeer|Rana A|RA|']
D000368:Aged D000369:Aged, 80 and over D002017:Budgets D049630:Esophageal Sphincter, Lower D004944:Esophagoplasty D005260:Female D005764:Gastroesophageal Reflux D006801:Humans D007348:Insurance, Health D059346:Magnets D008297:Male D006278:Medicare D008875:Middle Aged D018803:Models, Economic D016896:Treatment Outcome D014481:United States
Budget impact analysis Gastroesophageal reflux disease Payers Laparoscopic nissen fundoplication LINX Insurance coverage