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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

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Abstract

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.

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Author information

Correspondence to John Pandolfino.

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Disclosures

Drs. John Pandolfino and John Lipham act as advisors to Ethicon Inc. and have received funding for surgeon teaching and consulting on product development. Nicole Ferko, Andrew Hogan, and Rana Qadeer are employees of Cornerstone Research Group Inc. and have received funding from Ethicon Inc. to conduct the study. Amarpreet Chawla is a paid full-time employee of Ethicon Inc., manufacturer of the LINX Reflux Management System. John Pandolfino, John Lipham, Amarpreet Chawla, Nicole Ferko, Andrew Hogan, Rana A. Qadeer have no other conflicts of interest or financial ties to disclose.

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Appendix

Appendix

See Table 4.

Table 4 Summary of questionnaire administered for clinician opinion on model inputs

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Pandolfino, J., Lipham, J., Chawla, A. et al. 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. Surg Endosc (2019). https://doi.org/10.1007/s00464-019-06916-6

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Keywords

  • Budget impact analysis
  • LINX
  • Laparoscopic nissen fundoplication
  • Gastroesophageal reflux disease
  • Payers
  • Insurance coverage