OBJECTIVES: Gastroesophageal reflux disease (GERD) is a common condition. In Italy, 25% of patients are refractory to medical management (rMM). Treatment options for rMM are limited to laparoscopic Nissen Fundoplication (LNF). Procedures such as magnetic sphincter augmentation (MSA), have emerged with demonstrated clinical benefits. This study examines introducing MSA for treating rMM GERD from an Italian payer perspective.

METHODS: A budget impact model was developed capturing the payer-funded healthcare resources for MSA and LNF, over a one-year time horizon, including payments for the procedure, pre- and postoperative tests, readmissions, reoperations, and follow-up visits. Based on rMM rates, there are 82,955 Italian surgically-eligible patients. Currently, <1% of surgically-eligible patients receive surgery (n=489). The model compares the budget impact of a surgical landscape with LNF alone to a surgical landscape with both LNF (87%) and MSA (13%). Inputs were from ministry of health publications, GERD literature, and market research.

RESULTS: The model predicted potential savings for the future scenario with MSA: €7,416 for the population and €0.09 per patient. There were no differences for the surgery-specific and healthcare categories between current and future scenarios because procedure payments, diagnostic tests, and follow-up visits are the same for MSA and LNF. Savings of €5,945 were from lower reoperation rates for revisions (0.8% vs. 4.0%) and savings of €1,471 were from lower readmission rates (11.1% vs. 13.5%) with MSA versus LNF for the population. The very low proportion of surgically-eligible patients receiving surgical intervention is a core driver of the model outcome.

CONCLUSIONS: The model predicted that introduction of MSA for surgically treated rMM GERD patients was not associated with increased costs for the Italian payer, compared with the current scenario using LNF alone. Future studies should examine the impact of performing outpatient MSA procedures, which may increase savings due to lower inpatient costs.