Gastroesophageal reflux disease (GERD) is highly prevalent in the U.S., with various studies suggesting 15% to 30% of individuals are affected. According to a paper in the American Journal of Gastroenterology, the direct plus indirect costs of managing the disease have been estimated at $15 billion to $20 billion per year.
Many patients remain symptomatic on the first-line therapy for GERD, proton pump inhibitors (PPIs), or wish to discontinue the medications. Alternative treatments are needed, including endoscopic and surgical options.
Thomas R. McCarty, MD, MPH, formerly a fellow in the Division of Gastroenterology, Hepatology and Endoscopy at Brigham and Women’s Hospital, Christopher C. Thompson, MD, director of Endoscopy, and colleagues recently constructed a computer model to evaluate the cost-effectiveness of various strategies for treating GERD that is refractory to standard-dose PPI therapy. According to their report in Endoscopy International Open, endoscopy was cost-effective on short-term modeling. However, on modeling over a lifetime, surgery was more cost-effective for patients with symptoms despite maximal-dose treatment with PPIs.
The researchers developed a decision-analytic Markov cohort model that considered evidence from medical literature; “real-world” clinical data, including costs of pharmacotherapy; and insurance claims data on procedure-associated costs.
The model was applied to a hypothetical cohort of patients at least 50 years old who reported inadequate or unsatisfactory symptomatic response to 12 weeks of twice-daily PPI therapy (20 mg of omeprazole or equivalent). The researchers calculated the cost-effectiveness of the following:
- PPI therapy—Omeprazole 20 mg twice daily
- Endoscopy—Transoral incisionless fundoplication (TIF 2.0) using the EsophyX device (Endogastric Solutions, Redmond, WA)
- Surgery—The traditional approach, laparoscopic Nissen fundoplication (LNF)
The most cost-effective strategy in various scenarios was defined as the strategy with the highest incremental cost-effectiveness ratio under a willingness-to-pay threshold of $100,000 per quality-adjusted life year.
The principal findings were:
- In the base case analysis (reflecting the most likely input values), the average costs were $10,932 for PPI therapy, $13,979 for TIF 2.0, and $17,659 for LNF
- Over a 10-year time horizon, TIF 2.0 was more cost-effective than LNF or continued PPI therapy (incremental cost-effectiveness ratio of $10,423 per quality-adjusted life year gained)
- Over a lifetime horizon, TIF 2.0 remained the most cost-effective strategy for patients who had symptoms despite twice-daily 20 mg omeprazole
- LNF was the most cost-effective approach for patients who had symptoms despite maximal-dose PPI treatment (40 mg twice daily)
- TIF 2.0 remained cost-effective in various sensitivity analyses and in scenario analyses for multiple age groups
Guidance for Clinicians
TIF 2.0 is probably best reserved for patients with lower reflux burden who experience continued symptoms despite treatment on standard-dose PPI therapy. LNF may be the optimal strategy for patients whose symptoms are refractory to maximum-dose PPIs.
However, there has never been a prospective, randomized, head-to-head comparison of TIF 2.0 and LNF that could show whether the severity of reflux burden and response to PPIs at different dosing levels can guide patient selection for the two interventions.
A thorough evaluation remains key to identifying optimal candidates for anti-reflux interventions. That should include a detailed history, careful endoscopic assessment, and esophageal function testing with manometry and objective reflux monitoring.