Purpose: There have been very few randomized controlled trials (RCTs) comparing Laparoscopic Nissen Fundoplication (LNF) to medical management using proton pump inhibitors (PPIs) for treating patients with chronic gastro-esophageal reflux disease (GERD). These RCTs have reported mixed results with respect to symptom control and impact on patient quality of life (QOL) and economic evaluations of LNF have been inconclusive. The objective of this study is to determine the incremental cost-utility (CU) of LNF versus PPI for the treatment of patients with chronic GERD over a three-year period from the societal perspective.
Methods: The economic evaluation was conducted alongside a RCT in Hamilton, Canada. This RCT enrolled 104 patients from October 2000 to September 2004 and followed them for three years. The primary study outcome was GERD symptoms and secondary outcome measures included QOL and cost-utility (CU). Health resource utilization (total and GERD-related only) and QOL data (Health Utilities Index (HUI3), Short Form 6D (SF6D) and EQ5D ) were collected at regular follow-up intervals to determine the incremental cost per quality-adjusted-life-year (QALY) gained. Stochastic uncertainty was assessed using bootstrapping and methodological assumptions were assessed using traditional deterministic sensitivity analysis.
Results: There were no statistically significant differences in GERD symptom scores over 3 years, but LNF did result in fewer heartburn (HB) days and improved QOL. Costs were higher for LNF patients by a mean of $3,205 per patient over 3 years but QOL was also higher as measured by any QOL instrument. Based on total costs, the incremental CU of LNF was $29,404 per QALY gained when using the HUI3 and stochastic analysis of uncertainty showed LNF to be cost-effective at willingness-to-pay (WTP) ceiling ratio thresholds above $30,000 per QALY. CU results were sensitive to the utility instrument used ($29,404 per QALY for HUI3, $31,117 per QALY for SF6D and $76,310 per QALY for EQ5D).
Conclusions: Results varied depending on resource use/costs included in the analysis and the QOL instrument used, however, LNF was generally found to be a cost-effective treatment for symptomatic GERD patients requiring long-term management.