The clinical and economic impact of competing management strategies for gastro-oesophageal reflux disease

Background: Gastro-oesophageal reflux disease (GERD) is a common disorder in the primary care setting. Traditional management strategies consist of sequentially intensive therapeutic trials followed by invasive diagnostic testing for nonresponders. A high dose proton pump inhibitor trial (the 'proton pump inhibitor test') has been shown to be an accurate diagnostic alternative, and may be an efficient initial approach to patients with GERD symptoms. Aim: To examine the clinical, economic and policy implications of alternative management strategies for GERD. Methods: Decision analysis was used to calculate the clinical and economic outcomes of competing management strategies. The traditional strategy incorporates sequential therapeutic trials with more intensive therapy ('step-up' approach) followed by sequential invasive diagnostic testing of nonresponders. The 'proton pump inhibitor test' strategy includes an initial 'proton pump inhibitor test' (7 days of omeprazole: 40 mg AM + 20 mg PM daily) followed by less intensive therapeutic trials in those testing positive ('step-down' approach) with sequential invasive diagnostic testing as needed. Cost estimates were based on Medicare reimbursement and average wholesale drug prices. Probability estimates were derived from a systematic review of the published medical literature. Model results are reported as the average and incremental cost-per-symptom free patient and cost-per-quality-adjusted life-years (QALYs) gained. Results: The average cost per patient was $1045 for the traditional step-up management strategy, compared to $1172 for the 'proton pump inhibitor test' and step-down strategy. The percentage of patients who were symptom-free at 1 year was 50% for the traditional management strategy compared to 75% for the 'proton pump inhibitor test' strategy. The 'proton pump inhibitor test' strategy results in QALY gains of 0.01-0.05 depending on the utility estimate employed. The incremental cost-effectiveness ratio for the 'proton pump inhibitor test' strategy is $510 per additional symptomatic cure over 1 year, and between $2822-$10 160 per QALY gained. The traditional management strategy resulted in a greater than 5-fold increase in the utilization of upper endoscopy, which was partially offset by a 47% reduction in the use of ambulatory 24-h oesophageal pH monitoring. The reduced effectiveness of the traditional management strategy may be attributed in part to a 118% increase in the use of 'high-dose' H2RAs while reducing the use of standard dose proton pump inhibitors by only 42% and 'high-dose' proton pump inhibitors by 57%. Conclusions: Based on the results of this analysis, strategies utilizing the initial PPI test followed by a 'step-down' approach may result in improved symptom relief and quality of life over 1 year, and more appropriate utilization of invasive diagnostic testing at a small marginal increase in total costs. These findings warrant a prospective trial comparing these competing management strategies.