Cost-utility of laparoscopic Nissen fundoplication versus proton pump inhibitors for chronic and controlled gastroesophageal reflux disease: a 3-year prospective randomized controlled trial and economic evaluation.

Very few randomized controlled trials (RCTs) have compared laparoscopic Nissen fundoplication (LNF) to proton pump inhibitors (PPI) medical management for patients with chronic gastroesophageal reflux disease (GERD). Larger RCTs have been relatively short in duration, and have reported mixed results regarding symptom control and effect on quality of life (QOL). Economic evaluations have reported conflicting results. To determine the incremental cost-utility of LNF versus PPI for treating patients with chronic and controlled GERD over 3 years from the societal perspective. Economic evaluation was conducted alongside a RCT that enrolled 104 patients from October 2000 to September 2004. Primary study outcome was GERD symptoms (secondary outcomes included QOL and cost-utility). Resource utilization and QOL data collected at regular follow-up intervals determined incremental cost/QALY gained. Stochastic uncertainty was assessed using bootstrapping and methodologic assumptions were assessed using sensitivity analysis. No statistically significant differences in GERD symptom scores, but LNF did result in fewer heartburn days and improved QOL. Costs were higher for LNF patients by $3205/patient over 3 years but QOL was also higher as measured by either QOL instrument. Based on total costs, incremental cost-utility of LNF was $29,404/QALY gained using the Health Utility Index 3. Cost-utility results were sensitive to the utility instrument used ($29,404/QALY for Health Utility Index 3, $31,117/QALY for the Short Form 6D, and $76,310/QALY for EuroQol 5D) and if current lower prices for PPIs were used in the analysis. Results varied depending on resource use/costs included in the analysis, the QOL instrument used, and the cost of PPIs; however, LNF was generally found to be a cost-effective treatment for patients with symptomatic controlled GERD requiring long-term management.

Goeree R ，Hopkins R ，Marshall JK ，Armstrong D ，Ungar WJ ，Goldsmith C ，Allen C ，Anvari M ... -  《-》

Short-term cost effectiveness and long-term cost analysis comparing laparoscopic Nissen fundoplication with proton-pump inhibitor maintenance for gastro-oesophageal reflux disease.

This study examined the short-term cost-effectiveness and long-term cost of laparoscopic Nissen fundoplication (LNF) versus maintenance proton-pump inhibitor (PPI) medication for severe gastro-oesophageal reflux disease (GORD) based on a randomized clinical trial. Costs and outcomes for 12 months were obtained from the first 100 patients in the trial. Detailed costing was performed using resource use data from hospital records and general practitioners' notes. Short-term incremental cost-effectiveness ratios, calculated as the cost difference divided by the effectiveness difference between LNF and PPI therapy, were analysed using net benefit and bootstrap approaches. Long-term cost was examined using sensitivity analyses incorporating published data from other large series. The incremental cost of LNF compared with PPI therapy per additional patient returned to a physiologically normal acid score (less than 13.9) at 3 months was pound5515 (95 per cent confidence interval (c.i.) pound3655 to pound13 400) and the incremental cost per point improvement in combined Gastro-Intestinal and Psychological Well-being score at 12 months was pound293 (90 per cent c.i. pound149 to pound5250). On average, LNF cost pound2247 (95 per cent c.i. pound2020 to pound2473) more than PPI therapy in year 1 and broke even in year 8. Break-even was highly sensitive to hospital unit costs but less sensitive to PPI ingestion rate after LNF, LNF reoperation rate, PPI relapse rate, future PPI price, PPI dose escalation and discount rate. From a National Health Service perspective, LNF may be cost-saving after 8 years compared with maintenance PPI therapy for the treatment of GORD.

Cookson R ，Flood C ，Koo B ，Mahon D ，Rhodes M ... -  《-》

Long-term cost-effectiveness of medical, endoscopic and surgical management of gastroesophageal reflux disease.

The long-term cost effectiveness of medical, endoscopic, and operative treatments for adults with gastroesophageal reflux disease (GERD) remains unclear. We sought to estimate the cost effectiveness of medical, endoscopic, and operative treatments for adults with GERD who require daily proton pump inhibitor (PPI) therapy. A Markov model was generated from the payer's perspective using a 6-month cycle and 30-year time horizon. The base-case patient was a 45-year-old man with symptomatic GERD taking 20 mg of omeprazole twice daily. Four treatment strategies were analyzed: PPI therapy, transoral incisionless fundoplication (EsophyX), radiofrequency energy application to the lower esophageal sphincter (Stretta) and laparoscopic Nissen fundoplication. The model parameters were selected using the published literature and institutional billing data. The main outcome measure was the incremental cost-effectiveness ratio (cost per quality-adjusted life-year gained) for each therapy. In the base case analysis, which assumed a PPI cost of $234 over 6 months ($39 per month), Stretta and laparoscopic Nissen fundoplication were the most cost-effective options over a 30-year time period ($2,470.66 and $5,579.28 per QALY gained, respectively). If the cost of PPI therapy exceeded $90.63 per month over 30 years, laparoscopic Nissen fundoplication became the dominant treatment option. EsophyX was dominated by laparoscopic Nissen fundoplication at all points in time. Low-cost PPIs, Stretta, and laparoscopic Nissen fundoplication all represent cost-effective treatment strategies. In this model, when PPIs exceed $90 per month, medical therapy is no longer cost effective. Procedural GERD therapy should be considered for patients who require high-dose or expensive PPIs.

Funk LM ，Zhang JY ，Drosdeck JM ，Melvin WS ，Walker JP ，Perry KA ... -  《-》

The Stretta procedure versus proton pump inhibitors and laparoscopic Nissen fundoplication in the management of gastroesophageal reflux disease: a cost-effectiveness analysis.

Comay D ，Adam V ，da Silveira EB ，Kennedy W ，Mayrand S ，Barkun AN ... -  《-》

Efficacy of Laparoscopic Nissen Fundoplication vs Transoral Incisionless Fundoplication or Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease: A Systematic Review and Network Meta-analysis.

The effects of transoral incisionless fundoplication (TIF) and laparoscopic Nissen fundoplication (LNF) have been compared with those of proton pump inhibitors (PPIs) or a sham procedure in patients with gastroesophageal reflux disease (GERD), but there has been no direct comparison of TIF vs LNF. We performed a systematic review and network meta-analysis of randomized controlled trials to compare the relative efficacies of TIF vs LNF in patients with GERD. We searched publication databases and conference abstracts through May 10, 2017 for randomized controlled trials that compared the efficacy of TIF or LNF with that of a sham procedure or PPIs in patients with GERD. We performed a network meta-analysis using Bayesian methods under random-effects multiple treatment comparisons. We assessed ranking probability by surface under the cumulative ranking curve. Our search identified 7 trials comprising 1128 patients. Surface under the cumulative ranking curve ranking indicated TIF had highest probability of increasing patients' health-related quality of life (0.96), followed by LNF (0.66), a sham procedure (0.35), and PPIs (0.042). LNF had the highest probability of increasing percent time at pH <4 (0.99), followed by PPIs (0.64), TIF (0.32), and the sham procedure (0.05). LNF also had the highest probability of increasing LES pressure (0.78), followed by TIF (0.72) and PPIs (0.01). Patients who underwent the sham procedure had the highest probability for persistent esophagitis (0.74), followed by those receiving TIF (0.69), LNF (0.38), and PPIs (0.19). Meta-regression showed a shorter follow-up time as a significant confounder for the outcome of health-related quality of life in studies of TIF. In a systematic review and network meta-analysis of trials of patients with GERD, we found LNF to have the greatest ability to improve physiologic parameters of GERD, including increased LES pressure and decreased percent time pH <4. Although TIF produced the largest increase in health-related quality of life, this could be due to the shorter follow-up time of patients treated with TIF vs LNF or PPIs. TIF is a minimally invasive endoscopic procedure, yet based on evaluation of benefits vs risks, we do not recommend it as a long-term alternative to PPI or LNF treatment of GERD.

Richter JE ，Kumar A ，Lipka S ，Miladinovic B ，Velanovich V ... -  《-》