Medical or Surgical Therapy for Erosive Reflux Esophagitis: Cost-Utility Analysis Using a Markov Model

Joseph Romagnuolo, MD, FRCP(C), MSc, (Epid); Michael A. Meier, MD, FRCS(C); Daniel C. Sadowski, MD, FRCP(C)

Disclosures

Annals of Surgery. 2002;236(2) 

In This Article

Abstract and Introduction

Objective: To compare the cost and utility of healing and maintenance regimens of omeprazole and laparoscopic Nissen fundoplication (LNF) in the framework of the Canadian medical system.
Summary Background Data: Medical therapy with proton pump inhibitors for endoscopically proven reflux esophagitis is a safe and effective treatment option. Of late, the surgical treatment of choice for this disease has become LNF.
Methods: The authors' base case was a 45-year-old man with erosive reflux esophagitis refractory to H2-blockers. A cost-utility analysis was performed comparing the two strategies. A two-stage Markov model (healing and maintenance phases) was used to estimate costs and utilities with a time horizon of 5 years. Discounted direct costs were estimated from the perspective of a provincial health ministry, and discounted qual-ity-of-life estimates were derived from the medical literature. Sensitivity analyses were performed to test the robustness of the model to the authors' assumptions and to determine thresholds. A Monte Carlo simulation of 10,000 patients was used to estimate variances and 95% interpercentile ranges.
Results: For the 5-year period studied, LNF was less expensive than omeprazole ($3519.89 vs. $5464.87 per patient) and became the more cost-effective option at 3.3 years of follow-up. The authors found that 20 mg/day omeprazole would have to cost less than $38.60 per month before medical therapy became cost effective; conversely, the cost of LNF would have to be more than $5,273.70 or the length of stay more than 4.2 days for medical therapy to be cost effective. Estimates of quality-adjusted life-years did not differ significantly between the two treatment options, and the incremental cost for medical therapy was $129,665 per quality-adjusted life-years gained.
Conclusions: For patients with severe esophagitis, LNF is a cost-effective alternative to long-term maintenance therapy with proton pump inhibitors.

Symptoms of heartburn affect 7% of the North American adult population daily, 14% weekly, and 36% monthly.[1] Three percent of heartburn sufferers have severe symptoms.[2] Epidemiologic studies in ambulatory subjects have demonstrated that reflux is not limited by geography or culture. Seventy-three percent of subjects in Minnesota had moderate heartburn or regurgitation at least weekly.[3] In Finland, 54% of elderly women and 66% of the men had heartburn monthly.[4] In Sweden, 25% of the respondents to a questionnaire admitted to frequent heartburn.[5] These data suggest that symptomatic heartburn is one of the most common human ailments, despite apparent variations in its rate of occurrence. Further, it has recently been shown that there is a strong association between symptomatic reflux and esophageal adenocarcinoma (odds ratio 7.7).[6]

Distal esophageal erosions visualized on endoscopy indicate gastroesophageal reflux disease (GERD). While the symptom of heartburn is common, endoscopic changes are found in a minority of individuals. However, the finding of endoscopic GERD is significant in that it is highly predictive of poor healing rates with H2-blockers or prokinetic drugs. Nevertheless, proton pump inhibitors (PPIs) appear to offer significant therapeutic advantage in healing the subgroup of individuals with grade II-IV esophagitis, although healing success is dependent on the grade of esophagitis at presentation, with grade IV esophagitis having a much higher medical failure rate.[7,8]

The most frustrating aspect of GERD treatment is the high relapse rate after successful medical healing. More than 80% of patients with erosive (grade II or higher) esophagitis will relapse within 6 months, with 50% of the relapses occurring in the first month.[9,10] This observation has led some to conclude that maintenance therapy is necessary for all individuals with endoscopically proven reflux disease. Different classes of drugs have been studied in this context. Maintenance trials with prokinetic agents and H2-blockers have demonstrated modest efficacy in the severe esophagitis group, suggesting that the so-called "stepdown" approach may not be possible after healing is achieved with PPIs. An expert consensus has suggested that the drug successful in healing should be the drug chosen as maintenance.[11]

Before the advent of potent antisecretory drugs, surgery was a keystone in the long-term management of GERD. Open Nissen fundoplication was introduced by Rudolph Nissen in 1956 and has since gained respect as an effective alternative to medical maintenance therapy. Long-term follow-up data suggest that up to 90% of patients are symptom-free and require no maintenance medications after 20 years of observation.[12,13] While there are many established surgical approaches, they can all be categorized as either complete (360°) or partial (180°) wraps. The Nissen procedure is a complete fundoplication, whereas the Belsey Mark IV, Dor, and Toupet repairs are partial and have generally not been as successful in restoring lower esophageal sphincter competence.[14,15]

Since 1991, the laparoscopic Nissen fundoplication (LNF) has shown physiologic results similar to those of the open technique.[16,17] Ambulatory monitoring of esophageal pH in pre- and post-LNF patients has demonstrated a 10-fold reduction in acid exposure time in the distal esophagus.[18,19] Laparoscopic surgery was also found to normalize the 24-hour pH study in 91% of subjects.[20] Physiologic measurements of lower esophageal sphincter pressure demonstrated a mean increase of 8.3 to 16.2 mm Hg after LNF.[21,22,23,24] Thus, the effectiveness of LNF is similar to that of its open counterpart with over 3 years of follow-up.[25] Preliminary results (n = 310) from a European multicenter randomized trial showed no differences in the incidence of either endoscopic or symptomatic relapse between medical and laparoscopic therapy, with only 6.7% relapsing in the surgical arm over 5 years.[26] Quality of life was similar between the two groups at up to 5 years of follow-up.[27,28] For those individuals requiring long-term maintenance therapy for GERD, LNF is becoming an increasingly viable option, with the perceived advantages of decreased cost and avoidance of long-term drug side effects.[29] In this study, we sought to compare the costs and clinical consequences of two treatment options for erosive reflux esophagitis: LNF versus maintenance medical therapy with omeprazole.

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