Laparoscopic fundoplication compared with medical management for gastro-oesophageal reflux disease: cost effectiveness study

Abstract

Objective To describe the long term costs, health benefits, and cost effectiveness of laparoscopic surgery compared with those of continued medical management for patients with gastro-oesophageal reflux disease (GORD). Design We estimated resource use and costs for the first year on the basis of data from the REFLUX trial. A Markov model was used to extrapolate cost and health benefit over a lifetime using data collected in the REFLUX trial and other sources. Participants The model compared laparoscopic surgery and continued proton pump inhibitors in male patients aged 45 and stable on GORD medication. Intervention Laparoscopic surgery versus continued medical management. Main outcome measures We estimated quality adjusted life years and GORD related costs to the health service over a lifetime. Sensitivity analyses considered other plausible scenarios, in particular size and duration of treatment effect and the GORD symptoms of patients in whom surgery is unsuccessful. Main results The base case model indicated that surgery is likely to be considered cost effective on average with an incremental cost effectiveness ratio of £2648 (€3110; US $4385) per quality adjusted life year and that the probability that surgery is cost effective is 0.94 at a threshold incremental cost effectiveness ratio of £20 000. The results were sensitive to some assumptions within the extrapolation modelling. Conclusion Surgery seems to be more cost effective on average than medical management in many of the scenarios examined in this study. Surgery might not be cost effective if the treatment effect does not persist over the long term, if patients who return to medical management have poor health related quality of life, or if proton pump inhibitors were cheaper. Further follow-up of patients from the REFLUX trial may be valuable. Trial registration ISRCTN15517081.

Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial)

“…At 1 year in the Anvari et al [44][45][46] trial, the GERSS regurgitation subscore is significantly lower in the surgical group (p = 0.002); in the LOTUS trial, [47][48][49][50] graphical presentation clearly indicates less regurgitation in the surgical group, although no figures are reported; and in the REFLUX trial, [1][2][3] regurgitation rates in the surgical group are half those in the medical group. At 3 years, information is available only for the LOTUS and REFLUX trials and both report lower rates in the surgical groups.…”

“…In contrast, 'bloating/trapped wind' was reported less commonly in the surgical group in the REFLUX trial [1][2][3] (at 1 year: 72.1% vs 82.4%). A particular concern following fundoplication is an inability to vomit despite wanting to.…”

“…At 1 year in the Anvari et al trial, [44][45][46] the GERSS heartburn subscore is lower in the surgical group (p <0.001); in the LOTUS trial [47][48][49][50] there is clearly less heartburn in the surgical group but data are presented only graphically; and in the REFLUX trial [1][2][3] heartburn rates in the surgical group are around half those in the medical group. At 3 years, Anvari et al [44][45][46] report significantly more heartburn-free days in the surgical group (p = 0.008); in the LOTUS trial, [47][48][49][50] less heartburn in the surgical group is shown graphically and the p-value is reported as < 0.001; and in the REFLUX trial 1-3 51% of the randomised surgical group compared with 75% of the randomised medical management group report any heartburn (see Table 15).…”

“…[44][45][46] as it was in the REFLUX trial. [1][2][3] Unfortunately, it is reported only as the two summary component scores, physical (PCS) and mental (MCS), plus the 'general health' domain score. For comparability, in Tables 27 and 28 the same score formats are shown for the REFLUX trial but it should be borne in mind that the eight domain scores shown in Chapter 3 for the REFLUX trial are more informative.…”

“…The first stage, encompassing preliminary economic modelling, outcome development, trial recruitment, initial clinical management, follow-up to a time equivalent to 1 year after surgery and modelling of cost-effectiveness based on results available at that time, was reported in 2008. [1][2][3][4][5] The second stage, reported here, describes analyses based on further follow-up to 5 years after surgery.…”