Abstract

BackgroundNeurogenic bowel dysfunction (NBD) is a common sequela in Spinal Cord Injury (SCI) patients. Bowel dysfunction symptoms have a significant negative impact on quality of life (QOL) and are often socially disabling. Transanal irrigation (TAI) is a bowel management procedure that significantly mitigates NBD symptoms in patients refractory to standard bowel care (SBC) by reducing the incidence of fecal incontinence, ameliorating constipation, and improving QOL. TAI devices are used across many countries such as the United Kingdom, Germany, and France, and introduction of the devices is being considered in Japan. In this context, a cost-effectiveness analysis specific to Japanese settings is relevant.ObjectivesTo analyze the cost-effectiveness of TAI for bowel management of SCI patients with NBD in a Japanese clinical setting.MethodsA modified version of a previously developed and published Markov model was used to evaluate the cost-effectiveness of TAI. In the model, SCI patients using TAI due to NBD were compared with SCI patients not responding to TAI and continuing with SBC. Quality-adjusted Life Years (QALYs) were used as the primary effectiveness measure, and the analysis was conducted from the payer’s perspective.ResultsThe model predicts a lifetime incremental cost of TAI to be 3 198 687 yen compared with SBC. TAI provided an additional 0.8 QALY, which leads to an incremental cost-effectiveness ratio (ICER) of TAI vs SBC of 4 016 287 yen/QALY.ConclusionsAn ICER of 4 million yen falls within the range of reported willingness to pay (WTP) per QALY gain (5–6.7 million yen) in Japan, and TAI is therefore found to be a cost-effective treatment strategy compared to SBC. The result should be further corroborated in future Japanese trials of TAI.

Highlights

  • Nerve injury, neurological disease, or congenital defects of the nervous system that causes loss of normal bowel function is termed neurogenic bowel dysfunction (NBD)

  • The expected Quality-adjusted Life Years (QALYs) gained per Neurogenic bowel dysfunction (NBD) patient in a lifetime perspective was found to be 11.80 in the Transanal irrigation (TAI) group and 11.00 in the standard bowel care (SBC) group, which indicates an incremental effect of 0.80 QALY with Peristeen-TAI usage

  • The incremental cost-effectiveness ratio (ICER) of the TAI group when compared with that of the SBC group was 1 868 712 yen / QALY, 2 942 499 yen / QALY, and 4 016 287 yen / QALY for TAI procedure fees set at 8100 yen, 13 050 yen, and 18 000 yen, respectively

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Summary

Introduction

Neurological disease, or congenital defects of the nervous system that causes loss of normal bowel function is termed neurogenic bowel dysfunction (NBD) It usually includes combinations of fecal incontinence, constipation, abdominal pain, and bloating.[1,2] NBD greatly impacts patients’ quality of life (QOL) as well as their social lives.[3,4,5] Several studies across the world have indicated that appropriate bowel management can significantly improve NBD.[6,7,8,9,10,11,12,13] A stepped approach to bowel management has been recommended, consisting of “conservative” management options (eg, diet and lifestyle alterations), “minimally invasive” options (TAI) and “more invasive options” (eg, sacral nerve stimulation [SNS] or stoma creation).[14] The stepped approach is intended to offer patients improved NBD through the least invasive method.

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