Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II-III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial

Abstract

Aim: Haemorrhoids are a common condition, with nearly 30,000 procedures carried out in England in 2014/15, and result in a significant quality-of-life burden to patients and a financial burden to the healthcare system. This study examined the cost effectiveness of haemorrhoidal artery ligation (HAL) compared with rubber band ligation (RBL) in the treatment of grade II-III haemorrhoids.

Method: This analyses used data from the HubBLe study, a multicentre, open-label, parallel group, randomised controlled trial conducted in 17 acute UK hospitals between September 2012 and August 2015. A full economic evaluation, including long-term cost effectiveness, was conducted from the UK National Health Service (NHS) perspective. Main outcomes included healthcare costs, quality-adjusted life-years (QALYs) and recurrence. Cost-effectiveness results were presented in terms of incremental cost per QALY gained and cost per recurrence avoided. Extrapolation analysis for 3 years beyond the trial follow-up, two subgroup analyses (by grade of haemorrhoids and recurrence following RBL at baseline), and various sensitivity analyses were undertaken.

Results: In the primary base-case within-trial analysis, the incremental total mean cost per patient for HAL compared with RBL was £1027 (95% confidence interval [CI] £782-£1272, p < 0.001). The incremental QALYs were 0.01 QALYs (95% CI -0.02 to 0.04, p = 0.49). This generated an incremental cost-effectiveness ratio (ICER) of £104,427 per QALY. In the extrapolation analysis, the estimated probabilistic ICER was £21,798 per QALY. Results from all subgroup and sensitivity analyses did not materially change the base-case result.

Conclusions: Under all assessed scenarios, the HAL procedure was not cost effective compared with RBL for the treatment of grade II-III haemorrhoids at a cost-effectiveness threshold of £20,000 per QALY; therefore, economically, its use in the NHS should be questioned.

Keywords: Electronic Supplementary Material; National Health Service; Probabilistic Sensitivity Analysis; Rubber Band Ligation; Seemingly Unrelated Regression.

Conflict of interest statement

Availability of data

The datasets generated and/or analysed during the current study are not publicly available due to ethical restrictions but may be available from the corresponding author on reasonable request.

Conflicts of interest

Abualbishr Alshreef, Allan J. Wailoo, Steven R. Brown, James P. Tiernan, Angus J.M. Watson, Katie Biggs, Mike Bradburn and Daniel Hind declare that they have no conflicts of interest.

Funding

The HubBLe trial was funded by the UK NIHR Health Technology Assessment Programme (HTA 10/57/46). Abualbishr Alshreef was partly funded by the Yorkshire and Humber Academic Health Sciences Network.

Ethical approval

This study was approved by an NHS Research Ethics Committee (NRES Committee Yorkshire and The Humber—South Yorkshire [REC reference 12/YH/0236]) and has been performed in accordance with the ethical standards of the Declaration of Helsinki. Fully informed written consent was obtained from all individual participants included in the study.

Figures

Fig. 1

Cost-effectiveness acceptability curve showing the probability that HAL is cost-effectiveness at different thresholds (within trial analysis)

Fig. 2

Cost-effectiveness acceptability curve showing the probability that HAL is cost-effectiveness at different thresholds (extrapolation analysis)