This secondary analysis of a phase 3 randomized controlled trial evaluated the cost-effectiveness of laparoscopic versus open hemihepatectomy. The study included 332 patients randomized across 16 European centers (166 to laparoscopic hemihepatectomy [LH], 166 to open hemihepatectomy [OH]), with outcomes assessed over 1 year postoperatively. The primary outcome was quality-adjusted life years (QALYs), with secondary outcomes including intraoperative, postoperative, and overall costs, and the incremental cost-effectiveness ratio (ICER).
LH was associated with higher intraoperative costs (€13,208 vs €9,437 for OH) but lower postoperative costs (€5,774 vs €7,703). The mean overall cost per patient was higher for LH (€18,982 vs €17,141). However, patients in the LH group gained more QALYs over 1 year (0.834, SD 0.218) compared to the OH group (0.795, SD 0.237). The resulting ICER was €36,677 per additional QALY gained for LH, with a 77% probability of LH being cost-effective at a willingness-to-pay threshold of €50,000 per QALY.
Safety and tolerability data were not reported in this economic analysis. Key limitations include the lack of reported funding or conflicts of interest information and the absence of detailed adverse event reporting. The 1-year follow-up period may be insufficient to capture all long-term cost and quality-of-life implications. In practice, where resources allow, LH may represent an acceptable economic value for selected patients undergoing hemihepatectomy, but decisions should integrate these cost-effectiveness findings with clinical efficacy and safety data from the primary trial.
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BACKGROUND: Laparoscopic hemihepatectomy (LH) has favorable short-term outcomes compared with open hemihepatectomy (OH), including shorter hospital stay. An in-depth healthcare utilization and cost-effectiveness analysis of the international multicenter ORANGE II PLUS randomized controlled trial comparing LH and OH was performed.
PATIENTS AND METHODS: Patients were randomly assigned to LH or OH in 16 European centers from October 2013 to January 2019. Costs were determined as a product of unit costs using patient-level, clinician-reported resource utilization up to 90 days. Item-specific resource use per country was presented. The measure of effect was quality-adjusted life year (QALY). Cost and effect differences were compared between treatment arms using nonparametric bootstrapping, from a Dutch healthcare cost perspective. A cost-effectiveness analysis was performed to establish the incremental cost-effectiveness ratio (ICER), i.e., costs per QALY gained, for LH compared with OH 1 year postoperatively.
RESULTS: Among 332 patients randomized to LH (n = 166) and OH (n = 166), intraoperative costs were higher for LH (LH 13,208 € versus OH 9437 €), while postoperative costs were lower for LH (LH 5774 € versus OH 7703 €). Longer operative time and greater instrument use contributed to higher intraoperative costs, while shorter hospital stays contributed to lower postoperative costs. Mean overall costs per patient were higher in LH (LH 18,982 € versus OH 17,141 €). The QALYs gained over 1 year postoperative were mean (standard deviation [SD]) 0.834 (0.218) for LH and mean 0.795 (0.237) for OH. The ICER was 36,677 € per additional QALY gained, and uncertainty analyses showed that LH had a 77% probability of being cost-effective compared with OH at a willingness-to-pay (WTP) threshold of 80,000 €.
CONCLUSIONS: Although LH was more costly than OH, in a multicenter randomized trial, its clinical advantages translated into more QALYs gained over the first postoperative year and high probability of cost-effectiveness. These findings suggest that, where resources allow, LH may be preferred over OH for selected patients, offering both clinical benefits and acceptable economic value.