Cost-effectiveness analysis of intradiscal condoliase injection vs. surgical or conservative treatment for lumbar disc herniation

This study aimed to analyze the cost-effectiveness of intradiscal condoliase injection compared to surgical or conservative treatment for patients with lumbar disc herniation (LDH) who are refractory to conservative treatment. We performed the following cost-effectiveness analyses: (I) condoliase followed by open surgery (for non-responders to condoliase) vs. open surgery from the beginning, (II) condoliase followed by endoscopic surgery (for non-responders to condoliase) vs. endoscopic surgery from the beginning, and (III) condoliase + conservative treatment vs. conservative treatment. In the first two comparisons with surgical treatments, we assumed that utilities were equal in both groups and estimated the tangible (treatment, adverse events, postoperative follow-up) and intangible (mental and physical burden, and productivity loss) costs based on the existing literature, the medical expense scoring table, and online questionnaire. In the last comparison without surgical treatment, we estimated the incremental cost-effectiveness. The average cost per patient of condoliase followed by open surgery (for non-responders to condoliase) was 701,643 yen, with a reduction of 663,369 in comparison to that of open surgery from the beginning (1,365,012 yen). The average cost per patient of condoliase followed by endoscopic surgery (for non-responders to condoliase) was 643,909 yen, with a reduction of 514,909 in comparison to that of endoscopic surgery from the beginning (1,158,817 yen). ICER was 1.58 million yen/QALY (ΔQALY = 0.119, 95% confidence interval: 0.059–0.180; Δcost = 188,809 yen at 2 years post-treatment). Condoliase as a first line treatment option ahead of surgical treatment for LDH is superior, from a cost perspective, to surgical treatment from the beginning. Condoliase is also a cost-effective alternative to non-surgery conservative treatment.

本研究旨在对比经保守治疗无效的腰椎间盘突出症（lumbar disc herniation, LDH）患者采用椎间盘内胶原酶（condoliase）注射疗法，与手术治疗或保守治疗的成本效益。我们开展了如下三组成本效益分析：（I）先予胶原酶注射，对治疗无应答者行开放手术，与初始即行开放手术相比；（II）先予胶原酶注射，对治疗无应答者行内镜手术，与初始即行内镜手术相比；（III）胶原酶注射联合保守治疗与单纯保守治疗相比。在前两组与手术治疗的对比中，我们假设两组患者的健康效用值（utilities）相等，并基于现有文献、医疗费用评分表及线上问卷，估算了有形成本（含治疗费用、不良事件处置费用、术后随访费用）与无形成本（含身心负担、生产力损失）。在最后一组无需手术的对比中，我们估算了增量成本效益。先予胶原酶注射、无应答者行开放手术的患者人均总成本为701643日元，相较初始开放手术组的1365012日元，降低了663369日元。先予胶原酶注射、无应答者行内镜手术的患者人均总成本为643909日元，相较初始内镜手术组的1158817日元，降低了514909日元。增量成本效果比（incremental cost-effectiveness ratio, ICER）为158万日元/质量调整生命年（quality-adjusted life year, QALY），增量QALY为0.119，95%置信区间为0.059~0.180；治疗后2年的增量成本为188809日元。从成本效益视角来看，相较于初始即行手术治疗，胶原酶作为腰椎间盘突出症术前一线治疗方案更具优势；同时，胶原酶联合保守治疗相较单纯保守治疗，也是一种具备成本效益的替代方案。