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.

本研究旨在针对保守治疗无效的腰椎间盘突出症（lumbar disc herniation, LDH）患者，分析椎间盘内注射康得立酶（condoliase）对比手术治疗或保守治疗的成本-效果。我们开展了如下三项成本-效果分析：（I）康得立酶治疗后（对康得立酶无应答者行开放手术）vs. 初始即行开放手术；（II）康得立酶治疗后（对康得立酶无应答者行内镜手术）vs. 初始即行内镜手术；（III）康得立酶联合保守治疗vs. 保守治疗。
在前两项与手术治疗的对比分析中，我们假设两组患者的效用值相等，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（治疗、不良事件、术后随访）与无形成本（身心负担及生产力损失）。在最后一项未涉及手术治疗的对比中，我们估算了增量成本效果比（incremental cost-effectiveness ratio, ICER）。
初始即行开放手术的患者人均总费用为1,365,012日元，而康得立酶治疗后（对康得立酶无应答者行开放手术）的人均总费用为701,643日元，较前者减少663,369日元。初始即行内镜手术的患者人均总费用为1,158,817日元，而康得立酶治疗后（对康得立酶无应答者行内镜手术）的人均总费用为643,909日元，较前者减少514,909日元。治疗后2年的增量成本效果比为158万日元/质量调整生命年（quality-adjusted life year, QALY），其中ΔQALY=0.119，95%置信区间：0.059~0.180；Δcost=188,809日元。
从成本效益视角出发，相较于初始即行手术治疗，康得立酶作为腰椎间盘突出症手术治疗前的一线治疗方案更具优势。同时，康得立酶相较于非手术保守治疗，亦是一种具备成本-效果的替代治疗方案。