CHU Bordeaux, Public Health Department, Clinical Epidemiology Unit (USMR), Bordeaux, France.
University Bordeaux, ISPED, INSERM, U1219-Bordeaux Population Health Research Centre, Bordeaux, France.
JAMA Ophthalmol. 2023 Jul 1;141(7):625-629. doi: 10.1001/jamaophthalmol.2023.1716.
The efficacy and safety of femtosecond laser-assisted cataract surgery is well documented. An important requirement for decision makers is the evaluation of the cost-effectiveness of femtosecond laser-assisted cataract surgery (FLACS) over a sufficiently long horizon. Evaluating the cost-effectiveness of this treatment was a preplanned secondary objective of the Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery (FEMCAT) trial.
To estimate the cost utility of FLACS compared with phacoemulsification cataract surgery (PCS) on a 12-month time horizon.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter randomized clinical trial compared FLACS with PCS in parallel groups. All FLACS procedures were performed using the CATALYS precision system. Participants were recruited and treated in ambulatory surgery settings in 5 university-hospital centers in France. All consecutive patients eligible for a unilateral or bilateral cataract surgery 22 years or older with written informed consent were included. Data were collected from October 2013 to October 2018, and data were analyzed from January 2020 to June 2022.
FLACS or PCS.
Utility was measured through the Health Utility Index questionnaire. Costs of cataract surgery were estimated by microcosting. All inpatient and outpatient costs were collected from the French National Health Data System.
Of 870 randomized patients, 543 (62.4%) were female, and the mean (SD) age at surgery was 72.3 (8.6) years. A total of 440 patients were randomized to receive FLACS and 430 to receive PCS; the rate of bilateral surgery was 63.3% (551 of 870). The mean (SD) costs of cataract surgery were €1124.0 (€162.2; US $1235) for FLACS and €565.5 (€61.4; US $621) for PCS. The total mean (SD) cost of care at 12 months was €7085 (€6700; US $7787) in participants treated with FLACS and €6502 (€7323; US $7146) in participants treated with PCS. FLACS yielded a mean (SD) of 0.788 (0.009) quality-adjusted life-years (QALYs), and PCS yielded 0.792 (0.009) QALYs. The difference in mean costs was €545.9 (95% CI, -434.1 to 1525.8; US $600), and the difference in QALYs was -0.004 (95% CI, -0.028 to 0.021). The incremental cost-effectiveness ratio (ICER) was -€136 476 (US $150 000) per QALY. The cost-effectiveness probability of FLACS compared with PCS was 15.7% for a cost-effectiveness threshold of €30 000 (US $32 973) per QALY. At this threshold, the expected value of perfect information was €246 139 079 (US $270 530 231).
The ICER of FLACS compared with PCS was not within the $50 000 to $100 000 per QALY range frequently cited as cost-effective. Additional research and development on FLACS is needed to improve its effectiveness and lower its price.
ClinicalTrials.gov Identifier: NCT01982006.
重要性：飞秒激光辅助白内障手术的疗效和安全性已有充分的文献记载。对于决策者来说，一个重要的要求是评估飞秒激光辅助白内障手术（FLACS）在足够长的时间内的成本效益。对这种治疗方法的成本效益评估是 FEMCAT 试验的一个预先计划的次要目标。
目的：在 12 个月的时间范围内，评估 FLACS 与白内障超声乳化术（PCS）相比的成本效用。
设计、地点和参与者：这是一项多中心随机临床试验，在平行组中比较了 FLACS 与 PCS。所有的 FLACS 手术都使用 CATALYS 精密系统进行。参与者在法国 5 所大学医院的门诊手术环境中被招募和治疗。所有符合条件的单侧或双侧白内障手术的连续患者（年龄 22 岁或以上），均获得书面知情同意后被纳入。数据于 2013 年 10 月至 2018 年 10 月收集，数据于 2020 年 1 月至 2022 年 6 月进行分析。
干预措施：FLACS 或 PCS。
主要结果和测量：通过健康效用指数问卷测量效用。白内障手术的成本通过微成本法进行估计。所有住院和门诊费用均从法国国家卫生数据系统收集。
结果：在 870 名随机患者中，543 名（62.4%）为女性，手术时的平均（标准差）年龄为 72.3（8.6）岁。共有 440 名患者被随机分配接受 FLACS，430 名接受 PCS；双侧手术率为 63.3%（551/870）。FLACS 的白内障手术平均（标准差）费用为 1124.0 欧元（162.2 欧元；1235 美元），PCS 的平均（标准差）费用为 565.5 欧元（61.4 欧元；621 美元）。接受 FLACS 治疗的患者在 12 个月时的总平均（标准差）护理成本为 7085 欧元（6700 欧元；7787 美元），接受 PCS 治疗的患者为 6502 欧元（6502 欧元；7323 美元）。FLACS 产生的平均（标准差）质量调整生命年（QALY）为 0.788（0.009），PCS 产生的为 0.792（0.009）。平均成本差异为 545.9 欧元（95%CI，-434.1 至 1525.8；600 美元），QALY 差异为-0.004（95%CI，-0.028 至 0.021）。增量成本效益比（ICER）为-136476 欧元（150000 美元）/QALY。FLACS 与 PCS 相比，在 30000 欧元（32973 美元）/QALY 的成本效益阈值下，成本效益概率为 15.7%。在这个阈值下，完全信息的预期价值为 246139079 欧元（270530231 美元）。
结论和相关性：FLACS 与 PCS 相比的 ICER 不在经常被引用的 50000 至 100000 美元/QALY 的成本效益范围内。需要对飞秒激光辅助白内障手术进行更多的研究和开发，以提高其疗效并降低其价格。
试验注册：ClinicalTrials.gov 标识符：NCT01982006。
