Shijoh Yoko, Saito Shota, Dai Zhehao, Ohde Sachiko
Graduate School of Public Health St. Luke's International University, Chuo-City, Tokyo, Japan.
Niigata University Graduate School of Medical and Dental Sciences, Niigata-City, Niigata, Japan.
PLoS One. 2022 Jun 3;17(6):e0268690. doi: 10.1371/journal.pone.0268690. eCollection 2022.
Closure of a patent foramen ovale reduces the risk of recurrent stroke compared with medical therapy alone in young patients with cryptogenic strokes revealed by randomized control trials. Some cost-effectiveness analyses outside Japan have shown that patent foramen ovale closure is cost-effective, but no studies have examined cost-effectiveness in Japan. The objective of this study is to assess cost-effectiveness, from the perspective of a Japanese healthcare payer, of patent foramen ovale closure versus medical therapy alone for patients with patent foramen ovale related to cryptogenic strokes.
A cost-effectiveness study was conducted by developing a decision tree and a Markov model. Probabilities and a 5.9-year time horizon followed the RESPECT study. Utilities and costs were based upon published studies and assumptions. All assumptions were assessed by experts, including a cardiologist and a statistical expert. The target population comprised patients with cryptogenic stroke and patent foramen ovale, aged 60 years or younger. The model was discounted at 2.0% and its cycle was one month. A willingness-to-pay threshold is set at $50,000 / quality-adjusted life years (QALYs). Incremental cost-effectiveness ratio was evaluated. Then one-way sensitivity analyses as deterministic sensitivity analysis, and probabilistic sensitivity analyses were performed to assess data robustness.
Incremental quality-adjusted life years, incremental costs, and incremental cost-effectiveness ratio were 0.464, $13,562, and $29,208 per QALY gained, respectively. One-way sensitivity analysis showed that the stable state utility score difference between patent foramen ovale closure and medical therapy had the largest impact on incremental cost-effectiveness ratio. Patent foramen ovale closure is cost-effective at a stable state utility score difference of >0.051, compared with medical therapy. Probabilistic sensitivity analyses demonstrated that patent foramen ovale closure was 50.3% cost-effective.
Patent foramen ovale closure was cost-effective compared with medical therapy for Japanese patients with cryptogenic stroke who were ≤60 years.
在随机对照试验中发现，对于年轻的不明原因卒中患者，与单纯药物治疗相比，卵圆孔未闭封堵术可降低复发性卒中的风险。日本以外的一些成本效益分析表明，卵圆孔未闭封堵术具有成本效益，但尚无研究在日本考察其成本效益。本研究的目的是从日本医疗支付方的角度，评估卵圆孔未闭封堵术与单纯药物治疗相比，对于与不明原因卒中相关的卵圆孔未闭患者的成本效益。
通过构建决策树和马尔可夫模型进行成本效益研究。概率和5.9年的时间范围遵循RESPECT研究。效用和成本基于已发表的研究及假设。所有假设均由包括心脏病专家和统计专家在内的专家进行评估。目标人群为年龄60岁及以下的不明原因卒中和卵圆孔未闭患者。模型以2.0%进行贴现，周期为1个月。支付意愿阈值设定为50,000美元/质量调整生命年（QALY）。评估增量成本效益比。然后进行单向敏感性分析作为确定性敏感性分析，并进行概率敏感性分析以评估数据稳健性。
增量质量调整生命年、增量成本和增量成本效益比分别为0.464、13,562美元和每获得一个QALY 29,208美元。单向敏感性分析表明，卵圆孔未闭封堵术与药物治疗之间的稳态效用评分差异对增量成本效益比影响最大。与药物治疗相比，当稳态效用评分差异>0.051时，卵圆孔未闭封堵术具有成本效益。概率敏感性分析表明，卵圆孔未闭封堵术有50.3%的成本效益。
对于60岁及以下的日本不明原因卒中患者，卵圆孔未闭封堵术与药物治疗相比具有成本效益。
