Institute for Health Economics and Clinical Epidemiology, University of Cologne, Albertus-Magnus-Platz, 50923, Cologne, Germany.
Heart & Diabetes Centre NRW, General and Interventional Cardiology/Angiology, University Hospital of the Ruhr University Bochum, Bad Oeynhausen, Chelsea, Germany.
Eur J Health Econ. 2023 Apr;24(3):349-358. doi: 10.1007/s10198-022-01476-4. Epub 2022 May 27.
To evaluate the cost-effectiveness of the MitraClip device (MitraClip) in addition to optimal medical therapy (OMT) in patients with heart failure and secondary mitral regurgitation in Germany.
A model-based economic evaluation was performed to estimate the incremental cost per quality-adjusted life-years (QALYs) for patients with a moderate-to-severe or severe secondary mitral regurgitation receiving MitraClip plus OMT compared with OMT alone from the statutory health insurance (SHI) perspective. Transition probabilities, data on survival rates, and hospitalization rates were obtained from the COAPT trial, a randomized-controlled multicenter trial. Data on health utility and costs were taken from published evidence. To assess parameter uncertainty, several deterministic and probabilistic sensitivity analyses were performed. The incremental costs per QALY gained were € 59,728 (costs/incremental life years gained: € 42,360). The results were most sensitive to the transition probabilities and the hospitalization rates. The probabilistic sensitivity analysis showed that the MitraClip strategy was cost-effective with a probability of 80% at a willingness-to-pay threshold of € 67,000/QALY.
Depending on the willingness-to-pay threshold, for patients with heart failure and a moderate-to-severe or severe secondary mitral regurgitation the MitraClip can be cost-effective from the perspective of the German SHI.
评估在德国,心力衰竭伴中度或重度二尖瓣反流患者中,除最佳药物治疗(OMT)之外,使用 MitraClip 装置(MitraClip)的成本效益。
从法定健康保险(SHI)的角度,基于模型的经济评估估计了中度至重度或重度二尖瓣反流患者在接受 MitraClip 联合 OMT 治疗与单独接受 OMT 治疗相比,每获得一个质量调整生命年(QALY)的增量成本。从 COAPT 试验(一项随机对照多中心试验)中获得了转移概率、生存率和住院率的数据。健康效用和成本数据来自已发表的证据。为了评估参数不确定性,进行了几项确定性和概率敏感性分析。每获得一个 QALY 的增量成本为 59728 欧元(成本/增量生命年获得:42360 欧元)。结果对转移概率和住院率最为敏感。概率敏感性分析表明,在愿意支付的阈值为 67000 欧元/QALY 的情况下,MitraClip 策略具有成本效益,概率为 80%。
根据意愿支付阈值,对于心力衰竭伴中度或重度二尖瓣反流的患者,从德国 SHI 的角度来看,MitraClip 具有成本效益。