Lachaine Jean, Charron Jean-Nicolas, Gregoire Jean C, Hegele Robert A, Leiter Lawrence A
University of Montreal, Montreal, QC, Canada.
PeriPharm Inc., Montreal, QC, Canada.
Clinicoecon Outcomes Res. 2023 Apr 20;15:295-308. doi: 10.2147/CEOR.S377935. eCollection 2023.
Despite the use of statins, many patients with cardiovascular disease (CVD) have persistent residual risk. In a large Phase III trial (REDUCE-IT), icosapent ethyl (IPE) was shown to reduce the first occurrence of the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina.
We conducted a cost-utility analysis comparing IPE to placebo in statin-treated patients with elevated triglycerides, from a publicly funded, Canadian healthcare payer perspective, using a time-dependent Markov transition model over a 20-year time horizon. We obtained efficacy and safety data from REDUCE-IT, and costs and utilities from provincial formularies and databases, manufacturer sources, and Canadian literature sources.
In the probabilistic base-case analysis, IPE was associated with an incremental cost of $12,523 and an estimated 0.29 more quality-adjusted life years (QALYs), corresponding to an incremental cost-effectiveness ratio (ICER) of $42,797/QALY gained. At a willingness-to-pay of $50,000 and $100,000/QALY gained, there is a probability of 70.4% and 98.8%, respectively, that IPE is a cost-effective strategy over placebo. The deterministic model yielded similar results. In the deterministic sensitivity analyses, the ICER varied between $31,823-$70,427/QALY gained. Scenario analyses revealed that extending the timeframe of the model to a lifetime horizon resulted in an ICER of $32,925/QALY gained.
IPE represents an important new treatment for the reduction of ischemic CV events in statin-treated patients with elevated triglycerides. Based on the clinical trial evidence, we found that IPE could be a cost-effective strategy for treating these patients in Canada.
尽管使用了他汀类药物，但许多心血管疾病（CVD）患者仍存在持续的残余风险。在一项大型III期试验（REDUCE - IT）中，二十碳五烯酸乙酯（IPE）被证明可降低心血管死亡、非致死性心肌梗死、非致死性中风、冠状动脉血运重建或因不稳定型心绞痛住院等主要复合终点的首次发生风险。
我们进行了一项成本效用分析，从加拿大公共资助的医疗保健支付方的角度，使用时间依赖性马尔可夫转换模型，在20年的时间范围内，比较IPE与安慰剂在接受他汀类药物治疗且甘油三酯升高的患者中的效果。我们从REDUCE - IT试验中获取疗效和安全性数据，并从省级药品处方集和数据库、制造商来源以及加拿大文献来源获取成本和效用数据。
在概率性基础案例分析中，IPE的增量成本为12,523美元，估计多获得0.29个质量调整生命年（QALY），对应的增量成本效益比（ICER）为每获得一个QALY 42,797美元。在每获得一个QALY支付意愿为50,000美元和100,000美元时，IPE相对于安慰剂成为具有成本效益策略的概率分别为70.4%和98.8%。确定性模型得出了类似结果。在确定性敏感性分析中，每获得一个QALY的ICER在31,823美元至70,427美元之间变化。情景分析表明，将模型的时间范围延长至终身，每获得一个QALY的ICER为32,925美元。
IPE是降低接受他汀类药物治疗且甘油三酯升高患者缺血性心血管事件的一种重要新疗法。基于临床试验证据，我们发现IPE在加拿大可能是治疗这些患者的一种具有成本效益的策略。
