School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.
Patient Access, Novartis Korea, Ltd, Seoul, South Korea.
Clin Ther. 2019 Jun;41(6):1066-1079. doi: 10.1016/j.clinthera.2019.04.031. Epub 2019 May 15.
Sacubitril/valsartan, the first-in-class angiotensin receptor neprilysin inhibitor (ARNI), is a possible treatment option for chronic heart failure patients with reduced ejection fraction (HFrEF). The aim of this study was to estimate the cost-effectiveness of sacubitril/valsartan use in South Korea for treating patients with HFrEF compared with that of enalapril, an angiotensin-converting enzyme inhibitor, and with angiotensin receptor blockers (ARBs).
A Markov model was designed to estimate the lifetime cost-effectiveness of treatment for patients with HFrEF. Cohorts in the alive-state incurred a monthly risk of hospitalization because of deteriorated HF, adverse events (AEs), or death. Transition probabilities of sacubitril/valsartan and enalapril were estimated by using data from the PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. The effectiveness of ARBs (eg, reduction in mortality and hospitalization rates) was assumed to be identical to that of enalapril, according to the results of the meta-analysis. However, there was no comparative evidence for AEs. We therefore conducted a Bayesian network meta-analysis and adjusted the incidence rate of AEs for ARBs. The utility for estimating quality-adjusted life years (QALYs) was elicited by the survey of the general South Korean population by using EuroQol-5 dimensions. We calculated the medical costs, including medication, monitoring, hospitalization, AEs, and terminal care, from the health care sector perspective. Costs and effectiveness were discounted by 5%. One-way sensitivity analyses and a probabilistic sensitivity analysis were conducted to determine the model robustness.
The total cost per patient for sacubitril/valsartan and enalapril was $25,832 and $18,295, respectively. Sacubitril/valsartan was associated with an ∼8- month longer life expectancy compared with enalapril and a QALY gain of 0.59. As a result, the incremental cost-effectiveness ratio for sacubitril/valsartan versus enalapril was $12,722 per QALY. The incremental cost-effectiveness ratio of sacubitril/valsartan versus ARB was $11,970 with an incurred cost of $18,741 for the ARB group. The main results and those of various sensitivity analyses were lower than a threshold of $20,000.
From a health care sector perspective, sacubitril/valsartan is a cost-effective treatment for HFrEF compared with enalapril and ARBs. This finding could be helpful for cardiologists or decision makers in reaching cost-effective choices regarding the treatment selection process.
沙库巴曲缬沙坦，作为首个血管紧张素受体脑啡肽酶抑制剂（ARNI），可能是射血分数降低的慢性心力衰竭（HFrEF）患者的一种治疗选择。本研究旨在评估沙库巴曲缬沙坦在韩国用于治疗 HFrEF 患者的成本效益，与血管紧张素转换酶抑制剂（ACEI）依那普利和血管紧张素受体阻滞剂（ARB）相比。
设计了一个马尔可夫模型来估计 HFrEF 患者治疗的终生成本效益。在存活状态下的队列每月因 HF 恶化、不良事件（AE）或死亡而有住院风险。通过 PARADIGM-HF（沙库巴曲缬沙坦与 ACEI 比较以确定对心力衰竭全球死亡率和发病率的影响的前瞻性比较）试验的数据来估计沙库巴曲缬沙坦和依那普利的转移概率。根据荟萃分析的结果，假设 ARB 的有效性（例如，降低死亡率和住院率）与依那普利相同。然而，AE 方面没有比较证据。因此，我们进行了贝叶斯网络荟萃分析，并调整了 ARB 发生 AE 的发生率。通过对普通韩国人群的调查来估计质量调整生命年（QALY）的效用，使用了 EuroQol-5 维度。我们从医疗保健部门的角度计算了药物、监测、住院、AE 和临终护理的医疗费用。成本和效果贴现率为 5%。进行了单因素敏感性分析和概率敏感性分析，以确定模型的稳健性。
沙库巴曲缬沙坦和依那普利的每位患者总成本分别为 25832 美元和 18295 美元。与依那普利相比，沙库巴曲缬沙坦可延长约 8 个月的预期寿命，并可获得 0.59 个 QALY。因此，沙库巴曲缬沙坦与依那普利相比的增量成本效益比为每 QALY 12722 美元。沙库巴曲缬沙坦与 ARB 相比的增量成本效益比为 11970 美元，ARB 组的成本为 18741 美元。主要结果和各种敏感性分析的结果均低于 20000 美元的阈值。
从医疗保健部门的角度来看，与依那普利和 ARB 相比，沙库巴曲缬沙坦是治疗 HFrEF 的一种具有成本效益的治疗方法。这一发现可能有助于心脏病专家或决策者在治疗选择过程中做出具有成本效益的选择。
