College of Pharmacy/International Cooperative Laboratory of Traditional Chinese Medicine Modernization and Innovative Drug Development of Ministry of Education (MOE) of China, Jinan University, Guangzhou, China.
Guangzhou Huabo Biopharmaceutical Research Institute, Guangzhou, China.
BMC Med. 2022 Oct 25;20(1):407. doi: 10.1186/s12916-022-02601-z.
For hypertensive patients without a history of stroke or myocardial infarction (MI), the China Stroke Primary Prevention Trial (CSPPT) demonstrated that treatment with enalapril-folic acid reduced the risk of primary stroke compared with enalapril alone. Whether folic acid therapy is an affordable and beneficial treatment strategy for the primary prevention of stroke in hypertensive patients from the Chinese healthcare sector perspective has not been thoroughly explored.
We performed a cost-effectiveness analysis alongside the CSPPT, which randomized 20,702 hypertensive patients. A patient-level microsimulation model based on the 4.5-year period of in-trial data was used to estimate costs, life years, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) for enalapril-folic acid vs. enalapril over a lifetime horizon from the payer perspective.
During the in-trial follow-up period, patients receiving enalapril-folic acid gained an average of 0.016 QALYs related primarily to reductions in stroke, and the incremental cost was $706.03 (4553.92 RMB). Over a lifetime horizon, enalapril-folic acid treatment was projected to increase quality-adjusted life years by 0.06 QALYs or 0.03 life-year relative to enalapril alone at an incremental cost of $1633.84 (10,538.27 RMB), resulting in an ICER for enalapril-folic acid compared with enalapril alone of $26,066.13 (168,126.54 RMB) per QALY gained and $61,770.73 (398,421.21 RMB) per life-year gained, respectively. A probabilistic sensitivity analysis demonstrated that enalapril-folic acid compared with enalapril would be economically attractive in 74.5% of simulations at a threshold of $37,663 (242,9281 RMB) per QALY (3x current Chinese per capita GDP). Several high-risk subgroups had highly favorable ICERs < $12,554 (80,976 RMB) per QALY (1x GDP).
For both in-trial and over a lifetime, it appears that enalapril-folic acid is a clinically and economically attractive medication compared with enalapril alone. Adding folic acid to enalapril may be a cost-effective strategy for the prevention of primary stroke in hypertensive patients from the Chinese health system perspective.
对于没有中风或心肌梗死（MI）病史的高血压患者，中国脑卒中一级预防试验（CSPPT）表明，与依那普利单药治疗相比，依那普利叶酸治疗降低了首发中风的风险。从中国医疗保健系统的角度来看，叶酸治疗是否是高血压患者预防中风的一种负担得起且有益的治疗策略，尚未得到充分探讨。
我们在 CSPPT 中进行了成本效益分析，该试验共纳入了 20702 名高血压患者。基于 4.5 年的试验数据，采用患者水平的微观模拟模型来估算依那普利叶酸与依那普利相比，在支付者视角下的终生范围内的成本、生命年、质量调整生命年（QALY）和增量成本效益比（ICER）。
在试验随访期间，接受依那普利叶酸治疗的患者平均获得了 0.016 个 QALY，主要归因于中风的减少，增量成本为 706.03 美元（4553.92 人民币）。在终生范围内，与依那普利单药治疗相比，依那普利叶酸治疗预计将增加 0.06 个 QALY 或 0.03 个生命年，增量成本为 1633.84 美元（10538.27 人民币），依那普利叶酸与依那普利相比的 ICER 为 26066.13 美元（168126.54 人民币）每获得一个 QALY，61770.73 美元（398421.21 人民币）每获得一个生命年，增量成本分别为。概率敏感性分析表明，在 37663 美元（2429281 人民币）的阈值下，依那普利叶酸与依那普利相比，在 74.5%的模拟中具有经济吸引力（是当前中国人均 GDP 的 3 倍）。几个高风险亚组的 ICER 非常有利，低于 12554 美元（80976 人民币）每 QALY（是 GDP 的 1 倍）。
无论是在试验期间还是终生，依那普利叶酸似乎比依那普利单药治疗更具临床和经济吸引力。从中国卫生系统的角度来看，在依那普利中添加叶酸可能是预防高血压患者首发中风的一种具有成本效益的策略。
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