School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China.
Center for Social Science Survey and Data, Tianjin University, Tianjin, China.
Pharmacoeconomics. 2022 Dec;40(12):1187-1205. doi: 10.1007/s40273-022-01182-2. Epub 2022 Sep 8.
The aim of this study was to model the potential long-term disease progression and pharmacoeconomic value of sacubitril/valsartan for the treatment of essential hypertension from a Chinese healthcare system perspective.
A Markov cohort model with five health states was constructed to simulate the incidence of acute cardiovascular events and cost per quality-adjusted life-year (QALY) gained with sacubitril/valsartan compared with allisartan isoproxil and valsartan over a lifetime horizon with an annual cycle. Multivariable risk regression models derived from China-PAR data accompanied by hazard ratios were used to transform the dual mechanism of sacubitril/valsartan to lower blood pressure and left ventricular mass index into long-term fatal and non-fatal cardiovascular risks. Efficacy data were calculated using a network meta-analysis integrated by the results of clinical trials. Healthcare costs were determined from a real-world study and published literature, supplemented by expert opinion. Utilities were derived from literature. Both costs and health outcomes were discounted at 5.0% annually, and prices corresponded to 2021. Model validation, deterministic and probabilistic sensitivity analyses were conducted to test the robustness of results.
For simulated patients with hypertension, sacubitril/valsartan reduced the rates of myocardial infarction by 6.67% and 6.39%, stroke by 9.38% and 8.98%, and heart failure hospitalization by 9.92% and 9.62% relative to allisartan isoproxil and valsartan, respectively. It was also associated with gains in life expectancy among hypertensive individuals of 0.362-0.382 years. Eventually, lifetime costs per patient were CN¥59,272 (US$9187) for sacubitril/valsartan, CN¥54,783 (US$8492) for allisartan isoproxil, and CN¥56,714 (US$8791) for valsartan; total QALYs were 11.38, 11.24, and 11.25, respectively. The incremental cost-effectiveness ratio was CN¥31,805/QALY (US$4930/QALY) compared with allisartan isoproxil, and CN¥19,247/QALY (US$2983/QALY) compared with valsartan, both of which are below the one time per-capita GDP of CN¥80,976/QALY (US$12,551/QALY) in China. Similar results were obtained in various extensive sensitivity analysis scenarios.
This was the first study to evaluate the cost effectiveness of sacubitril/valsartan in the treatment of hypertension. Sacubitril/valsartan compares favorably with allisartan isoproxil and valsartan in the Chinese setting, which is mainly due to its higher efficacy resulting in fewer cardiovascular events and ultimately less related mortality over time. The results could inform deliberations regarding reimbursement and access to this treatment in China and may provide reference for facilitating more reasonable and efficient allocation of limited resources in such low- and middle-income countries.
本研究旨在从中国医疗体系的角度，构建一个模型来模拟沙库巴曲缬沙坦治疗原发性高血压的潜在长期疾病进展和药物经济学价值。
构建了一个具有五个健康状态的马尔可夫队列模型，以模拟与奥美沙坦酯和缬沙坦相比，沙库巴曲缬沙坦在终生范围内每年一个周期内急性心血管事件的发生率和每获得一个质量调整生命年（QALY）的成本。多变量风险回归模型来自中国 PAR 数据，并附有风险比，用于将沙库巴曲缬沙坦的双重降压和左心室质量指数机制转化为长期致命和非致命心血管风险。使用网络荟萃分析整合临床试验结果计算疗效数据。医疗保健成本来自真实世界研究和已发表文献，并辅以专家意见确定。效用值来自文献。成本和健康结果均以 5.0%的年贴现率贴现，价格对应于 2021 年。进行模型验证、确定性和概率敏感性分析，以测试结果的稳健性。
对于模拟高血压患者，与奥美沙坦酯和缬沙坦相比，沙库巴曲缬沙坦分别降低了 6.67%和 6.39%的心肌梗死率、9.38%和 8.98%的卒中率以及 9.92%和 9.62%的心衰住院率。它还与高血压患者的预期寿命增加了 0.362-0.382 年有关。最终，每位患者的终生成本分别为沙库巴曲缬沙坦 59272 元人民币（9187 美元）、奥美沙坦酯 54783 元人民币（8492 美元）和缬沙坦 56714 元人民币（8791 美元）；总 QALY 分别为 11.38、11.24 和 11.25。增量成本效益比为沙库巴曲缬沙坦相对于奥美沙坦酯为 31805 元人民币/QALY（4930 美元/QALY），相对于缬沙坦为 19247 元人民币/QALY（2983 美元/QALY），均低于中国 80976 元人民币/QALY（12551 美元/QALY）的人均一次国内生产总值。在各种广泛的敏感性分析情景中也得到了类似的结果。
这是第一项评估沙库巴曲缬沙坦治疗高血压的成本效果的研究。沙库巴曲缬沙坦在中国的表现优于奥美沙坦酯和缬沙坦，这主要是由于其更高的疗效导致心血管事件更少，最终随着时间的推移相关死亡率更低。研究结果可为中国有关该治疗方法的报销和准入决策提供信息，并可能为促进此类低收入和中等收入国家更合理和高效地分配有限资源提供参考。
