通过有效降脂药物控制高胆固醇血症的额外药物供应扩大心脏病学计划的经济方面

O. Obuhova, A. S. Bogomazova, A. N. Meshkov, M. Ezhov
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Aim: to evaluate the economic efficacy of alirocumab (INN) including in the federal program for patients who have suffered an acute coronary event, are receiving statins and have an LDL CH level of 5.0 mmol/l and higher.Materials and methods. Modeling was applied in a target group of 3029 patients of working age who had undergone ACS during the previous 12 months with severe, including familial, HCH, with LDL cholesterol 5.0 mmol/l and higher, receiving statins taking into account previously determined outcomes when using alirocumab + statins for 5 years. Direct medical and non-medical costs, as well as indirect costs, are identified. The cost-effectiveness analysis was applied from the point of view of the effectiveness of treatment (effects on mortality, temporary disability, disability) and direct health care costs (additional drug provision and outpatient follow-up, specialized, including high-tech, medical care in a 24‑hour hospital). Two healthcare technologies were compared: statin therapy and use of alirocumab + statins. The calculations used according to domestic methods used the cost of medical treatment, temporary disability, hospitalizations, loss of GDP and other parameters.Results. Modeling has shown a decrease in mortality, morbidity and disability when using alirocumab in even the first year of use. The economic effect of alirocumab from a decrease in temporary disability in the 1st year is 304.5 mln rub., in the 2nd — 301.5 mln rub., in the 3rd — 321.1 mln rub., in the 4th — 333.1 mln rub. The estimated amount of prevented GDP losses from mortality in the target group for 4 years in the case of alirocumab use amounted to 1,260.2 mln rub. The annual amount of avoidable GDP losses from mortality in the target group in the case of alirocumab is 27–30 %. The annual average savings per patient in the case of alirocumab use are from 7 to 17 %. 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引用次数: 0

摘要

联邦心脏病学药物优惠供应计划显示了其有效性。然而,高胆固醇血症(HCH)仍然是高剂量他汀类药物治疗无法使低密度脂蛋白胆固醇(LDL 胆固醇)达到目标水平的患者面临的一个重要问题。解决这一问题的方法是处方不同作用机制的降脂药物,例如 PCSK9 酶抑制剂。要建议将这类药物纳入计划,不仅需要有证据证明其救命效果,还需要证明使用这类药物的经济可行性。目的:评估将阿利珠单抗(INN)纳入联邦计划的经济效益,该计划适用于急性冠状动脉事件患者、正在接受他汀类药物治疗且低密度脂蛋白胆固醇(LDL CH)水平在 5.0 mmol/l 及以上的患者。建模对象为 3029 名在过去 12 个月内接受过急性冠状动脉综合征治疗的工作年龄段患者,这些患者患有严重的 HCH(包括家族性 HCH),低密度脂蛋白胆固醇水平在 5.0 mmol/l 及以上,正在接受他汀类药物治疗,同时考虑到了之前确定的阿利珠单抗+他汀类药物治疗 5 年的结果。确定了直接医疗和非医疗成本以及间接成本。成本效益分析从治疗效果(对死亡率、暂时残疾、残疾的影响)和直接医疗成本(额外的药物供应和门诊随访、24 小时医院的专业医疗,包括高科技医疗)的角度进行。比较了两种医疗技术:他汀类药物治疗和使用阿利珠单抗+他汀类药物。根据国内方法进行的计算使用了医疗费用、暂时残疾、住院、国内生产总值损失和其他参数。建模结果表明,使用阿利珠单抗后,即使在使用的第一年,死亡率、发病率和残疾率也会下降。阿利珠单抗第一年减少暂时性残疾的经济效益为 3.045 亿卢布,第二年为 3.015 亿卢布,第三年为 3.211 亿卢布,第四年为 3.331 亿卢布。在使用阿利珠单抗的情况下,目标群体 4 年中因死亡率而避免的国内生产总值损失估计为 12.602 亿卢布。在使用阿利珠单抗的情况下,目标群体每年可避免的死亡率造成的 GDP 损失为 27-30%。使用阿利珠单抗后,每位患者每年平均可节省 7%至 17%。在减少目标群体的残疾和死亡率损失方面,40-59 岁年龄组的影响最大。只有这个年龄段的人群使用阿利珠单抗后,每年因残疾和死亡造成的损失才有可能减少 1.592 亿卢布(占总经济效益的 83%)。从使用阿利珠单抗的第 4 年开始,在住院费用方面可以获得积极的经济效益。当阿利珠单抗被纳入心脏病学额外药物供应计划时,目标群体购买阿利珠单抗的费用比例可能仅为 0.01%。与此同时,仅在第一年纳入该计划所产生的经济效益就将达到至少 3.934 亿卢布的预算资金。由于使用阿洛库单抗而造成的可避免损失总额在 4 年内可能达到 16.38 亿卢布。
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Economic aspects of the cardiology program expansion of additional drugs provision by effective lipidlowering drugs for hypercholesterolemia control
The federal program of preferential drug provision in cardiology shows its effectiveness. However, hypercholesterolemia (HCH) remains a significant problem in patients in whom high-dose statin therapy does not provide the target level of low-density lipoprotein cholesterol (LDL cholesterol). The solution to the problem lies in the plane of prescribing lipid-lowering drugs of a different mechanism of action, for example, inhibitors of the PCSK9 enzyme. To recommend the inclusion of such kind drugs in the program, it is necessary not only to have evidence of their life-saving effect, but also the economic feasibility of their use. Aim: to evaluate the economic efficacy of alirocumab (INN) including in the federal program for patients who have suffered an acute coronary event, are receiving statins and have an LDL CH level of 5.0 mmol/l and higher.Materials and methods. Modeling was applied in a target group of 3029 patients of working age who had undergone ACS during the previous 12 months with severe, including familial, HCH, with LDL cholesterol 5.0 mmol/l and higher, receiving statins taking into account previously determined outcomes when using alirocumab + statins for 5 years. Direct medical and non-medical costs, as well as indirect costs, are identified. The cost-effectiveness analysis was applied from the point of view of the effectiveness of treatment (effects on mortality, temporary disability, disability) and direct health care costs (additional drug provision and outpatient follow-up, specialized, including high-tech, medical care in a 24‑hour hospital). Two healthcare technologies were compared: statin therapy and use of alirocumab + statins. The calculations used according to domestic methods used the cost of medical treatment, temporary disability, hospitalizations, loss of GDP and other parameters.Results. Modeling has shown a decrease in mortality, morbidity and disability when using alirocumab in even the first year of use. The economic effect of alirocumab from a decrease in temporary disability in the 1st year is 304.5 mln rub., in the 2nd — 301.5 mln rub., in the 3rd — 321.1 mln rub., in the 4th — 333.1 mln rub. The estimated amount of prevented GDP losses from mortality in the target group for 4 years in the case of alirocumab use amounted to 1,260.2 mln rub. The annual amount of avoidable GDP losses from mortality in the target group in the case of alirocumab is 27–30 %. The annual average savings per patient in the case of alirocumab use are from 7 to 17 %. The greatest impact on reducing losses from disability and mortality of the target group is noted in the group of people aged 40–59 years. Only for this group, if alirocumab is used, it is possible to reduce losses from disability and mortality by 159.2 million rubles per year (83 % of the total economic effect). Starting from the 4th year of alirocumab use, it is possible to obtain a positive economic effect in terms of hospitalization costs.Conclusion. When alirocumab is included in the program of additional drug provision in cardiology, the share of costs for the purchase of alirocumab for the target group may be only 0.01 %. At the same time, the economic effect of inclusion in the first year alone will amount to at least 393.4 million rubles of budget funds. The total amount of avoidable losses due to the alirocumab usage may amount to 1,638 million rubles over 4 years.
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