Zyryanov S K, Avdeev S N, Ivanov D A, Zhuravleva M V, Kniajeskaia N P, Matveev N V, Nenasheva N A, Fomina D S, Frolov M I
People's Friendship University of Russia.
City Clinical Hospital №24.
Ter Arkh. 2020 Dec 15;92(12):172-179. doi: 10.26442/00403660.2020.12.200494.
During last few years, the approaches to the management of patients with severe asthma have been revised. Monoclonal antibodies (MABs), inhibitors of interleukin-5 (reslizumab, mepolizumab, benralizumab) have been recently introduced for the treatment of severe eosinophilic asthma. The mentioned drugs were approved in Russia and included into the list of Vitally Essential Drugs.
The aim of this study was to compare the clinical and economic consequences of the use of biological agents that antagonize IL-5 in the treatment of severe eosinophilic asthma in adults.
Two methods of clinical and economic research were used: assessment of the cost-effectiveness ratio and analysis of the budget impact. The effectiveness of the drugs was assessed using indirect comparison; special attention was paid to comparability of the patient groups in the studies chosen for such an assessment. Two approaches were used for calculation of the cost of therapy for severe asthma: using DRGs (applicable to most regions of Russia), and without the use of DRGs, which is relevant only for few Russian regions.
Basing on the data obtained from a budget impact study without the use of DRG, it was shown that reslizumab was dominating for patients with body mass of up to 70 kg, while for the patients with body mass of 70 to 110 kg, mepolizumab was dominating, while utilization of reslizumab appeared to be somewhat more expensive. In the group of patients with body mass over 110 kg, mepolizumab also was dominating. The calculation of the cost-effectiveness ratio (CER) showed that reslizumab appeared to be dominating over two other MABs, The results of the study using the DRG demonstrated that the cost of an annual course of benralizumab in most cases in Russia would exceed the amount that can be compensated by Territorial Funds for Mandatory Medical Insurance to a healthcare institution for therapy of bronchial asthma in one adult patient with genetically engineered drugs. Therefore, further comparisons were made for reslizumab and mepolizumab only. Analysis of the impact on the budget demonstrated that treatment with reslizumab and mepolizumab would represent a similar burden for the budget. When applying cost-effectiveness analysis, reslizumab was more cost-effective than mepolizumab (regardless of patient body mass).
Thus, the results of the clinical and economic study suggested that, basing on the cost-effectiveness analysis, reslizumab appeared to be the dominant IL-5 antagonist (regardless of body mass if DRG approach was used and in patients with body mass up to 110 kg, if such an approach was not used). Basing on budget impact analysis, calculations without use of DRG approach showed superiority of reslizumab over mepolizumab and benralizumab for the patients with body mass up to 70 kg and the DRG-based approach showed equal burden for the budget for reslizumab and mepolizumab for the patients with any body mass.
在过去几年中，重度哮喘患者的管理方法已得到修订。单克隆抗体（MABs），即白细胞介素-5抑制剂（瑞利珠单抗、美泊利单抗、贝那利珠单抗）最近已被引入用于治疗重度嗜酸性粒细胞性哮喘。上述药物在俄罗斯获得批准，并被列入基本药物清单。
本研究的目的是比较使用拮抗白细胞介素-5的生物制剂治疗成人重度嗜酸性粒细胞性哮喘的临床和经济后果。
采用两种临床和经济研究方法：成本效益比评估和预算影响分析。使用间接比较评估药物的有效性；在选择用于此类评估的研究中，特别关注患者组的可比性。采用两种方法计算重度哮喘治疗费用：使用疾病诊断相关分组（DRGs）（适用于俄罗斯的大多数地区）和不使用DRGs（仅适用于俄罗斯的少数地区）。
基于不使用DRG的预算影响研究获得的数据表明，对于体重高达70kg的患者，瑞利珠单抗占主导地位；对于体重70至110kg的患者，美泊利单抗占主导地位，而使用瑞利珠单抗的费用似乎略高。在体重超过110kg的患者组中，美泊利单抗也占主导地位。成本效益比（CER）计算表明，瑞利珠单抗似乎优于其他两种单克隆抗体。使用DRG的研究结果表明，在俄罗斯，大多数情况下贝那利珠单抗年度疗程的费用将超过地区强制医疗保险基金可为医疗机构补偿一名成年基因工程药物支气管哮喘患者治疗费用的金额。因此，仅对瑞利珠单抗和美泊利单抗进行了进一步比较。预算影响分析表明，使用瑞利珠单抗和美泊利单抗治疗对预算的负担相似。应用成本效益分析时，瑞利珠单抗比美泊利单抗更具成本效益（无论患者体重如何）。
因此，临床和经济研究结果表明，基于成本效益分析，瑞利珠单抗似乎是主要的白细胞介素-5拮抗剂（如果使用DRG方法，无论体重如何；如果不使用该方法，则适用于体重高达110kg的患者）。基于预算影响分析，不使用DRG方法的计算表明，对于体重高达70kg的患者，瑞利珠单抗优于美泊利单抗和贝那利珠单抗；基于DRG的方法表明，对于任何体重的患者，瑞利珠单抗和美泊利单抗对预算的负担相同。
