Assessment of Clinical and Economic Effectiveness of Alectinib for Patients with ALK+ Non-Small Cell Lung Cancer without Previous Experience of Targeted Therapy

S. Nedogoda, A. Salasyuk, I. Barykina, V. O. Smirnova, E. Popova
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Abstract

Aim: to assess economic consequences of alectinib compared with the recommended therapy schemes for patients with non-small cell lung cancer (NSCLC) with tumor expression of anaplastic lymphoma kinase (ALK+) without previous experience of targeted therapy from the Russian healthcare system perspective. Material and methods. Markov model was developed in Microsoft Excel 2010 software for cost calculation. 5-year costs of alectinib, crizotinib and ceritinib were calculated, taking into account the differences in clinical effectiveness and safety of the compared drugs. Data about clinical effectiveness and safety were derived from the network meta-analysis Steenrod A. et al, 2018, where alectinib showed superior effectiveness in the first line of therapy for ALK+ NSCLC vs crizotinib and ceritinib: relative risk (RR) of progression-free survival (PFS) was 0,50 (95% confidence interval 0,36–0,70) and 0,41 (0,25–0,67) respectively. Safety of alectinib in the first line therapy was superior to the safety of ceritinib – RR of severe adverse events (SAE)3–4 grade 0,36 (95% CI 0,17–0,79), – and was comparable with safety of chemotherapy and crizotinib – RR of SAE 3–4 grade 0,81 (95% CI 0,44–1,52) and 0,65 (95% CI 0,51–1,04) respectively. Cost effectiveness analyses and budget impact analysis were conducted from the Russian healthcare system perspective. Results. Cost of one year course of alectinib was 3 431 970 rubles, which was comparable with crizotinib (3 435 405 rub.) and 55% higher than the one-year cost of ceritinib. Cost-effectiveness ratio was lower for alectinib compared with crizotinib, incremental cost-effectiveness ratio (ICER) for alectinib vs crizotinib was 2 735 900 rub., which was 66% lower than ICER for ceritinib vs crizotinib. Given the number of patients eligible for alectinib, it’s impact on State Guarantees Program of Free Medical Care is not much. Sensitivity analysis showed that the results of budget impact assessment are stable. Conclusion. Alectinib is a preferred option for patients with ALK+ NSCLC from economic point of view. It doesn’t have a significant impact on the budget within the State Guarantees Program of Free Medical Care, and also has higher effectiveness compared with crizotinib and ceritinib and better safety when compared with ceritinib.
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阿勒替尼治疗无靶向治疗经验的ALK+非小细胞肺癌患者的临床和经济效果评估
目的:从俄罗斯医疗保健系统的角度,比较阿勒替尼与推荐的治疗方案对无靶向治疗经验的肿瘤表达间变性淋巴瘤激酶(ALK+)的非小细胞肺癌(NSCLC)的经济后果。材料和方法。在Microsoft Excel 2010软件中建立马尔可夫模型进行成本计算。考虑到比较药物的临床有效性和安全性差异,计算阿勒替尼、克里唑替尼和西瑞替尼的5年成本。关于临床有效性和安全性的数据来自Steenrod A. et al ., 2018年的网络荟萃分析,其中阿勒替尼在一线治疗ALK+ NSCLC的有效性优于克里唑替尼和塞瑞替尼:无进展生存期(PFS)的相对风险(RR)分别为0.50(95%置信区间为0.36 - 0.70)和0.41(95%置信区间为0.25 - 0.67)。阿勒替尼在一线治疗中的安全性优于塞瑞替尼的安全性-严重不良事件(SAE) 3-4级的RR为0.36 (95% CI 0.17 - 0.79), -与化疗和克里唑替尼的安全性- SAE 3-4级的RR分别为0.81 (95% CI 0.44 - 1,52)和0.65 (95% CI 0.51 - 1,04)相当。从俄罗斯医疗保健系统的角度进行成本效益分析和预算影响分析。阿勒替尼1年疗程费用为3 431 970卢布,与克唑替尼(3 435 405卢布)相当,比塞瑞替尼1年疗程费用高55%。与克唑替尼相比,阿勒替尼的成本-效果比较低,阿勒替尼与克唑替尼的增量成本-效果比(ICER)为2 735 900例。,比塞瑞替尼与克唑替尼的ICER低66%。考虑到有资格使用alectinib的患者数量,它对国家免费医疗保障计划的影响并不大。敏感性分析表明,预算影响评价结果是稳定的。从经济角度来看,Alectinib是ALK+ NSCLC患者的首选。它对国家免费医疗保障计划内的预算没有显著影响,而且与克里唑替尼和塞瑞替尼相比,它的有效性更高,与塞瑞替尼相比,它的安全性更好。
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