Cummings Amy L, Sussell Jesse, Rosettie Katherine L, Moustaid Fadoua El, Ogale Sarika, Ngiam Celina, Jovanoski Nick, Arnold Melina, Lee Jay M
David Geffen School of Medicine at UCLA, Santa Monica Cancer Care, 2020 Santa Monica Boulevard, Suite 600, Santa Monica, CA 90404, USA.
Genentech, Inc., 1 DNA Way, Building 35, South San Francisco, CA 94080, USA.
Lung Cancer. 2025 Sep;207:108701. doi: 10.1016/j.lungcan.2025.108701. Epub 2025 Aug 6.
Based on the Phase III ALINA trial, alectinib gained US approval as the first anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor for adjuvant treatment of resectable ALK + non-small cell lung cancer (NSCLC). We used a treatment impact model to estimate associated population-level clinical benefits and cost savings of alectinib vs chemotherapy.
Treatment-associated costs for alectinib vs chemotherapy were estimated for five annual cohorts of US patients with stage IB-IIIA ALK+ NSCLC between 2024 and 2028; each cohort was followed for 10 years. Data sources included ALINA. Two treatment scenarios were modelled, with all patients receiving adjuvant treatment with (1) alectinib and (2) chemotherapy. For each scenario, the model simulated the number of patients who received adjuvant treatment and experienced metastatic or non-metastatic recurrence or death and treatment-associated and downstream recurrence costs. Key assumptions were varied in sensitivity analyses. The impact of joint parameter uncertainty was evaluated using probabilistic sensitivity analysis.
In 2024-2028, an estimated 3,130 patients with resectable ALK+ NSCLC would be eligible for adjuvant alectinib treatment. Relative to chemotherapy, alectinib was estimated to prevent 1,531 recurrences and deaths, including 1,059 recurrences to metastatic NSCLC, thus avoiding of $1.31 billion (USD) in costs associated with recurrences and death. Considering upfront adjuvant treatment costs, alectinib was estimated to save $347 million vs chemotherapy.
Adjuvant alectinib treatment improved population-level clinical outcomes and was predicted to generate cost savings in the US. Predicted alectinib benefits were maximized when all indicated patients were tested for the ALK biomarker.
基于III期ALINA试验，阿来替尼获批成为美国首个用于可切除的间变性淋巴瘤激酶（ALK）阳性非小细胞肺癌（NSCLC）辅助治疗的ALK酪氨酸激酶抑制剂。我们使用了一个治疗影响模型来估计阿来替尼与化疗相比在人群水平上的临床益处和成本节约情况。
估计了2024年至2028年美国5个年度队列的IB-IIIA期ALK阳性NSCLC患者使用阿来替尼与化疗的治疗相关成本；每个队列随访10年。数据来源包括ALINA。模拟了两种治疗方案，所有患者接受辅助治疗，（1）使用阿来替尼，（2）使用化疗。对于每种方案，模型模拟了接受辅助治疗并发生转移或非转移复发或死亡的患者数量以及治疗相关和下游复发成本。在敏感性分析中对关键假设进行了变化。使用概率敏感性分析评估联合参数不确定性的影响。
在2024 - 2028年，估计有3130例可切除的ALK阳性NSCLC患者有资格接受阿来替尼辅助治疗。相对于化疗，阿来替尼估计可预防1531例复发和死亡，包括1059例转移至NSCLC的复发，从而避免了13.1亿美元与复发和死亡相关的成本。考虑到前期辅助治疗成本，与化疗相比，阿来替尼估计可节省3.47亿美元。
阿来替尼辅助治疗改善了人群水平的临床结局，并预计在美国可节省成本。当所有符合指征的患者都进行ALK生物标志物检测时，阿来替尼的预测益处将最大化。
