IQVIA, Fairfax, VA, USA.
Genentech, South San Francisco, CA, USA.
Lung Cancer. 2018 May;119:103-111. doi: 10.1016/j.lungcan.2018.03.008. Epub 2018 Mar 9.
Despite improved progression-free survival, most patients treated with the first generation ALK inhibitor crizotinib ultimately experience central nervous system (CNS) progression. Brain metastases (BM) are associated with high clinical burden in patients with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC). In this study we estimate the real-world economic burden of BM in newly diagnosed ALK+ NSCLC patients and investigate whether alectinib, a second generation ALK inhibitor that delays CNS progression, may help reduce healthcare costs in patients with ALK+ NSCLC.
Cost of BM was measured in ALK+ NSCLC patients identified from a stacked PharMetrics Plus and MarketScan claims database from January 2008 to March 2016 and December 2015, respectively. Per patient per month (PPPM) cost of BM was calculated as the difference in baseline-adjusted total costs in patients with and without BM over a variable follow-up period of up to 24 months. Cumulative incidence of new BM was derived from 88 alectinib-treated and 93 crizotinib-treated patients without baseline BM in a randomized phase III clinical trial, ALEX (NCT02075840). Costs of BM per patient were then calculated by applying the PPPM BM cost to the number of incident BM patients in each treatment cohort.
207 patients with no BM and 198 with BM were selected from the claims database. Total cost of BM was estimated at $6,029 PPPM. 24-month cumulative incidence rates of BM from the clinical trial were 7.2% and 45.3% for alectinib and crizotinib, respectively. Over follow-up, alectinib was estimated to reduce BM-related costs by $41,434 per patient compared to crizotinib.
BM is associated with substantial economic burden. Alectinib was estimated to reduce BM-related costs by preventing or delaying the occurrence of BM compared to crizotinib.
尽管无进展生存期有所改善，但大多数接受第一代 ALK 抑制剂克唑替尼治疗的患者最终会出现中枢神经系统（CNS）进展。脑转移（BM）与晚期间变性淋巴瘤激酶阳性（ALK+）非小细胞肺癌（NSCLC）患者的高临床负担有关。在这项研究中，我们估计了新诊断的 ALK+ NSCLC 患者中 BM 的实际经济负担，并研究了第二代 ALK 抑制剂阿来替尼（可延迟 CNS 进展）是否可以帮助降低 ALK+ NSCLC 患者的医疗成本。
从 2008 年 1 月至 2016 年 3 月和 2015 年 12 月的堆叠 PharMetrics Plus 和 MarketScan 索赔数据库中分别确定了 ALK+ NSCLC 患者，以评估 BM 的成本。BM 的每位患者每月（PPPM）成本是通过在具有和不具有 BM 的患者之间的基线调整后的总费用之间的差异来计算的，随访期长达 24 个月。从一项随机 III 期临床试验 ALEX（NCT02075840）中，无基线 BM 的 88 名阿来替尼治疗患者和 93 名克唑替尼治疗患者中得出了新 BM 的累积发生率。然后，通过将每个治疗队列中发生 BM 的患者的 PPPM BM 成本应用于每位患者的 BM 成本，计算出每位患者的 BM 成本。
从索赔数据库中选择了 207 名无 BM 和 198 名有 BM 的患者。BM 的总成本估计为 6029 美元/人/月。临床试验中 24 个月的 BM 累积发生率分别为阿来替尼组的 7.2%和克唑替尼组的 45.3%。在随访期间，与克唑替尼相比，阿来替尼估计每位患者可降低 41434 美元的 BM 相关成本。
BM 与大量的经济负担有关。与克唑替尼相比，阿来替尼通过预防或延迟 BM 的发生，估计可以降低 BM 相关成本。
