OBJECTIVES: This retrospective observational cohort study aims to evaluate real-world outcomes for patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) receiving a first-line ALK tyrosine kinase inhibitor (TKI), focusing on drug acquisition costs, healthcare service utilization, and clinical outcomes.

METHODS: Data from the Optum Clinformatics Data Mart (CDM) spanning 2016-2021 were utilized. Patients were identified using ICD-10 codes for lung cancer and pharmacy claims for ALK tyrosine kinase inhibitors (TKIs). Baseline demographic and clinical characteristics were recorded. Healthcare resource utilization was measured in terms of pharmacy, inpatient, outpatient, professional service, and ancillary claims per-patient-per-month (PPPM), with costs expressed in 2024 US dollars. A generalized linear model examined factors influencing total monthly costs. Time-to-treatment discontinuation (TTD) and overall survival (OS) by treatment group were assessed using the Kaplan-Meier method, with a Cox proportional hazards model used to assess outcome heterogeneity.

RESULTS: The study population consisted of 696 patients, with treatment groups as follows: 267 for alectinib, 22 for brigatinib, 25 for ceritinib, 366 for crizotinib, and 16 for lorlatinib. Total PPPM costs encompassing treatment and healthcare resource utilization were estimated at $32,989 (SD: $34,480), while average monthly drug acquisition costs were $17,135 (SD: $1750) for alectinib, $18,474 (SD: $3051) for brigatinib, and $18,484 (SD: $3040) for lorlatinib. Medical utilization and clinical outcomes varied by treatment group, with lorlatinib patients experiencing greater utilization alongside poor clinical outcomes. Survival analysis revealed a median OS of 25.5 (95% CI: 21.1–32.5) months overall, with alectinib yielding the highest median OS at 41.1 (95% CI: 30.7–not reached) months.

CONCLUSIONS: Our study highlights the substantial economic burden, frequent healthcare resource utilization, and unfavorable clinical outcomes faced by patients with advanced ALK+ NSCLC. Given the scarcity of real-world data on novel ALK TKIs, these findings provide valuable evidence to support decision-making for providers, payers, and patients alike.