OBJECTIVES: This research aims to analyze the effectiveness and costs associated with anaplastic lymphoma kinase inhibitor (ALK-i) drug therapy in non-small-cell lung cancer (NSCLC) in real clinical practice.

METHODS: A retrospective observational study was designed. All patients treated with ALK-i for NSCLC from January 2016 to April 2023 in a reference hospital in oncology in southern Spain were included. The effectiveness variable was progression-free survival (PFS) and the economic variable was the cost of treatment. Kaplan-Meier analysis, measures of central tendency or dispersion and frequency analysis according to variable were performed.

RESULTS: Thirty-one treatments corresponding to 21 patients (52% male) were analyzed, eight patients were treated with two or more ALK-i. Mean age was 54.1 years (range: 21-78). Performance status was 86% ECOG 0-1. Twenty-one were treated with alectinib, six with crizotinib and four with lorlatinib, twenty-one for 1^st line therapy and ten in 2^nd or subsequent line therapy. Ten patients on alectinib, one on lorlatinib and none on crizotinib remained on treatment at the cut-off date. Median PFS was 20.2 months for the entire population, 15.3 months [95% CI: 0.5-30.2] for crizotinib treatments, and 6.5 months [95% CI: 0-24 .8] for lorlatinib. Alectinib did not reach the number of events needed to calculate the median, the mean was estimated at 35.7 months [95%CI: 24.8-46.6], in 8 of 13 alectinib patients censored for PFS its value was >29 months (range 29.5-56.8). The total cost of ALK-i at the cut-off date was €1,906,002 and the mean cost with ALK-i/treatment was €61,484. The median treatment cost by progression-free month was €3,043.

CONCLUSIONS: ALK-i showed comparable effectiveness to that obtained in clinical trials with a clinical benefit that would justify the cost of the drug. Alectinib showed greater effectiveness than crizotinib, although the follow-up time was short.