Objective: To evaluate the economic impact of NSCLC diagnosis in Spain based on the LungOne study, a non-interventional study designed to describe the usefulness of the comprehensive genomic approach for targeted therapy decisions in locally advanced, metastatic, adenocarcinoma second line NSCLC.

Methods: We analyzed healthcare resources and direct costs of the whole diagnostic procedure by collecting sample acquisition methods, related hospitalizations and biomarkers testing from medical-records of the 152 patients included in LungOne. Total costs were calculated by multiplying the natural resource units by the corresponding unit cost (€ 2019).

Results: Mean total cost of NSCLC diagnosis per patient was 3,610.56€. Mean cost per sample acquisition was 443.39€. Sample acquisition methods were core needle biopsy (32.5%), bronchoscopy (29.1%), surgery (19.2%), EBUS (11.9%), fine-needle aspiration (8.6%) and combined use of fine-needle aspiration and core biopsy (7.9%). 33.6% of patients required hospitalizations with mean hospital stay of 9.63 days, a long length probably including patients undergone surgery or diagnosis made in admitted patients, and mean cost per patient of 4,639€. Mean total cost per sample acquisition, whatever biomarker or NGS testing, was 2,206.18€ and mean total cost per biomarker testing was 1.128,82€. Mutational status of EGFR and ALK was tested in 99% of patients; ROS1 in 95%, PD-L1 in 93% and BRAF in 23%. Single-gene assays were: EGFR (RT-PCR 99%); ALK (IHC 91%, FISH 8%); ROS1 (IHC 74%, FISH 25%); BRAF (RT-PCR 91%). An analysis restricted to 3 genes costs 818.37€; cost for 4 genes increases to 1.015,03€; and for 5 genes to 1.639,05€.

Conclusions: Although non-NGS methods are valuable, CGP may be less costly as the number of novel potential predictive markers increases. To this efficiency in saving costs is added the potential usefulness of CGP for guiding therapy in about 30% of patients as other analysis of LungONe has shown.