OBJECTIVES : Biomarker-guided selection of patients with advanced or metastatic non-small cell lung cancer (NSCLC) for therapy decision is mandatory. The aim of this study is to determine the clinical and economic impact of current ALK testing scenario in Spain.

METHODS : A model combining a decision-tree with Markov models was developed to estimate the cost and health outcomes of NSCLC patients comparing standard testing scenario in clinical practice vs no-testing scenario in Spain. Distribution of ALK testing techniques and their sensitivity and specificity data were obtained from the literature and validated by a panel of experts. Depending on the molecular testing result, target-treatments were allocated based on expert opinion. For each treatment, 3-states Markov models were developed, where progression-free survival and overall survival curves were parameterized using exponential extrapolations, modelling the transitions among health states. Only medical direct costs were included (€, 2019). A lifetime horizon was considered and a discount rate of 3% was applied. Both deterministic and probabilistic sensitivity analyses were performed to address uncertainty.

RESULTS : A target population of 7,628 NSCLC (non-squamous and never-smoker squamous) patients was estimated. Over a lifetime horizon, the current ALK testing scenario produced additional 5,060 and 3,906 life years and quality-adjusted life years (QALYs), respectively, compared with no-testing scenario. Total direct costs were increased up to € 51,319,053 for testing scenario. The incremental cost-effectiveness ratio (ICER) was 13,136 €/QALY. The sensitivity analyses carried out confirmed the robustness of the base-case results, being the sensitivity and specificity variables the key drivers of the model.

CONCLUSIONS : ALK testing in non-squamous and never-smoker squamous advanced or metastatic NSCLC patients generates more than 3,000 QALYs in Spain over a lifetime horizon. Comparing this gain in health outcomes with the incremental costs, the resulting ICER shows that testing non-squamous and never-smoker squamous NSCLC is a cost-effective strategy in Spain.