Budget Impact Analysis of a patients’ selection strategy based on the expression of Programmed-Death Ligand 1 for the administration of immuno-oncologic treatments to patients affected with Non Small Cell Lung Cancer in Italy

Autori: U. Restelli, S. Artale, V. Pacelli, D. Croce


Immuno-oncology represents a new strategy for the treatment of different types of tumors. Among cancer types and locations, of particular relevance is non-small cell lung cancer (NSCLC) due to its incidence and mortality rate. Within randomized clinical trials, the expression of programmed death ligand 1 (PD-L1) above a certain threshold has been identified as associated with a higher outcome for immuno-oncologic treatment compared with chemotherapy. The aim of the analysis presented is to assess the financial consequences of a patients’ selection strategy, through the assessment of PD-L1 expression, for the treatment of patients affected by advanced previously treated NSCLC in Italy.


A budget impact model was implemented, assuming the Italian National Health Service perspective, considering a treatment algorithm related to the second and third lines of treatment. Two scenarios were compared: considering the assessment of PD-L1 expression or not. The costs considered (year 2017) referred to immune-oncologic treatments, adverse events’ management and PD-L1 test.


The cost to treat the 9,216 patients considered in the analysis in the base case scenario is almost 137 million €, with a per capita cost of 14,898 €. The treatment selection strategy considered, based on PD-L1 expression, would lead to a cost to treat the whole population of almost 112 million € (per capita cost of 12,119 €), with a differential cost of – 26 million € compared with the base case scenario, with a 18.7% cost reduction.


A patients’ selection strategy through the assessment of PD-L1 expression for the treatment of patients affected by advanced previously treated NSCLC in Italy would be sustainable, leading to a reduction of costs compared with a scenario in which such strategy is not considered.


non-small cell lung cancer, immuno-oncology, programmed death ligand 1, PD-L1, budget impact analysis.


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