OBJECTIVES: Non-small cell lung cancer (NSCLC) is the leading cause of cancer related death among men and the second among women worldwide. In Italy, about 41.000 new lung cancer diagnoses have been estimated in 2020. Cemiplimab monotherapy demonstrated significant survival benefit versus chemotherapy in the first-line treatment of advanced NSCLC with PD-L1 ≥50%. This study aims to assess the budget impact of adding cemiplimab monotherapy to the Italian clinical practice since the European Commission recently approved its use.

METHODS: The budget impact model simulates the average management cost of an NSCLC patient over a 3-year time horizon considering the establishment of a competitive dynamic due to the introduction of cemiplimab or other entrants in the clinical practice. Acquisition, administration, monitoring and adverse event costs as well as the progression free survival (PFS) used to estimate the treatment durations were considered. Data to populate the model were extrapolated from clinical trials, national tariffs, DRGs, national registries and literature data. Market intakes were based on published data and assumptions. We are assuming also a percentage of reduction in acquisition prices dependant by the number of entrants in the market during the three-year time horizon.

RESULTS: The results of our model indicate incremental savings in terms of average management cost per patient equal to -386,01 € for the year 1, -4.085,52 € for year 2 and -13.635,77 € for year 3 considering an incremental uptake of 10% per year of patients who are treated with cemiplimab.

CONCLUSIONS: The introduction of cemiplimab monotherapy in the Italian clinical practice would lead to a reduction in expenditure treating the same number of patients, maximizing the allocative efficiency of the National Health System resources. Our tool could be used also to inform policy making choices following the authorization of other therapies in patients with NSCLC.