OBJECTIVES: In Italy, cutaneous squamous cell carcinoma (CSCC) is the second most common non-melanoma skin cancer. About 3-5% of patients with localized CSCC progress to advanced CSCC (aCSCC), which include metastatic and locally advanced disease not amenable to curative surgery or curative radiation. The economic burden to Italy for the first year of management and care of CSCC patients was estimated at about €25 million. Cemiplimab was previously found to be cost effective in Italy, improving quality of life and extending survival. This analysis assesses the budget impact of introducing cemiplimab, the first systemic therapy approved for aCSCC patients, in the Italian clinical practice.

METHODS: A budget impact model was developed to estimate the cost impact of introducing cemiplimab to the Italian National Health Service (SSN) over a 3-year time horizon. Direct health costs (drugs acquisition and administration, adverse events and disease monitoring) until progression were considered. Treatment duration and safety were informed by the phase II EMPOWER-CSCC 1 study for cemiplimab and by published sources for chemotherapy. The ex-factory price and national tariff were used for cemiplimab and chemotherapy, respectively. Epidemiologic data and other costs were obtained from literature. Robustness of results was tested via deterministic sensitivity analyses (DSA).

RESULTS: The average number of patients treated for aCSCC per year in Italy would be 473. The average annual budget impact of introducing cemiplimab was estimated in €41 million, corresponding to an increase of €85,340 per patient per year. DSA results indicated that cemiplimab cost, treatment duration, and market share uptake, were the primary drivers of model outcomes.

CONCLUSIONS: Cemiplimab in Italy can improve outcomes for aCSCC patients with limited economic impact for the SSN.