OBJECTIVES: A real-world analysis was performed to study the evolution of systemic treatment pathways for patients with Non-Melanoma Skin Cancers (NMSC) before, during and after cemiplimab Early Access Program (EAP), aiming to understand the impact of a non-inclusion on liste en sus (LES [ex-Diagnosis Related Group funding]).

METHODS: This study is a retrospective longitudinal study based on data from the national hospitalization database (PMSI) between 2016 and 2021. Eligible patients were selected through ICD-10 code C44 - “other and unspecified malignant neoplasm of skin” and had to have received a systemic therapy for their NMSC in hospital. Among selected patients, therapies used via EAP or funded via LES were specifically identified and evolution of their use over time was described.

RESULTS: A total of 6749 patients were identified, mostly male (67%) with a median age of 75 years at treatment initiation. Total number of yearly NMSC treated patients highly increased during the study period (+120%). More-used therapies among the EAP and liste en sus ones were, in descending order: cemiplimab, cetuximab, nivolumab, pembrolizumab and avelumab. Study period is marked by the non-inclusion of cemiplimab on the LES, concomitantly to the end of its EAP for advanced-CSCC in January 2021. An important decrease of cemiplimab initiation among treated patients (-85%: from 499 to 73 patients) in 2021 coincides with a large increase of other anti-PD1 initiated, (e.g., +177%: from 120 to 332 patients), while no indication is approved in the NMSC perimeter.

CONCLUSIONS: Non-inscription of cemiplimab on LES in France is associated with increased usage of off-label alternatives in NMSC.