OBJECTIVES: Cemiplimab is the first treatment approved in patients with aBCC who progressed on or are intolerant to HHI, based on Study 1620 (NCT03132636), and received a positive assessment from the Italian Medicines Agency (AIFA) scientific committee using a landmark analysis to estimate survival for the comparator, best supportive care (BSC). Recently, new evidence reporting outcomes for BSC were published, providing an opportunity to re-evaluate the cost-effectiveness of cemiplimab.

METHODS: A partitioned survival model was constructed using an Italian perspective over a lifetime horizon. Progression-free survival (PFS) and overall survival (OS) with cemiplimab were sourced from Study 1620. Patients receiving BSC entered the model post-progression, where OS was estimated using 1) non-responders at 27-week landmark in Study 1620, and 2) a recent retrospective study evaluating patients receiving no systemic therapy post-HHI (n=15). Grade 3+ adverse events were included for patients treated with cemiplimab. Health-state utilities were derived from quality-of-life outcomes from Study 1620. Direct costs (EUR, 2022) included drug acquisition (ex-factory price net of mandatory discounts) and administration, routine care, adverse events, and end-of-life care.

RESULTS: Compared to non-responders as submitted to AIFA, the incremental cost-effectiveness ratio (ICER) was €66,418 per quality-adjusted life-year (QALY, incremental QALYs – 2.34). Compared to the retrospective real-world study for BSC, the ICER fell to €47,153 per QALY (incremental QALYs – 3.42). Key drivers of the analysis were the scale and shape parameters for cemiplimab OS, BSC OS and cemiplimab PFS.

CONCLUSIONS: From an Italian payer perspective, cemiplimab is a cost-effective treatment versus BSC for patients with aBCC following HHI. Inclusion of published real-world evidence for BSC confirms the value of cemiplimab in this population, resulting in a lower ICER than compared to the landmark analysis. Cemiplimab is anticipated to positively impact health outcomes in patients who would otherwise remain untreated, thus addressing significant unmet need in this population.