The National Institute for Health and Technology Assessment (NIHO) in Slovakia has recommended the categorization of cemiplimab (Libtayo) as a monotherapy for adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are unsuitable for curative surgery or radiotherapy. This decision aligns with clinical needs to provide effective treatment options for aggressive skin cancers.
Evaluation Overview
NIHO assessed the drug based on its clinical efficacy and cost-effectiveness. Cemiplimab demonstrated a significant improvement in overall survival (OS) compared to platinum-based chemotherapy regimens. However, the assessment highlighted substantial uncertainty in the cost-effectiveness analysis due to reliance on limited and low-quality clinical evidence, including data from single-arm phase 1 and 2 studies and a small retrospective observational study.
Cost-Effectiveness Concerns
The institute emphasized that the projected cost-effectiveness of Libtayo is highly uncertain. The recommended reimbursement price of €4,106 per package meets the legislative thresholds but may not hold in real-world clinical settings. Factors such as the quality of existing evidence and the variability in patient responses contribute to this uncertainty.
• Implementing restrictions to patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 could mitigate some cost-effectiveness risks.
• The proposed discount by the drug holder (€3,616.05) is below the initially requested price, potentially influencing the overall budget impact.
• Real-world application may reveal challenges in meeting the projected cost-effectiveness criteria due to the uncertainties identified.
Experts suggest that while the approval of Libtayo represents a positive advancement in treating advanced CSCC, careful consideration and monitoring are essential to ensure that the financial and clinical benefits are realized as anticipated. Adjustments to reimbursement strategies and further research to strengthen clinical evidence could enhance the drug’s integration into standard care protocols.
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