Preliminary Cost-Effectiveness and Cost-Utility Analysis of Cemiplimab in Patients with Advanced Cutaneous Squamous Cell Carcinoma in Italy

Abstract

Gianni Ghetti,1 Maria Claudia D’Avella,2 Lorenzo Pradelli1 1Department of Health Economics and Outcome Research, AdRes, Turin, Italy; 2Department of Market Access, Sanofi, Milan, ItalyCorrespondence: Gianni GhettiDepartment of Health Economics and Outcome Research, AdRes, Via Vittorio Alfieri 17, Turin, 10121, ItalyTel [phone]Email [email protected]: Cutaneous squamous cell carcinoma (CSCC) is a common cancer that in most cases is curable with surgery. About 3– 5% of patients develop advanced CSCC (aCSCC) and are no longer responsive to surgery or radiation therapy. The aim of this study was to assess the cost-effectiveness and cost-utility of cemiplimab, the first systemic therapy approved in Italy for patients with aCSCC, vs platinum-based chemotherapy from the Italian National Health Service (SSN) perspective.Methods: A partitioned survival model, which included three mutually exclusive health states, was developed to estimate costs and outcomes for patients with aCSCC, over a 30-year time horizon (lifetime). No direct evidence of the comparative efficacy and safety of cemiplimab versus other therapies currently exists. Therefore, a simulated treatment comparison (STC) was conducted to estimate the comparative efficacy of cemiplimab versus chemotherapy. Individual patient data for cemiplimab were collected from the EMPOWER-CSCC 1 trial whereas chemotherapy data were derived from a retrospective study. In the STC a regression model was used to predict outcomes for cemiplimab in the population observed in the comparator study. Costs of drug acquisition/administration and management of adverse events were included. Costs and outcomes were discounted at 3% per year. Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were calculated; sensitivity and scenario analyses were performed to assess the robustness of results.Results: In the base-case, treatment with cemiplimab was associated with a gain of 4.89 LYs and 3.99 QALYs, compared with a platinum-based chemotherapy regimen, resulting in an estimated ICER of 27,821 €/LY gained and an ICUR of 34,110 €/QALY gained. Both ICER and ICUR were below the commonly used Italian SSN willingness to pay thresholds.Conclusion: The use of cemiplimab, compared with a platinum-based chemotherapy regimen, can be considered a cost-effective option for the treatment of aCSCC patients in Italy.Keywords: Italian National Health Service, ICER, partitioned survival model, non-melanoma skin cancers

Keywords

• italian national health service
• icer
• partitioned survival model
• non-melanoma skin cancers