Ανάλυση κόστους-αποτελεσματικότητας του σχήματος Pembrolizumab-χημειοθεραπεία σε σύγκριση με το σχήμα Placebo-χημειοθεραπεία σε ασθενείς με μεταστατικό μη-μικροκυτταρικό καρκίνο του πνεύμονα
Cost-effectiveness analysis of Pembrolizumab plus chemotherapy versus Placebo plus chemotherapy for patients with metastatic non-small cell lung cancer

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Keywords
Μη-Μικροκυτταρικός Καρκίνος του Πνεύμονα (ΜΜΚΠ) ; Ανάλυση Κόστους-Αποτελεσματικότητας (CEA) ; Διαχωρισμένο Μοντέλο Επιβίωσης (PSM) ; ICER ; Pembrolizumab ; Non-Small Cell Lung Cancer (NSCLC) ; Cost-effectiveness analysis ; Partitioned survival modelAbstract
Lung cancer is the most common form of cancer worldwide and the leading cause of cancerrelated death. Non-small cell lung cancer (NSCLC) accounts for approximately 80–85% of all cases and is strongly associated with smoking. Modern oncology increasingly focuses on immunotherapy and targeted treatments, with PD-1 inhibitors representing a key therapeutic strategy. However, their high cost may present a barrier to broad patient access, particularly in health systems with limited resources. According to the results of the KEYNOTE-189 trial, pembrolizumab plus chemotherapy significantly outperformed chemotherapy alone, improving overall survival, progression-free survival (PFS: 8.8 vs. 4.9 months), and duration of response (11.2 vs. 7.8 months). The estimated 12-month progression-free survival rate was 34.1% for pembrolizumab and 17.3% for placebo, while the estimated 12-month overall survival probability was 69.2% and 49.4%, respectively. Pembrolizumab is a humanized monoclonal antibody targeting the programmed death-1 (PD1) receptor on T-lymphocytes, thereby restoring their activity and enhancing the immune response against tumor cells. In September 2014, it received FDA approval for the treatment of refractory advanced melanoma and was launched in the United States under the brand name KEYTRUDA. In recent years, it has been approved for the treatment of multiple additional oncological indications. Objective: This study focuses on evaluating the cost and effectiveness of pembrolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with metastatic NSCLC without EGFR/ALK mutations and no prior systemic therapy. The chemotherapy regimen consisted of pemetrexed and investigator’s choice of a platinum-based agent (cisplatin or carboplatin). The analysis was conducted from the perspective of the Greek National Health System. Methods: A partitioned survival model (PSM) with three health states—progression-free survival (PFS), progressed disease (PD), and death—was developed. The model used monthly cycles over a 240-month time horizon, with primary data extracted from trial Kaplan–Meier curves using the GetData Graph Digitizer software. An annual discount rate of 3.5% was applied to costs and outcomes. Sensitivity analysis was performed to assess the robustness of the results under parameter uncertainty. Results: The analysis showed that pembrolizumab was associated with an additional cost of €5,055.49 compared with placebo, while yielding 1.867 quality-adjusted life-years (QALYs) versus 1.464 for placebo. The resulting incremental cost-effectiveness ratio (ICER) was €12,564.57/QALY. Sensitivity analyses identified the model’s time horizon as the most influential parameter, but none of the tested variations altered the overall conclusion. Conclusions: According to the prevailing WHO guidelines for Greece, pembrolizumab plus chemotherapy appears to be a cost-effective first-line treatment option for patients with metastatic NSCLC without EGFR/ALK mutations.