Ανάλυση κόστους - αποτελεσματικότητας του σχήματος Nalirifox έναντι Nab-Paclitaxel και Gemcitabine ως θεραπεία πρώτης γραμμής του μεταστατικού αδενοκαρκινώματος του παγκρεατικού πόρου
Cost-effectiveness analysis of NALIRIFOX versus Nab-Paclitaxel and Gemcitabine as first-line treatment for metastatic pancreatic ductal adenocarcinoma

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Keywords
Ανάλυση κόστους-αποτελεσματικότητας ; NALIRIFOX ; ICER ; Λιποσωμιακή ιρινοτεκάνη ; Φαρμακοοικονομία ; Μεταστατικός καρκίνος παγκρέατος ; mPDAC ; Cost-effectiveness analysis ; Metastatic pancreatic cancer ; Liposomal irinotecan ; Partitioned survival model - PSM ; Διαχωρισμένο μοντέλο επιβίωσης ; QALYs ; 2026 ; Python 3Abstract
Objective: Metastatic pancreatic ductal adenocarcinoma (mPDAC) is a highly lethal malignancy associated with a substantial clinical and economic burden. The objective of this thesis is to evaluate the cost-effectiveness of the novel NALIRIFOX regimen (liposomal irinotecan, 5-fluorouracil, leucovorin, and oxaliplatin) compared to the standard nab-paclitaxel plus gemcitabine regimen, as a first-line treatment, from the perspective of the Greek National Healthcare System.
Methods: A Partitioned Survival Model (PSM) comprising three health states (progression-free survival, progressed disease, death) was developed over a lifetime horizon (360 months). Clinical efficacy data were derived from the NAPOLI-3 phase 3 randomized clinical trial. An annual discount rate of 3.5% was applied to both costs and health outcomes. Treatment effectiveness was measured in Quality-Adjusted Life Years (QALYs).
Results: The base-case analysis demonstrated that the NALIRIFOX regimen yielded 1.19 QALYs at a total mean cost of €53,402.26 per patient, whereas the nab-paclitaxel/gemcitabine regimen yielded 0.94 QALYs at €26,380.53. The incremental cost of the new therapy was €27,021.73 and the incremental benefit was 0.25 QALYs, resulting in an Incremental Cost-Effectiveness Ratio (ICER) of €108,992.57 per QALY. One-way sensitivity analysis revealed that the model is highly sensitive to the acquisition cost of liposomal irinotecan.
Conclusions: The estimated ICER significantly exceeds the GDP-based willingness-to-pay threshold for Greece (€19,400 - €58,200 per QALY). Consequently, the NALIRIFOX regimen is not considered cost-effective at its current list prices. A price reduction of 36.79% for liposomal irinotecan is required for the intervention to fall within the marginal cost-effectiveness threshold for the Greek healthcare system.


