Ανάλυση κόστους - αποτελεσματικότητας της δαρολουταμίδης με ανδρογονικό αποκλεισμό, σε άνδρες με μη μεταστατικό ευνουχοάντοχο καρκίνο του προστάτη (nmCRPC), με υψηλό κίνδυνο ανάπτυξης μεταστατικής νόσου
Cost-effectiveness analysis of darolutamide with androgen deprivation therapy for men with non-metastatic castration-resistant prostate cancer (nmCRPC) in high risk of progression
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Keywords
Καρκίνος του προστάτη ; Μη μεταστατικός ; Οικονομική αξιολόγηση ; Μοντέλο Markov ; Δαρολουταμίδη ; Prostate cancer ; Non-metastatic ; Economic evaluation ; Markov model ; QALYs ; ICER ; Darolutamide ; ADTAbstract
Background: Prostate cancer is the second most frequent cancer diagnosis made in men worldwide. The major risk factors are ageing, genetic predisposition and nationality. Patients with castration-resistant prostate cancer (CRPC) have developed resistance to androgen deprivation therapy (ADT) and have increased PSA levels. Until metastasis is diagnosed, these patients undergo frequent diagnostic tests while experiencing side effects deriving from drug castration. New therapies have been studied in recent years which aim to delay the disease progression and improve patients’ quality of life. Darolutamide is a novel androgen receptor inhibitor, approved in Europe in 2020 for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. According to the ARAMIS clinical trial, metastasis-free survival was significantly longer with Darolutamide treatment than with placebo in men with nmCRPC. However, the cost-effectiveness of Darolutamide plus ADT compared to ADT alone for the treatment of men with nmCRPC has not been evaluated in Greece yet. Objective: The objective of this dissertation is to assess the cost-effectiveness of Darolutamide plus ADT compared to ADT alone for the treatment of men with nmCRPC in high risk of metastatic progression in Greece.
Methods: This analysis was performed using a Markov model over a lifetime horizon (lifetime analysis) which adopted the perspective of the Greek healthcare system. Markov model consists of three health states: non-metastatic progression free state, metastatic progressed state and death. The assessment of the treatments’ effectiveness was based on the Kaplan-Meier curves of the ARAMIS clinical study and was measured in qualityadjusted life years (QALYs). The cost estimate was based on foreign literature and then adapted to Greek prices. Finally, in order to address the uncertainty around some parameters of the model, a sensitivity analysis was performed.
Results: Darolutamide treatment resulted in higher cost per patient, while it also increased QALYs compared to placebo. The incremental cost-effectiveness ratio (ICER) was estimated at € 25,131.96 per QALY gained through the patients' lifetime. Sensitivity analysis also showed that ICER is sensitive to changes in drug prices and palliative care cost.
Conclusions: Based on the results of this analysis, treatment with Darolutamide plus ADT compared to ADT alone could be considered a cost-effective therapy for men with nmCRPC in high risk of metastatic progression in the current Greek healthcare system.