Ανάλυση κόστους - αποτελεσματικότητας του Eribulin για την θεραπεία τοπικά προχωρημένου ή μεταστατικού καρκίνου του μαστού μετά από δύο ή περισσότερα προηγούμενα σχήματα χημειοθεραπείας
Cost - effectiveness analysis of Eribulin for treating locally advanced or metastatic breast cancer after two or more prior chemotherapy regimens
KeywordsQALY ; ICER ; Eribulin ; TPC ; Προχωρημένος ή μεταστατικός καρκίνος του μαστού ; Οικονομική αξιολόγηση ; Μοντέλο Markov
Background: Breast cancer is by far considered the most common type of cancer among women in the world. Still, it should be noted that at an advanced stage there is no single established therapeutic approach. Eribulin according to the EMBRACE clinical trial demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) in patients with advanced or metastatic breast cancer who had previously received at least two chemotherapeutic regimens including anthracyclines and taxanes. Eribulin is the most recently licensed chemotherapy drug in several countries including Greece for the treatment of adult patients with advanced or metastatic breast cancer after at least one chemotherapy regimen. The cost effectiveness of Eribulin compared to the existing treatments (TPC-group) for the treatment of metastatic breast cancer has not been evaluated in Greece. Objective: The objective of this study is to assess the cost-effectiveness of Eribulin therapy compared to the existing treatments given in patients with advanced or metastatic breast cancer who have already received two or more chemotherapy regimens. Method: The Markov model was used for the analysis. The source of data was derived from the international and Greek published literature. With regard to the clinical efficacy assessment, the analysis was based on the results of the EMBRACE clinical study. The viewpoint of the analysis was that of the Greek National Healthcare System. The survival model was divided into three health states, progression-free survival (PFS), progression disease (PD) and death. The hypothetical group of patients was 55 years of age from onset of the treatment to death, in one month cycles. Data and probabilities for PFS and PD were derived from the clinical trial EMBRACE and were extrapolated to a period of 60 months thus covering a lifetime analysis. Cost and clinical-effectiveness were calculated by combining the use of medical resources with their unit values and the quality of life that corresponds to each of the three health states. Survival, life years gained (LY’s) and quality-adjusted life years gained (QALY’s) are the clinical effectiveness indicators of the model. Finally, a sensitivity analysis was performed to address the uncertainty surrounding the model parameters. Results: Eribulin compared to existing treatments for the treatment of patients with locally advanced or metastatic breast cancer was found to have higher cost per patient and to increase overall survival (LY’s) and overall survival adjusted for quality of life (QALY’s). The incremental cost effectiveness ratio (ICER) was found to be 6280,934€ per QALY and 3683,917€ per life years gained (LY’s), over the lifetime of patients. The results of the sensitivity analysis indicated that the ICER is sensitive to the values of the probabilities of disease progression. Conclusions: According to the results of this study, Eribulin compared to TPC group as a treatment for locally advanced or metastatic breast cancer in patients who have already received two or more chemotherapy regiments is considered a cost-effective option at current prices for the National Healthcare System in Greece.