OBJECTIVES: Cost-effectiveness analysis and budget impact analysis require the availability of hard data (HD), which should preferably come from the country where the reimbursement decision in health policy is being made. The long-term unavailability of HD on healthcare management in Slovakia increases the likelihood of using incorrect data in the decision-making process. Therefore, a nationwide study analyzing the pharmacological oncological treatment of breast cancer (BC), is being conducted.

METHODS: The Medi-LINE^® project is a cross-sectional epidemiological study based on the analysis of data from medical records of treated BC patients in Slovakia. The collected parameters include disease history (simultaneous multifocal/multicentric tumor, year of diagnosis, histological type, clinical stage, hormone receptor status, HER2, PD-L1, BRCA1/2 status) and information about the treatment (current type of treatment, all other treatments for BC in the past).

RESULTS: The study analyzed data from 995 patients diagnosed with BC, which was a representative cohort considering the prevalence of the disease in the Slovak population. Ductal carcinoma was the most common histological type of BC (83.71 %). HER2 negative status was present in 78.35 % of patients, and ER+, PR+ status was identified in 71.96 % of patients. There were 25.36 % BRCA1/2 screened patients of which 15.04 % were positive. Pharmacological treatment was ongoing on average 2.85 years after BC diagnosis. Most patients were on adjuvant therapy (55.05 %) treated with 82 different treatment regimens containing 21 different active substances. The second most common treatment type was palliative treatment (35.36 %), where patients were treated with 68 different treatment regimens containing 33 different active substances. The most common treatment regimen was ribociklib plus letrozole, administered to 14.58 % patients.

CONCLUSIONS: The Medi-LINE^® project represents a unique source of data which might be used to identify management of the disease in pharmacoeconomic analyses in the Slovak setting.