Reimbursement of biomarkers in oncology: advantages and economic analysis of their application for diagnostics as part of the personalized medicine аpproach

Biomarkers are essential tools for determining the optimal therapeutic strategy for each cancer patient, maximizing therapeutic response, and minimizing treatment-related toxicities. Cancer cells exhibit a variety of genetic and protein variations, even within the same cancer type, impacting treatment response. Incorporating biomarker testing into the diagnostic process allows for a more accurate understanding of a tumor’s molecular profile, enabling oncologists to tailor and personalize treatment plans based on each patient's specific biomarkers. This personalized medicine approach not only increases treatment efficacy but also minimizes unnecessary exposure to therapies that may not be effective for the individual patient. The purpose of this analysis is to provide an economic assessment of the costs and benefits of biomarker testing in cancer patient care in Bulgaria, as well as the expected budgetary impact of incorporating reimbursement of biomarker diagnostics by the NHIF. If the estimated number of tests is paid for at the estimated cost of biomarker diagnostics, the total cost to the NHIF is estimated at BGN 10,885,100.00. The benefits linked to this increased cost are presented in two groups: health and economic benefits. Within the analysis, the health benefits are presented in terms of life years gained (LY) and quality-adjusted life years gained (QALY) when using biomarker-based targeted therapies. The data for LY and QALY are based on results from published studies and represent average increases in LY and QALY for each type of cancer and each biomarker. According to the analysis, the use of biomarker assays would result in an average increase in LY of 1.18 LY and 0.93 QALY per patient (average values for all cancer types in the analysis). Calculating the total health benefits for all patients included (and all diagnoses) in the analysis yields a total health benefit of +21,035.35 LY and +16,617.33 QALY (cumulative values for all patients considered in the analysis). In addition to the added health ...