Objectives: NGS technologies may improve decision making in oncology, especially in enabling personalized approach based on systematic examination of the cancer genome. Knowing the tumor genetic profile and certain biomarkers, could improve risk-based stratification of patients and therapy outcomes. Oncologists are now able to use data from tumour molecular profiling and MGTO to enhance patients’ management. The current study explores the opportunities for implementation of NGS and MGTOs into routine oncology practice in Bulgaria and its economic consequences.

Methodology: We performed two-step study evaluating the opportunities and possible barriers for implementation of NGS and MGTO in Bulgaria. First, we studied the current health care background in terms of diagnostics and therapy resource allocation and possible ways to use NGS and MGTO. Second, based on experience in other countries, to create a list with recommendations for gradual economic implementation of NGS and MGTO in Bulgaria.

Results: Currently most drug regimes in oncology require results of different validated biomarker tests, hence NGS can be an alternative to multiple tests by simultaneously examine broad spectrum of genes. This could reduce depletion of scarce materials and decrease cost and time for result. Recommended therapeutic regimes are included in the reimbursement lists and recently suggested legislation changes could provide possibilities for off-label use in certain cases, which could be a possible pathway to introduce MGTOs. Based on Belgian experience we created a recommendation list that could serve as a guidance for economic implementation of NGS and MGTO in Bulgaria. The list includes changes in legislation, creation of genomic database/registry, update of clinical guidelines, etc.

Conclusions: NGS and MGTO facilitate treatment choice and could improve clinical and policy decision making, especially in terms of health care resources allocation and optimization of costs. Further analyses are necessary to evaluate funding options, data management and other important implications.