OBJECTIVES: Societal costs and financial toxicity could be impacted by the adoption of regulation and value-based guidelines for shared-decision making (SDM) in clinical practice. The aim of the current study is to assess the possibilities for SDM and the cost to society of cancer therapy in Bulgaria.

METHODS: We conducted two step research. We made a desktop analysis on the current strategic policy documents on regional/national level with focus on SDM recommendations in oncology along with online anonymous survey among Bulgarian oncologists, assessing their attitudes towards to SDM. Second, we calculated societal costs related to targeted oncology treatment from the perspective of the Bulgarian healthcare system.

RESULTS: ESMO has included in its BC and NSCLC guidelines a recommendation for SDM as an essential part of the treatment process. NICE has also integrated guidelines on SDM in healthcare. The results from the survey show that Bulgarian oncologists support the need for the integration of SDM approach. Societal costs related to targeted cancer therapy in Bulgaria are mostly attributed to diagnostics (IHC&biomarkers). They are required by the Sick Fund before therapy initiation but aren’t yet covered. The societal costs account for almost 4 million euro yearly, which currently are paid out-of-pocket or through patient-support programs. These costs include disease confirmation/staging tests and variety of biomarkers for targeted/ immune therapies. These costs are expected to rise in the next years due to increased access to targeted/immune therapies and the implementation of NGS/CGP.

CONCLUSIONS: There is a need for integrated approach for the implementation of SDM within Bulgarian oncology and changes in respective regulations, allowing oncology diagnostics to be reimbursed, which could reduce societal costs and financial toxicity locally.