Pharmacotherapeutic recommendations for application of target oncological drug therapies for treatment of breast cancer in Bulgaria - therapeutic efficacy and cost effectiveness.

PURPOSE The purpose of this study was to determine the direct costs of targeted cancer therapies for the treatment of breast cancer, calculating the effectiveness of the additional costs (ICER) and the cost of life years gained (LYG), using data from randomized clinical trials cited in the summary of product characteristics (SPC) of medicinal products approved for use under the centralized procedure. METHODS Data from the SPC and clinical trials was analyzed. ICER and LYG of the medicinal therapies were compared using data from Phase III clinical trials cited in the Summary of product characteristics. The perspective of the payer was adopted. RESULTS The SPCs of five drugs were analyzed. Targeted therapies were compared to placebo or to best supportive care (BSC) in some of them, while in others monoclonal antibodies (mAbs) and tyrosine kinase inhibitors were compared to existing drug therapies. Cost-effectiveness of each therapy was calculated. The value of ICER was between 56 470 Bulgarian Levs/LYG and 879 480 Bulgarian Levs/LYG. CONCLUSION The current pharmacotherapeutic recommendations for targeted therapies for the treatment of breast cancer are based on evidence of therapeutic efficacy and cost effectiveness. Their application in therapeutic practice in Bulgaria is necessary to ensure patient access to effective therapies within the limited public funds.