OBJECTIVES: to carry out pharmacoeconomic modeling for an early health technology assessment (HTA) of the generic pegylated liposomal doxorubicin (PLD) drug in patients with metastatic breast cancer (MBC) at a high risk of cardiac events with prior adjuvant anthracycline therapy.

METHODS: а Markov model and Decision tree model were developed to simulate and to compare the costs and effects of new generic PLD versus doxorubicin. Treatment efficacy data were derived from the clinical trials: overall survival, fatal and non-fatal cardiac events. Time horizon of the analysis was 6 years, costs and benefits were discounted by 3.5%. Using the willingness to pay threshold (WTP) criteria for economic value, we determine value-based pricing for new generic PLD. WTP for Russian health care system was estimated at €26,383 (1648924 RUB), exchange rate mean in 2017 - €1 = 62.5 RUB.

RESULTS: in case of cardiac mortality events PLD provides additional 1.30 incremental life years gained (LYG) versus doxorubicin. At price 620 RUB/mg and lower (equivalent €10) new generic PLD will be more cost-effective (CER for 1 LYG) than doxorubicin. At price 620-4748 RUB/mg (€10-76) PLD will be more effective, but more expensive, showing ICER less then WTP threshold (€26,383). At price more than 4748 RUB (€76) PLD has ICER higher than WTP for Russian health care system. At price less than 1869 RUB/1 mg (€30) new generic drug will have advantages over original PLD from position of treatment cost.

CONCLUSIONS: pharmacoeconomic modeling can be used for an early HTA of new medicines to determine value-based pricing for new pharmaceuticals and its financial impact on Russian health care system.