OBJECTIVES: to perform the cost-effectiveness analysis of the first-line endocrine therapy (ET) with fulvestrant in the treatment of receptor-positive HER2-negative advanced (ABC) and metastatic breast cancer (MBC) in patients who had not received previous ET from the perspective of the Russian health care system.

METHODS: a Decision tree model was developed to compare two identical cohorts of patients: first one received fulvestrant 500 mg in 1st line therapy and the second - standard chemotherapy (CT) regimen in 1st, 2nd and 3rd line therapy (6 scenarios). Median treatment duration was 16.6 for fulvestrant and 14.0 months for 1-3 line CT. Treatment efficacy (progression free survival - PFS) and adverse events rate (febrile neutropenia) were estimated using a RCTs and survey of oncologists in Russia. Unit costs for drugs and other health services were estimated from nationally published sources (exchange rate mean in 2018 - €1 = 71.8 RUB). One-way sensitivity analyses were conducted to examine the robustness of our model.

RESULTS: fulvestrant was associated with longer time to disease progression (16.6 month) versus 5.6, 4.2 and 4.2 month (total 14.0) for 1st, 2nd and 3rd line CT respectively. The total cost for 1 patient for fulvestrant was €11,584 for course (831,718 RUB), three line CT – costs vary from €20,650 to €22,667 for 6 different scenarios (1,482,638-1,627,519 RUB). Cost-effectiveness ratio (for 1 month PFS) for fulvestrant was €698 (50,103 RUB), for three line CT CER was from €1,357 to 1,619 (97,454-116,251 RUB). The sensitivity analysis showed that the results are stable under a wide range of assumptions.

CONCLUSIONS: fulvestrant 500 mg in 1-st line ET of receptor-positive HER2-negative ABC and MBC is cost effective versus standard CT in tree lines, with better clinically significant PFS and safety.