The Value of Tucatinib in Metastatic HER2-Positive Breast Cancer Patients: An Italian Cost-Effectiveness Analysis

SIMPLE SUMMARY: Tucatinib is recommended by different guidelines as a third line of treatment in HER2(+) breast cancer. Although it is an effective treatment, different studies have highlighted that the high price of the drug makes it a not cost-effective treatment option. Therefore, this study aimed to assess the appropriate cost of tucatinib and its cost-effectiveness when used in combination with trastuzumab and capecitabine (TXC) compared with TDM-1 from the perspective of the Italian National Healthcare System. Results suggested that TCX is cost-effective at a willingness to pay (WTP) of 60,000 EUR, using a tucatinib cost of 4828.44 EUR per cycle, in contrast to 4090.60 EUR considering a WTP of 20,000 EUR. Our findings can be used by stakeholders to guarantee the affordability of this drug in the Italian setting and can be used by other European and non-European countries as threshold to establish the appropriate price for the drug. ABSTRACT: Background: This study was aimed at estimating the appropriate price of tucatinib plus trastuzumab and capecitabine (TXC), as third-line treatment, in HER2(+) breast cancer (BC) patients from the Italian National Health System (NHS) perspective. Methods: A partitioned survival model with three mutually exclusive health states (i.e., progression-free survival (PFS), progressive disease (PD), and death) was used to estimate the price of tucatinib vs trastuzumab emtansine (TDM-1), considering a willingness to pay (WTP) of 60,000 EUR. Data from the HER2CLIMB trial, the Italian population, and the literature were used as input. The model also estimated the total costs and the life-years (LY) of TXC and TDM1. Deterministic and probabilistic (PSA) sensitivity analyses were conducted to evaluate the robustness of the model. Results: In the base case scenario, the appropriate price of tucatinib was 4828.44 EUR per cycle. The TXC resulted in +0.28 LYs and +16,628 EUR compared with TDM-1. Results were mainly sensitive to therapy intensity variation. In PSA analysis, TXC resulted cost-effective in 53% of the simulations. Assuming a WTP ranging 20,000–80,000 EUR, the tucatinib price ranged from 4090.60 to 5197.41 EUR. Conclusions: This study estimated the appropriate price for tucatinib according to different WTP in order to help healthcare decision makers to better understand the treatment value.