Abstract
Trastuzumab emtansine (T-DM1) in the adjuvant treatment of patients with HER2-positive early breast cancer (HER2+ eBC) with residual invasive disease (RD) after neoadjuvant taxane-based and HER2-targeted therapy demonstrated a clinically and statistically significant improvement in invasive disease-free survival (iDFS) compared to trastuzumab in the KATHERINE trial. The aim of this study is to determine the efficiency of T-DM1 versus trastuzumab as adjuvant treatment of HER2+ eBC with RD in Spain through a cost-utility analysis. A six-state Markov model (iDFS, local recurrence, iDFS after local recurrence, metastatic-relapse [1L], metastatic-relapse [2L], and death) was adapted over a lifetime horizon (specifically 38 years), considering the Spanish National Healthcare System (SNHS) perspective. KATHERINE iDFS data were fitted with a log-normal distribution to extrapolate iDFS beyond the trial follow-up. Transition probabilities and costs (list prices of medicines considered and, for the adjuvant treatment, trastuzumab biosimilar price assumed; €2019) were obtained from literature and national databases. Utilities were based mainly on the 5Q-5D outcomes from KATHERINE trial. Model inputs were validated by an expert panel. A 3% annual discount rate was applied to both effects and costs. Deterministic and probabilistic sensitivity analyses (SA) were performed to explore uncertainties. The incremental cost-utility ratio (ICUR) for T-DM1 versus trastuzumab was €6,748 per quality-adjusted life-year (QALY). Compared to trastuzumab, T-DM1 provided 1.702 additional QALYs at an additional cost of €11,485. SA confirmed the robustness of the model. In the probabilistic analysis, the probability of T-DM1 being cost-effective when considering a threshold of €30,000/QALY was >95%. T-DM1 is a more efficient therapeutic alternative than trastuzumab as adjuvant treatment of HER2+ eBC with residual invasive disease for the SNHS.
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