A recent cost-effectiveness analysis has determined that margetuximab, when combined with chemotherapy, is not a cost-effective alternative to trastuzumab plus chemotherapy in pretreated patients with ERBB2-positive advanced breast cancer. The analysis, based on data from the Phase III SOPHIA trial, highlights the economic challenges associated with adopting margetuximab despite its demonstrated clinical benefits in progression-free survival (PFS) and overall survival (OS).
The SOPHIA trial, an international, randomized, open-label study, previously demonstrated that margetuximab plus chemotherapy improved PFS and OS compared to trastuzumab plus chemotherapy in patients with ERBB2-positive advanced breast cancer. This new analysis, however, focuses on the economic implications of these clinical outcomes.
Cost-Effectiveness Analysis Details
The cost-effectiveness analysis utilized a three-state Markov model to simulate the disease progression of patients with advanced breast cancer. Clinical data were sourced directly from the SOPHIA trial, while cost and utility data were obtained from standard fee databases and previously published literature. The study compared the costs and quality-adjusted life years (QALYs) associated with margetuximab plus chemotherapy versus trastuzumab plus chemotherapy.
The results indicated that margetuximab plus chemotherapy provided an incremental 0.04 QALYs at an incremental cost of $66,109.78, compared to trastuzumab plus chemotherapy. This resulted in an incremental cost-effectiveness ratio (ICER) of $1,486,442.35 per QALY, which significantly exceeds the generally accepted willingness-to-pay (WTP) threshold for new cancer therapies.
Subgroup Analysis: CD16A-158F Allele Carriers
A subgroup analysis was conducted to assess the cost-effectiveness of margetuximab in CD16A-158F allele carriers, a population that may derive greater benefit from the drug. In this subgroup, the ICER decreased to $592,669.73 per QALY. While this represents a substantial reduction, it still remains well above the WTP threshold, suggesting that even in this potentially more responsive population, margetuximab is not economically viable at its current price.
Sensitivity Analysis
One-way sensitivity analyses were performed to evaluate the impact of various factors on the model. The variance in the utility of the PFS state, the costs associated with margetuximab, and the utility of the progressive disease state were identified as the most influential factors affecting the cost-effectiveness of margetuximab. These findings suggest that reducing the cost of margetuximab or improving the quality of life during PFS could potentially improve its cost-effectiveness profile.
Implications for Clinical Practice
The findings of this cost-effectiveness analysis have significant implications for clinical practice and healthcare decision-making. While margetuximab has demonstrated clinical efficacy in treating ERBB2-positive advanced breast cancer, its high cost relative to its clinical benefits makes it a less attractive option from an economic perspective. Healthcare providers and payers will need to carefully consider these economic factors when making treatment decisions for patients with this condition.
