First-line Treatment with Ribociclib plus Endocrine Therapy for Premenopausal Women with Hormone-receptor-positive Advanced Breast Cancer: A Cost-effectiveness Analysis

We conducted a cost-effectiveness analysis incorporating recent phase III clinical trial (MONALEESA-7) data to evaluate the cost-effectiveness of ribociclib (RIB) as a first-line treatment for premenopausal women with HR-positive, HER2-negative ABC from the perspectives of the United States healthcare payers and the Chinese healthcare system. Our results suggest that, in the United States the addition of RIB to endocrine therapy for the first-line treatment of premenopausal women with HR-positive, HER2-negative ABC is unlikely to provide a reasonable return for the money spent. A greater discount in price is necessary. In China, the value-based price of RIB established in this study would prove help during drug price negotiations for the eligible patients. Background: We conducted a cost-effectiveness analysis incorporating recent phase III clinical trial (MONALEESA7) data to evaluate the cost-effectiveness of ribociclib (RIB) as a first-line treatment for premenopausal women with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) from the United States healthcare payer perspective. In addition, because RIB has not been marketed in China, we identified the range of drug costs for which RIB could be considered cost effective from a Chinese healthcare system perspective. Patients and Methods: A Markov model was developed to evaluate the cost-effectiveness of adding RIB to endocrine therapy over a lifetime. The clinical outcomes and utility data were obtained from published literature. Costs data were obtained from United States and Chinese official websites, and we determined the potential price for RIB in China based on its price in the United States. The main outcomes of this study were the incremental costeffectiveness ratio (ICER) and quality-adjusted life-years (QALYs). Results: The model projected that mean outcome was better with RIB and endocrine combined (3.83366 QALYs) than with endocrine therapy alone (2.71203 QALYs). In the United States, RIB and endocrine therapy cost an additional $604,960.06, resulting in an ICER of $539,357.95/QALY compared with endocrine monotherapy. Subgroup analyses indicated that, in China, the projected mean outcomes were better for RIB and endocrine therapy (6.37 QALYs) than for endocrine monotherapy (2.71 QALYs). The corresponding incremental costs were $224,731.88943. Thus, the ICER comparing RIB and endocrine therapy with endocrine therapy alone represented a $61,454.96/QALY gain. Conclusion: Additional use of RIB is estimated to not be cost effective as a first-line treatment for premenopausal women with HR-positive, HER2-negative ABC in the United States. A value-based price for the cost of RIB is less than $31.74/200 mg for China. (C) 2021 Elsevier Inc. All rights reserved.