Cost-effectiveness of ribociclib plus endocrine therapy versus placebo plus endocrine therapy in HR-positive, HER2-negative breast cancer

Abstract

BACKGROUND: The 2015 American Society of Clinical Oncology guidelines recommend first-line treatment of hormone receptor (HR)-positive breast cancer with endocrine therapy plus or minus palbociclib, a selective cyclin-dependent kinase (CDK)4/6 inhibitor. In 2018, the U.S. Food and Drug Administration approved ribociclib, a new orally available selective CDK4/6 inhibitor. While gains in progression-free survival (PFS) and overall survival (OS) from ribociclib are important for clinical and treatment outcomes, trade-offs in adverse events (AEs) and additional costs necessitate cost-effectiveness analysis (CEA) to assist consideration by third-party payer systems, physicians, and patients.OBJECTIVES: To (a) develop a Markov model and (b) determine the cost-effectiveness of ribociclib plus endocrine therapy versus endocrine therapy alone as treatment for premenopausal and perimenopausal patients with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. METHODS:A lifetime 3-state Markov model ("stable," "progressed," and "dead" health states) was developed using a U.S. payer perspective. Transition probabilities were calculated based on OS and PFS outcomes from the randomized controlled phase 3 trial MONALEESA-7. These Kaplan-Meier curves were extended to lifetime by estimating best-fit distributions using loglogistic distribution for ribociclib curves and Weibull distribution for placebo curves. Costs were obtained from national data sources using 2019 U.S. dollars (USD) and discounted by 3%. Utilities were obtained via published

Pharmacoeconomic evaluations of CDK4/6 inhibitors plus endocrine therapy for advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor-2 negative (HER2−) breast cancer: a systematic review

“…After a comprehensive search based on the inclusion and exclusion criteria, a total of 15 articles (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)…”

“…Eight studies were conducted in the United States (18,20,23,(25)(26)(27)(28)(29), 3 in China (24,26,28), and 1 each in Spain (15), the United Kingdom (16), Singapore (19), Canada (17), and Switzerland (21,22). One of the 14 studies did not describe the study perspective (25), 4 s t u d i e s a d o p t e d a h e a l t h s y s t e m p e r s p e c t i v e (15,19,21,22,24), 6 studies used a health insurance payer perspective (17,18,23,26,27,29), 1 study used a society-wide perspective (20), and 2 studies used both a health system perspective and a health insurance payer perspective (16,28). Study types included cost-effectiveness analysis (CEA) and/ or cost-utility analysis (CUA).…”

Comparison of healthcare resource utilization and costs of patients with HR+/HER2- advanced breast cancer treated with ribociclib versus other CDK4/6 inhibitors

“…Some recent studies have applied cost-effectiveness models to evaluate the CDK4/6 inhibitors, although differences in the measured outcomes and reported currencies limit comparisons between studies. [24][25][26][27] For example, Giuliani & Bonetti assessed the pharmacological costs of the three agents expressed in 2020 euros based on drug costs from a pharmacy in Italy and found that ribociclib was less expensive than abemaciclib and palbociclib. 25 The current study provides a novel comparison of the real-world economic burden for women with HR+/HER2-aBC receiving CDK4/6 inhibitors from a US payer's perspective, particularly as the three CDK4/6 inhibitors may differ in terms of efficacy and tolerability, which could have an impact on HRU and costs in this population.…”

“…Despite the clear clinical benefit of CDK4/6 inhibitors for the treatment of HR+/HER2-aBC, evidence is needed regarding their comparative healthcare resource utilization (HRU) and economic outcomes. Although several cost-effectiveness models in different countries have previously been published, [24][25][26][27] it is important to understand the real-world impact of these treatments from the payer perspective, particularly as all three CDK4/6 inhibitors may differ in terms of efficacy and tolerability which may impact HRU and healthcare costs. To help fill this knowledge gap, this study compares the HRU and healthcare costs of pre-and postmenopausal women diagnosed with HR+/HER2-aBC treated with ribociclib versus abemaciclib and ribociclib versus palbociclib in real-world practice from a US commercial payer perspective.…”

Cost-Effectiveness of Three Poliovirus Immunization Schedules in Shanghai, China

“…Two IPV-containing schedules were compared to the four-tOPV schedule, in terms of additional cost per VAPP case prevented and corresponding ICER. In addition, univariate sensitivity analysis was performed for key variables in the model, using Tornado plot as described elsewhere [30][31][32].…”