Introduction
The randomized phase III KEYNOTE-522 trial demonstrated that addition of pembrolizumab to neoadjuvant chemotherapy provided a significant improvement in event-free survival and a favorable trend in overall survival for high-risk early-stage triple-negative breast cancer (eTNBC). This analysis evaluated the cost-effectiveness of pembrolizumab in combination with chemotherapy as neoadjuvant treatment and continued as a single-agent adjuvant treatment after surgery vs. neoadjuvant chemotherapy for patients with high-risk eTNBC in the USA.
Methods
The analysis was conducted from a US third-party public healthcare payer perspective. A multistate transition model was developed using efficacy and safety data from the KEYNOTE-522 trial. The model included four mutually exclusive health states: event-free, locoregional recurrence, distant metastasis, and death to simulate patients' lifetime disease course. Quality-adjusted life years (QALYs) were calculated on the basis of EuroQoL-5 Dimensions utility data collected in KEYNOTE-522. Costs for drug acquisition/administration, adverse events, disease management, and subsequent therapies were reported (2021 US dollars). Costs and outcomes were discounted at 3% annually. A series of sensitivity analyses were performed to test the robustness of the main results.
Results
In the base case scenario, pembrolizumab plus chemotherapy followed by pembrolizumab resulted in expected gains of 3.37 life years (LYs) and 2.90 QALYs, and an incremental cost of $79,046 versus chemotherapy. The incremental cost per QALY gained was $27,285, which is lower than all commonly cited US willingness-to-pay thresholds. Sensitivity analyses showed the results were robust over plausible values of key model inputs and assumptions.
Conclusions
Compared with neoadjuvant chemotherapy, pembrolizumab in combination with chemotherapy as neoadjuvant treatment and continued as a single-agent adjuvant treatment after surgery is considered a cost-effective option for high-risk eTNBC in the USA.
Associated People
Weiguang Xue
Mr. Xue consults on cases involving health economics and outcomes research (HEOR). He specializes in using health economics analyses to inform product launch strategies, as well as decision making in early-stage clinical development. Mr. Xue has extensive experience in the economic evaluation of health technologies across multiple therapeutic areas, including oncology, infectious diseases, autoimmune diseases, central nervous system diseases, ophthalmology, and gynecology. His work includes cost-effectiveness analysis, budget impact analysis, systematic literature review, indirect treatment comparison, evaluation of health care resource use, global value dossier, and market access strategy. He has led successful health technology assessment (HTA) submissions to the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the All Wales Medicines Strategy Group (AWMSG). He has also developed global economic models across multiple indications and led country rollouts supporting market access in Europe, North America, and Asia.