OBJECTIVES: Fruquintinib is approved by the US Food and Drug Administration (FDA; November 2023) for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor therapy, and, if RAS wild-type and medically appropriate, an anti-epidermal growth factor receptor therapy. Other approved systemic therapies in this indication (target indication hereafter) include regorafenib, trifluridine/tipiracil (T/T), and trifluridine/tipiracil+bevacizumab (T/T+bev). This study quantifies the budget impact (BI) of introducing fruquintinib into a health plan from the US payer perspective.

METHODS: A BI model using a partitioned survival structure was developed to compare a reference scenario reflecting an equally distributed market mix of systemic therapies without fruquintinib (regorafenib, T/T, T/T+bev; 33.3% each) and a new scenario including fruquintinib (25% market share each). The analysis was conducted over 5 years accounting for direct medical costs: drug acquisition and administration of initial/subsequent treatments, adverse events, disease management, and end-of-life care. Epidemiological and cost inputs were from public databases and published literature. Efficacy and safety were from the randomized clinical trials in the FDA Prescribing Information for each treatment.

RESULTS: The BI per-member-per-month was $0.07 for Commercial and $0.17 for Medicare plans. Extensive scenario analyses demonstrated the robustness of results. There is no official threshold for budgetary significance in the US; the US Institute for Clinical and Economic Review (ICER) cited $735-777 million for prescription drugs in 2023-2024. Introducing fruquintinib into the market mix to treat all patients impacted by the target indication among the US adult population (285.3 million in 2023, 25% in Medicare and the rest assumed in a Commercial plan) has an incremental budget of $296 million, well below the proposed ICER threshold.

CONCLUSIONS: Introducing fruquintinib for its target indication has a limited BI from the US payer perspective.