HLX01（Hanlikang®）对比利妥昔单抗联合 CHOP 治疗初治弥漫大 B 细胞淋巴瘤的成本效果：分区生存模型分析

This study evaluates the cost-effectiveness of Hanlikang (HLX01), a biosimilar of rituximab, compared to rituximab (MabThera), both combined with the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen, for treatment-naive diffuse large B-cell lymphoma (DLBCL) patients. With biosimilars becoming more prominent in oncology, understanding their economic impact is crucial for optimizing treatment strategies and healthcare resource allocation.

A partitioned survival model was built using data from the HLX01-NHL03 trial, analyzing clinical outcomes in three health states-progression-free survival, progressive disease, and terminal state-over a 10-year time horizon. The incremental cost-effectiveness ratio (ICER) and quality-adjusted life years (QALYs) were compared across transplant-eligible and non-transplant-eligible patient subgroups. Sensitivity analyses were performed to confirm the robustness of the model.

Over 10 years, Hanlikang-CHOP (H-CHOP) patients gained 7.11 QALYs, compared to 6.50 QALYs for Rituximab-CHOP (R-CHOP). The ICER for transplant-eligible patients ranged from US$ 36,386.92 (CNY 263,215.70) to US$ 38,379.79 (CNY 277,631.72) per QALY, depending on the treatment. In non-transplant-eligible patients, the ICER was between US$ 7,079.15 (CNY 51,209.16) and US$ 17,094.61 (CNY 123,658.99) per QALY. Chimeric antigen receptor T-cell (CAR-T) therapy significantly increased the ICER to US$ 356,793.77 (CNY 2,580,974.77). Sensitivity analyses confirmed survival duration and drug costs as key factors.

Hanlikang offers a cost-effective alternative to rituximab in specific patient populations, particularly those not eligible for transplant. However, its economic benefits diminish in more complex treatment scenarios, such as those involving CAR-T therapy or novel agents.