Economic Evaluation of Axicabtagene Ciloleucel as a Second-Line Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in South Korea: A Cost-Utility Analysis Based on the ZUMA-7 Trial.

Abstract

Background and objectives: Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma in South Korea, with 30-40% of patients relapsing or becoming refractory after first-line therapy. Axicabtagene ciloleucel (axi-cel) demonstrated superior efficacy over standard-of-care (SoC) salvage chemotherapy plus autologous stem cell transplantation (ASCT) in the ZUMA-7 trial. While approved for second-line use in South Korea, its cost effectiveness has not yet been evaluated in the local healthcare setting. This study aimed to evaluate the cost effectiveness of axi-cel compared with SoC as a second-line treatment for adult patients with relapsed or refractory DLBCL eligible for ASCT from the perspective of the South Korean healthcare system.

Methods: A partitioned survival model with a mixture cure approach was developed based on ZUMA-7 data to compare axi-cel with SoC as second-line treatment for transplant-eligible relapsed/refractory DLBCL. The analysis was conducted from the healthcare system perspective over a lifetime horizon, with costs and outcomes discounted at 4.5% annually. Utilities were estimated from EQ-5D-5L data in ZUMA-7 using the South Korean valuation set. Costs included treatment, subsequent therapies, resource use, adverse event management, and end-of-life care. Deterministic and probabilistic sensitivity analyses were conducted. Cost effectiveness was evaluated using a willingness-to-pay threshold of 1.5-2 times the gross domestic product per capita of South Korea.

Results: Over a lifetime horizon, axi-cel yielded 8.68 life years (LYs) and 7.61 quality-adjusted life years (QALYs) versus 7.10 LYs and 5.91 QALYs for SoC. Total costs were higher for axi-cel, resulting in an incremental cost of KRW 93.9 million (US dollars (USD) 68,676). The incremental cost-effectiveness ratio (ICER) was KRW 55.5 million (USD 40,583) per QALY gained. Sensitivity analyses showed robust results, with subsequent therapy pattern as the most influential parameter.

Conclusions: Axi-cel as second-line treatment for relapsed or refractory DLBCL provided meaningful gains in survival and quality-adjusted life and appeared to be a cost-effective alternative compared to SoC in South Korea.