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Abstract：
BACKGROUND: The incidence and mortality rates of patients with chronic lymphocytic leukemia (CLL) in China have recently increased. This study performed a long-term economic evaluation of the first-line treatment strategies ibrutinib (IB) or bendamustine (BE) plus rituximab (RI) for previously untreated older patients with CLL without the del(17p)/TP53 mutation in China.
METHODS: Based on clinical data from large, randomized trials, a Markov model including four disease states (event-free survival, treatment failure, post-treatment failure, and death) was used to estimate the incremental costs per quality adjusted-life year (QALY) gained from the first-line IB strategy versus the BE plus RI strategy over a 10-year period. All costs were adjusted to 2022 values based on the Chinese Consumer Price Index, and all costs and health outcomes were discounted at an annual rate of 5%. Sensitivity analysis was performed to confirm the robustness of base-case results.
RESULTS: Compared to the first-line BE plus RI strategy, first-line IB treatment achieved 1.17 additional QALYs, but was accompanied by $88,046.78 (estimated in 2022 US dollars) in decremental costs per patient over 10 years. Thus, first-line treatment with IB appeared to have absolute dominance compared to the BE plus RI strategy. Sensitivity analysis confirmed the robustness of these results.
CONCLUSIONS: The first-line treatment with IB is absolutely cost-effective compared to the first-line BE plus RI treatment strategy for 65 or older patients with CLL without the del (17p)/TP53 mutation from the Chinese payer perspective. Therefore, it is strongly recommended that Chinese health authorities select the former strategy for these CLL patients.
METHODS: Based on clinical data from large, randomized trials, a Markov model including four disease states (event-free survival, treatment failure, post-treatment failure, and death) was used to estimate the incremental costs per quality adjusted-life year (QALY) gained from the first-line IB strategy versus the BE plus RI strategy over a 10-year period. All costs were adjusted to 2022 values based on the Chinese Consumer Price Index, and all costs and health outcomes were discounted at an annual rate of 5%. Sensitivity analysis was performed to confirm the robustness of base-case results.
RESULTS: Compared to the first-line BE plus RI strategy, first-line IB treatment achieved 1.17 additional QALYs, but was accompanied by $88,046.78 (estimated in 2022 US dollars) in decremental costs per patient over 10 years. Thus, first-line treatment with IB appeared to have absolute dominance compared to the BE plus RI strategy. Sensitivity analysis confirmed the robustness of these results.
CONCLUSIONS: The first-line treatment with IB is absolutely cost-effective compared to the first-line BE plus RI treatment strategy for 65 or older patients with CLL without the del (17p)/TP53 mutation from the Chinese payer perspective. Therefore, it is strongly recommended that Chinese health authorities select the former strategy for these CLL patients.
摘要：
背景：中国慢性淋巴细胞白血病（CLL）患者的发病率和死亡率最近有所增加。这项研究对一线治疗策略伊布替尼（IB）或苯达莫司汀（BE）加利妥昔单抗（RI）进行了长期经济学评估，以治疗先前未经治疗的无del（17p）/TP53突变的CLL老年患者。
方法：根据大型临床数据，随机试验，包括四种疾病状态的马尔可夫模型(无事件生存，治疗失败,治疗后失败,和死亡）用于估算10年期间从一线IB策略与BE加RI策略获得的每个质量调整生命年（QALY）的增量成本。所有成本均根据中国消费者价格指数调整为2022年的值，所有费用和健康结果均按5%的年增长率进行折扣.进行敏感性分析以确认基本情况结果的稳健性。
结果：与一线BE加RI策略相比，一线IB处理实现了1.17个额外的QALYs，但在10年内,每位患者的费用递减为88,046.78美元(按2022年美元估算).因此，与BE+RI策略相比,IB一线治疗似乎具有绝对优势.灵敏度分析证实了这些结果的稳健性。
结论：对于65岁或以上无del(17p)/TP53突变的CLL患者，与一线BE加RI治疗策略相比，一线IB治疗绝对具有成本效益。因此,强烈建议中国卫生部门为这些CLL患者选择前一种策略.
方法：根据大型临床数据，随机试验，包括四种疾病状态的马尔可夫模型(无事件生存，治疗失败,治疗后失败,和死亡）用于估算10年期间从一线IB策略与BE加RI策略获得的每个质量调整生命年（QALY）的增量成本。所有成本均根据中国消费者价格指数调整为2022年的值，所有费用和健康结果均按5%的年增长率进行折扣.进行敏感性分析以确认基本情况结果的稳健性。
结果：与一线BE加RI策略相比，一线IB处理实现了1.17个额外的QALYs，但在10年内,每位患者的费用递减为88,046.78美元(按2022年美元估算).因此，与BE+RI策略相比,IB一线治疗似乎具有绝对优势.灵敏度分析证实了这些结果的稳健性。
结论：对于65岁或以上无del(17p)/TP53突变的CLL患者，与一线BE加RI治疗策略相比，一线IB治疗绝对具有成本效益。因此,强烈建议中国卫生部门为这些CLL患者选择前一种策略.
