Parexel International, Stockholm, Sweden.
Parexel International, London, UK.
J Med Econ. 2022 Jan-Dec;25(1):660-668. doi: 10.1080/13696998.2022.2048573.
This economic analysis evaluated the cost-effectiveness of nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of platinum-doublet chemotherapy (PDC) compared with four cycles of PDC as first-line treatment for patients with advanced NSCLC in the United States (US).
A partitioned survival model was constructed with three mutually exclusive health states: progression free, progressed disease, and death. The analysis was conducted from a US healthcare payer perspective, using a time horizon of 25 years. Costs and outcomes were discounted at 3% annually. Survival outcomes from CheckMate 9LA were extrapolated with longer follow-up data from CheckMate 227 Part 1 (NIVO + IPI) and validated against data from other relevant clinical trials and real-world registries. Health-related quality of life utility values were derived from EQ-5D-3L data collected in CheckMate 9LA. US-specific costs (2020 dollars) were used for disease management; drug acquisition, administration, and monitoring; end-of-life care; adverse events; and subsequent treatments. Model outcomes included life years (LYs) gained, quality-adjusted LYs (QALYs) gained, and incremental cost-effectiveness ratio (ICER) for NIVO + IPI + PDC versus PDC. Sensitivity and scenario analyses were conducted.
NIVO + IPI + PDC was associated with higher projected health benefits than PDC, including gains in LYs (3.71 vs 1.89) and QALYs (2.86 vs 1.37), and higher costs ($317,581 vs $119,909). The ICER was $132,960/QALY gained. NIVO + IPI + PDC had a 78-100% probability of being cost-effective at a willingness-to-pay threshold of $150,000-$250,000/QALY. Sensitivity and scenario analyses indicated that the results were robust to changes in key parameters.
The inherent limitation in extrapolating clinical trial data was mitigated using data from the more mature CheckMate 227 Part 1 trial and validating the outcomes against data from other relevant trials and real-world registries.
NIVO + IPI + PDC (two cycles) provides a new first-line treatment option for patients with advanced NSCLC that is cost-effective within a range considered acceptable in the US.
本项经济分析旨在评估纳武利尤单抗（NIVO）联合伊匹木单抗（IPI）加两个周期铂类双药化疗（PDC）与四个周期 PDC 一线治疗美国晚期非小细胞肺癌（NSCLC）患者的成本效果。
采用三部分生存模型构建了三个互斥的健康状态：无进展、疾病进展和死亡。该分析从美国医疗支付者的角度出发，时间范围为 25 年。成本和结果按每年 3%贴现。CheckMate 9LA 的生存结果通过 CheckMate 227 第 1 部分（NIVO+IPI）的更长随访数据进行外推，并与其他相关临床试验和真实世界登记数据进行验证。健康相关生活质量效用值来自 CheckMate 9LA 中收集的 EQ-5D-3L 数据。采用 2020 年美国特定疾病管理成本（美元）；药物获取、管理和监测；临终关怀；不良事件；以及后续治疗。模型结果包括 NIVO+IPI+PDC 与 PDC 相比的生命年（LYs）获益、质量调整生命年（QALYs）获益和增量成本效果比（ICER）。进行了敏感性和情景分析。
NIVO+IPI+PDC 与 PDC 相比，预期健康获益更高，包括 LYs（3.71 比 1.89）和 QALYs（2.86 比 1.37）获益，成本更高（317581 美元比 119909 美元）。ICER 为每 QALY 增加 132960 美元。在支付意愿阈值为 150000-250000 美元/QALY 时，NIVO+IPI+PDC 有 78-100%的可能性具有成本效果。敏感性和情景分析表明，结果对关键参数的变化具有稳健性。
通过使用更为成熟的 CheckMate 227 第 1 部分试验的数据并将结果与其他相关试验和真实世界登记数据进行验证，缓解了对临床试验数据外推的固有限制。
NIVO+IPI+PDC（两个周期）为美国晚期 NSCLC 患者提供了一种新的一线治疗选择，在可接受范围内具有成本效果。
