MSD Colombia, Calle 127A #53A-45 T3 P8, 110111, Bogota, Colombia.
MSD Argentina, Buenos Aires, Argentina.
Adv Ther. 2023 Jun;40(6):2836-2854. doi: 10.1007/s12325-023-02484-3. Epub 2023 May 2.
The KEYNOTE-054 trial found that adjuvant treatment with pembrolizumab improved recurrence-free survival versus placebo in completely resected high-risk stage III melanoma patients. We assessed the cost-effectiveness of adjuvant pembrolizumab in Colombia compared with watchful waiting, a widely used strategy despite the high risk of recurrence with surgery alone.
A four-health state [recurrence-free (RF), locoregional recurrence (LR), distant metastases (DM), and death) Markov model was developed to assess the lifetime medical costs and outcomes (3% annual discount), along with cost-effectiveness ratios (ICERs). The transitions from the RF and LR states were modeled using KEYNOTE-054 data, and those from the DM state were modeled using data from the KEYNOTE-006 trial and a network meta-analysis of advanced treatments received after adjuvant pembrolizumab and watchful waiting. The health state utilities were derived from KEYNOTE-054 Euro-QoL data and literature. Costs are expressed in 2021 Colombian pesos (COP).
Over a 46-year time horizon, patients on adjuvant pembrolizumab and watchful waiting were estimated to gain 9.69 and 7.56 quality-adjusted life-years (QALYs), 10.83 and 8.65 life-years (LYs), and incur costs of COP 663,595,726 and COP 563,237,206, respectively. The proportion of LYs spent in RF state was 84.63% for pembrolizumab and 72.13% for watchful waiting, yielding lower subsequent treatment, disease management, and terminal care costs for pembrolizumab. Adjuvant pembrolizumab improved survival by 2.18 LYs and 2.13 QALYs versus watchful waiting. The ICER per QALY was COP 47,081,917, primarily driven by recurrence rates and advanced melanoma treatments. The deterministic sensitivity analysis results were robust and consistent across various reasonable inputs and alternative scenarios. At a willingness-to-pay threshold of COP 69,150,201 per QALY, the probability of pembrolizumab being cost-effective was 65.70%.
Pembrolizumab is cost-effective as an adjuvant treatment compared to watchful waiting among patients with high-risk stage III melanoma after complete resection in Colombia.
KEYNOTE-054 试验发现，与安慰剂相比，辅助治疗用 pembrolizumab 可改善完全切除的高危 III 期黑色素瘤患者的无复发生存率。我们评估了在哥伦比亚，与广泛使用的观察等待策略相比，辅助 pembrolizumab 的成本效益，尽管单独手术有很高的复发风险。
建立了一个四健康状态（无复发（RF）、局部区域复发（LR）、远处转移（DM）和死亡）的 Markov 模型，以评估终生医疗费用和结果（3%的年度折扣），以及成本效益比（ICER）。RF 和 LR 状态的转换使用 KEYNOTE-054 数据进行建模，DM 状态的转换使用 KEYNOTE-006 试验的数据和辅助 pembrolizumab 和观察等待后接受的高级治疗的网络荟萃分析进行建模。健康状态效用来自 KEYNOTE-054 的 Euro-QoL 数据和文献。成本以 2021 年哥伦比亚比索（COP）表示。
在 46 年的时间内，接受辅助 pembrolizumab 和观察等待的患者估计分别获得 9.69 和 7.56 个质量调整生命年（QALY）、10.83 和 8.65 个生命年（LY），并产生 663,595,726 哥伦比亚比索和 563,237,206 哥伦比亚比索的成本。pembrolizumab 组和观察等待组的 RF 状态 LY 比例分别为 84.63%和 72.13%，因此 pembrolizumab 的后续治疗、疾病管理和终末期护理成本较低。与观察等待相比，辅助 pembrolizumab 使生存延长了 2.18 LY 和 2.13 QALY。每 QALY 的 ICER 为 47,081,917 哥伦比亚比索，主要受复发率和晚期黑色素瘤治疗的影响。确定性敏感性分析结果在各种合理输入和替代方案下是稳健且一致的。在愿意支付的 COP 阈值为每 QALY 69,150,201 哥伦比亚比索的情况下，pembrolizumab 具有成本效益的概率为 65.70%。
在哥伦比亚，与观察等待相比，完全切除的高危 III 期黑色素瘤患者术后辅助 pembrolizumab 治疗具有成本效益。
