Department of Surgical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, the Netherlands.
ESMO Open. 2021 Dec;6(6):100303. doi: 10.1016/j.esmoop.2021.100303. Epub 2021 Nov 13.
The introduction of adjuvant systemic treatment has significantly improved recurrence-free survival in patients with resectable high-risk melanoma. Adjuvant treatment with immune checkpoint inhibitors and targeted therapy, however, substantially impacts health care budgets, while the number of patients with melanoma who are treated in the adjuvant setting is still increasing. To evaluate the socioeconomic impact of the three adjuvant treatments, a cost-effectiveness analysis (CEA) was carried out.
Data were obtained from the three pivotal registration phase III clinical trials on the adjuvant treatment of patients with resected high-risk stage III in melanoma (KEYNOTE-054, CheckMate 238, and COMBI-AD). For this CEA, a Markov model with three health states (no evidence of disease, recurrent/progressive disease, and death) was applied. From a societal perspective, different adjuvant strategies were compared according to total costs, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. To evaluate model uncertainty, sensitivity analyses (deterministic and probabilistic) were carried out.
In the adjuvant setting, total costs (per patient) were €168 826 for nivolumab, €194 529 for pembrolizumab, and €211 110 for dabrafenib-trametinib. These costs were mainly determined by drug acquisition costs, whereas routine surveillance costs varied from €126 096 to €134 945. Compared with routine surveillance, LYs improved by approximately 1.41 for all therapies and QALYs improved by 2.02 for immune checkpoint inhibitors and 2.03 for targeted therapy. This resulted in incremental cost-effectiveness ratios of €21 153 (nivolumab), €33 878 (pembrolizumab), and €37 520 (dabrafenib-trametinib) per QALY gained.
This CEA compared the three EMA-approved adjuvant systemic therapies for resected stage III melanoma. Adjuvant treatment with nivolumab was the most cost-effective, followed by pembrolizumab. Combination therapy with dabrafenib-trametinib was the least cost-effective. With the increasing number of patients with high-risk melanoma who will be treated with adjuvant treatment, there is an urgent need to reduce drug costs while developing better prognostic and predictive tools to identify patients who will benefit from adjuvant treatment.
辅助全身治疗的引入显著改善了可切除高危黑色素瘤患者的无复发生存率。然而，免疫检查点抑制剂和靶向治疗的辅助治疗大大影响了医疗保健预算，而接受辅助治疗的黑色素瘤患者数量仍在增加。为了评估三种辅助治疗的社会经济影响，进行了成本效益分析（CEA）。
数据来自三项关键性 III 期注册临床试验，评估了辅助治疗切除的高危 III 期黑色素瘤患者（KEYNOTE-054、CheckMate 238 和 COMBI-AD）。对于这项 CEA，应用了具有三个健康状态（无疾病证据、复发/进展性疾病和死亡）的马尔可夫模型。从社会角度来看，根据总成本、生命年（LY）、质量调整生命年（QALY）和增量成本效益比，比较了不同的辅助策略。为了评估模型的不确定性，进行了确定性和概率敏感性分析。
在辅助治疗中，纳武单抗、帕博利珠单抗和达拉非尼联合曲美替尼的每位患者总成本（欧元）分别为 168826 欧元、194529 欧元和 211110 欧元。这些成本主要由药物获得成本决定，而常规监测成本在 126096 欧元至 134945 欧元之间变化。与常规监测相比，所有治疗方法的 LY 提高了约 1.41，免疫检查点抑制剂的 QALY 提高了 2.02，靶向治疗的 QALY 提高了 2.03。这导致每获得一个 QALY 的增量成本效益比分别为 21153 欧元（纳武单抗）、33878 欧元（帕博利珠单抗）和 37520 欧元（达拉非尼联合曲美替尼）。
本 CEA 比较了三种已获 EMA 批准的辅助治疗 III 期黑色素瘤的系统治疗方法。纳武单抗辅助治疗最具成本效益，其次是帕博利珠单抗。达拉非尼联合曲美替尼的联合治疗最不具成本效益。随着接受辅助治疗的高危黑色素瘤患者数量的增加，迫切需要降低药物成本，同时开发更好的预后和预测工具，以确定将从辅助治疗中获益的患者。
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