Heidelberg Institute of Global Health, University Hospital and Medical Faculty, Heidelberg University, Im Neuenheimer Feld 130.3, Heidelberg, Germany.
Breast Unit, University Hospital, Heidelberg University, Heidelberg, Germany.
Appl Health Econ Health Policy. 2023 Mar;21(2):275-287. doi: 10.1007/s40258-022-00771-8. Epub 2022 Nov 21.
The American College of Surgeons Oncology Group Z0011 trial showed that complete axillary lymph node dissection (cALND) did not improve survival benefits in patients with one or two tumour-involved sentinel lymph nodes and undergoing breast conservation. Still, a considerable number of the Z0011-eligible patients continue to be treated with cALND in various countries. Given the potential economic gain from implementation of the Z0011 recommendations, we quantified population-level impacts of omitting cALND among Z0011-eligible patients in clinical practice.
This 2-year economic analysis adopted both the perspective of patients under statutory insurance and the societal perspective, using data collected prospectively from 179 German breast cancer units between 2008 and 2015. The estimation of cost savings and health gain relied on a single decision tree, which considered three scenarios: clinical practice at the baseline; actual implementation in routine care; and hypothetical full implementation in all eligible patients.
Data for 188,909 patients with primary breast cancer were available, 13,741 (7.3%) of whom met the Z0011 inclusion criteria. The use of cALND decreased from 94.3% in 2010 to 46.9% in 2015, resulting in a gain of 335 quality-adjusted life-years and a saving of EUR50,334,756 for the society. Had cALND been omitted in all eligible patients, the total gain would have been more than double.
The implementation of the Z0011 recommendations resulted in substantial savings and health gain in Germany. Our findings suggest that it is beneficial to introduce additional policy measures to promote further uptake of the Z0011 recommendations in clinical practice.
美国外科医师学院肿瘤学组 Z0011 试验表明，对于接受保乳治疗且仅有 1 个或 2 个肿瘤累及前哨淋巴结的患者，完全腋窝淋巴结清扫术（cALND）并不能提高生存获益。然而，在许多国家，仍有相当一部分符合 Z0011 标准的患者接受 cALND 治疗。考虑到实施 Z0011 建议可能带来的经济效益，我们量化了在临床实践中，对符合 Z0011 标准的患者省略 cALND 的人群影响。
本 2 年经济分析采用了患者法定保险视角和社会视角，使用了 2008 年至 2015 年期间从 179 个德国乳腺癌单位前瞻性收集的数据。成本节约和健康获益的估计依赖于一个单一的决策树，该决策树考虑了三种情况：基线临床实践；实际在常规护理中的实施；以及在所有符合条件的患者中假设的完全实施。
共有 188909 例原发性乳腺癌患者的数据可用，其中 13741 例（7.3%）符合 Z0011 纳入标准。cALND 的使用率从 2010 年的 94.3%下降到 2015 年的 46.9%，为社会带来了 335 个质量调整生命年的获益和 5033.4756 欧元的节省。如果所有符合条件的患者都省略了 cALND，总获益将超过两倍。
在德国，实施 Z0011 建议带来了显著的节省和健康获益。我们的研究结果表明，采取额外的政策措施，有利于在临床实践中进一步推广 Z0011 建议。
