Department of Management, Economics and Industrial Engineering, Politecnico di Milano, Milan, Italy.
Istituto Di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
PLoS One. 2024 Aug 29;19(8):e0309336. doi: 10.1371/journal.pone.0309336. eCollection 2024.
Breast cancer is a global health problem, and sentinel lymph node biopsy (SLNB) is the standard procedure for early-stage breast cancer. Technetium-99 (TC-99), alone or combined with blue dye (BD) are conventional tracers for SLNB, but they have safety, availability, and cost limitations. Indocyanine green (ICG) is an alternative tracer that has been gaining acceptance among healthcare professionals. This study aimed at assessing the clinical and economic value of ICG in hospital settings, using the health technology assessment (HTA) framework.
We conducted a comprehensive evaluation of ICG for SLNB, based on literature sources and data collected from two Italian hospitals that switched from TC-99 to ICG. We analyzed ICG's technical attributes through technology documentation and relevant databases. We performed a systematic literature review of 36 studies to assess the clinical effectiveness and safety of ICG. We obtained organizational insights from clinicians and the clinical engineer involved in the study. We applied Time-Driven Activity-Based Costing (TDABC) and Budget Impact Analysis (BIA) to estimate the economic impact of ICG. The ethical, legal, and social implications of ICG were considered through clinicians' inputs and technology documentation.
Our results showed that ICG had equivalent or superior clinical effectiveness compared to TC-99 and BD, with minimal adverse events. ICG simplified the surgical pathways, by streamlining procedures, reducing waiting times, and increasing flexibility in scheduling surgeries. Moreover, the TDABC analysis showed significant cost reductions by avoiding the need for pre-operative lymphoscintigraphy and hospitalization, with average savings per single care pathway of around 18% for ICG compared to TC-99. Finally, ICG improved patient experience, and proved regulatory compliance.
This study provided strong evidence for ICG's clinical and economic value for SLNB in breast cancer. It ascertained ICG as a valuable alternative to conventional tracers, ensuring clinical effectiveness along with economic and organizational benefits.
乳腺癌是一个全球性的健康问题，前哨淋巴结活检（SLNB）是早期乳腺癌的标准程序。锝-99（TC-99）单独或与蓝色染料（BD）联合使用是 SLNB 的常规示踪剂，但它们存在安全性、可用性和成本方面的限制。吲哚菁绿（ICG）是一种替代示踪剂，越来越受到医疗保健专业人员的认可。本研究旨在使用健康技术评估（HTA）框架评估 ICG 在医院环境中的临床和经济价值。
我们根据文献来源和从两家意大利医院的数据，对 ICG 用于 SLNB 进行了全面评估，这两家医院已从 TC-99 切换到 ICG。我们通过技术文档和相关数据库分析了 ICG 的技术属性。我们对 36 项研究进行了系统的文献回顾，以评估 ICG 的临床效果和安全性。我们从参与该研究的临床医生和临床工程师那里获得了组织方面的见解。我们应用时间驱动的活动成本核算（TDABC）和预算影响分析（BIA）来估计 ICG 的经济影响。我们通过临床医生的投入和技术文档考虑了 ICG 的伦理、法律和社会影响。
我们的结果表明，与 TC-99 和 BD 相比，ICG 具有等效或更高的临床效果，且不良事件较少。ICG 通过简化手术流程、减少等待时间和增加手术安排的灵活性，简化了手术途径。此外，TDABC 分析显示，通过避免术前淋巴闪烁显像和住院治疗，ICG 可显著降低成本，与 TC-99 相比，每个单一护理途径的平均节省约 18%。最后，ICG 改善了患者体验，并证明符合监管要求。
本研究为 ICG 在乳腺癌 SLNB 中的临床和经济价值提供了有力证据。它证实了 ICG 作为常规示踪剂的一种有价值的替代方案，确保了临床效果，同时还带来了经济和组织效益。
