Over the past decade, most publications on indocyanine green (ICG) fluorescence imaging have focused on clinical outcomes such as improved visualisation, higher sentinel lymph node detection rates and reduced surgical complications. While these remain fundamental, healthcare decision makers increasingly require a broader question to be answered:
Does introducing fluorescence-guided surgery provide value for the hospital as a whole?
This is where the work led by Professor Emanuele Lettieri and colleagues at the Politecnico di Milano has become particularly important.
Rather than examining clinical performance alone, the group has applied a Hospital-Based Health Technology Assessment (HB-HTA) framework to evaluate ICG fluorescence imaging across the full spectrum of healthcare delivery, considering clinical, organisational, economic, ethical and patient-centred outcomes. Their work represents one of the most comprehensive evaluations of ICG adoption published to date.
Looking Beyond Clinical Effectiveness
Traditional evaluations of new surgical technologies often focus on whether they improve patient outcomes.
Hospital management, however, must answer additional questions.
- Does the technology simplify clinical pathways?
- Does it reduce resource utilisation?
- Can theatre capacity be improved?
- Does it reduce costs?
- Is implementation practical?
- Will patients benefit from a better overall experience?
Hospital-Based HTA is designed specifically to answer these questions.
Professor Lettieri’s work applies this framework to compare ICG fluorescence imaging with conventional sentinel lymph node mapping using Technetium-99 (Tc-99) and blue dye.
Clinical Performance Remains Strong
The multidisciplinary review confirmed findings already reported across numerous systematic reviews.
ICG demonstrated:
- Clinical effectiveness at least equivalent to conventional tracers
- Excellent sentinel lymph node detection rates
- Very low rates of adverse events
- Reliable performance across breast cancer surgery
Importantly, the HTA concluded that these clinical advantages are achieved while simultaneously improving hospital workflows rather than adding complexity.
Organisational Benefits Often Receive Less Attention
One of the most valuable aspects of the work is its detailed assessment of hospital organisation.
The investigators collected real-world evidence from two Italian hospitals that transitioned from Tc-99 to ICG.
They found that adopting ICG simplified the patient pathway by:
- eliminating dependence on nuclear medicine scheduling
- avoiding pre-operative lymphoscintigraphy
- reducing unnecessary patient movement through the hospital
- improving operating theatre scheduling flexibility
- streamlining multidisciplinary coordination
Rather than requiring multiple departments and appointments before surgery, ICG enabled a more direct surgical pathway that reduced logistical complexity for both clinicians and patients.
Economic Value Extends Beyond the Cost of the Dye
Perhaps the most important contribution of Professor Lettieri’s work is demonstrating that the economics of fluorescence-guided surgery should not be judged by acquisition cost alone.
Using Time-Driven Activity-Based Costing (TDABC) together with Budget Impact Analysis, the investigators evaluated the complete patient pathway.
The analysis showed that replacing Tc-99 with ICG reduced overall pathway costs by approximately 18% per patient, largely through:
- elimination of nuclear medicine procedures
- removal of pre-operative hospital activity
- fewer staff interactions
- reduced resource utilisation
- simplified patient flow
The findings reinforce an increasingly recognised principle within HTA: technologies that simplify care pathways can generate meaningful savings even when device acquisition costs appear similar.
Benefits for Patients
The assessment also considered outcomes that are sometimes overlooked in conventional economic analyses.
Patients benefited from:
- fewer pre-operative appointments
- less time spent within hospital
- avoidance of radioactive tracers
- simpler treatment pathways
- improved overall care experience
These factors are increasingly recognised by HTA agencies as important contributors to healthcare value alongside traditional clinical endpoints.
Supporting Hospital Decision-Making
Earlier in 2023, Professor Lettieri presented these findings at the ISPOR European meeting as a Hospital-Based HTA evaluating near-infrared fluorescence using ICG for sentinel lymph node mapping in both breast and gynaecological cancers.
The objective was not simply to compare tracers but to provide hospital managers with evidence supporting technology adoption decisions using recognised HTA methodology. The subsequent 2024 peer-reviewed publication provides the detailed evidence underpinning those conclusions.
What does this mean for clinical practice?
Healthcare systems increasingly face pressure to improve outcomes while making more efficient use of limited resources. Professor Lettieri’s work demonstrates that the value proposition for ICG extends well beyond fluorescence imaging itself.
When assessed through a comprehensive Hospital-Based HTA framework, ICG has the potential to:
- maintain excellent clinical performance
- simplify surgical pathways
- reduce dependence on nuclear medicine infrastructure
- improve operating theatre efficiency
- lower overall treatment costs
- enhance the patient experience
As more hospitals evaluate fluorescence-guided surgery, evidence of this type is likely to become increasingly influential in procurement and adoption decisions, shifting the discussion from “Does it work?” to the more important question: “Does it improve the way care is delivered?”
References
- Pinelli M, Gerardi C, Lettieri E, et al. Comparison of Indocyanine Green with conventional tracers for sentinel lymph node biopsy in breast cancer: A multidisciplinary evaluation of clinical effectiveness, safety, organizational and economic impact. PLOS ONE. 2024;19(8):e0309336.
- Lettieri E, Sosa M, Tariq L, et al. Hospital-Based Health Technology Assessment of Near-Infrared Fluorescence Using Indocyanine Green for Sentinel Lymph Node Mapping for Breast Cancer and Gynecologic Cancer. Value in Health (ISPOR Abstract). 2023.
