A BUDGET IMPACT ANALYSIS FOR THE INTRODUCTION OF A TUMOUR-INFORMED CTDNA TEST TO GUIDE ADJUVANT CHEMOTHERAPY (ACT) DECISIONS IN PATIENTS WITH STAGE II AND III COLORECTAL CANCER (CRC) IN GREECE
Author(s)
Marios Athanasios Loupas, MSc1, Panagiota Naoum, PhD1, Faidon Negkiz, BSc2, Kostas Athanasakis, PhD1.
1Laboratory for Health Technology Assessment, Department of Public Health Policy, University of West Attica, Athens, Greece, 2Genekor Medical S.A., Athens, Greece.
1Laboratory for Health Technology Assessment, Department of Public Health Policy, University of West Attica, Athens, Greece, 2Genekor Medical S.A., Athens, Greece.
OBJECTIVES: To assess the budget impact of introducing a tumour-informed circulating tumour DNA (ctDNA) assay, which detects molecular residual disease (MRD) after surgery to guide adjuvant chemotherapy (ACT) decisions in patients with stage II (low and high risk) and III colorectal cancer (CRC) in Greece, from the national health system (NHS) perspective over a 5-year time horizon.
METHODS: A budget impact model was populated with Greek CRC incidence data to compare a Current Market scenario, where ACT decisions rely on clinical and pathological risk factors, with a Revised Market scenario, where one-time postoperative ctDNA testing to guide ACT decisions is gradually adopted according to market share. Each patient was followed through the treatment pathway, from testing and ACT decision-making to treatment-related costs, including drug acquisition and administration, adverse events, and follow-up/monitoring based on local clinical practice. Chemotherapy utilisation rates were informed by clinical experts. Costs (€, 2026) were obtained from official publicly available sources. MRD positivity rates were sourced from the GALAXY/CIRCULATE-Japan studies. Outcomes included incremental costs and budget impact. One-way sensitivity analyses were performed.
RESULTS: Over 5 years, 13,845 eligible patients and 8,305 ctDNA tests were estimated. MRD-guided treatment was cost-saving, reducing CRC-related expenditure by €11,880,236 (-11.98%; -€858 per patient treated per year), primarily driven by 6,554 fewer chemotherapy-treated patients. Testing costs (€32,639,671) were offset by reductions in adverse-event (-€34,679,976), drug acquisition (-€5,783,495), and drug administration costs (-€4,056,436). Results remained cost-saving across all sensitivity analyses, with ctDNA unit price being the most influential driver. Restricting testing to higher-risk patients increased savings to €14,168,389.
CONCLUSIONS: Use of tumour-informed ctDNA testing to guide ACT in patients with stage II and III CRC was projected to reduce unnecessary chemotherapy exposure and generate cost savings for the Greek NHS. Savings were maximised when testing was targeted to stage II high-risk and stage III patients.
METHODS: A budget impact model was populated with Greek CRC incidence data to compare a Current Market scenario, where ACT decisions rely on clinical and pathological risk factors, with a Revised Market scenario, where one-time postoperative ctDNA testing to guide ACT decisions is gradually adopted according to market share. Each patient was followed through the treatment pathway, from testing and ACT decision-making to treatment-related costs, including drug acquisition and administration, adverse events, and follow-up/monitoring based on local clinical practice. Chemotherapy utilisation rates were informed by clinical experts. Costs (€, 2026) were obtained from official publicly available sources. MRD positivity rates were sourced from the GALAXY/CIRCULATE-Japan studies. Outcomes included incremental costs and budget impact. One-way sensitivity analyses were performed.
RESULTS: Over 5 years, 13,845 eligible patients and 8,305 ctDNA tests were estimated. MRD-guided treatment was cost-saving, reducing CRC-related expenditure by €11,880,236 (-11.98%; -€858 per patient treated per year), primarily driven by 6,554 fewer chemotherapy-treated patients. Testing costs (€32,639,671) were offset by reductions in adverse-event (-€34,679,976), drug acquisition (-€5,783,495), and drug administration costs (-€4,056,436). Results remained cost-saving across all sensitivity analyses, with ctDNA unit price being the most influential driver. Restricting testing to higher-risk patients increased savings to €14,168,389.
CONCLUSIONS: Use of tumour-informed ctDNA testing to guide ACT in patients with stage II and III CRC was projected to reduce unnecessary chemotherapy exposure and generate cost savings for the Greek NHS. Savings were maximised when testing was targeted to stage II high-risk and stage III patients.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE532
Topic
Economic Evaluation, Health Technology Assessment, Medical Technologies
Topic Subcategory
Budget Impact Analysis
Disease
Oncology