A Micro-Costing Framework for Circulating Tumor DNA Testing in Dutch Clinical Practice.

Area of Science:

• Oncology
• Biomarkers
• Health Economics

Background:

• Circulating tumor DNA (ctDNA) is a significant biomarker in cancer care.
• Accurate cost estimation for ctDNA testing is vital for reimbursement and clinical integration.
• Workflow variations complicate the calculation of total ctDNA testing costs.

Purpose of the Study:

• To develop a micro-costing framework for consistent and reliable cost calculation of ctDNA testing.
• To establish a standardized methodology for assessing the economic impact of ctDNA diagnostics.
• To provide a tool for evaluating cost variations based on different laboratory settings and testing volumes.

Main Methods:

• A comprehensive diagnostic workflow for ctDNA testing was mapped.
• A micro-costing methodology was developed, incorporating personnel, material, equipment, overhead, and failure costs.
• The framework was validated by experts and applied to six case studies across three Dutch hospitals using diverse platforms (PCR, mass spectrometry, NGS).

Main Results:

• The developed framework covers the entire ctDNA diagnostic workflow from sample collection to result.
• Case studies revealed substantial cost variations, ranging from €168 to €7638 per sample.
• Costs were found to be sensitive to the specific platform used, the clinical setting, and the testing volume.

Conclusions:

• The micro-costing framework offers a standardized approach to calculating ctDNA testing costs.
• An open-access tool facilitates laboratory-specific cost estimations and sensitivity analyses.
• The wide cost range highlights the need for detailed economic evaluations in ctDNA implementation strategies.