Cost-effectiveness of ferumoxtran-enhanced macrophage-specific-MRI and PSMA-PET/CT versus ePLND for nodal staging in primary prostate cancer: a decision analysis based on updated phase-3 trial data.

内容摘要

Accurate nodal staging in intermediate- to high-risk prostate cancer (PCa) is crucial for treatment decisions. While extended pelvic lymph node dissection (ePLND) is the standard, it is invasive and has a low diagnostic yield. A 2019 analysis suggested that non-invasive imaging such as PSMA-PET/CT and ferumoxtran-enhanced macrophage-MRI (m-MRI) is cost-effective, but at the possible expense of a small QALY loss compared to ePLND, based on limited evidence. Recent Phase 3 trials have provided new data, prompting a reevaluation. Therefore, the aim of this article is to update a model with recent trial data to assess the cost-effectiveness of m-MRI and PSMA-PET/CT versus ePLND in Germany. We adapted a Markov model to simulate lifetime outcomes for men with intermediate- to high-risk PCa from a German insurer's perspective, with costs updated to 2025 level. Diagnostic accuracy data were derived from recent multicenter trials. Costs and QALYs were calculated using a 3% discount rate. Sensitivity analyses tested uncertainties. A practical interactive online-tool is provided for clinical decision-making and research purposes, which can incorporate various input data (https://macrophage-mri.app). Both imaging options were dominant over ePLND (€37,855; 18.11 QALYs). PSMA-PET/CT was €7,869 cheaper and gained 0.800 QALYs; m-MRI was €9,985 cheaper and gained 0.990 QALYs. m-MRI was superior, saving €2,116 and gaining 0.19 QALYs over PSMA-PET/CT. The probabilistic analysis showed that m-MRI was optimal over 95% of the time at an €80,000/QALY threshold; the probability of PSMA-PET/CT being optimal was less than 5%. An imaging-first approach outperforms routine ePLND, with m-MRI as a cost-effective option. PSMA-PET/CT's low sensitivity limits its usefulness, though it is still cheaper than ePLND. These results support including m-MRI in guidelines for initial staging.