前立腺がん再発検出における[¹⁸F]-DCFPyLの評価：スペインにおける代替PET放射性トレーサーとの費用対効果比較

Introduction: [¹⁸F]-DCFPyL (Piflufolastat [¹⁸F]) is a prostate-specific membrane antigen (PSMA)-targeted position emission tomography (PET) radiotracer for detecting the biochemical recurrence (BCR) of prostate cancer (PCa). This study evaluates its economic impact compared with [⁶⁸Ga]-PSMA-11, [¹⁸F]-FCH, and [¹⁸F]-PSMA-1007 from the Spanish National Healthcare System's perspective. Methods: A cost-consequence model, over a 5-year time horizon, simulated the diagnostic and treatment pathway based on radiotracer-specific accuracy and disease localization. Treatment options included a radical prostatectomy, radiation therapy, androgen deprivation therapy (ADT), and radiation therapy + ADT. Costs were calculated for true/false positives and negatives. Due to limited data availability, key inputs were informed by expert opinions, supported by published meta-analyses, public sources, and literature. Officially published Spanish prices were applied: EUR 2000 for [¹⁸F]-DCFPyL, [⁶⁸Ga]-PSMA-11, and [¹⁸F]-PSMA-1007, and EUR 1144 for [¹⁸F]-FCH. Results: The use of [¹⁸F]-DCFPyL led to fewer unnecessary therapies; specifically, it led to 11,229 (74%) fewer than [⁶⁸Ga]-PSMA-11, and 5180 (56%) and 7771 (66%) fewer than [¹⁸F]-FCH and [¹⁸F]-PSMA-1007, respectively. It achieved significant cost savings for repeated testing: EUR 15M (43%) versus [⁶⁸Ga]-PSMA-11, EUR 37M (65%) versus [¹⁸F]-FCH, and EUR 27M (58%) versus [¹⁸F]-PSMA-1007. Cost savings for false positives were EUR 15M (50%) against [⁶⁸Ga]-PSMA-11, EUR 22M (60%) versus [¹⁸F]-FCH, and EUR 29M (66%) compared with [¹⁸F]-PSMA-1007. The cost per correct diagnosis was reduced by EUR 198 (8%) compared with [⁶⁸Ga]-PSMA-11 and EUR 377 (15%) relative to [¹⁸F]-PSMA-1007, while showing a EUR 635 (40%) increase compared with [¹⁸F]-FCH. Conclusions: [¹⁸F]-DCFPyL offers a cost-saving option for BCR detection within the Spanish National Healthcare System by reducing the number of unnecessary therapies, the cost of false positives, and repeat testing compared with alternative radiotracers. These improvements support the potential for better diagnostic outcomes and more informed downstream clinical decision-making.