Piflufolastat F 18 是一种新型前列腺特异性膜抗原 (PSMA) 靶向正电子发射断层扫描 (PET) 放射性示踪剂，在前列腺癌的初始分期和生化复发检测方面优于护理标准 (SOC) 成像。由于 piflufolastat F 18 已在美国 (US) 批准用于该适应症，因此本模型研究评估了 piflufolastat F 18 与氟西洛素 F-18、镓 68-PSMA-11 (PSMA 11) 和 SOC 成像（a从美国医疗保健系统的角度来看，骨扫描、计算机断层扫描和磁共振成像的结合用于前列腺癌的诊断和分期。使用了美国第三方付款人的观点，对于这一人群来说，这反映了商业和医疗保险的结合，仅考虑直接医疗保健成本。本研究利用了三级医疗保健环境。决策树用于绘制诊断/治疗路径，包括患有局部疾病、区域疾病、远处疾病或无疾病的患者比例；前列腺特异性抗原 (PSA) ≤ 1.0 或 > 1.0；和成像方式的准确性。马尔可夫模型根据治疗决策预测疾病进展的长期结果。该模型的输入来自 OSPREY 和 CONDOR 临床试验的数据、公共数据和文献。治疗组合包括主动监测、放射治疗、前列腺切除术、雄激素剥夺疗法 (ADT) 和放射治疗 ADT，并听取专家意见。结果包括生命年（LY）、质量调整生命年（QALY）和增量成本效益比（ICER）。所有成本均采用美国劳工统计局消费者价格指数，以 2021 年美元为单位报告。 150,000 美元的支付意愿 (WTP) 门槛被认为具有成本效益，与临床和经济评论研究所用作价格基准标准的上限一致。通过确定性和概率敏感性分析评估基本案例结果的稳健性。在整个生命周期中，piflufolastat F 18 在 LY (6.80) 和 QALY (5.33) 方面具有最大有效性；对于比较器，LY 范围为 6.58 (SOC) 至 6.76 (PSMA 11)，QALY 范围为 5.12 (SOC) 至 5.30 (PSMA 11)。与氟西洛素 F 18、PSMA 11 和 SOC 相比，Piflufolastat F 18 更具成本效益，每 QALY 获得的 ICER 分别为 21,122 美元、55,836 美元和 124,330 美元。与 WTP 阈值 150,000 美元的其他选项相比，Piflufolastat F 18 具有最大的净货币收益（627,918 美元）。确定性和概率敏感性分析的结果支持了基本情况结果的稳健性。这项研究表明，piflufolastat F 18 对于美国男性前列腺癌患者来说是一种经济高效的诊断选择，具有较高的相关 LY、QALY 和比氟西洛素 F 18、PSMA 11 和 SOC 成像具有更大的净货币效益。© 2023。作者。

Piflufolastat F 18 is a novel prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) radiotracer that is superior to standard of care (SOC) imaging for the initial staging of prostate cancer and the detection of biochemical recurrence. As piflufolastat F 18 has been approved in the United States (US) for this indication, this modeling study assessed the cost effectiveness of piflufolastat F 18 versus fluciclovine F-18, gallium68-PSMA-11 (PSMA 11), and SOC imaging (a mix of bone scans, computed tomography, and magnetic resonance imaging) for the diagnosis and staging of prostate cancer from a US healthcare system perspective.A US third-party payer perspective was used, which for this population reflects a mix of commercial and Medicare, considering only direct healthcare costs.This study utilized a tertiary healthcare setting.A decision tree was used to map the diagnostic/treatment pathway, consisting of the proportion of patients with local, regional, distant, or no disease; prostate-specific antigen (PSA) ≤ 1.0 or > 1.0; and accuracy of imaging modalities. A Markov model predicted the long-term outcomes of disease progression according to treatment decisions. Inputs to the model were informed by data from the OSPREY and CONDOR clinical trials, public data, and the literature. Treatment mix included active surveillance, radiation therapy, prostatectomy, androgen deprivation therapy (ADT), and radiation therapy + ADT, informed by expert opinion. Outcomes included life-years (LY), quality-adjusted life-years (QALY), and the incremental cost-effectiveness ratio (ICER). All costs were reported in 2021 US dollars, using the US Bureau of Labor Statistics Consumer Price Index. A willingness-to-pay (WTP) threshold of $150,000 was considered cost effective, consistent with the upper range used as the standard for price benchmarks by the Institute for Clinical and Economic Review. The robustness of the base-case results was assessed in deterministic and probabilistic sensitivity analyses.Over a lifetime horizon, piflufolastat F 18 had the greatest effectiveness in terms of LYs (6.80) and QALYs (5.33); for the comparators, LYs ranged from 6.58 (SOC) to 6.76 (PSMA 11) and QALYs ranged from 5.12 (SOC) and 5.30 (PSMA 11). Piflufolastat F 18 was more cost effective compared with fluciclovine F 18, PSMA 11, and SOC, with ICERs of $21,122, $55,836, and $124,330 per QALY gained, respectively. Piflufolastat F 18 was associated with the greatest net monetary benefit ($627,918) compared with the other options at a WTP threshold of $150,000. The results of the deterministic and probabilistic sensitivity analyses supported the robustness of the base-case results.This study suggests that piflufolastat F 18 is a cost-effective diagnostic option for men with prostate cancer in the US, with higher associated LY, QALY, and greater net monetary benefit than fluciclovine F 18, PSMA 11, and SOC imaging.© 2023. The Author(s).