Cost-Effectiveness Modeling of Prostate-Specific Membrane Antigen Positron Emission Tomography with Piflufolastat F 18 for the Initial Diagnosis of Patients with Prostate Cancer in the United States

• Published in: PharmacoEconomics 2024-02, Vol.42 (2), p.231-247
• Main Authors: Yee, Christopher W., Harvey, Michael J., Xin, Yiqiao, Kirson, Noam Y.
• Format: Article
• Language: English
• Subjects: Aged; Androgen Antagonists; Antigens; Benchmarks; Cancer therapies; Carboxylic Acids; Computed tomography; Cost analysis; Cost-Benefit Analysis; Cost-Effectiveness Analysis; Cyclobutanes; Decision trees; Emissions; FDA approval; Gallium Radioisotopes; Health Administration; Health care; Health care expenditures; Health care policy; Health Economics; Humans; Localization; Magnetic resonance imaging; Male; Markov chains; Medical diagnosis; Medical imaging; Medicare; Medicine; Medicine & Public Health; Metastasis; Original Research Article; Patients; Pharmacoeconomics and Health Outcomes; Positron-Emission Tomography; Prostate - pathology; Prostate cancer; Prostatic Neoplasms - diagnostic imaging; Prostatic Neoplasms - pathology; Public Health; Quality of life; Quality of Life Research; Quality-Adjusted Life Years; Radiation therapy; Radioactive tracers; Scintigraphy; Sensitivity analysis; Standard of care; Tomography; United States
• ISSN: 1170-7690; 1179-2027; 1179-2027
• DOI: 10.1007/s40273-023-01322-2

Background and objectives 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. 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. Setting This study utilized a tertiary healthcare setting. Methods 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. Results 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,