Cost-effectiveness of serum, urine, and tissue-based prostate cancer biomarkers

Prostate cancer remains a leading malignancy among men in the United States. While prostate-specific antigen (PSA) screening improves early detection, it also leads to over-diagnosis and over-treatment. Biomarkers offer a promising solution for risk stratification and guiding treatment decisions. This review examines the cost-effectiveness of serum, urine, and tissue-based biomarkers to assess their impact on healthcare expenditures and clinical decision-making.

Serum-based biomarkers like 4Kscore and PHI reduce unnecessary biopsies and healthcare costs. Urine-based biomarkers, including SelectMDx and ExoDx Prostate IntelliScore (EPI), have shown potential to optimize prostate cancer detection while being more cost-effective than some serum-based alternatives. Tissue-based biomarkers, such as OncotypeDx and Decipher, help in treatment selection, though their economic impact varies. Economic analyses suggest that biomarkers can enhance clinical decision-making while reducing healthcare expenditures, but real-world validation remains limited.

Prostate cancer biomarkers improve risk stratification and may lower healthcare costs. However, variations in cost-effectiveness, reimbursement policies, and guideline recommendations limit widespread adoption. Prospective studies are needed to validate real-world cost savings and refine biomarker integration into clinical practice. Addressing financial and policy challenges is essential to ensure equitable access and maximize their impact on prostate cancer management.