Cost of Unnecessary Prostate Biopsy Procedures
According to the USPSTF report of 2012, the harms of PSA screening begin with the psychological harm of a false-positive PSA test results. The majority of men with an elevated PSA do not in fact have prostate cancer, but may have other reasons for an elevated PSA such as prostatitis or benign prostatic hyperplasia (BPH). Over a period of 10 years, 10-15% of men who are screened with PSA will present at some point with an elevated PSA and be recommended for an anxiety-provoking prostate biopsy. In 33% of men undergoing prostate biopsy, side effects that men consider a “moderate or major problem” will be experienced, including pain, fever, bleeding, infection, and transient urinary difficulties. A small percent (1%) will require hospitalization.
The prostate biopsy can either find a high-grade cancer, low-grade cancer or not find any cancer. If the biopsy shows high-grade cancer, which occurs about 20% of the time, it is likely that the patient will be treated and their disease-free survival prospects for all but highly advanced diseases are excellent. However, about 60% of men will have a negative biopsy and about 20% of men will be diagnosed with a low-grade (Gleason Score 6) prostate cancer.
Men with an initial finding of no cancer or a negative biopsy will usually be followed with PSA testing and if there is a rise in PSA or other clinical change, a repeat biopsy will be recommended. The problem of over diagnosis becomes particularly critical with finding of low-grade Gleason Score 6 cancer, as it may lead to uncertainty as to what course of action to take. Recent studies have demonstrated no benefit to treating Gleason Score 6 disease versus simple observation.
Therefore, it is important to find tools that help limit prostate biopsy to those patients who are at a high risk of having high-grade prostate cancer. The 4Kscore Test, in targeting high-grade cancer discrimination, can help to reduce the number of negative biopsies and biopsies finding low-grade pathology.
Patient Health and Experience
Like any medical procedure, there are some risks associated with getting a biopsy. Pain, bleeding and the risk of infection (complications) can all occur after a prostate biopsy, which involves making multiple incisions in the prostate. Although most complications are temporary and mild, they all come with economic consequences and occur to the detriment of the patient’s health or comfort. Therefore, it’s ideal to only perform a biopsy when the benefits clearly outweigh the risks.
Often, insurance companies do not provide full reimbursement for the cost of biopsy given rising co-pays and deductibles. Prostate biopsies use resources in the Urologist’s practice and at the pathology lab, resulting in significant costs for patients and payers alike. In addition there could be pre- and post procedure costs not covered by insurance. A recent clinical study suggests that the 4Kscore™ Test could result in annual savings approaching $1 billion in the United States.
Learn how the 4Kscore measures a patient’s risk for aggressive prostate cancer