CareFirst BlueCross BlueShield (CareFirst), today announced that it has reached a positive coverage decision for the ExoDx® Prostate(IntelliScore) or EPI test – meaning that the test will be covered for CareFirst members beginning in 2018. This coverage decision is based in part on results from an evidence development study conducted as part of a collaboration between CareFirst and Exosome Diagnostics – the developer of the EPI test. The EPI test improves both cost and quality outcomes for patients, helping urologists assess whether an individual presenting for an initial prostate biopsy is at greater risk for high-grade cancer and avoiding the cost and complications associated with unnecessary prostate biopsies as well as overtreatment of low-risk prostate cancer. Thus, it can improve care outcomes for CareFirst members and lower costs at the same time.
The ongoing collaboration between CareFirst and ExoDx is designed to evaluate new products using clinical outcome and cost analyses with the goal of accelerating health plan coverage for products demonstrating measurable benefits for patient care. The effort is part of CareFirst’s Healthworx program, that enables CareFirst to work with innovative companies to make new technologies and care advances available to CareFirst members.
“We are pleased that the first of our Healthworx initiatives has already demonstrated positive results,” said CareFirst President and Chief Executive Officer Chet Burrell. “While we will continue to monitor the members in the study, the positive results coupled with evidence from previous clinical trials led to our decision to cover the EPI test. This is just the type of advance that we are seeking to foster through our Healthworx program.”
The EPI test is a “rule out” test designed to more accurately predict whether a patient presenting for an initial biopsy does not have high-grade prostate cancer and, thus, could potentially avoid the discomfort, complications and cost of an initial biopsy and, instead, continue to be monitored.
“This coverage decision from a major regional health insurer is a significant milestone for any molecular diagnostic company,” stated John Boyce, Chief Executive Officer of Exosome Diagnostics. “We are thrilled to have reached this point in the first year of commercial launch for Exosome and we look forward to sharing the results from our evidence development study with other private and public health insurance payors.”
The EPI test was clinically validated in two large prospective clinical trials to reduce unnecessary initial prostate biopsies in men 50 years of age or older, with a PSA value between 2-10ng/ml (the gray zone). It is estimated that 75% of prostate biopsies in the U.S. each year are unnecessary. The evidence development study is being conducted at 22 Chesapeake Urology Associates centers. Chesapeake is the largest urology practice in Maryland and the Mid-Atlantic region, providing a comprehensive array of urologic services to patients.
“The EPI test is a urine based assay that can be utilized as an adjunct to PSA and assist urologists in deciding who may or may not need a prostate biopsy,” said Ronald Tutrone, MD, Medical Director of Chesapeake Urology Research Associates. “It is a great tool to help avoid unnecessary biopsies in over one-third of patients.”
The design of the evidence development study is novel. One thousand men being scheduled for an initial prostate biopsy are being tested with EPI. The study is blinded and the patients are separated into two groups. Urologists will get an EPI test report for 500 patients and can consider that result with other standard of care factors when making a final decision about biopsy. The other 500 patients are being treated by the same urologists following current standard of care without an EPI test result.
In an analysis of the first 500 patients, the biopsy rate for patients with an EPI report was 30% lower than for patients in the standard of care control group. Analyzing data from both populations showed that EPI avoided 39% of unnecessary biopsies (biopsies that would have resulted in a diagnosis of benign disease or low-grade disease that does not progress). The analysis also demonstrated 83% compliance between the EPI test result and the biopsy decision.
Source – GlobeNewsWire