Abstract
CareFirst BlueCross BlueShield announced in late summer it will assess Exosome Diagnostics’ ExoDx diagnostic tests in an evidence development collaboration whose value was not disclosed.
The companies said CareFirst will evaluate ExoDx tests through evidence development studies designed to assist the insurer’s members and providers in making more informed diagnostic and treatment decisions. The studies will analyze the tests’ clinical outcomes and costs, with the goal of accelerating health plan coverage for products that show measurable patient care benefits.
ExoDx CEO John Boyce told Clinical OMICs the study will be a clinical utility trial, and health economic assessment, designed to assess how the test impacts the way a doctor treats their patients in the real world. The initial study will assess the ExoDx Prostate IntelliScore (EPI) test, designed to predict that a patient does not have high-grade prostate cancer, and thus could be monitored rather than undergo an initial biopsy.
“Specifically, we are evaluating whether EPI can reduce the amount of unnecessary prostate biopsies on patients. At the same time, we are evaluating economic factors like net savings from avoiding such biopsies,” Boyce said. “Perhaps most importantly, we are following the medical outcomes of the patients that are being assessed with EPI throughout this trial and determining whether or not EPI can improve their quality of care in addition to their outcomes.
“EPI is an ideal test for a collaboration such as this,” Boyce continued. “Not only does it offer a clear clinical benefit for providers and patients by reducing the complications of unnecessary prostate biopsies, but it also offers clear value to CareFirst by reducing the cost that comes from said procedures and complications.”
The EPI test will be provided through selected urology group practices in Maryland, which will collect the pertinent data on how the testing results effect the provision, and value, of care.
As ExoDx’s preferred partner for evidence development studies, CareFirst will collaborate with Exosome Diagnostics to determine which diagnostic tests will be selected for study, the clinical endpoints of those studies, and the extent and qualifications of participating providers.
CareFirst BlueCross BlueShield plans to assess Exosome Diagnostics’ ExoDx Prostate IntelliScore (EPI) test and other ExoDx diagnostic tests through evidence development studies designed to assist the insurer’s members and providers in making more informed diagnostic and treatment decisions.
The collaboration is the first in a series of evidence development agreements to be reached through CareFirst’s new HealthWorx program. HealthWorx is designed to help CareFirst reduce costs and improve health care quality by partnering with early–stage companies to bring new technologies and care advances to the insurer’s members and providers.
“We hope that an innovative trial and partnership such as this has a profound impact on not only CareFirst, but other regional BCBS (BlueCross BlueShield) plans as well,” Boyce said. “It will be the first time that a diagnostics company can show actual, real-world proof to a payer that their test will deliver the promised clinical and economic value. Ultimately, this will lead to member satisfaction, further driving the value of EPI within the BCBS system.”
ExoDx and CareFirst said they expect HealthWorx will reduce the time it takes for the diagnostics developer to gain health insurer coverage for new tests.
“September marks one year since we have launched EPI. The potential to have such an important coverage decision within one year of launch would be a huge driver for EPI’s success. Traditionally, these decisions take 3 to 5 years,” Boyce said.