NEW YORK (360Dx) – CareFirst BlueCross BlueShield is looking to grow a new program aimed at helping diagnostic companies obtain insurance coverage for new tests.
The program, called HealthWorx, began operation in late August with a partnership with Exosome Diagnostics, a company developing exosome-based biofluid diagnostic tests. That partnership has already resulted in a completed 500-patient evidence development study of ExoDx's prostate cancer diagnostic, the ExoDx Prostate IntelliScore, or EPI Test, according to executives at CareFirst and ExoDx.
"One of the things that's a great challenge to companies that develop these ideas is, how do you get them introduced into a commercial insurance market and get what you develop covered as a benefit? If you can't do that, it's very hard to extend it to the broader population," said Chet Burrell, CEO of CareFirst, in an interview. Burrell aims for the program to have a portfolio of approximately 25 projects in development within two years' time.
Through the HealthWorx program, CareFirst leverages its extensive data on patient health trends to evaluate diagnostics that have the potential to broadly impact its members, according to Burrell.
"We have record of every service to every individual we have ever paid for by any of our providers anywhere, anytime," he said. "So, we have a lot of data on the longitudinal history of disease in the population that we serve."
In the case of ExoDx, early studies suggested its EPI urine test for prostate cancer has a higher sensitivity than the prostate-specific antigen or PSA test that is the current standard, Burrell said. The test, which would be performed after a PSA test to avoid unnecessary biopsies, is quicker and easier to perform than biopsies and has the potential to pose less risk and reduce cost, he said.
"If this were to prove efficacious, it becomes the new standard of care," Burrell said. "That's our mission, to find better, more cost-effective and higher-quality diagnostics," he said.
Because of the high rate of false-positive results from the PSA test, approximately 75 percent of the 1.2 million biopsies performed in the US each year prove to be unnecessary, resulting in 900,000 unnecessary biopsies, according to John Boyce, CEO of ExoDx. The company published results of a study in JAMA Oncology in July 2016 showing that its EPI Test has the potential to reduce that number.
"The team at HealthWorx was very particular. In our minds, what they were looking for was something with a large impact in improving patients' lives, and of course it has to have a lower cost than current methodologies, with a higher degree of certainty that inspires confidence from patients as well as doctors," Boyce said.
To facilitate a smoother path to getting coverage, once a diagnostic is selected for the HealthWorx program, CareFirst leverages its relationships with providers in its network to set up an evidence development study and assists with obtaining consent from its members to participate in the study, Burrell said.
For ExoDx's EPI Test, a trial was set up with Chesapeake Urology, the largest urology practice within the CareFirst network. ExoDx's head of diagnostics Elizabeth Cormier-May worked with Chesapeake Urology to recruit 70 doctors across 23 locations to conduct a 500-patient study in approximately six weeks, Boyce said. While a 500-patient study was the requirement set by HealthWorx, ExoDx is extending the study to include 1,000 patients in total, he said.
Through the evidence development study, CareFirst was looking to see if the EPI Test could obviate 15 percent of unnecessary biopsies. The study met and exceeded that metric, obviating 39 percent of unnecessary biopsies in the course of the study, according to Boyce, who said he expects that number to increase as physicians increase their familiarity with the test.
The challenge, Boyce said, was that through the study CareFirst was not just looking at lab test results, but looking to assess doctor confidence in the test and how useful it would be to doctors in the clinic.
"This was a real-world validation, where you have a defined time period, you are rolling out a test that a lot of these oncologists have never heard of, and you are asking them to obviate a biopsy based on this test," he said.
Through the HealthWorx program, CareFirst helps share in the cost of the study by agreeing to cover the diagnostic on a trial basis.
"A lot of these things in development are considered experimental, so our medical policy, like virtually every other payor's medical policy, says we will not cover either medically unnecessary or medically unproven, or experimental, things," Burrell said. "What we agree to do in a promising case is say, 'OK, we will cover it. We will waive that medical policy for a limited pilot or a limited trial.'"
In the case of ExoDx's EPI test, CareFirst paid list price for the test, which at the time was $595. In November, independent of the HealthWorx trial, ExoDx announced that the US Centers for Medicare and Medicaid Services included the EPI Test in the 2018 Clinical Lab Fee Schedule, with a price set at $760. Since then, the company has raised its list price for the EPI Test to $790.
Through HealthWorx, CareFirst can leverage its payor data to help companies establish prices for their diagnostics, according to Burrell.
"We advise firms on what we think would be the right way of approaching reimbursement, which is essentially to capture the value of what you have developed and then look at whether the reimbursement you seek is in some reasonable way connected to that value," Burrell said. "There is no formula; there is no fixed method. In some respects it's a judgment, but it's very hard to come to that judgment if you don't have the data about what things cost as things currently are, and how this changes the current lay of the land."
ExoDx estimates that based on the results of its study conducted with HealthWorx, if the EPI Test were used by CareFirst last year, it would have avoided biopsies for 1,400 men, ExoDx COO Tom McLain said during a presentation at the Q1 Diagnostic Coverage & Reimbursement Conference in Boston earlier this month. The deferred biopsies could have avoided complications with 1,100 members, including 76 hospitalizations associated with the biopsies, 55 of which were for biopsy-related infections.
In addition, patients with low-grade prostate cancer often push for unnecessary treatment, McClain said. If used by CareFirst last year, the test would have avoided unnecessary treatment in 150 men, he said.
"We have an economic model that we developed with Ernst & Young. Using the data that we have so far from CareFirst, we know that translated into $62 million in savings per year," he said.
To grow its HealthWorx program to be able to accommodate a portfolio of 25 projects in two years' time, the company is building its capacity, Burrell said. HealthWorx has already begun to work with other companies in addition to ExoDx, but has not yet formally announced other partnerships, he said.
"We have, right now, a steady stream of companies coming forward and saying, 'Will you see what we have?'" Burrell said. "We want to get everyone properly evaluated and then make decisions."
The challenge in building the program is in investing in resources to set up studies, including recruiting doctors and members to participate and establishing data criteria. The company enlists external expertise to assist with the evaluation of tests. Once a trial is completed, HealthWorx arranges for the study to be evaluated by an independent review board. If approved, it is referred to a medical review committee to determine if it should become part of the carrier's standard medical policy.
ExoDx has presented the results of the EPI Test study to CareFirst, but insurer has not yet issued its final coverage decision. Boyce expects to hear a decision on coverage soon.
Without the HealthWorx collaboration, Boyce estimates the path to get reimbursement is on average a three- to five-year process, compared to a process with HealthWorx that has so far lasted less than five months. ExoDx built a companion diagnostics arm to enable the company to generate revenue, but Boyce noted that many investors balk at funding a three- to five-year development process that is not guaranteed.
"A lot of these diagnostic companies will run out of funding while they are trying to get reimbursement," he said.
ExoDx plans to leverage the relationship with the HealthWorx program for evidence development on other molecular diagnostic tests. The company's urine test for bladder cancer is one of its next priorities.
If it receives a positive coverage decision from CareFirst, Boyce said, data from the HealthWorx vetting process can be shared across the other Blue Cross Blue Shield insurers in the US.
Burrell also expects data from HealthWorx studies will help other private insurers outside of Blue Cross Blue Shield make coverage decisions as well.
"We are a large Blue plan in a very important part of the country, and we could become a gateway into the carrier market by highlighting what these companies have developed," he said. "Once we've decided to cover something, that greatly enhances chances that other carriers might cover it, and they could look to the studies we did that underpin why we think it's effective."