NEW YORK (GenomeWeb) – On Vermillion's third quarter financial call last week, President and CEO Valerie Palmieri noted that while the company has seen sales growth for its OVA1 ovarian cancer test among large OB-GYN groups, "work still needs to be done in the hospital systems and networks."
In part to drive this effort, the company in April entered a collaboration with Kaiser Permanente's Southern California Permanente Medical Group under which it aims to develop better understandings of that organization's current ovarian cancer care pathways and where Vermillion's tests might be able to offer improvements.
The company's approach is a well-considered one, said Devansu Tewari, a gynecologic oncologist within Kaiser Permanente Southern California Orange County who is participating in the collaboration. "I think they are taking the right approach. I think that their investment has the potential to identify an unmet need that could payoff down the line.” Tewari is a member of both the Taskforce on Quality Outcomes for the Society of Gynecologic Oncology (SGO) and the National Cancer Institute’s National Clinical Trials Network, NRG ONCOLOGY.
However, other of his remarks in a recent interview with GenomeWeb highlight the challenges Vermillion faces as it seeks to drive uptake of OVA1 and, in the near future, its second-generation test Overa, within large hospital systems and integrated care networks like Kaiser.
Both tests are intended for triaging patients with ovarian adnexal masses as part of preoperative evaluations to determine the likelihood that a mass is cancerous. The primary rationale underlying the tests is that by helping determine if a mass is likely benign or likely cancerous they can help gynecologists decide whether they can undertake a surgery to remove the mass themselves or if they should refer their patient to a gynecological oncologist.
Tewari, who made clear that he does not speak for the larger Kaiser organization but is, rather, expressing his own personal views, noted that such a test has obvious utility for patients who, for reasons such as geography or insurance coverage, might have difficulty accessing a gynecologic oncologist. But, in the case of an organization like Kaiser, where patients typically have timely access to these specialists, its usefulness is less clear.
OVA 1 is not routinely used within Kaiser because "there has not been a clinical value that we can identify," Tewari said. "I'm not saying we wouldn't use it, but I just don't think we know where we could use it effectively, which is the same issue being faced by [other] biomarker, genomic, and proteomic companies."
"Within our program, access to me or my partners in our specialty is not an issue," he added. "If a patient gets referred to our group with ovarian cancer, our standard is to see them immediately, which is within a week to expedite their care pathway so there is no delay."
Tewari was specifically addressing Kaiser in his comments, but they point towards a possible factor underlying the challenges with driving uptake of OVA1 among large hospital systems and networks that Palmieri mentioned during the Q3 call. In systems where patients can quickly access a gynecological oncologist, the test's value is perhaps less clear cut.
Nonetheless, Vermillion is hoping that through work like its Kaiser collaboration, it will be able to make the case for its tests, said Donald Munroe, the company's chief scientific officer and senior vice president of business development.
"So let's say you had two solutions," he said. "One is to hire 30 more [gynecologic-oncologists] across Southern California to pack the deck. That may not be practical. The second method may be to come up with a care path that utilizes biomarkers as part of a risk assessment where you err on the side of not missing cancer."
Gynecologic oncologists within Kaiser don't look at every patient adnexal mass as a matter of course, Tewari said. However, if there is concern by a doctor regarding a mass, the organization's specialists are able to quickly review, and, if necessary, treat these masses to evaluate the potential for malignancy due to its universal electronic health record system and otherwise integrated system of care, he noted.
To build the case for its tests within the Kaiser system, Vermillion is engaged in a retrospective analysis of the organization's ovarian cancer patients to look for possible gaps in care.
"I believe that when we look at the data and analyze it in our retrospective chart pull we will be able to propose a better solution that utilizes biomarker testing," Munroe said. And, he noted, if the company is able to do that with Kaiser, it could help it penetrate large hospital systems across the country.
"We are fact finding, collecting data, on what goes on in a large system where you can actually see the primary care, the secondary care, the specialist care, the costs, recovery time, and outcomes," Munroe said. "That is the beauty of working with Kaiser. And the data and what we learn are probably going to be relevant to other systems that are either like Kaiser or want to be like Kaiser. We can say, if you are a large hospital or healthcare system that meets the following descriptions, then we may have a solution for you because we have worked it out with Kaiser."
From Kaiser's perspective, the goal has less to do with Vermillion's test specifically than with taking a look at their own pathways of ovarian cancer care to see where they might be improved," Tewari said.
"The partnership with Vermillion is a quality study to look back at all our ovarian cancers and see where disparities may have existed," he said. "All our patients have insurance. All our patients have access to gynecologic oncology care, but there still might be differences in care."
"If you map out an organization's pathways like you can in Kaiser and see where the differences may lie, then you can start to look at, well, where did we have a delay in care? In referrals? Did we have a group of ovarian cancers that fell into the lap of OB-GYNs and not gynecologic oncologists? And then you can start to map things out," he said.
While the rationale for OVA1 in individual OB-GYN practices less connected to gynecological oncologists is perhaps more straightforward than it is for an organization like Kaiser, getting its tests into such organizations remains key to Vermillion's success, Munroe said.
"You can't just work around the fringes," he said. "You need to be in the mainstream. So, the big medical centers matter."
In addition to Kaiser, Vermillion also has an ongoing collaboration with Moffitt Cancer Center looking at models of care in ovarian cancer. By working with multiple organizations, Munroe said, the company hopes to gather more data than these organizations could on their own.
National Comprehensive Cancer Network centers "are great in general at cancer, but a really good one might handle only 30 or 40 cases [of ovarian cancer] a year," he said. "By working across these different networks, we have a reach that may involve 200 or 300 cases a year. And we have data on where they go wrong, what causes quality issues or delays, what can we do to optimize care paths, and so we may have a better pathway than they have figured out themselves."
In addition to investigating where its tests could help in managing referrals of patients with adnexal masses to gynecologic oncologists, Vermillion is also interested in identifying other points in care pathways where the test could improve outcomes or reduce costs.
For instance, Munroe said, even if in an organization like Kaiser Orange County where gynecologic oncologists are easily accessible, being able to predict the likelihood of malignancy could be helpful for purposes like scheduling surgeries.
OVA1, he suggested, could help identify masses "so likely to be benign that you could schedule surgery for an hour or two hours" versus surgery for a malignant mass, which could take on the order of eight hours.
"What are the costs savings if you can know that beforehand?" he asked.
Whether or not the data garnered from the collaboration proves compelling enough for Kaiser to adopt Vermillion's tests remains to be seen. In fact, Tewari said he is not even evaluating whether or not to use the test at this point. "It is not even on our radar right now at all," he said, adding that he is aware that, nationally, other organizations that Vermillion is partnering with will sort out its true value.
But, he said, he believes the approach Vermillion is taking of carefully studying the actual care pathways they hope to place their tests within while partnering with all stakeholders is one that all test developers would do well to follow as the US healthcare system "moves from a one-size fits-all strategy to a value-based patient-centric approach."