NEW YORK (GenomeWeb) – With a series of recent payor decisions, Integrated Diagnostics now has more than 200 million covered lives for its Xpresys Lung cancer test.
Indi's success in securing insurers for Xpresys stands out in a proteomics testing space that has often struggled to win both physician adoption and payor coverage and, according to the company, stems both from the test's positioning within the healthcare system and an early focus on demonstrating its value to insurers.
"We went early and often to try to get health plans' attention," Jim Garner, Indi's chief business officer, told ProteoMonitor. This, he added, stands in contrast to approaches taken in the past by other firms, some of which he said had simply submitted claims until insurers reached out for a meeting due to "the costs they were generating."
The company has secured coverage agreements for Xpresys with UnitedHealthcare, MultiPlan, and preferred provider organizations FedMed, Fortified Provider Network, InterWest Health, Stratose, and Three Rivers Provider Network.
It is also finalizing data for a submission to Medicare contractor Palmetto in hopes of securing coverage from that organization.
Indi's work on securing coverage began in 2011, two years before the test launch, Garner said, noting that the company's strategy was to approach large commercial payers and Centers for Medicare & Medicaid Services "as soon as we could get enough meaningful data to share with them."
The company targeted the larger “forward thinking” commercial plans likely to give a novel test like Xpresys a serious look, he said.
Palmetto was – perhaps obviously – an early target because of the importance of securing the Medicare reimbursement, he said. "We wanted to get an audience with Palmetto early so that we could be sure we were designing our clinical trials appropriately, designing our data analytics package appropriately, so that when we were ready to submit to we would be most assured of having a positive decision."
The Xpresys test uses multiple-reaction monitoring mass spec to quantify the levels of 11 proteins in patient blood samples with the aim of identifying whether lung nodules detected via CT scans are likely benign, and it held potential appeal for payors in that it could help reduce overtreatment of benign nodules.
"There are about 3 million patients a year identified [via CT] with a lung nodule," he said. "And we're focused on only those nodules that are between 8 mm and 30 mm in patients over 40 years old, which is, conservatively, 600,000 patients."
Only a fraction – perhaps around 10 percent, Garner said – of these 600,000 patients will turn out to have lung cancer. Nonetheless, many will undergo invasive, and expensive, procedures such as fine needle aspiration and thoracotomies to determine if their nodules are malignant or benign.
Already significant, such overtreatment stands to grow even more significantly as new studies and coverage rules in the Affordable Care Act drive increased use of CT scans for screening patients at high risk of lung cancer, Garner said.
"That's one reason major payors wanted to talk to us as early as they did," he said. "They knew in May of 2012 the Affordable Care Act was going to mandate lung cancer screening be covered starting in 2014."
Indi also began early on to tailor its trial development based on input from the payors it planned to target. "We met with Palmetto in 2011," Garner said. "So we were well informed by both on their expectations and what they wanted. They gave us feedback. We responded."
For instance, he noted that in early conversations with payors, Indi was told that "when you come in with your health economic model, it can't be hypothetical, you have to have actual data on actual patients."
This, Garner said, was a major driver of the company's decision to embark on a 3,000-patient chart review study in which they abstracted medical records to determine how, in reality, lung nodule patients were being treated and how the Xpresys test might cut costs or otherwise add value.
"We saw that in order to be able to come up with a good clinical utility argument as well as a good health economic argument, we had to know how patients were actually being cared for," he said. "And that is the data we used in mid-2013 to show the health economic impact."
With this and other data, Garner noted, Indi was able to secure commitments to cover Xpresys even before its launch and signed contracts for coverage within a year of the test's release in October 2013.
Another key aspect of the test's success to date in luring payors is its large intended patient population, Garner said.
"I think a big problem with products for a lot of companies these days is that tests are for very narrow population segments," he said. "The kind of numbers we are talking about is huge compared to perhaps other technologies. So 600,000 or 800,000 patients annually compared to, say, 50,000 patients annually – there is a big difference in the attention you can get just by the numbers."
Indi is now working to complete a 1,000-plus-patient prospective study in which they have followed patients with nodules to correlate their outcomes with the results from the Xpresys lung test. That study, Garner said, will be included as part of the company's submission to Palmetto.
The company continues to add to that study, as well, and will present this data to United and other insurers, he said. "We are absolutely working on expanding coverage for Xpresys Lung."