By Turna Ray
Amid ongoing discussions with payors and outcomes studies to help secure reimbursement for its predictive non-small cell lung cancer test, VeriStrat, Broomfield, Colo.-based Biodesix has put in place various assistance plans to facilitate access for those who need the test.
VeriStrat, which costs $2,860, operates on a mass spectrometry-based platform and utilizes Biodesix' proprietary algorithms to determine if second-line NSCLC patients are "VeriStrat Good," meaning they will benefit from EGFR-tyrosine kinase inhibitors, or are "VeriStrat Poor," meaning they will not benefit from such treatment.
The company offers to help pay for the cost of the test for patients whose doctors have determined they need it, but who don't have adequate insurance coverage.
"Discussions with payors are just commencing," since the test launched commercially in May as a laboratory-developed test, CEO David Brunel told Pharmacogenomics Reporter earlier this month. "Our financial assistance program is for people who have insurance, but have trouble with the co-pay. You'd need to be making more than $100,000 before you'd have to pay." Under the patient assistance program, those who are uninsured and earning an annual salary under $100,000 may be eligible for Biodesix to pay for the test entirely.
In 2007, researchers from the Vanderbilt-Ingram Cancer Center and others published in the Journal of the National Cancer Institute a study on the predictive ability of an algorithm based on matrix-assisted laser desorption ionization mass spectrometry to stratify patients for NSCLC treatment with an EGFR-TKI, either gefitinib or erlotinib. The 460-patient multi-national clinical study found that patients identified as poor responders had a higher rate of death compared to those who were found to be good responders and thus were treated with EGFR-TKIs.
That study would form the basis of the VeriStrat assay, which Biodesix partnered with Vanderbilt to develop and commercialize. That initial study also showed that the algorithm underlying VeriStrat identifies patients for EGFR-TKIs who may otherwise not have been considered candidates for treatment based on clinical factors alone, such as a history of smoking or tumor tissue histology.
Biodesix is marketing the test to community oncologists as a tool that can be used with clinical factors to guide NSCLC treatment in the second-line setting. The company is marketing the test through its sales force, which it plans to expand in the middle of next year. The company didn't disclose the exact size of its sales team.
Biodesix also didn't release exact sales figures for VeriStrat, but said it has "seen a steady increase in the number of tests performed each month."
"We look at ourselves as complementary to [clinical factors], in terms of giving a full picture of the patients' status and how to use therapy," Brunel said.
"EGFR mutations now indicate use in a first-line setting for Tarceva, for example, or for Iressa. But there are very few mutations in the first-line setting, so a very small number of people [have these mutations]," he added. "Everyone who progresses on chemotherapy in the second line, they are also candidates for one of these EGFR inhibitors, [so] at that point you should use our test to figure out whether you should go on Tarceva or Alimta or another chemo agent available in the second-line setting."
Another advantage of VeriStrat is that it is a serum-based test.
"A lot of these second-line patients don't have readily available tissue," Paul Beresford, Biodesix VP of business development and strategic marketing, told Pharmacogenomics Reporter. "So, the serum test really fits well with community-based oncologists' ability to treat their patients better."
VeriStrat was launched for research use a year ago in Biodesix's CLIA laboratory. Although Brunel suggested that VeriStrat may fall under the US Food and Drug Administration's definition of an in vitro diagnostic multivariate index assay, a subset of laboratory-developed tests the agency has said it intends to regulate, the company will continue to market the test as a homebrew until more definitive regulatory guidance from the FDA.
After issuing two contentious draft guidances on the regulation of IVDMIAs, the FDA has said it is revisiting the issue [see PGx Reporter 08-12-2009].
"Our anticipation is that the FDA will further regulate IVDMIAs," Brunel said. "We're prepared for that. In the meantime … we're happy to offer it in a laboratory-developed test setting."
Payors and Partners
In an effort to capture the clinical outcomes associated with VeriStrat, which would certainly impact the test's reimbursement prospects, Biodesix is conducing observational studies using the assay.
"Our primary focus is on improving clinical outcomes with the same amount of money," Brunel said. "Depending on your definition [of cost-effectiveness], we certainly think we are … maximizing dollars when it comes to TKI therapy."
Brunel acknowledged that sometimes in oncology, a companion test that saves healthcare dollars by avoiding a certain treatment might mean that the alternative is more expensive. "In the end we think we will be cost effective," he said. "That is, we will save the system money because there are strong generic drugs in the third- and fourth-line treatment of lung cancer, and there are a significant number of patients that should never see TKIs."
Biodesix is collaborating with the Hospitale San Raffaele and 14 other Italian institutions to conduct a prospective trial using VeriStrat. The company has research partnerships for VeriStrat with the Southwest Oncology Group and is taking part in the Addario Lung Cancer Medical Institute's observational trial investigating molecular diagnostic testing and banking of advanced-stage lung cancer tissues. New data on the clinical outcomes associated with VeriStrat will be presented at the annual meeting of the Association of Clinical Oncology next June.
The company is also testing VeriStrat's ProTS mass spectrometry-based platform to stratify patient populations for neurodegenerative diseases, inflammation, and other types of cancers. In this regard, the company has inked 52 academic collaborations.
Although Brunel couldn't disclose Biodesix's partnerships with industry, he noted that the company is actively working with commercial firms to further validate its technology platform and develop it into a companion test for various drugs.
"We're working very closely with probably a half-dozen pharmaceutical companies right now to move forward with classifier development, as well as further validation of our VeriStrat test," Beresford said. "The fruits of that labor have yielded three preliminary tests, with one really looking pretty robust."
The most promising of these efforts will move into development in the "next few months," he said.
Improvements to Come
One improvement Biodesix is planning for VeriStrat is to make it more sensitive to capture "super-responders" to EGFR-TKIs.
"The message from our test is that the patients who are 'poor' should not be getting any of these EGFR-inhibiting therapies at all," Brunel said. "We know in the 'good' response patients … you do find 15 percent of patients that do remarkably well. You have people in the US still getting Tarceva or Iressa after five years.
"So an improvement in the test for us would be to identify that part of the population, the super-responders."
Beresford noted that the company is also working to improve the format of the test. "Currently, we rely on a flash frozen dry ice shipment," Beresford said. "Our goal is to convert that into an ice-pack shipment of samples … That's a format change that will help facilitate the adoption in the field and in the doctor's office."