Leading diagnostics developers and lab services companies announced the mid-November launch of the Access to Comprehensive Genomic Profiling Coalition (ACGP), whose mission is to advocate for the effectiveness of comprehensive genomic profiling (CGP) in advanced cancer care. Specifically, ACGP aims to advocate for broader coverage of these tests with both public and private payers.
“The idea is that patients will get better if they have better access to these tests,” Jim Almas, M.D., chair of ACGP, and vice president and national medical director of clinical effectiveness at LabCorp tells Clinical OMICs. “It is also critical they have access to these tests for better opportunities to enroll in clinical trials.”
Founding members of ACGP announced at the Association for Molecular Pathology virtual conference are Exact Sciences, Foundation Medicine, Illumina, LabCorp, QIAGEN, Roche Diagnostics, and Thermo Fisher Scientific. Since it’s announcement, the coalition has embraced the participation of additional companies, notably pharmaceutical companies that market targeted cancer therapies as well as diagnostic labs such as NeoGenomics.
Making the case for CGP
CGP tests assess the genomic alterations within a patient’s cancer. Current CGP tests analyze more than 300 specific genetic markers that can help treating physicians take a more precise approach to treating an individual patient’s specific cancer type. Sequencing a tissue biopsy or a blood sample, a CGP detects the four main classes of alterations known to drive cancer growth: base substitutions, insertions and deletions, copy number alterations (CNAs), and rearrangements or fusions.
These tests can reveal clinically relevant alterations and biomarkers in the tumor’s DNA and RNA to identify patients who may respond to specific targeted therapies and immunotherapy that can be more effective and may have fewer side effects. Healthcare professionals can use CGP to help predict patient benefit across multiple targeted therapies and cancer indications, with benefits in progression-free survival for patients with non-small cell lung cancer (NSCLC), as one example.
CGP testing performed soon after a diagnosis of advanced cancer better informs medical management, including treatment decisions and patient care, which can improve clinical outcomes.
“We have now an incredible number of very powerful molecular based therapies for oncology patients and there is a lot of hope patients in the years to come to have more and more options that will translate to better clinical outcomes,” says Luca Quagliata, vice president, global head of medical affairs at Thermo Fisher Scientific. “But there is one barrier in between having these treatments and getting to these treatments and that is testing. No testing, no treatment. It is pretty straightforward.”
According to ACGP members, while there is an understanding among the testing community, labs, and pharmaceutical companies that CGP is a valuable tool in helping to set treatment plans for patients with late-stage cancer, there is a broad lack of awareness of their availability, the information they provide to treating physicians, and the health economics value they provide in the broader landscape of cancer care.
“If we can’t move the concept that this information is fundamental for the original assessment of a patient with newly diagnosed late-stage cancer; if we can’t establish that understanding between physicians, payers, and patients, we are not going to realize the kind of rapid progress that this technology can bring us,” adds Julia Elvin, senior vice president, pathology and diagnostic medicine with Foundation Medicine.
According to Elvin, patients and their physicians can easily get confused based on some of the early molecular tests that have been touted for the diagnosis of cancer. Elvin says she sees this even among savvy physicians and others in healthcare during what she describes as “curbside consults” with people who know her background. Common among these conversations are those who mention a friend or relative having a genetic test for their cancer, and after further discussion it is revealed the test only looked for one particular biomarker.
“They tested for only one thing versus 25 things that would be very relevant in lung cancer and the one thing they tested for is negative,” she notes. “But that test is a placeholder for having done testing and not having found anything.”
A cornerstone of ACGP will be education of a range of stakeholders including both physicians and patients, so they understand what testing options are available to them to help direct the treatment plans for individual patients, while also better understanding that single-marker tests, as in Elvin’s example, don’t provide the “C” in the coalition’s name—comprehensive.
Quagliata thinks it is also a matter of getting care givers to feel comfortable ordering these types of tests for their patients. Citing research Thermo Fisher has conducted, he notes that about half of all doctors the company surveyed simply don’t feel comfortable ordering a CGP for their patients.
Getting buy-in from payers
While education of physicians and patients on the treatment side is important, so too is educating health payers to ensure that as many people as possible can have access to these tests. A successful model for such a coalition that brings together multiple stakeholders for this purpose already exists. According to Almas, the idea of bringing together leading diagnostics companies took shape last January based on conversations he had with representatives from some of the founding member companies and modeled on the success of the Coalition for Access to Prenatal Screening (CAPS).
“Nearly all of us are involved in the Friends of Cancer Research TMB Harmonization Project, which is a great program with a lot of solid people behind it,” Almas explains. “So, let’s give some thought to having the leading diagnostic companies and manufacturers sitting down at a table to say these tests are of value to patients with advanced cancer and advocating for them.”
A driving reason for the formation of ACGP is the lack of payer coverage for these tests. Almas says that in a previous job with the Centers for Medicare & Medicaid Services (CMS), he was involved for a time in the parallel review project for the Foundation Medicine comprehensive genomic profiling test that eventually won both FDA approval and a CMS coverage decision in 2018.
“I think there was thought at that point that broad comprehensive genomic profiling, covered by Medicare, would also be picked up by commercial carriers, managed care, and Medicaid,” he notes. “It didn’t happen.”
Some of the reason for this may be that such tests are relatively new and the data needs to catch up with their utility.
“Over the last couple of years, the economic data, I would say is mixed,” notes Robert Dumanois, director of reimbursement with Thermo Fisher. Some of the studies that may have given pause to payers were based on data that was two to five years old, collected at a time when comprehensive testing was in its very infancy. Further, these highlighted both the reluctance of doctors to use molecular testing, as well as the lack of penetration of these methods beyond academic medical centers and cancer centers.
“What we saw were community practices that were almost never ordering this for first-line patients, and in many instances I think only about two-thirds of them were taking the actual evidence or the findings on the reports and putting that advice into their practice,” Dumanois notes.
Paving the way to broader physician adoption is getting payers on board. Medicare through its Molecular Diagnostic Services (MolDX) Program, has led the way. But because not all states are part of MolDX, the coverage for seniors is spotty. As for commercial payers, Dumanois says “the landscape is tremendously varied. There is almost zero continuity between what Aetna, CIGNA, Humana, or Anthem are doing in these categories.”
ACGP intends to help close the gaps in coverage collectively. “Each of the partners recognized that we need to do a better job getting to payers with one voice as opposed to a cacophony of seven or eight different voices saying things with our own flavor,” Dumanois adds.
Another element of getting payers on the same page is to make sure their reimbursement policies synch with published NCCN clinical guidelines. Many payers say they follow the guidelines, but in some cases they are following guidelines from two and three years ago, a lifetime in terms of advances in molecular testing for cancer.
While achieving this goal will undoubtedly be a years-long effort for ACGP, the partners ultimately hope that via its educational efforts it can make CGP more broadly employed in the community setting where the bulk of cancer patients get their care. This, and more comprehensive coverage of the tests by payers, promises also to reduce disparities in care.
Finally, the coalition hopes that increasing the number of advanced cancer patients receiving CGP will provide more opportunities for them to participate in clinical trials, to improve on the 2% to 8% rate of current cancer patients enrolled in these trials.
“We know there are obstacles to these tests, and you have disparities in care for the same reason,” Almas notes. “We believe some clinicians are not aware of the advantages of a comprehensive testing approach and the benefits of one CGP test to provide genomic profiling, detect microsatellite instability and tumor mutational burden, and help physicians identify clinical trials for which patients may be candidates.”
To learn more about ACGP, go to www.accesstoCGP.com