A panel discussion during the 2nd PMC/BIO Solutions Summit identified barriers and discussed the path forward to improve clinical integration of precision medicine.
“Comprehensive genomic testing is precision medicine and it is a component of personalized medicine (PM). All patients should have personalized medicine and comprehensive genomic testing.” This was how Bonnie J. Addario, chair and founder of the Bonnie J. Addario Lung Cancer Foundation, opened up the panel on Demonstrating the Value of Personalized Medicine in Clinical Practice at the PMC/BIO Solution Summit held October 14, 2015, in Washington, DC.
As Daryl Pritchard, PhD, vice president of Science Policy of the Personalized Medicine Coalition (PMC) reminded the audience, this was a solutions summit, aimed at initiating dialogue among stakeholders on what the existing barriers are, the means to overcome them, and to improve the reach of PM.
The panel was well balanced with a payer, Michael Kolodziej, MD, national medical director for Oncology Solutions, Aetna; an oncologist, Funda Meric-Bernstam, MD, medical director, MD Anderson Cancer Center; and the head of a diagnostics company, Peter Magg, PhD, president and CEO, CareDx, Inc.
Kolodziej provided his interpretation of PM saying it’s about the best patient experience aided by the best possible evidence-based treatment. “Precision medicine helps achieve the goal of PM. If you look at the progress in lung cancer, we now have the tools to identify the subpopulations of patients to narrow down their treatment options. We have enough tests to help us define treatment,” said Kolodziej, and he credited the progress to data sharing.
“In terms of being solutions-oriented, we should consider OMD or outcome-modified data. We need outcome-oriented clinical trials,” said Maag.
Addario brought in her own perspective to the discussion saying that today there’s hope for lung cancer unlike a decade ago, when she was diagnosed with advanced lung cancer. “The collaborative arena still exists in lung cancer and could be the crux for other diseases,” Addario said.
When prompted by the moderator on validating data, Meric-Bernstam said that some of her breast cancer patients, who have not relapsed for an extended period, want to know if they should opt for genomic testing. She said that while she understands their concern, we need to have some restrictions. “The other issue is off-label use, which worries me. Physicians sometimes order off-label use of drugs despite the presence of clinically-proven agents, based on new molecular evidence based on a test,” added Meric-Bernstam. So both providers and patients need education and patients should also consider second opinions when making care decisions.
Addario pointed out that in the community arena, where 80% of cancer patients are treated, access to clinical trials is very poor. “We have to bring genomics and trials to the patient.”
At the same time, we have to ensure that the tests are being used appropriately and the patients are getting the value out of the test, stressed Kolodziej. He suggested a couple of ways that he believes can aid the “value” process: a decision on which test to cover and developing clinical registries similar to CancerLinQ being developed by the American Society of Clinical Oncology (ASCO).
“We have done that—we have developed a registry for heart transplant patients,” said Maag. But he pointed out that being procedure-based creates barriers.
“Health plans can facilitate, but will not sponsor patient registries. There are innumerable challenges associated with these.” He applauded the efforts of ASCO saying that CancerLinQ and TAPUR registries by ASCO are wonderful endeavors that deserve support.
He pointed out that two-thirds of Aetna’s enrollees are through employer-sponsored plans, adding that a major concern among employers is absenteeism. Should medical data be available to couple with their absenteeism information, Kolodziej said they could develop personalized interventions. “But we don’t have that data. So need to penetrate these silos.”
As the discussion progressed toward data sharing, Addario described a trial coordinated by her foundation for young lung cancer patients. The trial, which had global participants, used the social media platform for recruitment and received an overwhelming response. The sampling kits were shipped to the participants—samples were drawn by their respective physicians and then shipped back. They were then sent to either a diagnostics company or the Broad Institute for analysis/test development, based on the person’s family history and whether they had previously undergone genomic testing. “This is a prime example of data-sharing and innovation to improve outcomes,” said Addario. “It’s doable, we just need the right people together in a room t make this happen,” she stressed.
Maag pointed to a technical limitation that is commonly faced with electronic medical records (EMRs). “The data integration issue across systems is also a key barrier to the process. Also, EMRs with scanned PDFs are hard to read.”
“Personalized medicine is where all the hope is for lung cancer and we need to help these patients and all other cancer patients by opening up these options for them,” said Addario.
Kolodziej agreed saying that PM “will force us to accept a world of collaborations, flexibility, and transparency to ensure the best patient experience.”
“What I need as a practicing oncologist is a clear path forward to be able to translate all this information into clinical practice,” added Meric-Bernstam.