Although few would argue there are challenges to equitably implementing precision cancer care, the barriers flagged by a doctor trying to deliver biomarker-informed treatments are quite different from those experienced by a patient trying to access genomic profiling and targeted therapies, and still different from the views of an insurance company executive tasked with appraising the value of the medical interventions.
That was the conclusion of a group of researchers from AstraZeneca, the Personalized Medicine Coalition (PMC), and the consulting firm Health Advances after they surveyed more than 650 medical oncologists, surgeons, lab directors, payors, and patients about hindrances to biomarker testing for personalizing oncology treatment. According to the survey results, which were recently published in the Journal of Precision Medicine, these five groups all felt differently about the biggest challenges facing precision oncology.
This misalignment of views, in and of itself, may hinder implementation of biomarker-directed cancer treatment, said Daryl Pritchard, senior VP of science policy at PMC, a group of industry players, scientists, patients, providers, and payors that advocates for personalized medicine adoption. “If we can use this survey to understand these differing perspectives, then we can work to address them taking the perspectives into account,” Pritchard said.
The original idea to conduct the survey, according to Pritchard, came from Omar Perez, the head of medical diagnostics at AstraZeneca. The drugmaker markets a number of therapies that rely on patients having access to biomarker testing, for example, the EGFR inhibitor Tagrisso (osimertinib), the PARP inhibitor Lynparza (olaparib), and the HER2-targeted antibody-drug conjugate Enhertu (trastuzumab deruxtecan). Accordingly, the drugmaker has an interest in addressing the barriers that stand in the way of patients receiving biomarker testing, which in turn can enable sales of its treatments. Surveys like this one are part of AstraZeneca’s efforts to improve biomarker test adoption under a broader initiative, called “Precision Medicine Ambition.”
The biggest difference in attitudes captured in the survey was between oncologist and payor groups, which is unsurprising given the well-documented reimbursement inconsistencies in precision oncology. While for medical oncologists the lack of payor coverage for comprehensive genomic profiling for early-stage cancer patients presented the biggest barrier to delivering precision medicine, payors cited over-utilization of precision medicine by clinicians as their toughest challenge.
Surgeons agreed with medical oncologists about the difficulties getting reimbursed for early-stage biomarker testing. Lab directors, meanwhile, ranked long turnaround times between specimen collection and reporting test results as the greatest challenge. Ultimately, patients found equally problematic when their doctors told them that the benefits of biomarker testing were less studied in individuals of the same background and when their doctors failed to explain the importance of test results.
If stakeholders like AstraZeneca and others in the healthcare system hope to truly improve precision oncology access, they will have to contend with the needs of these different stakeholder groups that seem to be at loggerheads.
“The community should focus on articulating the value of comprehensive genomic profiling to payors with targeted educational efforts such as they do with healthcare professionals,” they wrote. “Additionally, education of clinicians on the appropriate use cases of comprehensive genomic profiling is critical to the ecosystem of personalized medicine evolving in the near-term.”
Of course, articulating the value of comprehensive genomic profiling to payors — especially private and commercial payors — is easier said than done. It will require evidence.
“We need to establish the value proposition more, and we only can do that by developing more evidence,” said Pritchard, adding that these different stakeholder groups will need that evidence in different forms. Payors, for instance, might be hesitant to accept new types of evidence, like real-world data or trial designs that stray from the gold-standard randomized-controlled trials. To generate the type of evidence that will be meaningful to payors, Pritchard said, the most important thing is to include payors in the conversation.
“It’s the same strategy that the US Food and Drug Administration has when they’re talking about new drug applications. … They say, ‘Talk to us first to make sure it’s done right,'” he said. “We probably need to talk to all of these stakeholders while we’re developing the evidence to make sure it’s being done right.”
Educating oncologists — including those in the community setting, who comprised 16 percent of medical oncologists and one-third of the surgeons surveyed — on the appropriate use of comprehensive genomic profiling is also a heavy lift. In a Precision Oncology News-led survey last year, for instance, oncologists said their ability to keep up with the rapid pace of advancement was a major challenge, which speaks to the difficulty of staying up to date on which biomarker tests are supported by practice guidelines and considered medically necessary by payors.
The survey also revealed differences between how well oncologists think their patients understand precision medicine and patients’ own perceptions about their understanding.
“Basically, doctors don’t think their patients understand personalized medicine all that well, but patients have a lot of confidence that they do understand personalized medicine,” Pritchard said, adding that he thinks this may be reflective of a greater trust issue between providers and patients.
Only 1 percent of oncologists and 2 percent of surgeons said in the survey that they felt “patients have performed significant research and proactively ask about therapies,” whereas 25 percent of patients felt they did such research.
“If doctors are aware that their patients are confident in their knowledge, that may allow for greater communication about personalized medicine … and this could help solve some of these problems in implementation,” Pritchard said.
The authors further suggested that incorporating genetic counseling into multidisciplinary cancer care teams may help improve patients’ understanding of complex topics, such as the role of germline genetic testing in gauging cancer risk and the difference between germline and somatic biomarker testing. Insurers could do more to support such patient education, the authors suggested, since one-third of the payors surveyed did not cover telemedicine-based genetic counseling, which limits access for those who live in remote regions and cannot access in-person counseling, even if covered.
Optimism amid challenges
Despite the significant challenges identified in the survey, most of the groups felt optimistic that precision oncology implementation would continue to improve. In fact, all but one group — the lab directors — felt that barriers would significantly decrease in the next five years.
Lab directors were outliers in their pessimism, which Pritchard chalked up to the fact that the primary concerns of this group were test turnaround time, standardizing biospecimen processing, and other logistical roadblocks.
“These are practical challenges they’ve been dealing with for years in the diagnostics world, even outside of precision medicine,” he said. “Lab directors have a different perspective on how quickly those challenges can be addressed because they’ve been [trying to do so] for a long, long time and don’t see changes as rapidly.”
Patients, oncologists, and payors, meanwhile, may be less focused on those longstanding logistical challenges faced by labs and more likely to look to the progress that has been made in the form of new drugs and tests.
“Because personalized medicine has progressed and advanced so much over the last five years, you can get the feeling that all of these stakeholders think that in another five years we’re going to make more progress still,” Pritchard said, pointing out that an advocacy organization like the PMC is no longer trying to make the case for personalized medicine, as it felt it needed to do for many years, but is now concentrating on how to make commercially available precision drugs and tests more accessible.
Just a decade ago, precision oncology was really just a concept, Pritchard recalled, whereas now it is implementable, and is even the standard of care for certain cancers.