PHILADELPHIA – Accurate diagnosis is a prerequisite for precision medicine. But diagnostics as a whole languishes in the provinces.
At several sessions at the 2018 MedTech conference, though, panelists gave a mix of advice, encouragement and tough love suggestions for how to realize its potential.
At a Monday session on "Companion Diagnostics: Trends and Perspectives," Lena Chaihorsky, vice president of payer strategies at consulting firm Alva10, told the audience that overall, there is an increasing recognition of that potential.
With the approval of Foundation Medicine's genomic profiling test, Companion Dx, and the ongoing development of other more complex tests, "payers are finally starting to see diagnostics through the lens of possibility," she said.
In the here and now, though, the vicious cycle of diagnostics development – poor clinical validation resulting in low value, leading to low reimbursement, meaning there is no investment available to develop higher-value diagnostics – still characterizes an uncomfortably large part of the sector.
At the session, Jeff Allen, president and CEO of Friends of Cancer Research, said there are a number of reasons diagnostics development has lagged behind therapeutics. Oncologists are "often more actively involved in the development of the drugs than the diagnostic, and that places the stress on the therapy a little more up front," he said.
Furthermore, "it's not in the historic purview of the oncologist... to think about the differences between the tests," or about the test at all.
Oncologists have typically diagnosed a patient based on the anatomical location of the tumor.
New technologies enable a much more detailed molecular view of tumors. But that molecular view often remains disconnected from information about how it interacts with anatomy to affect a patient's clinical perspective.
As the science of oncology has evolved to a more mutation-based understanding of cancer classification, "what we've seen over the last several years is that there are challenges to educating the physician to make sure patients are being tested appropriately."
Patients, too, are naturally more interested in the drug they are getting, and what its effects will be, than in the complex decision-making that characterizes precision medicine.
Allen's prescription, though, was tough love. "This whole environment needs to be thought through a little bit instead of just complained about," he told the audience.
He pointed out that diagnostics developers have not been particularly proactive in gathering the sort of evidence that is necessary to convince payers of their value.
"Early on, if you have completed a phase I trial that shows a drug of transformational potential... there needs to be a conscious effort made very early on to do what it takes to take both drug and diagnostic to market."
Part of what that means is standardizing assays and procedures across trial sites. No matter how exciting a biomarker is, relying on local testing means that "you're left with an unaddressed component of the development plan."
That point was echoed by Chaihorsky, who said that "we need to raise the money for robust trials, and we need to sit down and level with payers early on... on the true level of evidence necessary to get a test covered."
In general, Chaihorsky stressed the idea that engaging with payers early and often is a key to getting diagnostics out of the bargain basement.
"For a long time as an industry, the model for diagnostics was very much to partner with pharma," she said. "It's been a real mindshift for us as an industry to say that 'payers are the real customer, and patients are the target'."
The pharma industry's relationship with diagnostics is somewhat ambivalent.
While biomarkers have been instrumental in enabling the development of some targeted therapies for rare mutations, other therapies, despite being molecularly targeted, do not have a companion diagnostic – and so, a larger potential market.
Where diagnostics uncover futility as well as efficacy, the more natural partnership is with payers, who want to know not only that a test can change treatment decisions, but that in doing so, "it will lead to a better outcome, preferably at lower cost," Chaihorsky said. "We have not had that conversation proactively."