April 2016, Vol. 5, No. 3
How Do We Measure Quality in the Age of Precision Medicine?
Assessing quality in the age of precision medicine can be challenging for stakeholders. In a session at the 2016 ASCO Quality Care Symposium, experts from an array of fields presented their perspectives on the unique opportunities and hurdles faced by different parties and their advice for assessing quality in this rapidly changing landscape.
The Clinician Perspective
“We have a tremendous amount of information that’s coming at us very quickly and changing rapidly, and we need to think about how to be able to incorporate these data in a way that allows for the highest quality of care,” said Stacy Gray, MD, Thoracic Cancer Physician at Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School. “But for patients and providers, this is like drinking out of a fire hose.”
Gray framed the relationship between precision medicine and care quality according to the 6 domains of healthcare quality outlined by the Institute of Medicine, starting with effective care. “What this means is that it needs to be evidence based, and we need to know that the care we provide improves health outcomes,” she said. “We also need to provide safe and equitable care, meaning that all patients should have access to high-quality care.”
According to these domains, care should also be patient-centered, delivered in a timely fashion, and efficient, creating little waste in the system.
“I think in the era of precision medicine, there is great promise that we can really improve the quality of care,” she said. Effectiveness of care could be facilitated through the identification of subpopulations most likely to respond to a given therapy.
Gray also warned of significant threats to care quality that come with the introduction of precision medicine.
“The first is insufficient evidence,” she said. “We’re often practicing in a gray zone where there’s preliminary or potential evidence suggesting that things might be helpful, but we don’t have clear evidence of clinical utility.”
Flaws in human data processing are another threat to care quality. From a provider perspective, mistakes with human data processing can jeopardize both the effectiveness and the safety of care, and from a patient perspective, these flaws can lead to care that is not patient-centered.
Access to care is also an issue, and with the increasing specialization of care, genetic and genomic care, and immunotherapy, care is sometimes more fragmented.
Finally, physicians now face the challenge of understanding genomic information. Studies are showing that up to 25% of providers are not confident in their knowledge about genomics, their ability to explain genomic concepts to patients, and their ability to make treatment recommendations based on genomic information. “Interventions targeting physician education are desperately needed,” Gray said.
The Payer Perspective
Lee Newcomer, MD, MHA, Senior Vice President at UnitedHealthcare with strategic responsibility for oncology, genetics, and women’s health, presented some questions for payers to consider when assessing quality.
“The first problem that we’ve tried to solve is, what are we paying for?” he asked the audience. “Also, does this test really have any analytic validity? Is it really measuring what we think it measures? These are important considerations in gene sequencing, because we don’t have good national standards yet to talk about what’s adequate testing when we do sequencing.”
“There’s huge variation out there, and if you took the same samples to 5 labs, you’re very likely to get 4 different sets of results,” he added. “We need standardization quickly.”
According to Newcomer, the second issue for payers is that of clinical validity, and determining whether a variance is really associated with a disease or risk. “Again, there’s a lot of variation there, but I actually think the industry is doing a pretty good job with addressing this question,” he stated.
The third question involves clinical utility testing, and the question of what, exactly, a gene means in a different cancer. “Here’s where, as oncologists, we have a huge obligation to collect and use those data as quickly as possible,” he said. “Personalized medicine centers are going up everywhere, but the question is, how many of them are systematically reporting what happens and evolving that information so that we can learn about what works and what doesn’t work?”
“So the big question is, are we ready to call personalized medicine a strategy, or is it a series of anecdotes?” he asked.
The Industry Perspective
“In terms of moving forward, certainly precision medicine is moving to the center of global healthcare challenges and solutions,” said Steven Shak, MD, Chief Scientific Officer and Cofounder of Genomic Health.
“Clearly, we have needs if we’re going to deliver precision medicine,” he said. “We have a need for the tools to accompany precision medicine, and a need for diagnostics, not just drugs.”
According to Shak, the good news is that there is now an expanding range of methods and approaches arising from trials and observational studies that can be used by clinicians to generate evidence.
“Certainly, from an industry perspective, we know that we need to innovate and enhance transparency using clinical science, as well as this new field of implementation science,” he said.
Finally, as stated by Shak, in order to bring precision medicine into quality practice, industry and all stakeholders need to collaborate from a patient-centered perspective to not only “know what works,” but also to more consistently “do what works.”
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