How Do We Measure Quality in the Age of Precision Medicine? Stakeholder Perspectives

Meg Barbor, MPH

May 2016, Vol 7, No 4 - Personalized Medicine


Assessing quality care in the age of precision medicine can be challenging. In a special session at the 2016 Quality Care Symposium, various stakeholders presented their perspectives on the challenges and opportunities related to quality care in this rapidly changing landscape.

The Clinician Perspective

“We have a tremendous amount of information that is 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 W. Gray, MD, Dana-Farber Cancer Institute, Boston. “But for patients and providers, this is like drinking out of a fire hose.” Dr Gray discussed the relationship between precision medicine and care quality based on 6 domains of quality outlined by the Institute of Medicine. “What this means is 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.” Care should also be patient-centered, delivered in a timely fashion, and efficient, creating little waste in the system, Dr Gray said. “In the era of precision medicine, there is great promise that we can really improve the quality of care,” Dr Gray said. Effective care can be facilitated by identifying subpopulations that are most likely to respond to a given therapy. There are also significant threats to quality care from the introduction of precision medicine. “The first is insufficient evidence,” she said. “We are often practicing in a gray zone, where there is preliminary or potential evidence suggesting that things may be helpful, but we do not have clear evidence of clinical utility.” From a provider perspective, mistakes with human data processing can jeopardize the safety and effectiveness of care, and from a patient perspective, these flaws can lead to care that is not patient-centered. Access to care is another concern: with increasing specialization of care, genetic and genomic care, and immunotherapy, care is sometimes more fragmented. Physicians now face the challenge of understanding genomic information. Studies are showing that up to 25% of providers are unsure about their ability to explain genomic concepts to patients, and their ability to make treatment decisions based on genomic information. “Interventions targeting physician education are desperately needed,” Dr Gray said.

The Payer Perspective

Lee N. Newcomer, MD, MHA, Senior Vice President, Oncology, Genetics and Women’s Health, UnitedHealthcare, presented concerns for payers. “The first problem that we have tried to solve is, what are we paying for?” Dr Newcomer 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 do not have good national standards yet to talk about what is adequate testing when we do sequencing,” he said. “There is huge variation out there, and if you took the same samples to 5 labs, you are very likely to get 4 different sets of results,” Dr Newcomer added. “We need standardization quickly.” The second issue for payers, he said, is clinical variation and variation in outcomes. The third question involves clinical utility testing, and what exactly a gene means in different cancers. “Here is where, as oncologists, we have a huge obligation to collect those data and use them as quickly as possible,” Dr Newcomer 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 does not 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

“Certainly precision medicine is moving to the center of global healthcare challenges and solutions,” said Steven Shak, MD, Chief Scientific Officer and Co-Founder of Genomic Health. “Clearly we have needs if we are going to deliver precision medicine,” Dr Shak said. “We have a need for the tools to accompany precision medicine, and a need for diagnostics, not just drugs.” The good news is, he said, the expanding range of approaches arising from trials and observational studies can be used by clinicians to generate evidence. “Certainly, from an industry perspective, we know that we need to innovate and enhance transparency,” he said. To bring precision medicine into quality clinical practice, industry and all stakeholders need to collaborate from a patient-centered perspective, to “know what works” and to more consistently “do what works,” Dr Shak said.