April 2016, Vol. 5, No. 3
How Do We Measure Quality in the Age of Precision Medicine?
2016 ASCO Quality Care Symposium
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
â€śWe have a tremendous amount of information thatâ€™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,â€ť said Stacy Gray, MD, Thoracic Cancer Physician at Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School. â€śBut for patients and providers, this is like drinking out of a fire hose.â€ť
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. â€śWhat this means is that it needs to be evidence based, and we need to know that the care we provide improves health outcomes,â€ť she said. â€śWe also need to provide safe and equitable care, meaning that all patients should have access to high-quality care.â€ť
According to these domains, care should also be patient-centered, delivered in a timely fashion, and efficient, creating little waste in the system.
â€śI think in the era of precision medicine, there is great promise that we can really improve the quality of care,â€ť 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.
â€śThe first is insufficient evidence,â€ť she said. â€śWeâ€™re often practicing in a gray zone where thereâ€™s preliminary or potential evidence suggesting that things might be helpful, but we donâ€™t have clear evidence of clinical utility.â€ť
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. â€śInterventions targeting physician education are desperately needed,â€ť Gray said.
The Payer Perspective
Lee Newcomer, MD, MHA, Senior Vice President at UnitedHealthcare with strategic responsibility for oncology, genetics, and womenâ€™s health, presented some questions for payers to consider when assessing quality.
â€śThe first problem that weâ€™ve tried to solve is, what are we paying for?â€ť he asked the audience. â€śAlso, 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 donâ€™t have good national standards yet to talk about whatâ€™s adequate testing when we do sequencing.â€ť
â€śThereâ€™s huge variation out there, and if you took the same samples to 5 labs, youâ€™re very likely to get 4 different sets of results,â€ť he added. â€śWe need standardization quickly.â€ť
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. â€śAgain, thereâ€™s a lot of variation there, but I actually think the industry is doing a pretty good job with addressing this question,â€ť he stated.
The third question involves clinical utility testing, and the question of what, exactly, a gene means in a different cancer. â€śHereâ€™s where, as oncologists, we have a huge obligation to collect and use those data as quickly as possible,â€ť he said. â€śPersonalized 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 doesnâ€™t work?â€ť
â€śSo the big question is, are we ready to call personalized medicine a strategy, or is it a series of anecdotes?â€ť he asked.
The Industry Perspective
â€śIn terms of moving forward, certainly precision medicine is moving to the center of global healthcare challenges and solutions,â€ť said Steven Shak, MD, Chief Scientific Officer and Cofounder of Genomic Health.
â€śClearly, we have needs if weâ€™re going to deliver precision medicine,â€ť he said. â€śWe have a need for the tools to accompany precision medicine, and a need for diagnostics, not just drugs.â€ť
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.
â€śCertainly, 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,â€ť 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 â€śknow what works,â€ť but also to more consistently â€śdo what works.â€ť
Secondary Pathology Review Improves Clinical Outcomes
Secondary pathology review can significantly improve clinical outcomes through precise and accurate pathologic diagnoses, according to Lavinia P. Middleton, MD. â€śAccurate pathological diagnoses have become a high priority in cancer diagnosis,â€ť said Middleton, Professor, Department of Pathology at The University of Texas MD Anderson Cancer Center in Houston. Increasing costs [ Read More ]
Stem Cell Inhibitor Active in Pancreatic Cancer, CRC
A first-in-class cancer stem cell inhibitor demonstrated activity in advanced pancreatic cancer and colorectal cancer (CRC), according to 2 small studies reported at the Gastrointestinal Cancers Symposium in San Francisco. About half of 31 patients with heavily pretreated pancreatic cancer achieved disease control when treated with BBI608 plus paclitaxel. All [ Read More ]