How to Assess Quality in the Age of Precision Medicine

TON July 2016 Vol 9 No 4 - Conference Correspondent
Meg Barbor, MPH

Phoenix, AZ—Even though many patients have profound responses to targeted therapy, they can often develop resistance, and this can happen quickly. Physicians understanding of what it means to treat these patients must evolve as do their tumors and their biology, according to a presentation at the 2016 American Society of Clinical Oncology (ASCO) Quality Care Symposium.

"Precision cancer medicine offers patients a new range of therapies and unprecedented hope," said Stacy Gray, MD, a thoracic cancer physician at Dana-Farber Cancer Institute and assistant professor of medicine at Harvard Medical School, Boston, MA. "One of the things that's really interesting and exciting about practicing in precision medicine is that we're practicing in a rapidly changing landscape."

Dr Gray elaborated on some of the challenges and opportunities clinicians now face in assessing quality in the age of precision medicine.1

Precision Medicine and Care Quality

A relationship exists between precision medicine and care quality according to the 6 domains of healthcare quality outlined by the Institute of Medicine, starting with effective care.2 According to these domains, care should also be patient centered, delivered in a timely fashion, and efficient, creating little waste in the system.

Effectiveness of care could be facilitated through the identification of subpopulations most likely to respond to a given therapy. "We also know that many of our targeted therapies are significantly less toxic than chemotherapy, thus improving safety," she added. "In addition, as we understand cancer biology better and we understand an individual patient's tumor better, we can give them information that's really tailored to their specific situation."

There are significant threats to care quality that come with the introduction of precision medicine, such as insufficient data and human error, Dr Gray warned. 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.

Finally, tests and therapies are extremely expensive, with many targeted therapies costing tens of thousands of dollars per month. Access to care is also an issue, and with the increasing specialization of care, genetic and genomic information, and immunotherapy, care is sometimes more fragmented. Additionally, dealing with genetic and genomic information can raise concerns about discrimination for providers and patients, potentially threatening equity.

Precision Cancer Care at the Bedside

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," Dr Gray said.

The question about when to adopt new precision medicine technologies is an important one, she stressed. When mature studies confirm preliminary data, then early adopters of tests or treatments have benefited their patients; however, should the data not be confirmed, then their patients may have been harmed.

Patients Are Not Populations

In the practice of precision medicine, patients are divided into groups based on their likelihood of responding to therapies according to biomarkers or genomic information, but biomarkers and genomic tests are not always perfect, she emphasized.

Patients' test results may differ by assay, and there is not a lot of consistency from test to test, according to Dr Gray. Many trials exclude biomarker-negative patients, but in the case of anti–PD-1/PD-L1 therapies, approximately 15% of patients with PD-L1–negative tumors respond to therapy.

The issue of understudied groups is also extremely important in genomic medicine because of the underrepresentation of racial and ethnic minorities and elderly patients in genomic resource reference databases. Providers must also consider the issue of access—how to obtain access for their patients, and what kind of information patients need.

"We don't have the adequate workforce to be able to deliver genomic care, and we know that many patients who may stand to benefit from enrollment in clinical trials of targeted agents may not live anywhere close to where those trials are being conducted," she said. "Access to care is an issue that providers face on a day-to-day basis."

Clinical Trial Enrollment

Lee Newcomer, MD, MHA, a senior vice president at UnitedHealthcare with strategic responsibility for oncology, genetics, and women's health, posed a more aggressive approach toward clinical trial enrollment.

"We have an obligation to be stewards, not only on behalf of our patients, but also on behalf of the entire country and its healthcare system," said Dr Newcomer. "And part of our stewardship is making sure that we put people in clinical trials so we can catch the data very quickly, so that it can fall into the field equally as quickly."

In particular, he encourages patient clinical trial enrollment. For example, enrolling 100,000 patients in phase 2 trials for actionable genes in 3 years would allow greater patient access to clinical trials and create a database of information about targeted agents.

Provider Considerations of the Patient Experience

Many targeted therapies are extra­ordinarily expensive. Approximately 25% of patients spend most or all of their savings during cancer treatment, and 10% have out-of-pocket costs in excess of $18,000 a year.

"I think when providers think about precision medicine, they think about what it means for the patient, and one of the most pressing concerns is financial toxicity," said Dr Gray. "But one of the movements that has been wonderful in oncology is the awareness of this financial toxicity."

According to the literature, approximately 50% of oncologists are now considering total cost when making treatment recommendations, and 84% consider out-of-pocket costs when they talk to their patients about treatment recommendations. "I think it's impor­tant to remember that, given the efficacy of some of these drugs, they're impossible to ration at an individual level," she added. "These are decisions that really can't be made at an individual doctor-patient level, but need to be made at a policy level."

In regard to patients' information needs and preferences, early data suggest that most patients want somatic and germline information. "Oncologists want to honor patients' preferences when returning results, so we need to build systems that allow them to do that in an effective way," she said.

"Although there are some threats to quality as we introduce these kinds of tests and treatments into care, personalized medicine really does promise to improve care quality," said Dr Gray. "I think that in terms of effectiveness, we really need to create a much broader evidence base through more comprehensive research, we need education for patients and providers to address flaws in human data processing, and when we think about cost and access to care, we really need to work in the policy space." 


1. American Society of Clinical Oncology. How do we assess quality in the age of precision medicine? ASCO Quality Care Symposium; February 26-27, 2016; Phoenix, AZ. BySession/9063/5261.
2. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001. Accessed March 31, 2016.

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Last modified: July 27, 2016