Evolving Tools for Clinical Decision-Making

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Do we achieve better value for cancer patients by standardizing their care or personalizing their care?

Alan Balch, PhD

Value in cancer care—and how to define it—is a hot topic. There is general agreement that it is some measure of benefit vs cost, but “should the focus be on providing value to patients at a population level or at an individual level?” asked Alan Balch, PhD, CEO of the Patient Advocate Foundation, speaking at the National Comprehensive Cancer Network® (NCCN®) Patient Advocacy Summit: Value in Cancer Care—Patient Perspectives, held in Washington, DC. “Do we achieve better value for cancer patients by standardizing their care or personalizing their care?”

The panel discussion on defining value that followed Dr. Balch’s presentation focused on personalized care, particularly as embodied in several novel clinical decision-making tools that emerged in 2015. They include NCCN Evidence Blocks™, which were initially published late in 2015, and ASCO’s Value Framework, now in development. Both are designed to help weigh the benefits, risks, and costs of various treatment options in terms of value important to individual patients.

Terry Langbaum, MAS

Terry Langbaum, MAS

In the clinic, these tools provide a framework for decision-making, allowing physicians and patients to “have an intelligent conversation about options,” panel member Terry Langbaum, MAS, Chief Administrative Officer of Johns Hopkins Kimmel Cancer Center in Baltimore, put it.

They also, say experts, reflect broad societal shifts over the past 2 decades in which patients’ voices have grown stronger and in which standardized care, while remaining fundamental to treating cancer, has expanded to include the concepts of value and patient-centered care.

Dana Wollins, MGC

Dana Wollins, MGC

These tools need to be tested, validated, and improved over time. The more comfortable clinicians become in having these discussions with patients, and the better we get at harnessing data to personalize them for the individual, the more effective these tools will be.

“Standardization, does not mean lack of personalization,” panel member Dana Wollins, MGC, Senior Director of Health Policy at ASCO, said in an e-mail interview with The ASCO Post. “To effectively employ standardization to improve care quality and value, it must be done with individual patient differences in mind.”

Decision-Making Tools

ASCO’s Value Framework compares the clinical benefits, side effects, and costs of treatment regimens that have been tested head-to-head in clinical trials. It lists the benefits and risks of each regimen and calculates a numerical “net health benefit” based on survival and toxicity data. For patients with advanced cancer, a higher net health benefit is awarded for regimens that also offer relief from cancer-related symptoms or allow a treatment-free period. The net health benefit is presented alongside the patient’s expected out-of-pocket costs for each regimen, as well as overall drug acquisition costs.

The Value Framework concept was published for public comment in June 2015 in the Journal of Clinical Oncology, and ASCO is now incorporating the more than 400 comments that were received, said Ms. Wollins. The next step is to refine the tool and work toward developing it for the clinic, she added.

The NCCN Evidence Blocks™, which will be incorporated into the library of NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), are designed to help physicians and patients discuss treatment options in terms of the patient’s values. The blocks are used visually to rate five components of value: efficacy, safety, the quality and quantity of evidence in support of the regimen, the consistency of the evidence, and affordability. The shading of only one block in a column indicates “least favorable,” whereas five shaded blocks indicate “most favorable.”

Robert Carlson, MD

Robert Carlson, MD

As of January 2016, NCCN Guidelines® with NCCN Evidence Blocks™ for multiple myeloma, chronic myelogenous leukemia, and kidney cancer are available online. NCCN Evidence Blocks™ for all systemic therapies in the NCCN Guidelines are expected to be completed sometime in 2017, NCCN CEO Robert Carlson, MD, a panel member, said in an interview. Future plans include expanding the tool to include surgery and radiation treatments as well as systemic ­therapies.

A third tool, from the Institute for Clinical and Economic Review, is targeted for use by patients, clinicians, payers, manufacturers, and policymakers. The Institute for Clinical and Economic Review will produce public reports on new drugs approved by the U.S. Food and Drug Administration, providing for each one a “care value” and a “health-system value,” said Dan Ollendorf, PhD, Chief Scientific Officer of the Institute for Clinical and Economic Review (ICER), who also served on the NCCN panel.

Dan Ollendorf, PhD

Dan Ollendorf, PhD

The care value reflects considerations of clinical benefit, potential harm, cost-effectiveness, and any additional benefits such as a novel method of action or more convenient dosing and is intended to inform physician-patient conversations, he said. The health-system value shows the drug’s impact on the health-system budget, taking into account not only the costs of the drug but also any cost savings, due to lower hospitalization rates, perhaps, or less time away from work.

ICER will also calculate for each new drug a value-based price “anchored to the real benefits the drug brings to patients,” according to its statement in June 2015, when the program was launched.

Other Value-Oriented Tools

ASCO, NCCN, and ICER are not the only groups producing value-oriented tools. ESMO, the European Society for Medical Oncology, has created the ESMO Magnitude of Clinical Benefit Scale, intended to assist oncologists in evaluating cancer drugs, according to a statement issued in May 2015. Although this tool is targeted at policy makers, according to ESMO, it can also be used in day-to-day clinical situations.

Also in 2015, Memorial Sloan Kettering Cancer Center in New York created DrugAbacus, another tool targeted primarily at policymakers. The online, interactive tool compares the cost of more than 50 cancer drugs with what the prices would be if they were tied to factors such as the side effects the drugs produce and the amount of extra life they provide patients. In many cases, the website calculates a price that is lower than the drug’s market price, according to a statement from the Memorial Sloan Kettering Cancer Center.

‘Incubators of Change’

All of the tools reflect increasing concern—in some cases outrage—over drug costs. However, they also reflect other trends in cancer care.

At the NCCN meeting, Dr. Balch noted that the personalized approach is consistent with multiple trends in health care, such as precision medicine, cost shifting to the patient, shared decision-making, and patient centricity.

And in the case of tools intended for clinical use with patients, they reflect the evolving relationship between physicians and patients, Dr. Carlson said. NCCN Guidelines, first intended for providers and payers, have evolved along with “the changing contract between the physician and patient,” he added. The Guidelines panels, once made up of only oncologists, now include patient representatives, and NCCN publishes patient versions of the Guidelines. “It’s been not only a shift in Guidelines but also a societal change, said Dr. Carlson.

And continued evolution can be expected as these tools are used and evaluated. Although patient advocates were consulted in the development of these tools, it is still important to “test them with real patients,” emphasized panel member Sherry Fuld Nasso, MPP, CEO of the National Coalition for Cancer Survivorship.

In fact, the tools themselves may be “incubators of change,” noted Ms. Wollins. “This is an emerging area of clinical practice,” she said, “and these tools need to be tested, validated, and improved over time. The more comfortable clinicians become in having these discussions with patients, and the better we get at harnessing data to personalize them for the individual, the more effective these tools will be.” ■

Disclosure: Drs. Balch, Carlson, and Ollendorf as well as Ms. Wollins reported no potential conflicts of interest.




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