Value of Patient-Reported Outcomes in Oncology Care

With the increasing success of oncology regimens in extending overall survival, quality-of-life discussions are making their way into oncology care. Defined as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else,”¹ patient-reported outcomes (PROs) regarding symptoms, quality of life, and functional status are now routinely being measured in clinical trials.² PROs also provide a big boost to the movement toward a patient-centered approach in medicine, and may influence regulatory and reimbursement decisions in oncology.

However, several questions remain and opinions vary on the collection of PRO data. To discuss some of these questions, The American Journal of Managed Care convened a panel of healthcare experts to participate in the Oncology Stakeholders Summit, Spring 2015 Peer Exchange. The moderator of the panel, Bruce Feinberg, MD, vice president and chief medical officer of Cardinal Health Specialty Solutions, was joined by Scott Gottlieb, MD, resident fellow at the American Enterprise Institute; Brian Kiss, MD, vice president of Healthcare Transformation at Blue Cross Blue Shield of Florida; Michael Kolodziej, national medical director for Oncology Strategy at Aetna; and Ted Okon, MBA, executive director of Community Oncology Alliance. Their diverse backgrounds enabled each expert to bring a unique perspective to the table.

Feinberg opened the discussion by asking each panelist to provide his definition of patient-centered medicine, because “There seems to be a lot of miscommunication or a misperception about what patient-centered medicine really means to different stakeholder groups.” According to Kiss, while patient-centered is an overused term, it has revolutionized the American healthcare system by placing the patient front and center. Traditionally, he said, the healthcare system in the United States fragmented, despite being of high quality tried to fit the patient into an existing framework of care. “What the patient-centered concept really does is begin to look at the patient, and then create a system that meets their needs,” he added. Drawing a parallel to personalized medicine, Kiss emphasized the importance of the healthcare system recognizing patient needs and adapting accordingly.

Gottlieb, who has worked at CMS and also with the FDA, said that payment reform would have a tremendous influence on this way of thinking, to the extent that he predicts that reimbursement will be driven by objective measures in the clinic. He pointed out, though, that CMS struggles with identifying measures for outcomes or quality of care delivered, compared with gathering patient data through surveys and patient-reported outcomes. Pay-for-performance, in his view, will be influenced by information on patient experience with the healthcare setting.

And Kolodziej appreciates the change from provider-centric to more patient-centric and welcomes the move to incorporate accountability in the healthcare system with respect to patient experience and outcomes. In his vision, the impact of this changing outlook in the healthcare system will radiate out beyond reimbursement policies and influence both innovation and accountability in healthcare. He pointed out that a substantial evidence base has shown that physician assessment is not a good surrogate for a patient’s actual performance. Although the healthcare system has not yet operationalized the tools for shared decision making, he thinks this will happen soon.

Feinberg argued that the healthcare culture usually disregards what the patient wants, leading Okon to echo Kolodziej’s thoughts on the need for changing the current culture. Pointing out the important role played by the oncology nurse, he suggested that the processes within a practice should converge on the patient, who should be the focus instead of the physician.

In terms of the day-to-day working of a clinic becoming patient-centered, Gottlieb thinks, the current survey tools in the clinic are far from ideal, making the developing of specific tools to capture the patient experience with treatment and treatment outcomes vital. This, he indicated, is a need to which even the FDA is actively paying attention, with the goal of potentially including PROs in drug labels, he said.

How would the patient feedback gathered by these tools influence reimbursement? According to Kiss, PROs are a healthcare quality measure that needs enrichment to be effectively quantified and connected to outcomes in order to assess technical quality, interpersonal quality, and efficiency of care delivery. Okon added that some of these measures are being tested through the patient-centered medical home model. Citing the example of the Come Home project, headed by Barbara McAneny, MD, he explained that the 7 practices participating in the project have adopted several changes, such as building a function for a nurse navigator throughout the practice and incorporating 19 measures of quality and value into the electronic medical record. “So there are a bunch of other things, but what’s really fascinating about this is, a sea change is actually being implemented right now on a real basis.”

Gottlieb believes that while reimbursement will be tied to measures established in the clinical setting, it may be harder for government agencies to adopt them; patient experience and PROs, he said, would be much easier to implement. The panel agreed that, probably because of the bureaucracy involved, government agencies have a much harder time than payers in assimilating and analyzing data, and then use it to implement changes in the clinical setting. Gottlieb, based on his experience at CMS, mentioned that it was hard to follow an episode-based payment model because of the difficulty in keeping track of the services a patient would utilize.

Added Kolodziej, “The other thing is, you don’t even have to go to an episode model, because in an episode model there are winners and there are really big losers. You can actually do benefit design or network design” to achieve the ultimate objective of high quality care, which he said can be achieved through narrow networks easier for private payers to do.

And how about the regulatory aspect of incorporating PROs in drug labels? Gottlieb acknowledged that while the agency could have a tremendous impact on facilitating the process, there is concern about PROs potentiating excessive use, and the worry that patients might overemphasize quality of life claims over efficacy claims. While the current FDA guidance³ is primarily for the pharmaceutical industry to support their efforts to incorporate PROs into labels there have been additional public efforts to identify the right measures.

EBO

“The whole thing about patient reported outcomes is really an attempt to identify what it’s going to cost the patient. I think what’s much more likely is that [PROs] will be part of shared decision making, because although there may not be a best way to do things, I guarantee you there’s a worst way to do things, and, to the extent that we can avoid that, everybody benefits,” said Kolodziej.

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References

1. Patient-reported outcomes. National Quality Forum website. http://www.qualityforum.org/Projects/n-r/Patient-Reported_Outcomes/Patient-Reported_Outcomes.aspx. Accessed May 5, 2015.

2. Basch E, Snyder C, McNiff K, et al. Patient-reported outcome performance measures in oncology. J Oncol Pract. 2014;10(3):209-211.

3. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. FDA website. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm193282.pdf. Published December 2009. Accessed May 5, 2015.

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