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Key news updates and reports from the latest meetings in oncology and hematology.

Wednesday, October 15, 2014

ONLINE FIRST: ‘Turning the Tide’ Working Group Issues Recommendations on Patient-centered, Value-based Cancer Care




WASHINGTON—Stating that progress in oncology is at a critical juncture, a multidisciplinary working group released a comprehensive issue brief at a conference here intended to improve the value of cancer care and ensure that it is always patient-centered.  The document discussed at the conference, titled “A Pathway for Change: Supporting the Shift to Patient-Centered Cancer Research and Care and Addressing Value and Cost of Cancer Care, makes 13 specific recommendations.


The working group that wrote the issue brief was sponsored by the Personalized Medicine Coalition (PMC), the American Association for Cancer Research, and Feinstein Kean Healthcare as part of a national initiative called Turning the Tide Against Cancer. This initiative was launched in 2011 with the aim of identifying options that will sustain medical innovation while also addressing rising health care costs. The first Turning the Tide conference was held in 2012 (OT 7/10/12 issue); this was the second.


“The price tags of new therapies have become a contentious issue,” said PMC President Edward Abrahams, PhD, in introductory remarks. “We are, in fact, at a critical juncture in our fight against cancer. Getting the right treatment to the right patient is what people want; we need to deploy all of our resources at our disposal, just as if we were at war.”


It is “unacceptable” that patients cannot get the treatments they need because of high costs, emphasized another  speaker, Newton F. Crenshaw, Vice President for North American Oncology Commercial Operations, Global Business Development and Advocacy at Eli Lilly and Company, and a cancer survivor. In an interview, he suggested two ways that high-quality cancer therapies might be made more affordable:


He noted that certain approved anti-cancer agents are effective across tumor types, but that the efficacy varies. So, might it be possible to find mechanisms to vary the price of a drug based upon the clinical benefit derived in an individual tumor type, and on its dosage regimen? Second, when a cancer patient takes a “cocktail” of multiple drugs from different pharmaceutical companies, which is increasingly the norm, might it be possible to set a price for that combination therapy (rather than charging for each individual drug) without violating antitrust laws?


“These are two definable problems with very hard solutions,” he said. Asked if the Centers for Medicare and Medicaid Services (CMS) might be the agency to tackle such a pricing challenge, he said that might be a workable strategy.


Whatever steps are taken to contain cancer-care costs, though, must not happen at the expense of medical innovation, he stressed. “There is a need for us to reward continuous innovation. Progress happens in an incremental fashion; successive benefits are added on top of each other.” 


Thus, he said, companies need to be rewarded for “hitting singles” (i.e., not just home runs) that give cancer patients additional weeks and months of survival.


Ensuring Patient-Centered Care

Patient-centered care by its very nature tends to be value-based care because of its collaborative decision-making process. But in order to ensure that cancer care is always patient-centered, the reimbursement system needs to shift to cover the time a physician sits with a patient explaining that patient’s treatment options, said Richard L. Schilsky, MD, Chief Medical Officer of the American Society of Clinical Oncology, Professor Emeritus at the University of Chicago, and a member of the working group that wrote the issue brief discussed at the conference.


When it comes to high costs, “I’m getting a little tired of the finger-pointing between pharma and insurance companies,” he said. “Pharma says, ‘Oh, it’s the insurance companies’; insurance companies say, ‘Oh, it’s high drug prices.’ The whole concept of value is highly nuanced and not static. We are stuck in a sort of static regulatory and reimbursement system. As far as I know, drug prices never go down.”


Schilsky added, “Doctors, like everybody else, have varying communication skills. The one thing doctors don’t have is time… patients need to get the education they need when they need it in order to avoid an adverse outcome.”


For this to happen, he stressed, the reimbursement system must reward the physician who takes the time to carefully explain high-value treatment options to newly diagnosed cancer patients.


Luncheon speaker and cancer survivor Suleika Jaouad, author of the New York Times column “Life, Interrupted,” agreed: “To me, patient-centered care is about communication,” said Jaouad, who at age 22 was diagnosed with myelodysplastic syndrome and acute myeloid leukemia.


Also agreeing was Shelley Fuld Nasso, CEO of the National Coalition for Cancer Survivorship and a member of the issue-brief working group: “If those conversations don’t happen, the patient might receive treatment that is not consistent with their preferences and goals,” she said.


ASCO Value Framework Project

In an interview, Schilsky described the ASCO Value Framework project, which is developing a new tool to allow a physician to sit down with a newly diagnosed cancer patient and a computerized “dashboard” that sets forth factors important to a patient’s preferences and quality of life in selecting treatment A over treatment B.


With this tool, the patient could state which factors are most important to him or her and participate in decision-making. For example, reducing toxicity and side effects may be more important to some patients than others; some may want to extend their survival as long as possible regardless of toxicity. Some young female patients, like Jaouad, might wish to preserve fertility. In the case of a cancer patient with advanced disease cited at the conference, all she cared about was being able to play the piano until she died – so avoiding peripheral neuropathy was very important to her.


“It’s got to be fairly simple to use,” Schilsky said of the tool, which he noted would be downloadable from the ASCO website.  Asked if the tool would be field-tested before release, Schilsky said it would be fully vetted: “We will test it with focus groups of patients, doctors, and insurance companies.”  


Another member of the group that wrote the issue brief, Linda House, RN, MSM, Executive Vice President for External Affairs at the Cancer Support Community, said, “We talk about what we do for patients versus what we are doing with patients, Engaging with patients, she said, means involving them in treatment decisions and in their treatment plan. (It was she who cited the case of the patient who wanted to keep playing the piano until she died.)


Foundation of Accurate Clinical Trial Data

Speaker after speaker emphasized that patient-centered, value-based cancer care must rest on a firm foundation of accurate clinical trial data.


“I think about clinical trials as a way to solve some of these problems,” House said, noting that patient-reported outcomes such as overall quality of life, tolerability of a drug, patient satisfaction, time off work, and other such factors can be built into the trial data collected.


Most important, the rush to give patients treatments without trial evidence – such as giving breast cancer patients bone marrow transplants without adequate data – can turn into a costly mistake that must be avoided, said Anna Barker, PhD, Co-Director of the Complex Adaptive Systems Initiative, President and Director of the National Biomarker Development Alliance, and Professor in the School of Life Sciences at Arizona State University. “We can’t ever do that again; we need the trials.”


Agreeing was Lee N. Newcomer, MD, MHA, Senior Vice President for Oncology, Genetics and Women’s Health at UnitedHealthcare. “My fear is that we sometimes leap ahead of the evidence,” he said.


“We need to be careful not to read more into the data than is really there,” added Stephen L. Eck, MD, PhD, Vice President and Global Head of Oncology Medical Sciences at Astellas Pharma Global Development.


Higher Bar

“We need a higher bar for our clinical trials,” said Lowell E. Schnipper, MD, the Theodore W. And Evelyn G. Berenson Professor in the Department of Medicine at Harvard Medical School, Chief of Hematology/Oncology at Beth Israel Deaconess Medical Center, and Clinical Director of Beth Israel Deaconess Medical Center Cancer Center. 


Recognizing the need for that higher bar spurred the Lung Cancer Master Protocol, known as Lung-MAP, said Roy S. Herbst, MD, PhD, Ensign Professor of Medicine, Professor of Pharmacology, Chief of Medical Oncology, Director of the Thoracic Oncology Research Program and Associate Director for Translational Research at Yale Comprehensive Cancer Center and Yale School of Medicine.


Lung-MAP, a multi-center public/private partnership, is a Phase III randomized trial studying the efficacy of targeted therapies based on biomarker profiles of patients with advanced squamous cell lung cancer. “It really is a wave of the future,” said Herbst of this trial. “This is bringing profiling to the community.”


Several speakers agreed with Linda House that clinical trials should collect patient-reported outcomes as part of the process of moving toward truly patient-centered care.


“Stitching the patient’s voice into the center of the process of care means that I shouldn’t just collect the data, but should use it for better care,” said Amy P. Abernethy, MD, PhD, Professor of Medicine at Duke University School of Medicine, Chief Medical Officer and Senior Vice President of Oncology at Flatiron Health, Inc., and a member of the working group that wrote the issue brief. For example, she said, if a patient reports that she is having trouble sleeping, Abernethy could and should use the data clinically to help that patient sleep better.



The following at the Turning the Tide working group’s specific recommendations:

            1.  Congress should fund and the National Institutes of Health should implement public/private partnerships to encourage the use and acceptance of innovative clinical trial designs;

            2.  The Food and Drug Administration should promote the modernization of the framework for bringing new medicines to patients by facilitating and encouraging the use of innovative approaches to drug development and regulatory review;

            3.  FDA should continue making progress in defining and applying a clear, efficient, and coordinated review process for personalized medicine products;

            4.  The US Department of Health and Human Services should establish a cross-department work group to identify opportunities to enhance data transparency and sharing in support of innovation in oncology;

            5.  Congress should provide funding to support the development and updating of quality and performance measures for cancer care by private-sector organizations (including oncology and related medical specialty societies with expertise in patient experience and patient-reported outcomes measures);

            6.  HHS and states should ensure patient access to quality and affordable care in federal and state health exchanges by requiring broader coverage of cancer services and drugs and assuring adequate networks of cancer providers;

            7.  The Centers for Medicare and Medicaid Innovation should prioritize additional funding for Oncology Patient-Centered Medical Home demonstrations, with a focus on supporting patient navigation, access to care providers and treatment options, and personalized, evidence-based treatment plans, using tools such as shared decision-making;

            8.  Medicare reimbursement models should support innovative practice models to improve patient access and support patient engagement, such as paying for telemedicine, oncology nursing support, visiting consultants, e-mail, and use of mobile devices;

            9.  The Centers for Medicare and Medicaid Services (CMS) should adopt more specific codes (developed by the American Medical Association) to capture the complexity of cancer tests and services and ensure reimbursement--including molecular and personalized medicine testing, as well as palliative care;

            10.  CMS should ensure that cancer clinical pathways or similar decision support tools used to guide clinical decision-making are transparent to beneficiaries and the public, and the institute of Medicine should consider convening a multi-stakeholder committee to make recommendations on standards for clinical pathways;

            11.  Federal health agencies, including HHS and the Office of the National Coordinator for Health Information Technology (ONC) should support oncology decision support tools that are timely, clinically appropriate, and patient-centered, and ONC should propose certification standards for electronic health records;

            12.  The IOM should convene a multi-stakeholder committee and develop a report on how to define and measure value in oncology care that addresses dynamics previously identified by Turning the Tide Against Cancer leaders; and  

            13. The Patient-Centered Outcomes Research Institute (PCORI) should continue to support research to evaluate and identify innovative, effective methods for the use of decision support tools to communicate to patients and caregivers risks and benefits and uncertainty of evidence.