Next Steps To Turn the Tide Against Cancer

Three weeks ago, 200+ health care leaders representing a broad spectrum of stakeholders convened in Washington, D.C., for the second conference of the Turning the Tide Against Cancer Through Sustained Medical Innovation initiative. There were intense discussions — among panelists and in the hallways between sessions — on the challenges facing cancer research and care.

Now back at our desks, the question arises, what do we want to do next — as individuals, as a community, and as a nation? And, critically, what must we do next to enable and encourage innovation in cancer research?

In 2011, Feinstein Kean Healthcare joined forces with the Personalized Medicine Coalition (PMC) and the American Association for Cancer Research (AACR) to create the Turning the Tide Against Cancer initiative, in response to disconnects within the health care system that threatened to stifle advances, ironically at an unprecedented moment of scientific progress.

We saw disconnects between patients and the health care system…disconnects between the accelerating pace of science and the slowness of change in our policy environment…and disconnects between the exigencies of driving innovation and the sober realities of a cost-contained era.

As we observed these disconnects, we also noted that as a nation we were attempting to solve complex problems while operating within traditional vertical silos (e.g., patients in patient advocacy organizations; physicians in physician professional societies; researchers in scientific societies) rather than cross-sector collaborations.

And so, we sought to catalyze the entire cancer and health policy community towards action by connecting all stakeholders through the Turning the Tide Against Cancer initiative. Uniquely, stakeholders from across the cancer ecosystem have been represented in all events and deliberations of the initiative.

Now, building upon several years of intellectual exploration, research, dialogue, debate and the deliberations of the broad range of experts that produced the Issue Brief, “A Pathway for Change: Supporting the Shift to Patient-Centered Cancer Research and Care and Addressing Value and Cost of Cancer Care” released at the conference, we ask again, what’s next?

I propose that every individual touched by cancer, and every organization concerned about the nation’s cancer burden, take responsibility for three actions.

1. Review the Issue Brief, and share your thoughts/ideas about the policy options and/or propose other options.
2. Involve your organization in the Turning the Tide Against Cancer Through Sustained Medical Innovation initiative, by participating in our activities and events.
3. Join our partners PMC and AACR and advocate for those options that you agree with, integrating them into your own policy platforms and your communications with policymakers in order to drive momentum and catalyze change.

In the past, individual champions such as the renowned Mary Lasker were a driving force to advance and change our approach to cancer research and care. As Dr. Len Lichtenfeld of the American Cancer Society asked following the first Turning the Tide Against Cancer conference, “Where is our Mary Lasker going to come from? …Who is going to guide this revolution?”

I believe that in this era, we are all destined and empowered to be leaders. And as I looked out at the attendees of the Turning the Tide Against Cancer conference, I saw Mary Lasker in the face of each participant. We are all Mary Lasker. We must all be Mary Lasker.

Please join us as we take the next step.

A Patient-Centered Perspective on Cancer Research and Care

Shelley Fuld Nasso, M.P.P., CEO, National Coalition for Cancer Survivorship, addressing the role of payment reforms in supporting innovative cancer care at the Turning the Tide Against Cancer 2014 national conference (Photo: Liz Roll)

A key theme at the Turning the Tide Against Cancer national conference was the need for a patient-centered approach to cancer care. Shelley Fuld Nasso, M.P.P., CEO, National Coalition for Cancer Survivorship (NCCS), shared her thoughts on the importance of patient education, shared decision-making, and aligning a treatment plan with the goals and priorities of the patient.

Read more about Shelley’s thoughts on incentive structures that encourage innovation, as well her personal experience with cancer, and the urgent need to push discovery to help save lives on the NCCS blog.

Turning the Tide Against Cancer: Collaboration to Improve Outcomes

Over the past few weeks, the Age of Personalized Medicine editorial team has been talking to leaders from the co-convening organizations of the second Turning the Tide Against Cancer Through Sustain Medical Innovation national conference, which will be held on October 9, 2014, in Washington, D.C.

Our conversation with Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of the American Association for Cancer Research, on the need for continued collaboration across the diverse spectrum of stakeholders in the cancer community, can be viewed below.

We also heard from Edward Abrahams Ph.D., president of the Personalized Medicine Coalition and Marcia A. Kean, M.B.A., chairman of Feinstein Kean Healthcare, on the need for policies that encourage and keep pace with innovation in cancer research and personalized medicine.

Visit the Turning the Tide Against Cancer website to register for the conference and learn more about ways you or your organization can support the ongoing initiative. If you are unable to attend the conference in person, please join us via webcast on October 9 by visiting the Turning the Tide Against Cancer homepage. The Age of Personalized Medicine will also be tweeting live from the conference using #T3cancer.

Turning the Tide Against Cancer: Policies to Sustain Innovation

Leading up to the second Turning the Tide Against Cancer Through Sustain Medical Innovation national conference on October 9, 2014, in Washington, D.C., the Age of Personalized Medicine editorial team had the chance to sit down with leaders from the initiative’s co-convening organizations to talk about the current cancer research and care landscape, what progress has been made since the start of the initiative, and the upcoming conference.

Last week, we heard from Edward Abrahams Ph.D., president of the Personalized Medicine Coalition on the importance of patient-centered care and value, and the need for policies that encourage innovation in cancer research and personalized medicine in order to improve patient outcomes.

Our conversation with Marcia A. Kean, M.B.A., chairman of Feinstein Kean Healthcare, on the importance of enacting policies that keep pace with the rapid development of innovative cancer treatments, can be viewed below. Stay tuned for our video interview with Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of the American Association for Cancer Research.

Visit the Turning the Tide Against Cancer website to register for the conference and learn more about ways you or your organization can support the ongoing initiative. The Age of Personalized Medicine will also be tweeting live from the conference on October 9 using #T3cancer.

A Preview of the Turning the Tide Against Cancer National Conference – Part 2

Leading up to the Turning the Tide Against Cancer 2014 national conference, the Age of Personalized Medicine editorial team posed two questions to leaders in the cancer community who will be speaking at the event on October 9 in Washington, D.C. In part one, we asked speakers to share their insights on the role of innovation in advancing cancer research and care. The second question focused on the shift to patient-centered research and care, and how patient-centric approaches can improve healthcare.

QUESTION: What does having a patient-centered healthcare system mean, and why it is important for the healthcare system as a whole?

Here’s what some of the conference speakers had to say:

 

Patricia J. Goldsmith, CEO, CancerCare

“Consistent with the IOM definition, patient-centered care is respectful of and responsive to the individual patient’s preferences, needs and values. The days when clinicians make all of the decisions are over. Now that the consumer movement has reached healthcare, patients are becoming empowered to partner with their physicians to get the treatment they believe is best for them. The balance of power is shifting so that decision-making is shared. Within this environment, patients can fully engage in the process of developing and managing their own treatment. This is important because we know that engaged patients have better outcomes, higher levels of satisfaction with their health care, and consume fewer clinical resources.”

 

Tanisha V. Carino, Ph.D., Executive Vice President, Avalere Health

“In order to strive for a more patient-centered approach to cancer care, it is important to consider how patients are engaged in defining healthcare priorities, including identifying areas of unmet need and the types of study designs that best reflect the risks and tradeoffs they experience in care practice. Sustained medical innovation plays a central role in meeting these constantly evolving patient needs, which are particularly complex for cancer patients. Moreover, patients are now bearing much more financial responsibility for their care than in the past. The majority of exchange enrollees chose plans in the Silver metal level, which come with average deductibles up to $2,260 and maximum out-of-pocket costs reaching up to $6,350 for in-network care, according to Avalere PlanScape™ analysis. With increased financial accountability, patients, along with their caregivers, are increasingly engaged in making choices regarding the most appropriate treatment. Payment mechanisms for cancer care and new insurance products will need to keep pace with both medical advances and the financial realities facing patients and their caregivers.”

 

Amy P. Abernethy, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine; Chief Medical Officer and Senior Vice President of Oncology, Flatiron Health, Inc.

“Cancer care isn’t about cancer and cancer care isn’t about health systems.  Nor is it about research or researchers. It’s about real people who are touched by, afflicted with, and hopefully live way beyond the experience of cancer.  So fundamentally, we need to build our medical innovations with the patient in mind.  For this reason, I’ve always thought we have to have the patient at the center of our data story – where data from one patient tells a longitudinal story across a life and then it’s the data of many patients that are aggregated together to form our foundational data set to support innovation.  Similarly, patients need to be the cornerstones of our clinical trials and basic research – our muse.”

 

Newton F. Crenshaw, Vice President, North American Oncology Commercial Operations, Global Business Development and Advocacy, Eli Lilly and Company

“Patient-centered care means exactly that: treatment choices and care that reflect the preferences, needs, and values of someone with cancer, for whom each treatment decision has a profound implication on health and quality of life. Every patient’s experience is unique: for some people, progress means a better prognosis and more time spent with their families; others prioritize treatment that has fewer side effects or is easier to administer. Ultimately, patient-centered care respects these differences and prioritizes the values of each individual person.”

 

Tony Coelho, Former Member, U.S. House of Representatives; Chairman, Partnership to Improve Patient Care

“Personalized and patient-centered cancer care will improve health outcomes by identifying the treatments that work best for individual patients, improving outcomes by avoiding trial and error medicine. To further support patient-centered care, policies must not limit access or push ‘one-size-fits-all’ treatment solutions. Patient-centeredness consists of a series of principles focused on patient engagement, patient activation, access to a range of treatments, and shared decision-making. Patient-centered principles must be incorporated into the early phases of evidence development, translation and implementation, as well as in the design and implementation of new payment and delivery reform models for cancer care.”

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Visit the Turning the Tide Against Cancer website to register for the conference and learn more about ways you or your organization can support the ongoing initiative. The Age of Personalized Medicine will also be tweeting live from the conference on October 9. Join the conversation with #T3cancer.

A Preview of the Turning the Tide Against Cancer National Conference – Part 1

Leading up to the Turning the Tide Against Cancer 2014 national conference, the Age of Personalized Medicine editorial team posed two questions to leaders in the cancer community who will be speaking at the event on October 9 in Washington, D.C. In part one, we asked speakers to share their insights on the role of innovation in advancing cancer research and care. Check back for part two where we ask leaders to define patient-centered and explain how patient-centric approaches can improve healthcare.

QUESTION: What role does medical innovation play in paving the pathway to progress towards a sustainable and high-value, patient-centric cancer care system?

Here’s what some of the conference speakers had to say:

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Amy P. Abernethy, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine; Chief Medical Officer and Senior Vice President of Oncology, Flatiron Health, Inc.

“One area of important medical innovation is the generation and use of data. This is not just hype around ‘big data’ but the recognition that we need amalgamation of data streams that tell the whole person’s story. This includes information about the cancer itself, and also the individual’s personal life: their values and needs, their personal experiences, as well as biometric monitoring. The longitudinal story expressed through data can then be used to support many innovations in cancer care. It can act as a clinical annotation stream to inform biological research such as annotation of biospecimens, biomarkers and basic discovery. It can be used to optimize cancer care delivery, or used for quality monitoring and to highlight gaps in care to be resolved. It can be used to compare differing interventions to figure out what works for whom and when. Advancing high quality and sustainable medical care is dependent on innovations around the generation and use of data.”

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Newton F. Crenshaw, Vice President, North American Oncology Commercial Operations, Global Business Development and Advocacy, Eli Lilly and Company

“Medical innovation is absolutely central to advancing the fight against the over 200 types of cancer. Each new advance, no matter how small, contributes to our scientific understanding of this collection of diseases, and provides new hope and cures to people with cancer. This cycle of continuous innovation has had impressive results and generated savings throughout the health care system: since 1975, the 5-year survival rate for cancer patients has increased by about 40%. To sustain–and accelerate–this progress, our society must continue to foster and reward innovation.”

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Tony Coelho, Former Member, U.S. House of Representatives; Chairman, Partnership to Improve Patient Care

“The rapid pace of medical innovation in oncology is increasing our ability to provide more personalized, patient-centered care (based on their biomarkers, quality of life considerations, etc.). Achieving more efficient delivery of high quality care will require continued medical innovation, including development of new treatments, improvements to existing treatments, and increasing efficiencies in the delivery system that support higher quality care and an overall a reduction in the economic and health burden of disease. But innovation is worthless without access to it.”

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Visit the Turning the Tide Against Cancer website to register for the conference and learn more about ways you or your organization can support the ongoing initiative. The Age of Personalized Medicine will also be tweeting live from the conference on October 9. Join the conversation with #T3cancer.

Required Reading: June 2014

Great stories are published daily about the impact personalized medicine is having on individual patients, and the medical community as a whole, but it can be a challenge to stay on top of the news. With that in mind, we bring to you a monthly roundup of the three to five most thought-provoking articles we are reading, sharing and discussing with our colleagues.

This is the first installment of Required Reading.

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Drugmakers Find Breakthroughs in Medicine Tailored to Individuals’ Genetic Makeups by Brady Dennis, The Washington Post

One-size-fits-all blockbuster drugs are giving way to treatments tailored to individuals’ genetic makeups. This article highlights the advantages of these targeted treatments, posing important questions that regulators, drug makers, insurers and patients alike need to consider as more specialized drugs come to market, including who will benefit and how to ensure patients have access to life-saving treatments.

In a First, Test of DNA Finds Root of Illness by Carl Zimmer, The New York Times

Diagnosis is a crucial step in medicine, but it can also be the most difficult. A new DNA sequencing technology, called unbiased next-generation sequencing, can identify a pathogen by testing DNA samples from a patient and then comparing fragments with genetic sequences stored in online databases. This technology has the potential to not only provide speedy diagnoses to critically ill patients, but could lead to more effective treatments for diseases that can be hard to identify.

The Perfect Drug by Erin Biba, Newsweek

This article highlights how continued innovation in our understanding of cancer and the emergence of companies providing personalized treatments helped change one patient’s life by turning his cancer diagnosis from a death sentence into a managed chronic illness.

Keeping the Patient at the Center of Cancer Innovation by Amy Abernethy, M.D., Ph.D. and Arif Kamal, M.D., The Hill’s Congress Blog

Hot on the heels of the 2014 American Society of Clinical Oncology annual meeting and Institute of Medicine’s National Cancer Policy Forum earlier this month, this op-ed focuses on the role of medical innovation and patient-centered approaches in the growing discussion on the cost and value of cancer research and care.

Collaboration Key to Improved Reimbursement Policies for Personalized Medicine

Significant reimbursement challenges to personalized medicine began in 2012 when the Centers for Medicare and Medicaid Services (CMS) changed payments for diagnostics from a stack of different types of codes describing different parts of lab testing to a unique code for a type of test.

The Personalized Medicine Coalition (PMC) has engaged with CMS on reimbursement issues for personalized therapies and companion diagnostics in a variety of ways, most recently when Patrick Conway, M.D., Deputy Administrator for Innovation and Quality and Chief Medical Officer, CMS, delivered the keynote address at the Tenth Annual State of Personalized Medicine Luncheon.

Dr. Conway outlined his perspective on the state of personalized medicine and where it is headed, noting that we are in an era in which the power of genetics is driving innovation, informing treatments and improving patient outcomes.

As Dr. Conway noted, diagnostics are a challenge as a new market, and CMS is working with FDA to streamline the process further. We want and need diagnostics that enable physicians’ to tailor therapies for individual patients and influence decision making, all resulting in better health outcomes and improved patient care.

Dr. Conway emphasized innovation, noting that we need a system that values innovation and pays for it appropriately. We should cover and pay for technology that may have greater costs in the short-term, but which will result in long-term savings and improved outcomes.

Yet, innovators are facing significant challenges stemming from CMS policies, through the unintended consequences related to coding, in particular. PMC is focused on working with CMS to ease the pressure on innovators, and identifying opportunities to make sure this does not happen again.

A key theme of Dr. Conway’s talk was that of collaboration. PMC will continue to facilitate engagement with CMS, taking up Dr. Conway on his open door policy to ensure that future policies encourage innovation and support continued developments in personalized medicine.

Dr. Conway’s presentation is available at the PMC website.

Putting the Pieces Together for Personalized Medicine

At the Personalized Medicine Coalition, our goal is to open the path to innovation in the science and practice of personalized medicine. “Personalized medicine” is the tailoring of medical treatment to the individual characteristics of each patient. For personalized medicine to work, many pieces must align, including detailed knowledge of the genomics underlying a given disease, effective targeted treatments, and accompanying diagnostic tests to identify the patients who are most likely to benefit.

Those pieces do not line up overnight but, instead, each aspect advances as knowledge builds cumulatively over time. For example, the technology to sequence genes has come a long way in the last 15 years. According to our latest edition of The Case for Personalized Medicine, the cost of sequencing the human genome dropped from $300 million in 2001 to $5,000 in late 2011. This dramatic price drop reflects the evolving science that built over time. Without the initial $1 billion investment to sequence the human genome by public and private partners, this progress would not have been possible.

Likewise, we see the same accumulation of knowledge related to personalized treatments over time. Even within one medicine, our understanding of its potential benefits and indications evolves.

Today, we can sub-classify certain diseases based on genetics: Melanoma can be BRAF positive or non-small cell lung cancer can be EGFR positive or ALK positive. Making these distinctions has led to targeting these gene mutations with specific treatments, leading to improvements in patient outcomes and quality of life. Tomorrow, our scientific knowledge base will continue to grow and is coupled with the technological advances that are enabling the analysis and interpretation of findings like no other time in history.

Increasingly, our expanding knowledge of the role of genetic variation in patient response to treatments will drive continuous learning about the optimal role and value of treatment regimens and diagnostic/treatment combinations. This emerging capability holds great potential to improve patient care and healthcare value, but it is at odds with our conventional approaches to assessing value at a point in time based on broad average study results.

To foster continued progress, the private and public sectors must work together to develop policies that align with scientific advances. We need adequate reimbursement for advanced diagnostics and targeted therapies, and flexible methods to access the value of personalized medicines, rather than one-size-fits-all determinations that don’t take the individual into account. We need policies that recognize the many factors that come into play to make personalized medicine possible, including the research, development, and performance of molecular testing.

At the Personalized Medicine Coalition, we firmly believe that we can and must bring personalized medicine to all patients. Collaboration among the many stakeholders involved will move us closer to this goal.

– A version of this blog originally appeared in The Catalyst series highlighting incremental innovation posted at the PhRMA website.

Do Not Stymie Innovation by Denying Reimbursement

Last week the public comment period closed for the Centers for Medicare and Medicaid Services (CMS) proposed payment determination for Multianalyte Assays with Algorithmic Analyses (MAAAs) in the CY 2013 New and Reconsidered Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Payment Determinations (“the Preliminary Determination”).

MAAAs are procedures that utilize multiple results derived from assays of various types. The American Medical Association gives the following definition: “Algorithmic analysis, using the results of these assays as well as other patient information (if used), is then performed and reported typically as a numeric score(s) or as a probability. MAAAs are typically unique to a single clinical laboratory or manufacturer. The results of individual component procedure(s) that are inputs to the MAAAs may be provided on the associated laboratory report; however these assays are not reported separately using additional codes.”

MAAAs are not new.  CMS and private payers routinely pay for them and many of them, having been added to clinical care guidelines, are now considered standard of care.

The proposal, as it stands, will likely prevent providers from receiving reimbursement for MAAAs. Without a clear reimbursement pathway, we risk stifling innovation by sending a powerful message to developers and providers that they cannot recoup investments made in the development, clinical validation, and commercialization of innovative diagnostic products.

Innovators focused on developing new therapies and accompanying diagnostics have difficult decisions to make regarding what products to invest in and bring to market. They must have confidence that future innovative diagnostics will be recognized and valued or improvements in patient care could be at risk.

At the urging of our members, the Personalized Medicine Coalition (PMC) sent a letter to CMS on this issue, noting that the Preliminary Determination:

• Reverses current practice as many of the MAAAs are well-established tests that have been covered and reimbursed by Medicare for several years and are medically necessary given their status as the standard of care in treatment guidelines;
• Jeopardizes personalized medicine and medical innovation by not separately recognizing and valuing the MAAA CPT codes; and
• Represents a lack of transparency in the CMS decision-making process.

PMC recommended that the Preliminary Determination be altered to take into consideration these perspectives, shared by all PMC member organizations, to ensure that the decision does not inadvertently impact current patient care and the future of biomedical innovation.

Healthcare delivery and our research enterprise continue to change as innovators apply new scientific discoveries to the development of new therapies to treat and manage illnesses.  Our reimbursement policies must also adjust in step in order to support our evolving healthcare system.

Today, physicians across the country use sophisticated diagnostics to guide treatment decisions, a trend that we expect will continue. The rise in personalized medicine will lead to efficiencies in the healthcare system that increase the quality of patient care while saving patients exposure to unnecessary treatments that may not help them. Let us not halt innovation in healthcare by hasty policy decisions, such as the Preliminary Determination, that are not fully vetted for unintended consequences.