Special Edition Required Reading: Turning the Tide Against Cancer 2014 National Conference

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 a special installment of Required Reading reporting on coverage of the Turning the Tide Against Cancer 2014 national conference, which was held on October 9 in Washington, D.C. The following articles focus on the passionate and engaging discussion that took place at the conference, delving into the importance of moving towards a more high-value, patient-centric system of cancer care that helps to improve patient outcomes and represents each individual’s unique needs and definition of “value.”

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Through Len’s Lens: Putting a Price on Value by J. Leonard Lichtenfeld, M.D., MACP, MedPage Today

Cancer Community Turns Focus to ‘Value’ by Alicia Ault, OncologyPractice.com

‘Turning the Tide’ Working Group Issues Recommendations on Patient-Centered, Value-Based Cancer Care  by Peggy Eastman, Oncology Times

Turning The Tide Against Cancer: A Discussion on Value by Amy O’Connor, PACE USA Blog

ASCO’s Tool for Scoring Cancer Drug Value to be Released in Early 2015 by Cathy Kelly, The Pink Sheet Daily (Subscription Required)

The Pharmaceutical Research and Manufacturers of America’s (PhRMA) Conversations blog also featured a video series with several speakers from the Turning the Tide Against Cancer 2014 national conference to get their thoughts on scientific advances in cancer treatments. The full set of responses can be viewed below.

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

Linda House, R.N., B.S.N., M.S.M., Executive Vice President, External Affairs, Cancer Support Community

J. Leonard Lichtenfeld, M.D., MACP, Deputy Chief Medical Officer, American Cancer Society

Stephen L. Eck, M.D., Ph.D., Vice President, Global Head of Oncology Medical Sciences, Astellas Pharma Global Development

Roy S. Herbst, M.D., Ph.D., Ensign Professor of Medicine, Professor of Pharmacology, Chief of Medical Oncology, Director of the Thoracic Oncology Research Program, and Associate Director for Translational Research, Yale Comprehensive Cancer Center and Yale School of Medicine

To follow the news on the Turning the Tide Against Cancer initiative, visit the News page.

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.

Reflections from the Turning the Tide Against Cancer Conference

Following the Turning the Tide Against Cancer national conference last Thursday, I’ve had time to reflect on what we must do next to improve how patients experience cancer care.

To make that change we must acknowledge key truths.

Science is driving us towards more targeted solutions and novel approaches to treatment. The clinical trials and regulations necessary to get new products to market must change with the science. They must be nimble to keep pace with the extraordinary advances we are seeing.

Coverage and payment decisions must also allow patients access to advanced treatments and not disincentivize innovations in health care. While new products sometimes seem expensive, we must remember that costs are saved by getting the right treatment to the right patient at the outset of care.

We must educate. Each of us has a responsibility and a role to play in educating all participants in health care about the changes we are seeing in cancer. We must educate patients and their families about the complexity of decision-making and share information with them so that each patient can make informed choices. We must provide resources so health care providers are able to stay current with the latest developments in care. We also must educate policy makers to ensure that negative unintended consequences of policies are avoided.

Everyone working in health care wants to provide patients with the absolute best treatments imaginable – and those we have not yet even begun to imagine. Sometimes that will require addressing very tough questions in order for personalized medicine to be fully integrated into the health system.

Finally, we should celebrate the improvements made in cancer care from innovations in clinical trial design, to imaginative diagnostic testing of solid tumors that allow for better targeting of treatments, and tests that help physicians and patients make the best treatment choices. Advances are being made in science that are extending and improving lives. This is no small feat, and while our goals are great, we must celebrate the achievements that have taken us this far, and acknowledge the policies and pathways that made those discoveries possible.

We have an opportunity and responsibility to change the future of cancer care through continued education and advocacy. I invite you to help be a part of this change by sharing your thoughts and joining us on this journey to turn the tide against cancer.

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.

Q&A with Suleika Jaouad, The New York Times Emmy® Award Winning Columnist, “Life, Interrupted,” and Cancer Survivor

In advance of the Turning the Tide Against Cancer 2014 national conference, the Age of Personalized Medicine editorial team posed questions to Suleika Jaouad, The New York Times Emmy® Award winning columnist of “Life, Interrupted,” and cancer survivor, who will be speaking at the event on October 9 in Washington, D.C. Below, Suleika shares insights from the patient perspective on the need for a patient-centered approach to cancer care.

QUESTION: As a cancer patient, would you describe your health care experience as “patient-centered”? Why or why not?

Suleika Jaouad: Yes and no. I feel deeply grateful and indebted to my doctors who have always gone above and beyond to provide me with the very best care, but the lack of patient-clinician communication has been an ongoing struggle and source of frustration for me. For example, just a few days after my diagnosis, I learned via Google search that the chemotherapy treatments I was scheduled to undergo in less than a week would most likely leave me infertile. It was only after I initiated a conversation about fertility that my doctors told me about the available options. This felt like a major breach of trust early on in my treatment and I couldn’t help but wonder what else my doctors weren’t telling me. At 22, I hadn’t had the chance to start a family yet. Preserving my ability to be a mother one day felt like a lifeline to an already uncertain future. After explaining this to my medical team, they agreed to delay chemotherapy so that I could undergo fertility preservation treatments. This experience was the first of many that made me realize I needed to take an active role in my medical care in order to better advocate for myself.

QUESTION: In your opinion, how can we create a more patient-centered approach to cancer research and care?

Suleika Jaouad: Communication is the golden ticket. We live in the WebMD age where patients often consult Google before they consult a doctor. This can be dangerous and can lead to misinformation and misunderstandings. Creating an environment where the patient feels comfortable asking questions and talking to their medical team is crucial. It’s also very important for clinicians to educate their patients and to take the time to explain things more than once in clear, simple language. My doctors are some of the smartest people I’ve ever met. This made me feel safe and like I was in good hands, but half of the time I felt lost in the conversation. A lot of the terminology and medical jargon they used sounded like a foreign language to me. I wanted to understand and learn more about my disease but I often felt overwhelmed and didn’t know where to start.

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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 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.

Required Reading: August 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 August 2014 installment of Required Reading.

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The Price of Personalization by Timothy Gower, Proto Magazine

This article explores the growing debate over the cost and value of personalized medicines and identifies ways that the healthcare system may need to adapt to accommodate the development and use of increasingly more targeted therapies that work for smaller patient populations.

FDA to Regulate Thousands Of Cancer, Genetic, and Other Diagnostics by Matthew Herper, Forbes

Earlier this month, the U.S. Food and Drug Administration (FDA) announced plans to regulate laboratory developed tests, many of which are diagnostics developed as result of the exploding field of genetics. The new regulatory framework proposes that any test used to diagnose a disease or to decide on a course of treatment will need to be cleared by FDA before it can be utilized.

It’s Time for Us to Think About Cancer Differently by Paul Mejia, Newsweek

A recent genomic study published in the journal Cell suggests that 1 in 10 cancer patients could be more accurately diagnosed if cancer were defined by molecular and genetic characteristics, rather than by where it is located. Researchers believe that reclassifying cancer by identifying the type of cell that caused the disease, instead of the tissue type, could ultimately lead to better treatment in the future.

RNA Combination Therapy for Lung Cancer Offers Promise for Personalized Medicine by Kevin Leonardi, MIT News

Early research at the Koch Institute for Integrative Cancer Research at MIT offers promise for personalized cancer treatments using RNA combination therapies to improve therapeutic response. The development of an efficient delivery system of individual or combined small RNAs to solid tumors could help regulate genetic mutations underlying a given patient’s cancer.

Strategies for Accelerating Progress in Personalized Medicine

Last year around this time, I wrote a blog aimed toward skeptics of personalized medicine, citing the progress we have made in lung cancer as just one example of how well this approach works for treating diseases. As I have reflected upon the advances we have made in areas like cancer and diabetes and how personalized medicine now seems to be the cornerstone for drug discovery and development for many pharmaceutical companies, it has become clear to me that there are still a number of areas for continued investment and focus.

What can we do to continue to grow the field of personalized medicine, find new and exciting therapies, and maintain the momentum we have seen over the past few years?

I believe that developing a personalized medicine strategy is the answer, but this is far from simple.

It begins by first appreciating that one needs to study the diversity inherent in diseases. When a new medicine is introduced in human clinical trials, for example, it is important to describe and understand the diversity of human responses to the medicine and to determine ways to identify those who will benefit the most from the medicine.

While we would ideally like to have such a clear scientific understanding of a disease that we can predict in advance who the likely benefiting patients are (which can be done in some instances), in most cases the personalization of a medicine comes from the observations made in clinical studies of diverse populations.

In contrast to basic laboratory research, where experimental designs seek to minimize variation, the “noise” in clinical trials can actually provide us with important clues to help form the basis of a personalized medicine. Well-designed studies, therefore, should study both the variation of the response as well as the scientific basis for that variation. When done well this can uncover biologic marker that become diagnostic agents for patient selection.

In addition to designing more clinical trials with these two aspects included, I would propose that those of us working in the field of personalized medicine should continue to support efforts that:

• Fund basic research on the biologic basis of disease. Personalized medicine is based on fundamental scientific discoveries. Without these, there will be no improvement in our understanding of disease.
• Fund research in diagnostic testing. Companion diagnostics can be useful tools to help healthcare providers and their patients make more informed treatment decisions.
• Educate physicians and other healthcare providers about personalized medicine. Patients in specialized populations that may respond to a good therapy for their subgroup need to have access to the appropriate tests. This means making sure that those who can order the tests and use them as a part of standard care are aware that these tests and potential therapies exist.
• Reimburse for diagnostic testing. Personalized medicine drugs will not have any benefit if they are not used and a healthcare provider won’t know to use a potentially life-saving drug unless the correct diagnostic tests have been performed.

Together, we can maintain and even accelerate the progress we have already made in delivering the right drug to the right patient at the right dose, every time.

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Join Dr. Stephen Eck on November 6, 2013 at the 9th Annual Personalized Medicine Conference hosted by Partners HealthCare Center for Personalized Genetic Medicine, Harvard Medical School, and Harvard Business School. 

View Dr. Eck’s video interview “Personalized Medicine: How Progress Happens” online at the Personalized Medicine Coalition.

Angelina Jolie Lends Her Voice and Experience to Personalized Medicine

It was great to see Angelina Jolie’s eloquent op-ed in the May 14 edition of The New York Times. She carefully wove her personal experience with the importance of genetic testing and using the resulting information to make an informed health decision. I applaud her decision to go public with her story as a great example of patient empowerment but also as a powerful example of personalized medicine in action.

Despite all the advances we have made in recent years, we all know that the concept of personalized medicine is still foreign to most Americans. PMC recently conducted focus groups which strongly reminded us of the uphill battle that remains to gain public understanding of and support for personalized medicine. In our groups only one or two out of 52 participants were able to correctly describe the concept.

We found that people are very enthusiastic about personalized medicine once they understand it but it is a complex concept which is often misunderstood. It turns out that giving clear, specific examples of personalized diagnostics and treatments is the best way to explain what personalized medicine is and the benefits it can bring.

Ms. Jolie’s contribution demonstrates that without patients who are educated, empowered to get tested and to act, the progress and innovation could be for naught. We need to make sure that patients are knowledgeable enough to pursue personalized options for their own health but also so that they are motivated to support policies that foster continued progress in this area.

Angelina Jolie’s op-ed is an important and high-profile contribution to the discourse about patient experience and personalized medicine.  Her voice echoes the words of Adriana Jenkins, who courageously shared her battle against breast cancer and joins other advocates like Donna Cryer, who works tirelessly to remind all stakeholders about how personalize medicine is a patient-centric approach to healthcare. Courageous individuals, like Ms. Jolie, who publicly share their personal stories have the power to bolster both public and media discourse around patient empowerment, for example with CNN “Early Start” co-anchor Zoraida Sambolin’s disclosure of her own breast cancer diagnosis and treatment decision live on air.

I hope that Ms. Jolie’s op-ed raises awareness of personalized medicine and the options patients have to take control of their healthcare.  No single organization alone can raise public awareness on the scale that we need but through a steady stream of individual op-eds, blog posts, conversations, etc., we in the personalized medicine community can spotlight more stories like this and begin to educate the public.  I look forward to hearing more voices from the community and hope that their contributions will support personalized medicine research, patient and provider engagement, and thoughtful policy.

Congress Recognizes Value of Personalized Medicine Approaches in FDA User Fee Authorization Legislation

Regulatory uncertainty has long been a concern for personalized medicine innovators and the Turning the Tide Against Cancer conference earlier this month reinforced the need for regulatory changes to facilitate personalized medicine.  While that uncertainty is not gone, the Food and Drug Administration (FDA) user fee reauthorization legislation, which passed its last major hurdle through Congress yesterday, contains personalized medicine-relevant policy changes that will enhance the regulatory process for new products.

We applaud Congress for passing this legislation and commend the measures it takes to smooth the way for more personalized medicine products.  Provisions directly related to personalized medicine include:

• The development of FDA’s capacity to review submissions involving pharmacogenomics and biomarkers by integrating and training staff with pharmacogenomics and biomarker expertise into the product review process.
• The creation of an expedited approval process for “breakthrough therapies” — drugs that are both developed using biomarkers and used to treat serious or life-threatening ailments.
• A requirement that the FDA notify Congress two months in advance of the Agency’s planned release of any guidance or draft guidance document related to the regulation of laboratory-developed tests.

We look forward to continuing to work with FDA to improve the complex regulatory process for personalized medicine and accelerate adoption new personalized treatments.