2014: The Year of the Patient

As we reach the end of another year, we once again look back at recent advancements and milestones in the field of personalized medicine. As we celebrated 10 years of progress, we also looked toward the future, identifying changes needed to ensure another decade of discovery. Reflecting upon the highlights of 2014, it is clear that this truly was the year of the patient. A renewed sense of urgency to shift towards a more patient-centered approach to care has been created across the healthcare system.

The following captures highlights from The Age of Personalized Medicine Blog for 2014.

Michael Kolodziej, M.D., National Medical Director for Oncology, Office of the Chief Medical Officer, Aetna, kicked off the year with reflections on the challenges facing the adoption of personalized medicine.

So what are the practical challenges? There are many. And many share the underlying theme that the old paradigms do not work so well. … Perhaps the biggest challenges lie in the area of clinical utility, which impacts providers, payers and regulatory agencies. Patients are impacted in a huge way. Most people have an idea of where we need to go, but we have a shortage of ideas about how to get there. Finally, all of this occurs in the setting of unsustainable growth in health care spending, and the near uniform agreement that we need to spend our money in a more intelligent, impactful way. … We have a lot of work to do together.

In March, we were honored to share the personal and candid story of Stephanie Dunn Haney, a lung cancer survivor, and her experience with molecular testing and targeted therapies. Stephanie’s story continues to remind us of the hope personalized medicine offers to so many.

Molecular testing and personalized medicine gave me my life back, and my sense of a future back. While I’m realistic enough to know that my daughters are fairly certain to lose their mother before they are grown, I also know I have tools to fight with, and a responsibility to share my story.

As we talk about the need to keep the patient at the center of all that we do, we at the Personalized Medicine Coalition (PMC) saw a need to establish a baseline of consumer awareness, knowledge and attitudes about personalized medicine. In July, PMC released a national survey, U.S. Public Opinion About Personalized Medicine, with key findings that will guide future outreach and education efforts.

We’re at the beginning of the golden age of personalized medicine. Armed now with a clear picture of the public’s opinion, we have an opportunity to raise awareness and increase understanding of what personalized medicine is, and how it can transform approaches to healthcare delivery.

Of course, in order to bring molecular tests and targeted therapies to patients, key regulatory and reimbursement areas must be addressed. PMC also published The Future of Coverage and Payment for Personalized Medicine Diagnostics in July, which took a critical look at CMS policies, highlighting specific challenges to the further implementation of personalized medicine diagnostics.  Later that month, the U.S. Food and Drug Administration’s (FDA) released its long-awaited final guidance on the regulation of companion diagnostic devices, as well as proposed framework for regulating laboratory developed tests (LDTs).

Investors have long argued that clarity is necessary in both regulation and reimbursement for continued advancement of personalized medicine. We now have clarity on FDA’s current thinking although many issues remain unresolved. The community has time to consider this framework and may soon have a chance to provide public comments. And finally, the pharmaceutical industry has the FDA’s assurance that targeted treatments will not be held up by co-development challenges.

In October 2014, the PMC, the American Association for Cancer Research (AACR), and Feinstein Kean Healthcare (FKH) convened the second national Turning the Tide Against Cancer national conference, which brought together leaders throughout the healthcare and policy communities for a passionate and engaging discussion on the importance of moving towards a more high-value, patient-centric system of cancer care.

Keynote speaker, cancer survivor, and The New York Times Emmy® Award winning columnist of “Life, Interrupted,” Suleika Jaouad, shared insights into communication challenges patients face during a Q&A session. Suleika’s words serve as a reminder that if we are to increase adoption of personalized healthcare, we must ensure patients are given the tools and education needed to properly understand their treatment options.

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.

Following the conference, FKH Chairman, Marcia A. Kean, M.B.A., proposed next steps:

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
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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.

We encourage you to learn more about the Turning the Tide Against Cancer initiative, and the important work we are doing to make a difference for cancer patients.

As an appropriate end to the year, we celebrated the 10th Anniversary Personalized Medicine Conference in November, and conference organizer Raju Kucherlapati, Ph.D., Paul C. Cabot Professor of Genetics, Harvard Medical School, reflected on a decade of developments in personalized medicine.

The past decade has witnessed many exciting new developments in personalized medicine: the significant reduction in the cost of DNA sequencing and related technologies; the use of these technologies for an unprecedented rate of discovery of human disease genes; a near universal acceptance of the importance of genetics and genomics in drug development, especially for cancer; the levels of investment in personalized medicine companies; recognition of the importance of personalized medicine by professional societies; and the deep involvement by the administrative and legislative bodies in the U.S. and throughout the world.

2014 was a milestone year. We look forward to the year ahead, and the continued opportunity to engage with leaders throughout the personalized medicine community, and across the healthcare system, to discuss the future of personalized healthcare and how we can provide the best value to patients.

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.