Examining the Relationship Between Payment Policies and Personalized Medicine

In an era of increased focus on containing rising healthcare costs, personalized medicine represents an important solution in addressing these concerns, while improving the quality of patient care. In order to ensure that these important advances continue, it is essential to ensure payment policy supports personalized medicine.

Much of PMC’s policy work in the coming year will focus on both the challenges and opportunities in Medicare payment policy. For several years, ongoing efforts to reduce reimbursement for advanced diagnostic tests have been at the leading edge of this work. Recent proposals to cut reimbursement for diagnostics and drugs in Medicare Part B underscore the importance of our continued focus in this area.

Building on the success of our reimbursement issues brief from 2010, we will soon publish an updated brief outlining the difficulties facing personalized medicine in coverage and reimbursement decisions. This paper will cover coding changes as well as the challenges that CMS has placed on innovators. It will also outline evidence issues and how the field might consider tackling them.

In addition, PMC will address how emerging, alternative payment models (such as medical homes, accountable care organizations, and pathway- or episode-based payment) also will have a significant impact on development and adoption of personalized medicine. While some of these approaches appear to hold promise, we must pay attention to the details to ensure that they are designed in ways that allow physicians to tailor care based on an individual’s genetics and other factors, and that support adoption of novel targeted therapies.

PMC already has begun engaging on this important set of issues. Based on our policy principles for deficit reduction, we are developing additional messaging and conducting further analysis to engage Centers for Medicare and Medicaid Services (CMS) throughout the year. Our next opportunity will be on April 10 when we will respond to a request for comments on Specialty Practitioner Payment Models. In our response, we will encourage CMS to see targeting drugs with diagnostic tools as a way to increase the quality of patient care and to ensure that policies encourage this direction.

As we engage on a growing range of important policy issues, it is timely that Dr. Patrick Conway, the acting director of the Center for Medicare and Medicaid Innovation (CMMI), will be joining us this week at our Tenth Annual State of Personalized Medicine Luncheon. CMMI has responsibility for testing and implementing alternative payment models at CMS. We look forward to hearing from Dr. Conway as he shares his vision of personalized medicine, CMS’ perspective of innovation and quality health care reform, and answers questions about developing payment policies.

We recognize that personalized medicine depends on our ability to pay for both diagnostic and therapeutic products, and to that end, the PMC is focused on advocating for public policies that support personalized medicine’s development through scientific, regulatory, and reimbursement-related activities. I invite you to join PMC at the Tenth Annual State of Personalized Medicine Luncheon Address at the National Press Club in Washington, D.C., on March 13.

The Pathway to Progress: An update from the Turning the Tide Against Cancer initiative

Recent advances in cancer research have expanded our understanding of how cancer develops, and how to target treatments for specific cancer types. However, cancer – a collective term to describe more than 200 unique diseases – remains the second most common cause of disease-related death in the United States according to the AACR Cancer Progress Report 2013.

The American Association for Cancer Research (AACR) supports the need for ongoing research and the translation of scientific discoveries into new and better ways to prevent, detect, diagnose and treat cancer. To that end, along with the Personalized Medicine Coalition (PMC) and Feinstein Kean Healthcare (FKH), the Turning the Tide Against Cancer national conference was convened in 2012.

As members across all stakeholder groups joined together to consider the status and future of innovation in cancer research and care, it became clear that an ongoing discussion was needed to sustain progress against cancer. Today, the conference has evolved into an initiative to unite stakeholders within the cancer community to identify specific policy proposals policies that align with emerging science and evolving perceptions of value.

Last week, Clinical Cancer Research published an article authored by members of the initiative’s advisory committee. “Turning the Tide Against Cancer Through Sustained Medical Innovation: The Pathway to Progress” examines the themes that have emerged from ongoing discussions in the cancer stakeholder community. Key points of discussion include the need to develop policies and regulatory pathways that reward innovation and acknowledge the unique dynamics of patient-centered cancer care.

The report also points out that while we have a greater ability to collect and analyze scientific information than at any other point in medical history, a deluge of data alone will not answer the basic question of how value is defined. I encourage you to review the article to learn more about the challenges of defining value in a field where patient experiences and expectations can vary widely based on their clinical and life circumstances and personal preferences.

To address some of these challenges, the authors have identified policy suggestions that move towards better alignment with patient needs and values, and also consider the way science and clinical practice evolves over time, including incentivizing patient-centered research and care, and promoting a learning health care system. These are not prescriptive, but rather are a call for further discussion and community action. This fall, AACR, PMC and FKH will convene a national conference in Washington, D.C., to explore specific policy solutions that have emerged from our continued work. These policy solutions seek to foster continued innovation in cancer research and care so that improved outcomes for patients are delivered. Please stay tuned for additional information in the coming weeks.

To learn more, please visit www.turningthetideagainstcancer.org.

Read the article, “Turning the Tide Against Cancer Through Sustained Medical Innovation: The Pathway to Progress”.

A Response to Ezekiel J. Emanuel’s NYT Op-Ed about the Cost of Cancer Care

Ezekiel J. Emanuel’s “A Plan to Fix Cancer Care” (The New York Times, Op-Ed, March 23, 2013) highlights the need for collaboration and commitment across the oncology community to find solutions for the financial burden cancer poses to our healthcare system.

In order to sustain progress while containing cost, though, we must recognize the heterogeneity of the dreaded disease by eschewing a one-size-fits-all approach. We must, in short, devise strategies that make medical sense. These strategies necessarily will involve adaptive clinical trials, an intelligent regulatory policy that encourages linking therapy and diagnosis, and a willingness to pay for products that improve patient care.

Progress is driven by a dynamic process in which the full value of intervention evolves over time. We must be careful not to stifle innovation by overlooking the critical steps that can provide an answer to the correct question, which is: how can we maximize value from our growing, but not always wise, investments in health care?

Our Health Policies Can’t Ignore Where Science Is Leading Us

Do we want continued progress in personalized medicine, or don’t we? Based on events last week, the answer might be ‘both.’ I attended a press conference here in Washington that celebrated the achievements made by the health sector in our efforts to turn cancer from a sure death sentence into a chronic disease. Simultaneous to this, the Medicare Payment Advisory Commission (MedPAC) proposed policies to offset the cost of a physician payment fix under Medicare. The disconnect between the two was striking. Unfortunately, the MedPAC proposals have the unintended effect of heavily impacting those on the leading edge of personalized medicine. Of the $233 billion in 10-year savings, $114 billion would come out of the biopharmaceutical and clinical laboratory sectors, thus possibly robbing seniors of access to the latest targeted therapies and the diagnostics used to guide them. The proposal includes savings from giving the Centers for Medicare and Medicaid Services (CMS) new authority to impose “least costly alternative” payment, which would result in locking us into our current one-size-fits-all medical paradigm and weakening physicians’ power to tailor care using diagnostics and targeted therapies.  Another troubling aspect of these suggestions is that they propose cuts by sector, ignoring the reality that personalized medicine brings efficiencies to the system of health care.

The proposal appears to reflect a lack of awareness of the impact that personalized medicine is making in health care and underscores the importance of the Personalized Medicine Coalition’s legislative work.  One of our policy suggestions, released over the summer, calls for inclusion of a personalized medicine representative on MedPAC and the creation of a new personalized medicine advisory committee to foster alignment of the policies across the entire Department of Health and Human Services with the science of personalized medicine. Personalized medicine challenges the status quo in medicine – the blockbuster business model, diagnostic coding and payment, or health care delivery systems. Maybe it’s time it challenged MedPAC, too.

The Ultimate Patient-Centric Solution

Personalized Medicine is the ultimate in patient-centric solutions.

Emerging personalized services can help guide treatment not only on efficacy, but also on likely side effect profiles, helping physicians select therapies to maximize the patient experience and shape that experience to patient preferences and tolerance levels.  My personal story exemplifies these possibilities.

I have experienced the promise of personalized medicine first hand. As a liver transplant recipient, I have to be constantly monitored to ensure that my body is not rejecting the transplanted organ nor leaving me open to life-threatening infections. Traditionally, this is done with painful and invasive liver biopsies as well as blood testing.

Recently, a new blood analysis-test was developed that can assess my immune system’s individualized response to the immunosuppressive medications I must take.  This test gives unique information about my immune system and the degree to which I am at risk for rejecting my organ or to vulnerable to infections. Using this information, my physician can determine the appropriate combination and dosing for my immunosuppressive medications.

 Although this test is FDA-cleared, current policy does not provide a level of reimbursement that accurately reflects the value of this new technology. Without proper funding and support, there is a strong risk that the test, and others like it, will be removed from the market.

If this happens, we will be taking a huge—and costly—step backward in patient care. Removing this test from the market would mean a return to invasive and expensive liver biopsies and a trial-and-error approach to managing my immunosuppressive medications. This would not only put me at significantly increased risk of hospitalization and organ rejection or retransplantation, but would also incur a much greater expense to the health care system. All these things are easily avoidable through the use of a personalized medicine test, but require its value-based reimbursement.

The patient experience is often marred by pain, fear, and confusion, particularly in the face of a life-threatening condition.  Personalized medicine can provide answers. As my experience shows, meaningful information to guide treatment and prevent adverse events can, indeed, be the best medicine.

Personalized Medicine – Part of the Health Cost Solution

At the Research!America’s National Health Research Forum last week, personalized medicine was identified by several leaders as a solution to our health care cost challenges.  In reply to a question from the audience about how we can afford new cancer treatments,  NIH Director Francis Collins said “encouraging possibilities” exist with our “more precise understanding of the molecular basis of disease.” His comments underscore how medical innovation will be part of the solution not just for patients with unmet medical needs, but for our growing cost challenge as well. 

With the emergence of personalized medicine, we are in a better position to target treatments in cancer. Stratifying patients should make for smaller, more successful clinical trials. In addition, biomarkers are helping give more precise information earlier in the process. Collins said that if all goes well, the outcome “should be that we can actually get approvable compounds through the pipeline at a higher frequency of success and a lower cost than has often been the case in the past.” He stressed that partnerships with industry will be crucial.

PhRMA President and CEO, John Castellani added that drug development is getting dramatically more expensive, costing more than $1 billion and lasting more than 11-12 years per drug. “We have to get better. We have to get smarter. We have to get more targeted,” he said, “That’s where the science is going.” Biopharmaceutical companies are working on personalized medicine, he pointed out, and if we have a system that recognizes and delivers the “right care at the right time,” it will be “much more affordable than the trajectory that we’re on now.”

To listen to the full commentary from Collins, Castellani, and the other panelists on personalized medicine at the National Health Research Forum, visit http://www.researchamerica.org/forums, beginning at minute 137:00.