April 2013, Vol 2, No 2

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Promoting the Adoption of Personalized Medicine Concepts:

An Interview with Edward Abrahams, PhD, of the Personalized Medicine Coalition

Edward Abrahams, PhD

Interview with the Innovators

The Personalized Medicine Coalition (PMC) is an organization representing innovators, scientists, patients, providers, and payers. PMC promotes the understanding and adoption of personalized medicine concepts, services, and products for the benefit of patients and the health system. It has grown from its original 18 founding members in 2004 to over 225 members today.

The mission of the PMC is to educate federal and state policymakers and private sector healthcare leaders about personalized medicine – helping them to understand the science, the complex issues associated with implementation, and the requirements for the positive evolution of personalized medicine. The PMC has demonstrated its unique role in the field by encompassing all sectors of the biomedical enterprise within its membership and effectively framing the debate around the key obstacles to adoption of personalized medicine.
The PMC has 4 goals: 1) to provide opinion leadership on public policy issues that affect personalized medicine; 2) to help educate the public, policymakers, government officials, and private sector healthcare leaders about the public and personal health benefits of personalized medicine; 3) to serve as a forum for identifying and informing others of those public policies that may impede the ability to deliver the promise of personalized medicine; and 4) to create a structure for achieving consensus positions on crucial public policy issues and supporting changes needed to further the public interest in personalized medicine.

Personalized Medicine in Oncology (PMO) recently had the great pleasure of meeting with the president of the PMC, Edward Abrahams, PhD, to discuss his views of personalized medicine and the vital role the PMC plays in the adoption of personalized medicine principles in our healthcare systems.

Dr Abrahams is President of the Personalized Medicine Coalition. Previously he has served as Executive Director of the Pennsylvania Biotechnology Association, Assistant Vice President for Federal Relations at the University of Pennsylvania, and in a senior administrative position at Brown University. Dr Abrahams also worked for 7 years for the US Congress as a legislative assistant to Senator Lloyd Bentsen, as an economist for the Joint Economic Committee under the chairmanship of Representative Lee Hamilton, and as an AAAS Congressional Fellow for the House Committee on the Interior.

PMO Thank you so much for taking the time to speak with us, Dr Abrahams. To start, how does personalized medicine (PM) empower both the cancer patient and the physician regarding its broadening of clinical options that it offers them? Does this broadening of options require oncologists to invest more time in dialogue with patients and caregivers? And finally, does the financial system currently reimburse oncologists for these added cognitive services?

Dr Abrahams Personalized medicine, as the Personalized Medicine Coalition envisions it, incorporates new discoveries in biology and the development of new diagnostic tools to enable physicians to target treatments more precisely, thereby improving their efficacy and sparing unnecessary and adverse side effects to those who will not benefit. The evolution of medicine away from one-size-fits-all to one that is personalized is likely to require physicians to engage in a more complex dialogue with patients and caregivers. It has been said that a good doctor treats the disease, while a great doctor treats the patient. However, the current system of reimbursement for oncologists might not yet recognize this increased burden on physicians’ time.

PMO What tactics have proven most successful in bringing the advances of PM out of the research laboratory and into practice for the oncologist?

Dr Abrahams While science points us toward a better appreciation of the understanding of the heterogeneity of cancer as well as patients, we know that how products are regulated and, more importantly, how they are reimbursed make an enormous difference regarding their adoption by oncologists.

PMO Your Web site mentions that the Personalized Medicine Coalition is dedicated to overcoming the obstacles to PM. What would you regard as the leading obstacle to the proliferation of oncology PM?

Dr Abrahams There are a number of obstacles that slow down the emergence of personalized medicine. Chief among them are an evolving regulatory system that does not yet ideally review combined therapeutic and diagnostic products; a reimbursement system that does not clearly define what levels of evidence are necessary to make payment decisions, and reimbursement sometimes does not cover the cost of performing the test, much less the R&D for it; and a time lag by medical societies to adopt new approaches into their guidelines.

PMO Can you name an outstanding example of overcoming an obstacle to PM?

Dr Abrahams There has been enormous progress in overcoming obstacles to personalized medicine, including the recent and rapid approvals of new targeted therapeutics for non–small cell lung cancer, for melanoma, and for cystic fibrosis. Clearly science points us in the direction of linking diagnosis and therapy. We expect more progress in the future as key decision makers in academia, industry, and government continue to invest in personalized medicine.

PMO How supportive are the business, government, and clinical sectors regarding PM? Is the climate between these sectors essentially cooperative, adversarial, or indifferent to one another?

Dr Abrahams Given that all 3 sectors have been mired in a one-size-fits-all/trial-and-error world for decades, it is understandable that they are not able to turn on a dime. We have a lot of work to do to convince each that investing in personalized medicine will pay dividends for patients and the health system. But we need more evidence to convince them.

PMO Is the Affordable Care Act (ACA) financially compatible with the growth of PM overall and specifically in oncology, or will its additional costs reduce the spread of PM overall and in oncology in particular?

Dr Abrahams By creating accountable care organizations, which will be under considerable pressure to produce better outcomes while lowering overall costs, the ACA could put a premium on prescribing the right drugs for the right patients and avoiding the inefficiencies that result from one-size-fits-all/trial-and-
error medicine. It will be very hard to maintain progress while lowering costs if we do not look to personalized medicine to provide answers that patients are going to want. So on balance, we are optimistic about healthcare reform.

PMO Value is more than cost – it is the balance of cost, quality, and access. What percent of oncology healthcare expenditures go to PM treatment and diagnostics, and how long will it take for PM to begin “paying dividends” economically (it already pays dividends clinically) and become attractive to payers by showing “value”? And finally, how would you articulate the value proposition justifying the cost of PM – in cancer, and overall – to the clinical, business, and government sectors…and to patients?

Dr Abrahams These are the key questions. Beginning with the last first: We believe that even if the cost of individual products increases, by increasing efficacy and decreasing inefficiency we can increase value both to the individual patient and to the system. While it is hard to determine what percentage of oncology healthcare expenditures are personalized, we do know that 75% of current treatments in oncology don’t work as intended for a given patient. That’s a lot of room for improvement. We believe that payers understand this, and we hope that they will work with us to get the right drugs to the right patients as we move away from a one-size-fits-all world.

PMO Is the pricing methodology of manufacturers for PM therapies and diagnostics becoming more sophisticated/skillful and less arbitrary, so as to balance necessary profit with product affordability?

Dr Abrahams Price and value should be correlated, something industry and payers both understand. If society wants innovation, it has to be willing to pay for it and be patient enough to facilitate its sometimes incremental development.

PMO If a biologic is developed that treats a cancer with a large patient population so well that it keeps the patient alive for the rest of their normal life expectancy, how do we avoid bankrupting the healthcare system?

Dr Abrahams The question overlooks the value of a patient returning to work, and becoming a productive person again who pays for the treatment he or she receives. That should be the goal of the healthcare system.

PMO How can manufacturers and payers work together to avoid this cost/quality clash of PM?

Dr Abrahams Again, we believe that manufacturers and payers are on the same page regarding a common wish to develop and pay for products that prevent illness, cure disease when it occurs, and keep citizens productive.

PMO Dr Vicki Seyfert-Margolis of the FDA stated that the current reward system causes each failure in research of biologics to be repeated many times. This results in the largest attrition for pioneer products being at clinical trial, from phase 2 on – greatly increasing developmental costs of biologicals. What is the remedy for this problem of nontransparency?

Dr Abrahams As Dr Seyfert-Margolis notes, there are many things the FDA could do to increase the efficacy of clinical trials and reduce their costs, including allowing smaller sample sizes, not requiring trials of biomarker-negative populations for lifesaving products until after approval, and permitting, if not encouraging, adaptive trials based on early results.

PMO How prominent a role do you expect PM to play in treating conditions in indications outside oncology? Are there any impediments to PM’s application in them?

Dr Abrahams In the future, we expect that we will not refer to personalized medicine at all because all medicine will be personalized. Obviously, we have a lot of work to do before that happens. Because of the obvious heterogeneity of cancer, more progress has been made in oncology to personalize treatment, but this does not mean that CNS disorders, for example, will not lend themselves to same sort of sophisticated diagnoses in the future. Progress depends on it.

Value-Based Cancer Care - April 22, 2013

Introducing the Third Annual Conference of the Association for Value-Based Cancer Care

As we know, the American healthcare system is going through exorbitant changes, changes that will affect all providers and all stakeholders in the cancer care ecosystem. The goal of the Association for Value-Based Cancer Care (AVBCC) is to bring together all the cancer care stakeholders in one unified meeting to [ Read More ]

Uncategorized - April 22, 2013

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About 3% to 5% of the general population is believed to have a mutation in the gene that encodes a major 5-fluorouracil (5-FU) metabolizing enzyme. This mutation can extend the half-life of 5-FU, leading to increased plasma concentrations and potential toxicities, said Colleen Rock, PharmD, PhD, at the Hematology/Oncology Pharmacy [ Read More ]