TY - JOUR
AU - Thompson, Cheryl, A.
AB - In concept, personalized medicine—which leverages genotype to guide decisions about therapeutics—is possible for all patients. But in practice, patients with cancer seem to be the focus. That’s because abnormalities in DNA sequences “are obviously what are driving” cancerous cells’ growth, said Walter Koch, head of global research for Roche Molecular Systems Inc., the diagnostics branch of Roche Group. In contrast, he said, a similar relationship does not exist between genotype and, say, inflammatory diseases’ severity. Koch said personalized medicine involves knowing the molecular pathophysiology of the patient’s disease and differentially diagnosing the disease on the basis of those underlying molecular defects. “The world of the future, of course, is that we hope we can differentially diagnose non-small cell lung cancer, for example, into what may turn out to be several dozen different subtypes,” he said, “and hopefully we have companion drugs that can target the defects for each one of those.” Koch made those remarks January 24 during a panel discussion at the Personalized Medicine World Congress in Mountain View, California. Slow uptake David R. Parkinson, who oversaw oncology development at Biogen Idec, Amgen Inc., and Novartis Pharmaceuticals Corporation and now runs a clinical diagnostics company, bemoaned the level of physicians’ knowledge about molecular diagnostic tests. “Most physicians are not really knowledgeable about advances in technology,” he told conference attendees. Parkinson, president of Nodality Inc., acknowledged the abundance of policy statements from professional associations urging members to learn about the tests. Those statements, however, do not educate, he said. “The RxDx model, in which pharma[ceutical company] partners come in to talk about their drug but also talk about the fancy new biological test is, I think, a very effective model” for educating physicians, Parkinson said. “But, frankly, that’s the carrot part,” he continued. “There’s the stick part, which is what you’re starting to see all over the place in Europe and what you have in the United States . . . physician guidelines.” Parkinson said payers use the guidelines in deciding whether to pay for the use of a drug. And if a guideline links a drug’s use with a diagnostic, he said, “it’s amazing how much education will occur. It’s just a wonderful thing.” Ted Snelgrove, who was responsible for Genomic Health Inc.’s commercialization of the Oncotype DX Breast Cancer Assay, said psychology plays a part in physicians’ use of any molecular diagnostic test. If a company markets a test whose results suggest a need to change the treatment decision 40–50% of the time, Snelgrove said, “you’re going to run into a credibility problem, because doctors don’t believe they’re that bad” at making good decisions. Yet, if the test results suggest a need to change the treatment decision only 15% of the time, he said, physicians may not think the test has sufficient value to their population of patients. Snelgrove said, with regard to molecular diagnostic tests, the “threshold of actionability” seems to be “the mid-30s.” In other words, physicians are interested in using a test if its results suggest a need to change a treatment decision roughly 35% of the time. Incremental benefit An attendee at the conference expressed concern to the panel about the actual benefit of advances in molecular diagnostics to patients with cancer. The specific concern is the seemingly incremental benefit—perhaps a couple more months of life—that the newest oncology drugs offer over the standard of care. Panelist Scott Patterson said, in his personal view, any discussion about the seemingly paltry benefit to date of personalized medicine over standard care needs to consider dates of drug approvals and advances in the standard of care. A new drug, “likely a targeted drug,” against a disease that has had a dearth of new treatment options in many years “has a very good chance of offering a large degree of benefit,” said Patterson, executive director of medical sciences at Amgen. “The next drugs that come along,” he said, “will probably not show that same large benefit beyond the new drug.” Nodality’s Parkinson pointed out that an incremental benefit may be enough for a drug to overcome a regulatory hurdle but not a payment hurdle. The payment model known as pay for performance, he said, “raises a really interesting challenge to the model of a pharmaceutical company, which is producing an agent that is sold as a product.” “All of a sudden, if you’re paid only if the person benefits, you’re now talking about creating a pharmaceutical company who has a product that is a service—and you only get paid if the service is excellent,” Parkinson said. Pay for performance, he declared, presents a huge opportunity for the molecular diagnostics part of personalized medicine to make the pharmacotherapy part more efficient. Copyright © 2012 by the American Society of Health-System Pharmacists, Inc. All rights reserved.
TI - Industry panel discusses status of personalized medicine
JF - American Journal of Health-System Pharmacy
DO - 10.2146/news120017
DA - 2012-03-01
UR - https://www.deepdyve.com/lp/oxford-university-press/industry-panel-discusses-status-of-personalized-medicine-1htdtlfoa4
SP - 366
VL - 69
IS - 5
DP - DeepDyve
ER -