Oncology and the President's Precision Medicine Initiative

While President Barack Obama outlined a series of budget plans for oncology care in the fall of 2015, which was designed to allocate an estimated $130 million to sequence 1 million volunteers, $70 million to identify “genome drivers” and $10 million to the FDA to build databases, Michael A. Kolodziej, MD, FACP, national medical director of Oncology Solutions at Aetna, believes there to be different areas of oncology care that need more attention and resources. Kolodziej presented at The American Journal of Managed Care’s 4th Annual Patient-Centered Oncology Meeting.

Kolodziej explained that there are 4 areas that need more attention: analytic validity, clinical validity, clinical utility, and value. Analytic validity aims to understand what tests are being done and who should watch how it’s being done. Even though physicians may understand the methodology of the tests, there’s uncertainty as to if the tests are being done correctly. He added that the coding system still remains far behind technology, which he said was very problematic.

Clinical validity refers to how the mutation is being expressed, whether it alters the gene function and how context matters. With this understanding comes clinical utility, referring to the certain characteristics of the mutation and how those specific markers can change from person to person. Kolodziej explained that giving a blanket treatment to everyone with a certain mutation is ineffective, because the physician doesn’t know if that mutation is active in each individual or whether there are subsets of the mutation at play. Not every individual responds the same way to the same treatment options.

“This cataloging, this lumping in the absence of splitting, is not doing our patients any good,” Kolodziej said. “We can do better. Part of our problem is, we’ve dumbed this down too much. We think that if you’ve got a mutation, that represents a lock and we got that key, and we’re going to open it. But, that, actually, turns out not to be the case.”

And, lastly, value considers the goals and costs of therapy and research and defines how exceptional responders should be valued. The problem, he said, may not always be the test but the drug and its associated costs. Often, costs alone can prohibit further study.

“If everyone is doing the test different, collecting different information, treating things different, we’re going to get nowhere because you won’t be able to pull those analyses,” Kolodziej said. “We need to agree to agree.”