Physician Quandary: Data Shortage, Surfeit Impinge on Precision Medicine

Marcus Neubauer, MD

Precision medicine has become fashionable. President Obama explained its significance in his State of the Union Address in January, and followed up by including a $215 million initiative to collect genetic information from 1 million Americans as part of the budget he sent to Congress. But even before his speech, precision medicine was receiving a great deal of attention, particularly in oncology.

This exciting new approach to medical diagnosis and decision making is a hot topic for good reason. Very few healthcare initiatives in our lifetime have evolved as quickly and shown as much promise, especially relating to the way we treat patients with cancer. But like all new ideas or technologies, rapidly occurring changes present both opportunities and challenges for everyone involved, including government, patients, payers and physicians.

Meeting Challenges Head On

It’s hard to argue with the benefits of precision medicine. Oncologists dream about treating cancer with more exact therapies that improve outcomes and reduce side effects. However, we must acknowledge and find ways to overcome some of the challenges that will arise along with such rapid and sweeping change.

The first challenge oncologists struggle with is ordering the appropriate tests for their patients. A proliferation of diagnostic companies offer molecular tests, but only limited guidance on which tests are clinically appropriate and, also important, which tests insurance companies will cover. Although genetic tests are becoming more affordable, some are still quite expensive. Payers wrestle with decisions on what types of tests to pay for and under what circumstances, often leaving the patient stuck in the middle. More evidence on the clinical utility of molecular panels is required to solve this problem.

Another challenge oncologists face is how to use the results of increasingly large molecular panels. The results of a panel may suggest a clinical trial the physician doesn’t have access to, a drug that is off label, or simply an ambiguous result. As new, more-specific information about each variation within a cancer type is unveiled, oncologists will face a substantial increase in the amount of information they must review to stay up-to-date and provide the highest quality of care. This is especially true for many community oncologists who practice as generalists, treating patients with all types of cancer.

Results that lead to expensive off-pathway therapies are particularly difficult for physicians, patients, and payers. An oncologist and his or her staff may have to spend hours on the phone trying to get a treatment authorized, and payers must struggle with the decision of whether to authorize a treatment with limited evidence of efficacy. Once prescribed, the outcomes of these treatments are not systematically recorded, resulting in the loss of potentially valuable data.

Out of Challenges Come Opportunities

The vast amount of information and knowledge required for precision medicine underscores the value of participating in a network that offers access to shared best practices and continually updated evidence-based pathways. These pathways will become increasingly nuanced as we expand our understanding of how different mutations impact treatment decisions. Oncology-specific healthcare information technology with real-time updates on the latest pathways, drugs, and clinical trials will be required for oncologists to practice effectively in the future.

The rapidly growing world of precision medicine also creates an unprecedented need for clinical research. Driver mutations must be identified and then studied to determine if related targeted therapy really makes a difference. Already, more efficient trials are being designed to test multiple drugs against multiple targets. We need to continue to push to have these trials in the community-based setting, where oncologists deliver a majority of the cancer care. In addition, we know that a great amount of valuable retrospective data is generated every time an oncologist prescribes a treatment for a patient and documents it in an electronic health record. When everyone in the oncology community has started linking patients, cancer mutations, and treatments, and begins tracking outcomes, we will truly be driving cancer care forward.

Looking Ahead

Cancer is smart and hard to treat. Precision medicine may give us the advantage we need to more directly target a specific disease, reduce toxicity, and avoid older treatments that have unpredictable results.

Whether or not the proposed initiative is approved in this year’s budget, I expect genetic testing to continue to become more prevalent and to have an unprecedented impact on our healthcare system. In the coming years, we’re going to gain even more clarity regarding which gene mutations matter and see tremendous progress in the development of new treatment options. And as we do, precision medicine will help us improve cancer survivorship and ultimately reduce the costs of care.

Marcus Neubauer is medical director of oncology services at McKesson Specialty Health and The US Oncology Network.