In 2016, the National Institute of Health (NIH) will be introducing the Precision Medicine Initiative, a program designed to better understand the role that individual differences play in health, with a goal of developing better prevention and treatment strategies tailored to the individual.1 The government’s $215 million investment in precision medicine includes $70 million to the National Cancer Institute (NCI) to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment.2 Clearly, the path toward precision medicine and molecular diagnostics is set, and manufacturers, physicians, and payers alike will need to develop their understanding of the challenges and promises they bring.
For insight into how molecular diagnostics is reshaping oncology treatment, Encuity Research surveyed oncologists immediately after last month’s meeting of the American Society of Clinical Oncology (ASCO). Encuity received responses from more than 100 clinicians engaged in direct patient care, and the results suggest that oncologists fully anticipate the increasing adoption of molecular diagnostics over the next decade.
Three-quarters of the oncologists surveyed report a high level of familiarity with molecular diagnostics in the cancer marketplace. Thirty-one percent of physicians report that they were exposed to themes concerning molecular diagnostics at ASCO, with the biggest focus on personalized treatment and future use.
The rise of molecular diagnostics goes against the trend toward treatment pathways over the last decade. For physicians, treatment pathways were appreciated because they offered a certain level of predictability in terms of outcomes. Payers liked them because they helped with budgeting for the next year. Now, however, the use of molecular diagnostics will shift the trend away from grouping patients into certain treatment pathways toward the less structured terrain of personalized medicine.
Molecular diagnostics requires physicians to look at the patient individually to understand the nuances of the disease—nuances traditional diagnosis methods would not have captured. This may necessitate a change to the treatment paradigm in which treatment pathways tree out into multiple different branches. This is an overarching problem in the market today, and the question faced by physicians is, “Do I trust the new molecular diagnostic test or do I trust the existing standard protocol?”
More than half of oncologists Encuity surveyed report that they would be likely to use molecular diagnostics for patients who lack other therapy options. But in cases where patients had options, only 24% of oncologists said they’d use the new diagnostic tools. In the same way, physicians are more likely to try the new immunotherapies on patients who have failed to respond to traditional first-line therapies. Doctors report that robust clinical trials with defined outcomes would have the biggest impact on their future use of molecular diagnostics.
Numerous types of tests fall under the label of molecular diagnostics. Among the most interesting are comprehensive genomic testing, circulating tumor cell tests, and cell-free DNA technology.
Comprehensive genomic testing uses a single test to provide physicians with a broad view of the targeted treatment options available by detecting all types of alterations, in all the regions where they can occur, for all the genes that are known to be associated with cancer.3
Cell-free DNA technology and circulating tumor cell technology are genomic tests that do not require a biopsy as in standard genomic testing. Rather than surgically removing tissue from the patient using a needle puncture, cell-free DNA technology and circulating tumor cell technology are diagnostics cased on a blood draw. Because blood sampling can be performed more often, such tests can be used as a diagnostic tool and for monitoring patient progress.
The vast majority of physicians surveyed are aware of both comprehensive genomic testing (92%) and circulating tumor cell tests (89%), while only 57% of respondents indicated they are aware of cell-free DNA technology. Asked to indicate their level of excitement with regard to the potential impact of these tests on cancer diagnosis and treatment on a scale of 1 (Not At All Excited) to 7 (Extremely Excited), comprehensive genomic tests and cell-free DNA technology received a rating of 5.5, while circulating tumor cell tests received a ranking of 4.7.
When asked to look out over the next 10 years, oncologists say they expect to see their use of comprehensive genomic testing increase to nearly half their patients, while they anticipate that emerging molecular diagnostic tests will account for one-quarter of their treatment decisions.
Encuity Research is the marketing research group within Campbell Alliance/inVentiv Health Consulting. For a full version of Encuity’s ASCO Impact Report, please visit http://www.encuity.com/asco.
By Dave Johnson, Vice President, Encuity Research
1 The National Institute of Health. Precision Medicine Initiative. Available at http://www.nih.gov/precisionmedicine/. Accessed 6/25/2015.
2 The White House. FACT SHEET: President Obama’s Precision Medicine Initiative. Available at https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative. Accessed 6/25/2015.
3 Foundation Medicine. Comprehensive Genomic Profiling May Offer More Treatment Options to Patients with Lung Cancer. Available at http://www.foundationmedicine.com/2015/01/comprehensive-genomic-profiling-may-offer-more-treatment-options-to-patients-with-lung-cancer/. Accessed 6/25/2015.