An expert panel focused on the need for more data, standardization, and accurate marketing during a session discussing the implications of molecular testing on practice and policy at the National Comprehensive Cancer Network® (NCCN®) 16th Annual Conference.
An expert panel at the NCCN 16th Annual Conference discussed these challenges and called for higher standards in regulating how and where the tests are done, better data to determine their value and cost effectiveness, and new approaches to determining their optimal uses for today’s patient populations.
Dr. Goodman challenged the panel to consider the issue of molecular testing from four perspectives; regulatory responsibility, evidence that a test “works,” translation into everyday practice, and value.
Dr. Gottlieb pointed out that molecular tests are currently regulated by how they are marketed, not by claims for what the test can do, and that there is enormous heterogeneity in how and where the tests are performed. He supports having the
Dr. Jacques, described the field of molecular testing as immature, and predicted that it would take a number of years and additional experience before it became possible to assess either the true analytic or clinical validity of the growing number of molecular tests.
Dr. Newcomer discussed the challenge of working within a juvenile system particularly when trying to assess the quality of the test being done or its clinical utility. He explained that even with one of the best established tests, the HER2 gene test for breast cancer, there is a high percentage of inaccurate or misused tests in some settings. He added that the system used to code procedures for insurance payments is also outdated and does not specify what molecular test is being performed.
“The coding is so antiquated that we don’t know what we are paying for. It just says ‘genetic test,’ which doesn’t allow us to assess either the upfront costs or the downstream benefits that might result from this kind of testing,” said Dr. Newcomer.
Dr. Kris, who specializes in treating lung cancer, noted that the EGFR test that is used to predict the efficacy of a specific type of chemotherapy in patients with advanced adenocarcinoma of the lung has been proven to be both valid and useful. Properly done, the test can identify patients who have the genetic mutation and the potential to benefit from chemotherapy while sparing those who don’t from ineffective therapy.
“It is our job as clinical researchers to provide the data that regulators and payors need to make decisions,” said Dr. Kris.
“We are aspiring to an era of personalized medicine, but we aren’t there yet,” said Dr. Kolodziej.
From the patient perspective,
Despite viewing the issues related to how best to use and pay for this emerging field of medicine, the panel agreed that there was a need for better regulation, more data, and improved methods of making the tests accessible to patients across the spectrum of clinical settings.
About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 21 of the world’s leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.
The NCCN Member Institutions are:
Source: National Comprehensive Cancer Network (NCCN)