BALTIMORE – While prognostic tests tied to specific chemotherapy agents may offer a clear benefit in guiding treatment and improving outcomes for certain malignancies, applying the tests more broadly may not offer information that is clinically relevant.
Members of the Medicare Evidence Development & Coverage Advisory Committee were asked to examine prognostic tests for three types of cancers – adenocarcinoma of the colon and rectum, breast cancer (both invasive duct and lobular cancers), and non–small cell lung cancers – in a preliminary effort to determine how Medicare should pay for the use of such tests. They found little evidence on how these tests could lead to better outcomes, despite evidence showing the tests did confirm the analytic and clinical validity of the biomarkers.
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Turning to the usefulness of such tests in aiding clinical decision making by physicians and patients, data on “the downstream effects of these tests ... got very thin very quickly,” according to advisory committee member Dr. Beverly A. Guadagnolo of the department of radiation oncology at M.D. Anderson Cancer Center, Houston.
At its March 24 meeting, the committee found that only three tests – microsatellite instability tests in adenocarcinoma of the colon and rectum, and MammaPrint and Oncotype DX Breast – showed evidence of some level of utility in managing patients and improving outcomes; however, none reached an average of 3 (intermediate confidence) on the committee’s 5-point scale of evaluating the strength of the evidence. Oncotype DX Breast was the highest, with a 2.875 average vote across the eight voting members.
Dr. Mitchell Kamrava of the department of radiation oncology at the University of California, Los Angeles, also noted that physicians are doing their best to understand what the different biomarkers actually mean when it comes to treating patients, “but the data are just not quite there yet.”
For Medicare officials, the emphasis going forward will be how useful these tests will be for improving care.
“We approached various lab vendors and they are able to show us plenty of information in terms of analytic validity as well as clinical validity,” Dr. James Rollins, director of the Division of Items and Devices in CMS’ Coverage & Analysis Group, said. “Some of them feel that demonstrating clinical utility is something that they don’t need to provide commercial insurers. I don’t know why they feel that way. But as I said, as time goes on, we will be using more and more clinical utility.”
CMS currently does not have any open national coverage analysis decisions that relate to prognostic cancer tests.
Dr. Rollins said the agency is defining clinical utility as information that leads to improved health outcomes either due to increased benefit or reduction in harm.